An Inventory Of Federally Sponsored HIV And HIV-Relevant Databases

Publication Date

Jun 30, 2000

Center for Health Services Research and Policy
School of Public Health and Health Services
George Washington University Medical Center

Introduction

Many federal agencies within the Department of Health and Human Services (DHHS), the Social Security Administration (SSA), and the Department of Veterans Affairs (VA), maintain major HIV-related databases. The databases maintained or sponsored by these agencies contain a range of potentially useful information, including epidemiologic and patient-level clinical data as well as health resource utilization, disability benefits, and insurance claims information. Despite the potential utility of these databases to address multi-agency policy issues, there is no single inventory that fully describes their study design, data collection methodology, and common and unique data elements. As a result, both policy makers and researchers may not be fully aware of the breadth of data available to support their policy making, administrative, program evaluation, and research needs.

This report is designed to help address this information gap. It is part of a project sponsored by the DHHS Office of the Assistant Secretary for Planning and Evaluation (ASPE) entitled “An Inventory of Federal HIV-Related Databases,” undertaken by the George Washington University Center for Health Services Research and Policy (CHSRP) under contract with ASPE. It is our hope that this resource can be used to catalyze collaborations among government agencies, philanthropies, industry, and academia to increase the understanding of HIV disease and its impact on the health care delivery system.

The inventory summarizes the types of HIV-related research supported by DHHS, SSA, and the VA. The report describes the major issues addressed by the various studies reviewed in the inventory, their study designs, and their research applications. The inventory is not exhaustive or comprehensive, it includes primarily major studies and databases. The report also identifies selected policy, clinical, evaluation, or other questions that might be the focus of new studies or database development. Finally, the inventory describes each major study and database in detail to provide additional information.

Methods

With the guidance of the ASPE Project Officer, CHSRP staff developed a provisional list of databases for inclusion in the inventory. CHSRP staff then consulted with staff in the DHHS, SSA, VA to identify the key databases that either focus specifically on HIV positive populations or that address issues related to HIV. Federal staff or contractors responsible for development and maintenance of those databases were initially consulted during either face-to-face meetings or telephone or electronic discussions. During the initial discussions, we identified any additional databases that should be considered for inclusion in the inventory, as well as addressed the characteristics of the databases previously identified.

After developing a provisional list of databases, we developed a set of inventory items that were used to review and describe the databases. These items include:

Purpose of the database;
Study design used to collect the data;
Nature of the data collected;
Unit(s) of analysis;
Data collection methods;
General attributes (e.g., time frame covered by the database, size of the database and its various components, medium used to store the database);
Major data constructs and key data elements within those constructs;
Strengths and weaknesses of the study design and database, including methods used to validate data collection;
Gaps in the data collected and factors leading to the gaps; and
Feasibility of linking databases or using multiple databases to address questions, as well as specific restrictions on allowable uses of individual databases.

CHSRP staff consulted with key federal staff and their contractors during face-to-face or telephone meetings in which each of these elements were examined. Federal staff and their contractors also provided written materials related to the databases that further described these elements. To supplement these consultations, CHSRP staff retrieved written materials from Internet web sites related to the databases. The materials obtained by the CHSRP included: source materials stating the purpose of the databases and planned applications, data collection instruments, database documentation (e.g., file layouts, data dictionaries, etc.), evaluations of the data collection methods used to create the databases, and reports and other published or unpublished materials demonstrating the uses of these databases.

CHSRP staff conducted bibliographic searches for each database to identify journal articles, meeting abstracts, or other published materials that document how the databases have been or are being used to address policy, clinical, administrative, or other topics. The citations included for most of the databases are illustrative rather than an exhaustive list of published articles and reports, due to the large volume of materials published about the databases in this inventory.

CHSRP staff convened an expert panel of HIV researchers and representatives of federal agencies, philanthropies, and industry in July 1999 to discuss potential areas of multi-agency collaboration and new research strategies. Results of the expert panel meeting were used to identify additional databases for inclusion in the inventory, gaps in knowledge that might be addressed through new studies or linkage of exiting databases, and new research topics.

Using the materials gathered in the consultations and bibliographic search, CHSRP staff prepared a summary of each database. The summaries included in this report should be considered synopses of each database rather than a comprehensive review of the database and its attributes. Many of the databases included in the inventory have complex study designs and extensive data sets that cannot be fully captured in this report. The reports and websites that are cited offer more detailed information.

Following completion of the consultations and the materials review, CHSRP staff excluded some databases from the inventory. Some of these databases were surveys that had been conducted on a specific policy topic or undertaken in the mid-1990s, and for which ongoing data collection was not planned. Several other databases were analysis files derived from the databases already included in this inventory. Federal staff then reviewed the inventory for completeness, accuracy, and timeliness.

Use Of Federally Supported HIV-Related Research

An array of HIV-related research has been supported by the federal government since the 1980s to address key HIV policy, epidemiologic, and clinical issues.¹ This research has focused on essential areas including:

Epidemiology;
Behaviors associated with transmission and prevention of HIV;
Therapeutics and treatment strategies;
Clinical practice, including effectiveness of therapeutics and quality of care;
Organization, delivery, and financing of clinical and support services; and
Service program administration and evaluation.

As illustrated in this inventory, the federal government has supported several HIV-related research strategies in these essential areas:

On-going population and institution-based surveys, such as the National Health Care Survey (NHCS) and its various subsidiary surveys funded by the National Center for Health Statistics (NCHS), have been expanded to address HIV-related questions. Their study designs have been maintained intact, with additional HIV-related questions added. Because these surveys have a broader focus than HIV, the nature and scope of HIV-related issues that they address is narrowly defined. Additionally, the sample sizes of the surveys have not been expanded, and thus the resuls of these surveys have limited generalizability to HIV positive populations or institutions serving people with HIV.
Existing administrative databases, such as those maintained by DHHS and VA to support administrative and policy information needs, have been expanded. Some of these databases have been slightly modified to include HIV-related data that are required to administer and monitor services provided to the populations for which they are responsible. Others have been modified to provide data needed to conduct research in a variety of clinical, financing, organizational, policy, and other research areas.
Existing health care financing and income maintenance program databases, such as those maintained by the DHHS Health Care Financing Administration (HCFA(now known as CMS)) to administer the Medicaid and Medicare programs, have been adapted to conduct HIV program evaluations and health services, financing, clinical, and epidemiologic research. The disability claims system maintained by SSA has also been used by federally funded researchers to conduct HIV financing studies and program evaluations.
Newly established administrative, epidemiologic, financing and clinical databases have been supported to monitor statutory and administrative requirements, administer service programs, and evaluate programmatic performance. The Health Resources and Services Administration (HRSA), for example, has established several databases used to monitor the activities of grantees of the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act. These databases include cross-sectional data obtained from administrative, epidemiological, financial, and clinical information systems maintained by governmental and direct service agencies. The Centers for Disease Control and Prevention (CDC) has established several databases to monitor trends in the HIV epidemic, address epidemiological research questions, and act as the basis for allocation of federal HIV services and prevention funds. These databases include HIV Counseling and Testing Reports and the HIV/AIDS Reporting System (HARS).
Newly established HIV-related research databases have been supported by the Agency for Healthcare Research and Quality (AHRQ), ASPE, CDC, HRSA, National Institutes of Health (NIH), and other federal agencies. The study designs of these databases vary substantially. Some studies, such as the Healthcare Cost and Services Utilization Study (HCSUS), have used sampling to achieve a nationally representative cohort of HIV positive adults that are followed for a time-limited period to address care utilization and cost questions. Other studies, such as the AIDS Cost and Services Utilization Survey (ACSUS), were designed as time-limited longitudinal studies, but used convenience samples that had limited generalizability. In other population-based studies, such as the HIV Epidemiologic Research Study (HERS) and the Multicenter AIDS Cohort Study (MACS), long-standing natural cohorts of volunteers have been studied to address an array of epidemiologic, clinic, health care financing, and health services research questions. The study designs are sufficiently flexible to allow emerging issues to be addressed with the existing cohorts.
Ad hoc population or institution-based studies, such as the CDC-funded HIV Outpatient Study (HOPS) and outcomes studies supported by HRSA were conducted to address emerging policy topics.

Federally supported HIV-related databases reflect a variety of research designs. Table 1 summarizes the temporal nature (i.e., cross-sectional versus longitudinal) of the study designs used to create the databases included in the inventory. The table also outlines the types of data that are collected in the database (e.g., population-based surveys, administrative data sets, medical record reviews, clinical specimen collection and physical examinations, and interviews conducted in conjunction with physical examinations). As indicated in Table 1, many of the population-based surveys conducted by NCHS and the CDC are cross-sectional. The HIV/AIDS Bureau of HRSA also maintains primarily cross-sectional databases. Databases maintained by the SSA, HCFA(now known as CMS), and the VA are longitudinal. The SSA and HCFA(now known as CMS) databases are primarily administrative. In contrast, the VA maintains databases that include administrative records, medical records, specimen data, and physical examination data reflecting the nature of their multi-faceted responsibilities. Longitudinal databases supported by the NIH, AHRQ, and CDC include medical record, laboratory specimen, physical examination, and interview data.

Table 2 summarizes the types of research areas covered by the databases. Many HIV-related databases supported by the federal government have been used to conduct research in several areas: policy studies, program evaluation or performance measurement, clinical research or therapeutic effectiveness, epidemiologic studies, health services research, and health care financing studies. The database descriptions in the inventory provide further details about the designs used. Many of the databases have policy applications either for issues specifically pertaining to HIV, or relating to the role of HIV in a broader health care financing and service delivery context. Many of the databases also contribute to the federal government’s ability to evaluate programs either directly or indirectly by measuring outcomes of health care financing and services delivery systems.

1 - The federal government has also supported basic research and drug and vaccine development. These research topics are outside the scope of this project.

Filling Gaps in HIV-Related Research: Opportunities for Collaboration

Several developments in HIV pose new challenges and opportunities for federally supported and and other research endeavors. These developments include:

Rapid introduction of new, expensive HIV antiretroviral therapies which are used in combination in demanding, complex treatment regimens;
Increasing demand for chronic disease services as HIV positive individuals live longer and enjoy greater quality of life from antiretroviral therapy;
Growing numbers of HIV positive minority populations, women, and injecting drug users, many of whom have poor access to care and substantial needs for substance abuse and mental health treatment and social support services;
Continued lags between HIV counseling and testing and initiation of treatment;
Disparities in access and quality of care among HIV positive individuals, even among individuals enrolled in Medicaid and receiving their care from providers supported by the Ryan White CARE Act;
New understanding of the need to better integrate HIV financing streams to more effectively use resources, as well as eliminate gaps in health care coverage as HIV positive individuals transition through the spectrum of HIV disease;
Emerging health care delivery models that adopt managed care strategies; and
Growing evidence that existing models of health care delivery and financing for people with HIV have substantial opportunities for improving accessibility and quality of care.

These emerging developments and new insights into the changing nature of the HIV epidemic and evolving health care delivery and financing system present interesting or unique opportunities for research collaboration- not only among federal agencies but also in partnership with academic, clinical, and health services researchers, the pharmaceutical industry, and others in the research community. A number of research questions that could be addressed through such collaborations might include:

Why do lags continue between HIV counseling and testing and initiation of treatment? How can HIV counseling and testing services be more effectively linked with HIV care? What behavioral, educational, and service delivery strategies effectively assist newly identified HIV positive individuals to rapidly enter and remain in HIV treatment?
What impact has the use of new HIV antiretroviral therapies had on the natural history of HIV disease?
What effect do comorbidities have on the course and manifestations of HIV disease?
How do rates of dissemination of new HIV antiretroviral therapies vary among sub-populations? What impact do those variations have on the natural history of disease among sub-populations of HIV positive individuals?
What educational strategies and clinical and social support services can effectively assist HIV positive individuals who are using antiretroviral therapies?
How has the growing demand for chronic disease services by HIV positive individuals affected the organization and financing of HIV service delivery systems?
What types of care and social services can most effectively meet the needs of minority populations, women, and injecting drug users? What measures are needed to close the gap in access to care among these groups?
What is the quality of care being provided to HIV positive individuals? How can quality be improved?
What steps are necessary to better integrate HIV financing streams to more effectively use resources and eliminate gaps in health care coverage?
What is the impact of managed care programs, such as those implemented by Medicaid, on HIV care and social support service providers and HIV positive individuals?

The new challenges presented by emerging issues in the HIV epidemic provide an opportunity to design and support research that involves creative, effective approaches to using current databases and designing new databases that can rapidly address emerging questions that affect public policy, clinical practice, health care financing, and other key areas. This opportunity will require new collaborations among consumer advocates, clinicians, policymakers, industry, foundations, and other key stakeholders.

Table 1. Summary of the Study Designs of HIV-Relevant Databases

DATABASE	Crosssectional	Longitudinal	Survey	Administrative	Medical Records	Specimens & exam	Interview
Department of Health and Human Services
Agency for Healthcare Research and Quality
AIDS Cost and Services Utilization Survey		X			X		X
Healthcare Cost and Utilization Project	X			X	X
HIV Cost and Services Utilization Study		X			X	S	X
Centers for Disease Control and Prevention
Adult/Adolescent Spectrum of Disease Project		X			X
Behavioral Risk Factor Surveillance System	X		X
HIV Counseling and Testing System	X					S	X
HIV Epidemiologic Research Study		X			X	X	X
HIV Outpatient Study		X			X
HIV/AIDS Reporting System		X			X		X
Multiple Cause-of-Death Files	X			X
National Ambulatory Medical Care Survey	X		X		X		X
National Death Index	X
National Health Examination Statistics Surveys	X		X			X	X
National Health Interview Survey	X		X				X
National Home and Hospice Care Survey	X		X		X		X
National Hospital Ambulatory Medical Care Survey	X		X		X		X
National Hospital Discharge Survey	X		X		X
National Nursing Home Survey	X		X		X		X
National School-Based Youth Risk Behavior Survey	X		X
National Survey of Ambulatory Surgery	X		X		X
National Survey of Family Growth	X		X				X
Pediatric Spectrum of HIV Disease Project		X			X
Supplement to Routine HIV and AIDS Surveillance	X						X
Health Care Financing Administration(now known as Centers for Medicare and Medicaid Services(CMS))
Medicaid Statistical Information System		X		X
Medicare		X		X
HRSA HIV/AIDS Bureau
AIDS Drug Assistance Program Monthly Report	X			X
AIDS Education and Training Centers	X		X	X
Annual Administrative Report	X			X
Uniform Reporting System Client Data Demonstration Project		X		X	X
Grantee Applications, Titles I and II	X			X
HIV/AIDS Dental Reimbursement Program	X			X	X
Special Projects of National Significance Program	X	X		X	X		X
Title III Program Data Report	X			X	X
Title IV Data Reporting System	X			X	X
National Institutes of Health
Adult AIDS Clinical Trial Group	X	X			X	X	X
AIDS Link to the Intravenous Experience					X	X	X
Terry Beirns Community Programs for Clinical Research on AIDS	X	X			X	X
HIV Vaccine Clinical Trials Network and HIV Prevention Clinical Trials Network	X	X	X		X	X	X
Multicenter AIDS Cohort Study		X			X	X	X
Reaching for Excellence in Adolescent Care and Health		X			X	X	X
Women and Infants Transmission Study		X			X	X	X
Women’s Interagency HIV Study		X			X	X	X
Substance Abuse and Mental Health Administration
HIV Outreach Demonstration Program	X	X	X	X			X
Department of Veterans Affairs
Immunology Case Registry (ICR)		X		X	X	X
Social Security Administration
Title II, Title XVI Concurrent Determinations		X		X

S (specimens only)

Table 2. Summary of the Research Applications of HIV-Relevant Databases

DATABASE	Policy	Program Evaluation	Clinical	Epidemiology	Health Services Research
Department of Health and Human Services
Agency for Healthcare Research and Quality
AIDS Cost and Services Utilization Survey	X	X	X		X
Healthcare Cost and Utilization Project	X				X
HIV Cost and Services Utilization Study	X	X	X		X
Centers for Disease Control and Prevention
Adult/Adolescent Spectrum of Disease	X	X	X	X
Behavioral Risk Factor Surveillance System	X	X		X
HIV Counseling and Testing System	X
HIV Epidemiologic Research Study		X	X	X
HIV Outpatient Study		X	X
HIV/AIDS Reporting System	X	X	X	X
Multiple Cause-of-Death Files			X	X
National Ambulatory Medical Care Survey	X			X	X
National Death Index	X		X	X	X
National Health Examination Statistics Surveys	X		X	X
National Health Interview Survey	X			X
National Home and Hospice Care Survey	X			X	X
National Hospital Ambulatory Medical Care Survey	X			X	X
National Hospital Discharge Survey	X			X	X
National Nursing Home Survey	X			X	X
National School-Based Youth Risk Behavior Survey	X	X		X
National Survey of Ambulatory Surgery	X			X	X
National Survey of Family Growth	X			X
Pediatric Spectrum of HIV Disease Project	X	X	X	X
Supplement to Routine HIV and AIDS Surveillance	X	X	X	X
Health Care Financing Administration(now known as Centers for Medicare and Medicaid Services(CMS))
Medicaid Statistical Information System		X	X	X	X
Medicare		X	X	X	X
Health Resources and Services Administration, HIV/AIDS Bureau
AIDS Drug Assistance Program Monthly Report	X	X			X
AIDS Education and Training Centers	X	X
Annual Administrative Report	X	X
Uniform Reporting System Client Data Demonstration Project		X	X		X
Grantee Applications, Titles I and II	X	X			X
HIV/AIDS Dental Reimbursement Program	X	X			X
Special Projects of National Significance Program	X	X	X		X
Title III Program Data Report	X	X			X
Title IV Data Reporting System	X	X			X
National Institutes of Health
Adult AIDS Clinical Trial Group			X
AIDS Link to the Intravenous Experience			X	X
Terry Beirns Community Programs for Clinical Research on AIDS			X
HIV Vaccine Clinical Trials Network and HIV Prevention Clinical Trials Network	X			X
Multicenter AIDS Cohort Study			X	X	X
Reaching for Excellence in Adolescent Care and Health		X	X	X
Women and Infants Transmission Study		X	X	X
Women’s Interagency HIV Study		X	X	X
Department of Veterans Affairs
Immunology Case Registry (ICR)		X	X		X
Social Security Administration
Title II, Title XVI Concurrent Determinations	X	X			X

Guide To Acronyms

AACTG

Adult AIDS Clinical Trial Group

AAR

Annual Administrative Report

ACSUS

AIDS Cost and Services Utilization Survey

ADAP

AIDS Drug Assistance Program

AHA

American Hospital Association

AHRQ

Agency for Healthcare Research and Quality

AIDS

Acquired immune deficiency syndrome

AETC

AIDS Education and Training Center

ALIVE

AIDS Link to the Intravenous Experience

AMA

American Medical Association

ASD

Adult/Adolescent Spectrum of HIV Disease Project

ASPE

Assistant Secretary for Planning and Evaluation

AVEG

AIDS Vaccine Evaluation Group

BMAD-IV

Medicare Annual Data Beneficiary File IV

BRFSS

Behavioral Risk Factor Surveillance System

CARE

Comprehensive AIDS Resources Emergency Act

CASI

Computer assisted self-interviewing

CATI

Computer assisted telephone interview

CDC

Centers for Disease Control and Prevention

CHSRP

Center for Health Services Research and Policy

CLDS

Client Level Data Set

CPCRA

Terry Beirn Community Programs for Clinical Research on AIDS

CPT

Common Procedural Terminology

CRCE

Consolidated Report of Contract Expenditures

CTS

HIV Counseling and Testing System

DAIDS

Division of AIDS, National Institute for Allergy and Infectious Diseases

DHHS

Department of Health and Human Services

EMA

Eligible Metropolitan Area

FQHC

Federally qualified health center

FFY

Federal fiscal year

HCUP-3

Healthcare Cost and Utilization Project

HAB

HIV/AIDS Bureau, Health Resources and Services Administration

NAMCS

National Ambulatory Medical Care Survey

HARS

HIV/AIDS Reporting System

HCFA(now known as CMS)

Health Care Financing Administration(now known as Centers for Medicare and Medicaid Services(CMS))

HCSUS

HIV Cost and Services Utilization Study

HEDS

HIV Early Detection Study

HERS

HIV Epidemiologic Research Study

HIO

Health insuring organizations

HIV

Human immunodeficiency virus

HIVNET

HIV Network for Prevention Trials

HMO

Health maintenance organization

HOPS

HIV Outpatient Study

HPTN

HIV Prevention Clinical Trials Network

HRSA

Health Resources and Services Administration

HVTN

HIV Vaccine Clinical Trials Network

ICD-9-CM

International Classification of Diseases, Ninth Edition, Clinical Modifications

ICF

Intermediate care facility

ICI

Interactive computer interviewing

ICR

Immunology Case Registry

IPC

Infected Participant Cohort

IRB

Institutional Review Board

MACS

Multicenter AIDS Cohort Study

MEDPAR

Medicare Provider Analysis and Review

MSA

Metropolitan Statistical Area

MSIS

Medicaid Statistical Information System

NCHS

National Center for Health Statistics

NDI

National Death Index

Nursing facility

NHAMCS

National Hospital Ambulatory Medical Care Survey

NHANES

National Health Examination Statistics Surveys

NHCS

National Health Care Survey

NHDS

National Hospital Discharge Survey

NHHCS

National Home and Hospice Care Survey

NHIS

National Health Interview Survey

NIAID

National Institute of Allergy and Infectious Diseases

NICHD

National Institute of Child Health and Human Development

NIDA

National Institute on Drug Abuse

NIH

National Institutes of Health

NIMH

National Institute of Mental Health

NNHS

National Nursing Home Survey

NSAS

National Survey of Ambulatory Surgery

NIS

Nationwide Inpatient Sample

NSFG

National Survey of Family Growth

NTIS

National Technical Information Service

NVSS

National Vital Statistics System

ODB

Observational Data Base

Opportunistic infection

OMB

Office of Management and Budget

PCCM

Primary care case management

PHS

Public Health Service

PIDS

Public Information Data Set

PSD

Pediatric Spectrum of HIV Disease Project

PSU

Primary statistical unit

REACH

Reaching for Excellence in Adolescent Care and Health Project

RWCA

Ryan White Comprehensive AIDS Resources Emergency Act

SAMSHA

Substance and Mental Health Administration

S-CHIP

State Children’s Health Insurance Program

SHAS

Supplement to Routine HIV and AIDS Surveillance Project

SID

State Inpatient Database

SLAITS

State and Local Area Integrated Telephone Survey

SPNS

Special Projects of National Significance

SSA

Social Security Administration

TANF

Temporary Assistance to Needy Families

Uniform billing

VAMC

Veterans Affairs Medical Center

VPS

Vaccine Preparedness Study

WITS

Women and Infants Transmission Study

WIHS

Women’s Interagency HIV Study

YRBS

National School-Based Youth Risk Behavior Survey

Agency for Healthcare Research and Quality (AHRQ)

Database: AIDS Costs and Services Utilization Survey (ACSUS)

Purpose Of The Database And Study Design: The goals of ACSUS were to: (1) address the need for comprehensive data on the patterns of health care delivery to HIV positive people and (2) overcome the limitations of prior research by obtaining data on health services use and costs from a large heterogeneous sample in several US communities with substantial HIV prevalence. Westat, working under contract for AHRQ, began collecting data in March 1991. Data collection was completed in late 1992.

Nature Of The Data Collected: Longitudinal sample including up to six interviews per respondent. Medical and financial record data were also collected.

Unit Of Analysis: HIV positive adults and children

Data Collection Methods: Sample selection was undertaken in three stages: selection of geographic areas, selection of medical care providers within each area, and selection of patients within each provider. Following a brief recruitment period, on-site coordinators distributed a self-administered screening questionnaire to all patients using a specific clinical site at each provider (e.g., HIV clinic). Patients indicated on the questionnaire if they ever had received a positive HIV test, if they had experienced HIV-related symptoms in the past five years, or if they had been diagnoses with an AIDS-related condition in the past five years. Additional information regarding demographic characteristics and HIV exposure routes was collected. After the screening questionnaire was completed, the coordinator determined if the patient was eligible for participation in the study. Only HIV positive patients were recruited. The screening questionnaire was used to create three disease strata: asymptomatic, symptomatic non-AIDS, and AIDS. A systematic random sample was selected for each stratum, with oversampling of women and pediatric cases. After initial acceptance into the sample, the site coordinator requested the patient formally participate in the interview phase of the study. Health service utilization data were obtained for an 18-month period between March 1991 and August 1992. Respondents were interviewed six times during that period. Each interview requested information regarding service utilization events during the previous three-month period.

General Attributes: Almost 2,100 HIV positive respondents were recruited from 26 medical care providers in ten cities. Of these, 1,949 were adults (aged 13 year of age or older) and the remainder were children. However, very few adolescents who were 13 years of age or older were enrolled in the study.

Major Data Constructs And Key Data Elements: Self-reported data were collected regarding the number of inpatient admissions and length of stay for each admission; the number of ambulatory care visits to hospital clinics, other clinics, or private physicians’ office; use of other health care services; health history; health status; stage of HIV infection; medication use; employment history and income; services received from social service agencies; physical functioning; pain; mood; activities of daily living; living arrangements; access and barriers to care; demographic characteristics; insurance coverage; and out-of-pocket expenditures. Disease stage (i.e., asymptomatic, symptomatic, AIDS) was based on review of medical record data.

Strengths And Weaknesses Of The Study Design And Database: Selection of locations and providers was undertaken on a purposeful basis, resulting in a nonrandom sample of patients. Although the ACSUS data may present useful historical data, its results are unlikely to accurately predict current HIV cost and service utilization patterns.

Gaps In The Data Collected And Factors Leading To The Gaps: ACSUS does not describe current cost and service utilization patterns

Feasibility Of Linking With Other Databases: Linkage with other databases, including Medicaid claims and eligibility records, was undertaken to validate the self-reported data.

Process To Access The Database And Contact Person: Public use data for adults and (separately) for children are available through the National Technical Information Service (NTIS) for a fee. Contact John Fleishman, PhD, AHRQ, for details: (301) 594-2007.

Selected Citations:

Smith SR, Kirking DM. Access and use of medications in HIV disease. Health Services Research. 34(1): 123-144, 1999.

Joyce GF, Goldman DP, Leibowitz A, Carlisle D, et al. Variation in inpatient resource use in the treatment of HIV: do the privately insured receive more care? Medical Care. 37(3): 220-227, 1999.

Hsia DC. Medications used for pediatric HIV infection in the USA, 1991-1992. AIDS Care. 10(6): 761-770, 1998.

Niemcryk SJ, Bedros A, Marconi KM, O’Neill JF. Consistency in maintaining contact with HIV-related service providers: an analysis of the AIDS Cost and Service Utilization Survey (ACSUS). Journal of Community Health. 23:137-152, 1998.

Fleishman JA. Transitions in insurance and employment among people with HIV infection. Inquiry. 35: 36-48, 1998.

Fleishman JA. Functional status transitions and survival in HIV disease: evidence from the AIDS Costs and Service Utilization Survey.Medical Care. 36(4): 533-543, 1998.

Fleishman JA. Utilization of home care among people with HIV infection. Health Services Research. 35(1): 155-175, 1997.

Fleishman JA. Dental services use among adults with human immunodeficiency virus infection. Medical Care. 35(1): 77-85, 1997.

Schur CL, Berk ML. Health insurance coverage of persons with HIV-related illness: data from the ACSUS screener. Pediatric AIDS and HIV Infection. 5(6): 362-362, 1994.

Fahs MC, Waite D, Sesholtz M, Muller C. Results of the ACSUS for pediatric AIDS patients: utilization of services, functional status, and social severity. Health Services Research. 29(5): 549-567, 1994.

Fleishman JA, Hsia DC, Hellinger FJ. Correlates of medical service utilization among persons with HIV infection. Health Services Research. 29:527-548, 1994.

Hellinger FJ, Fleishman JA, Hsia DC. AIDS treatment costs during the last months of life: evidence from the ACSUS. Health Services Research. 29(5): 569-581, 1994.

Hellinger FJ. The use of health services by women with HIV infection. Health Services Research. 28(5): 543-561, 1993.

Database: Healthcare Cost and Utilization Project (HCUP-3)

Purpose Of The Database And Study Design: HCUP-3 is a public-private partnership between the Federal and State governments and health care industry to produce health care data. The objectives of HCUP are to obtain data from statewide sources (principally State governments and hospital associations); design and develop a multi-state health care database for use in health services research and policy analysis; and release data to public and private users for a variety of purposes. HCUP-3 consists of two hospital inpatient databases: the HCUP-3 Nationwide Inpatient Sample (NIS) and the HCUP-3 State Inpatient Database (SID). These databases contain data elements that are similar to a typical discharge abstract.

Nature Of The Data Collected: Cross-sectional administrative and clinical records

Unit Of Analysis: Inpatient discharges

Data Collection Methods: The HCUP-3 NIS contains inpatient and hospital-based ambulatory surgery data from about 900 US hospitals, or about a 20 percent sample of hospitals. The NIS uses a stratified probability sample of hospitals, selected to be representative of US community hospitals as based on the American Hospital Association (AHA) Annual Survey. AHA defines community hospitals as non-Federal short-term general hospitals that are open to the public, as well as specialty hospitals. Short-term stays have an average length of less than 30 days. The AHA Annual Survey is used to stratify hospitals by several characteristics: ownership/control, bed size, teaching status, rural or urban location, and US region. Where possible, a 20 percent sample is drawn of each strata. The NIS contains records for all stays in the sampled hospitals. The sample was drawn from states including: Arizona, California, Colorado, Connecticut, Florida, Illinois, Iowa, Kansas, Maryland, Massachusetts, New Jersey, New York, Oregon, Pennsylvania, South Carolina, Washington, and Wisconsin. The NIS includes core inpatient data elements. The HCUP-3 SID contains 100 percent of hospitals and discharges from State government and private data agencies with statewide inpatient data systems. The SID includes common inpatient data elements. After conversion of the submitted data to AHRQ and processing to create a uniform format, the processed tape is returned to the data source. Dissemination of the SID is controlled by the original data source. The identity of individual patients and physicians is not included in the records to protect their confidentiality. These databases are supplemented with data from sources including the AHA Annual Survey of Hospitals, the Area Resource File maintained by HRSA’s Bureau of Health Professions, and Bureau of the Census.

General Attributes: HCUP-3 was initiated on an annual basis in 1988. HCUP-1 data collection occurred in 1970 through 1977. HCUP-2 data collection spanned 1980 through 1987.

Major Data Constructs And Key Data Elements: Patient demographic, geographic, and payer characteristics; principal and secondary diagnoses; principal and secondary procedures; length of stay; total charges; admission and discharge status; and hospital characteristics.

Strengths And Weaknesses Of The Study Design And Database: HCUP-3 databases are available through public use tapes. HCUP documentation states that since the data were originally gathered for administrative purposes, there may be reliability and validity problems with some data elements. Additional problems cited include missing data, under-reporting of socially stigmatizing conditions such as mental illness or drug use, and under-reporting of minor procedures.

Gaps In The Data Collected And Factors Leading To The Gaps: None identified

Feasibility Of Linking With Other Databases: Linkage to other databases is feasible.

Process To Access The Database And Contact Person: The Nationwide Inpatient Sample can be purchased from NTIS. A confidentiality agreement must be signed. General questions about the database can be addressed to hcup@ahrq.gov. Information is also available through the HCUP website at: http://www.ahrq.gov.

Selected Citations:

Bentham WD, Cai L, Schulman KA. Characteristics of hospitalizations of HIV positive patients: an analysis of data from the 1994 Healthcare Cost and Utilization Project. JAIDS. 22(5): 503-508, 1999.

Maynard C, Chapko MK, Every NR, Martin DC, Ritchie JL. Coronary angioplasty outcomes in the Healthcare Cost and Utilization Project.American Journal of Cardiology. 81: 848-852, 1998.

Elixhauser A, Steiner CA, Whittington CA, McCarthy E. Clinical Classifications for Health Policy Research, Hospital Inpatient Statistics, 1995. Rockville: Agency for Health Care Policy and Research. AHCPR Publication No. 98-0049, 1998.

Duffy SQ, Elixhauser A, Sommer JP. Diagnosis and Procedure Combinations in Hospital Inpatient Data. Rockville: Agency for Health Care Policy and Research. AHCPR Publication No. 96-0047, 1996.

Elixhauser A, McCarthy E. Clinical Classifications for Health Policy Research, Version 2: Hospital Inpatient Statistics. Rockville: Agency for Health Care Policy and Research. AHCPR Publication No. 96-0017, 1996.

Database: HIV Cost and Services Utilization Study (HCSUS)

Purpose Of The Database And Study Design: HCSUS is designed to be a national sample representative of the adult US population infected with HIV. HCSUS uses a multistage national probability sampling frame to select the study cohort. To participate in the study, individuals must have been at least 18 years of age with known HIV infection. They must have made at least one visit for regular care in the contiguous US to other than a military, prison, or emergency department facility between January 5 and February 29, 1996 (except for one city where sampling began and ended two months later). In Stage 1 of the sample, 28 metropolitan statistical areas and 24 clusters of rural counties that together contained about 70 percent of all AIDS cases in the US were randomly selected. In Stage 2, 58 institutional or individual physicians known to care for HIV positive patients in urban areas and 28 in rural areas were randomly selected. Using data from the American Medical Association (AMA) Master File, about 4,000 physicians were randomly sampled in relevant specialties among whom 87 urban physicians and 23 rural physicians confirmed that they cared for eligible patients. In Stage 3, sampling rates were set to equalize probabilities within subgroups while increasing the over-sample rate for women and members of private staff-model health maintenance organizations (HMOs). Subjects were randomly selected with the appropriate predetermined probability from anonymous lists of those individuals receiving outpatient or inpatient care from participating providers during January and February 1996. Participation agreements were obtained from selected providers.

Nature Of The Data Collected: Longitudinal nationally representative sample that records clinical, laboratory specimen, and interview data (with clinical and laboratory specimen data abstracted from medical records); some information from pharmacy records and bill records were obtained for a subsample of cohort members; blood samples were obtained from approximately 2000 respondents in 1998 (blood samples themselves not available for analysis but a data file containing CD4 and viral load data will be available in 2000).

Unit Of Analysis: HIV positive adults in care.

Data Collection Methods: Three rounds of interviews were conducted: baseline, first follow-up, and second follow-up. Respondents were interviewed using 90 minute long forms. The baseline sample consisted of 2,864 long-form respondents interviewed between January 1996 and April 1997. The first follow-up sample included 2,466 respondents interviewed between December 1996 and July 1997. The second follow-up sample consisted of 2,267 respondents interviewed between August 1997 and January 1998. Short or proxy forms were administered if the respondent was too ill to participate in the long-form interviews or otherwise unavailable for interview. The medical records of the respondents were reviewed at their primary site of ambulatory care.

Major Data Constructs And Key Data Elements: Major constructs included in the interview forms include: usual source of care, HIV tests and clinical stage, symptoms, insurance coverage, utilization of care (i.e., inpatient, outpatient visits, emergency department visits, mental health use, home health care, dental services, medication), residential status, health-related quality of life measures, social support and coping (including satisfaction with care), unmet needs for medical and non-medical care, mental health screening, illicit drug use, sociodemographic characteristics, region, knowledge about AIDS and HIV, and preferences regarding care (e.g., advance medical directives).

Strengths And Weaknesses Of The Study Design And Database: Strengths include: HCSUS is a probability sample that enables generalization to the overall HIV population; rate of attrition in sample is low over time. Weaknesses include: cohort represents those receiving care in 1996; the population of persons in care for HIV may have changed since the introduction of HAART.

Gaps In The Data Collected And Factors Leading To The Gaps: Unavailable

Feasibility Of Linking With Other Databases: Minimal; names are strictly confidential and no identifying information is available.

Process To Access The Database And Contact Person: Procedures for accessing public use data files are under development, were completed on April 15, 2000. For information, contact John Fleishman, PhD, AHRQ at (301) 594-2007.

Selected Citations:

Shapiro MF, Berk ML, Berry SH, et al. National probability samples in studies of low-prevalence diseases, part 1: Perspectives and lessons learned from the HIV cost and services utilization study. Health Services Res. 34(5): 951-968, 1999.

Frankel MR, Shapiro MF, Duan N, et al. National probability samples of low-prevalence diseases, part 2: Designing and implementing the HIV cost and services utilization study sample. Health Services Res. 34(5): 969-992, 1999.

Cunningham WE, Anderson RM, Katz MH, et al. The impact of competing subsistence needs and barriers on access to medical care for persons with Human Immunodeficiency Virus receiving care in the United States. Medical Care. 37:1270-1281, 1999.

Shapiro MF, Morton SC, McCaffrey DM, et al. Variations in the care of HIV positive adults in the United States. JAMA. 281:2305-2315, 1999.

Bozzette SA, Berry SA, Duan N, et al. The care of HIV positive adults in the United States. NEJM. 339:1897-1904, 1998.

Berry SH, Brown JA, Athey L, et al. HCSUS Baseline Patient Questionnaire Documentation. Santa Monica: RAND, MR-1090-AHCPR, 1998.

McCutchan A, Bozzette S, Shapiro M, Turner B, et al. Lifetime prevalence of opportunistic infections in a nationally representative sample (HCSUS) of HIV positive persons in care. International Conference on AIDS. 12: 133 (Abstract No. 13238), 1998.

Bozzette S, Berry SH, Duan N, Frankel MR, et al. Characteristics of HIV positive patients receiving regular care in the US: results from the HIV Cost and Services Utilization Study (HCSUS). International Conference on AIDS. 12: 131 (Abstract No. 13229), 1998.

Asch S, McCutchan JA, Bozzette S, Shapiro M, et al. Underuse of primary prophylaxis for Mycobacterium avium complex (MAC) in a representative sample of HIV positive patients in care in the USA: who is missing out? International Conference on AIDS. 12: 295 (Abstract No. 22167), 1998.

Duan N, McCaffrey DR, Frankel MR, et al. HCSUS Baseline Methods Technical Report. Santa Monica: RAND, MR-1060-AHCPR, 1998.

Knouse DE, Collins RL, Senterfitt JW, Mathews WC, et al. Attitudes of HIV positive persons toward taking antiretroviral therapies: a matter of trust? International Conference on AIDS. 11(2): (Abstract No. Th.D.5123), 1996.

Lam NS, Liu KB. Use of space-filling curves in generating a national rural sampling frame for HIV/AIDS research. Professional Geographer. 48(3): 321-332, 1996.

Collins RK, Kanouse DE, Senterfitt JW, McCutchan AJ, et al. Use of alternative treatments for HIV: patterns and correlates. International Conference on AIDS. 11(1): (Abstract No. Mo.B.183), 1996.

Centers for Disease Control and Prevention (CDC), Division of HIV/AIDS Prevention, Surveillance, and Epidemiology

Database: HIV Counseling and Testing System (CTS)

Purpose Of The Database And Study Design: The CDC supports anonymous and confidential HIV counseling and testing services in each State, the District of Columbia, Puerto Rico, and US territories. The objectives of the HIV counseling and testing service program are to: provide a convenient opportunity for persons to learn their current HIV serostatus; allow those individuals to receive prevention counseling to help initiate behavior change to avoid infection or, if already infected, to prevent transmission to others; assist individuals to obtain referrals to receive additional prevention, health care, and other needed services; and provide prevention services and referrals for sex and needle-sharing partners of HIV positive persons. In 39 states, testing can be obtained anonymously (i.e., individuals do not have to give their names to get tested). All States provide confidential testing by name and have confidentiality laws and regulations to protect this information.

Nature Of The Data Collected: Cross-sectional interview and laboratory specimen data

Unit Of Analysis: Individual HIV tests

Data Collection Methods: HIV counseling and testing services are offered in about 11,000 sites, including dedicated HIV counseling and testing sites, sexually transmitted disease clinics, drug-treatment centers, hospitals, and prisons. Data is collected from each individual client encounter at a site. Site staff complete a survey instrument (i.e., HIV Counseling and Testing Report Form; a State-based form; or a summary record report) during or after a pre-test counseling session. Information from each individual client encounter can be determined from the HIV Counseling and Testing Report Form and most State-based forms. Information from aggregate client encounters is available from eleven States and six territories. Completed survey instruments are batched and transmitted to the State health department for processing. Electronic data are transmitted to CDC for analysis and report generation.

General Attributes: About 2.5 million forms are completed annually. Of the 9.7 million federally-funded HIV tests performed in 1995 through 1998, individual client encounter information on 8.3 million tests was available for analysis. The database is maintained in a mainframe environment at CDC.

Major Data Constructs And Key Data Elements: Site type and location, counseling date, source of referral, client demographic characteristics, risk behaviors, reason for visit, type of testing (anonymous or confidential), reasons if the test was not conducted, test results, and outcome of counseling.

Strengths And Weaknesses Of The Study Design And Database: The data collected include information from all HIV counseling and testing service client encounters, including information from clients with positive or negative HIV serostatus, in 65 reporting areas, including each State, the District of Columbia, Puerto Rico, and US territories. The data collection methods vary by reporting area. It is unclear what impact this variability has on the data recorded in the HIV Counseling and Testing System. Data submitted to the HIV Counseling and Testing System represents HIV tests and not unique counts of individuals. As a result, the number of persons returning for testing over time cannot be computed. These data represent HIV counseling and testing services conducted at federally funded counseling and testing sites. Some unknown number of HIV tests are also conducted by health care providers and funded by health insurance, out-of-pocket payments, and other mechanisms. Home test kits are also available. Therefore, the number of total HIV tests conducted in the US and their results are not available.

Gaps In The Data Collected And Factors Leading To The Gaps: Individual encounter data are not available from eleven States and six territories. These areas report data on the total number of tests in a summary record format, not on each individual client encounter.

Feasibility Of Linking With Other Databases: It is unclear how feasible it is to link data from confidential test sites to other databases. Data from confidential test sites have been linked with the HIV/AIDS Reporting System (HARS) database. In anonymous test sites, the test subject does not provide unique identifiers. Therefore, linkage to other databases is not feasible. Public use data tapes can be made available upon request.

Process To Access The Database And Contact Person: For more information contact: Chief, Prevention Services Research Branch, Division of HIV/AIDS Prevention, Surveillance, and Epidemiology, CDC, Mailstop E-46, 1600 Clifton Road, NE, Atlanta GA 30333: (404) 639-2080.

Selected Citations:

HIV counseling and testing in publicly funded sites: 1997-1998 summary report. DHHS. Atlanta: CDC, (in preparation).

Nakashima AK, Horsley R, Frey RL, Sweeney PA, Weber JT, Fleming PL. Effect of HIV reporting by name on use of HIV testing in publicly funded counseling and testing programs. JAMA. 280(16): 1421-1426, 1998.

HIV counseling and testing in publicly funded sites: 1996 summary report. DHHS. Atlanta: CDC, May 1998.

Valdiserri RO, Weber JT, Frey RL. Trends in HIV seropositivity among clients attending publicly funded HIV counseling and testing sites across the USA:1990-1994. American Journal of Prevention. 14(1): 31-42, 1998.

HIV counseling and testing in publicly funded sites: 1995 summary report. DHHS. Atlanta: CDC, September 1997.

Weber JT, Frey RL, Horsley R, Gwinn ML. Publicly funded HIV counseling and testing in the United States, 1992-1995. AIDS Education and Prevention. 9, Supplement B, 79-91, 1996.

HIV counseling and testing in publicly funded sites: 1993-1994 summary report. DHHS. Atlanta: CDC, March 1996.

Valdiserri RO, Gerber AR, Dillon BA, Campbell CH. Clients without health insurance and publicly funded HIV counseling and testing sites: implication for early intervention. Public Health Reports. 110(1): 47-52, 1995.

HIV counseling, testing, and referral: standards and guidelines. DHHS. Atlanta: CDC, 1994.

CDC. Differences between anonymous and confidential registrants for HIV testing- Seattle, 1986-1993. MMWR. 42(3): 53-56, 1993.

Holtgrave DR, Valdiserri RO, Gerber AR, Hinman AR. Human immunodeficiency virus counseling, testing, referral, and partner notification services: a cost-benefit analysis. Archives of Internal Medicine. 153(10): 1225-1230, 1993.

Valdiserri RO, Jones TS, West GR, Campbell CH, Thompson PI. Where injecting drug users receive HIV counseling and testing. Public Health Reports. 108(3): 294-298, 1993.

Valdiserri RO, Moore M, Gerber AR, Campbell CH, Dillon BA, West GR. A study of clients returning for counseling after HIV testing: implications for improving rates of return. Public Health Reports. 108(1): 12-18, 1993.

CDC. Testing for HIV in the public and private sectors- Oregon, 1998-1991. MMWR. 41(32): 581-584, 1992.

CDC. Publicly funded HIV counseling and testing- US, 1991. MMWR. 41(34): 613-617, 1992.

Database: HIV/AIDS Reporting System (HARS)

Purpose Of The Database And Study Design: The goals of HARS are to: monitor trends in HIV and AIDS in the US and determine the scope of severe morbidity due to infection with HIV and its related conditions. HIV and AIDS surveillance data are used to allocate resources for patient care, target HIV prevention activities, and evaluate the impact of public health recommendations.

Nature Of The Data Collected: Predominantly medical record reviews, some interviews with health care providers, and occasional interviews of patients; also laboratory reports and death certificates

Unit Of Analysis: Individual patients

Data Collection Methods: AIDS case reporting responsibility varies among States. In some jurisdictions, health care providers are required by State communicable disease statutes to report AIDS case reports to local health departments (e.g., city or county). Those agencies then in turn submit copies of those reports to State health departments. In other states, the State health department is responsible for receipt of reports and investigation of AIDS cases. The statutory definition of which health care providers must report HIV or AIDS cases varies by States. In some jurisdiction, clinical laboratories must report patients who are found through laboratory testing to have a condition meeting the HIV or AIDS case definition. Laboratories directly report the case to the health department. Following submission of an initial AIDS case report, a case investigation is completed which involves review of medical records. An interview with the reporting physician may be conducted in those instances in which HIV transmission factors or other information required to complete the investigation is unclear. An interview of the patient is sometimes required to ascertain missing information. A similar process is undertaken in States with HIV reporting. Completed HIV/AIDS investigations are documented using standardized report forms: the Adult HIV/AIDS Confidential Case Report and the Pediatric HIV/AIDS Confidential Case Report. Case report forms are entered into the HARS at the State and local level and these data are transmitted electronically to CDC on a monthly basis. No patient names are transmitted to CDC. Rather, a SOUNDEX, an alphanumeric code based on patient name, is automatically generated by HARS.

General Attributes: Reporting of AIDS cases was instituted for all States by 1985.

Major Data Constructs And Key Data Elements: Reporting of AIDS and HIV follows a well-established set of case criteria. The case report forms gather detailed data regarding the following constructs: vital status, HIV exposure category, AIDS or HIV case definition category, clinical or laboratory information required to meet the HIV or AIDS case definition, date of diagnosis, geographic location, and patient demographic characteristics. In addition, information on payer, facility of diagnosis, antiretroviral use, treatment and service referrals, and mortality (e.g., cause of death, place of death) may be collected but information is often incomplete. The Pediatric HIV/AIDS Confidential Case Report also collects data regarding: maternal HIV testing history, use of zidovudine or other antiretrovirals in pregnancy, during delivery, or for the neonate, and prenatal care utilization.

Strengths And Weaknesses Of The Study Design And Database: Completeness and accuracy of HIV and AIDS case reporting is the responsibility of the local health department with jurisdiction over case reporting. Historically, reporting of HIV and AIDS cases by health departments has been categorized as passive or active. In the case of passive reporting, health departments rely solely on health care providers to submit case reports. In the instance of active reporting, health departments work closely with an array of health care providers to assure that reporting is complete and accurate. Active surveillance also commonly involves using secondary sources for case reports such as systematic review of death certificates, patient lists at major HIV ambulatory care clinics, Medicaid claims files, and other administrative databases. Completeness of HIV and AIDS case reporting varies across local jurisdictions and States. Moreover, completeness of the case report forms varies substantially by jurisdiction. Deaths are ascertained by matching HIV/AIDS registries to vital registries in most States.

Gaps In The Data Collected And Factors Leading To The Gaps: As of November 1999, name-based HIV reporting is required in 33 States and another six States have code-based or hybrid (name-to-code) systems. Once an AIDS case has been reported, it is unlikely that additional diagnostic or other longitudinal data will be added to the case report. As a result, the case reports may be considered a base-line assessment of the patient’s clinical status at the time of AIDS case reporting.

Feasibility Of Linking With Other Databases: Linkage at the local or State level is very feasible. A number of research and other projects have been conducted that have linked HARS databases to insurance claims, administrative records, National Death Index (NDI) other vital statistics records, observational study files, clinical trial files, and other databases.

Process To Access The Database And Contact Person: AIDS Public Information Data Set (PIDS) is available at http://www.cdc.gov. Contact person: Chief, Surveillance Branch, Division of HIV/AIDS Prevention, Surveillance, and Epidemiology, CDC, Mailstop E-47, 1600 Clifton Road, NE, Atlanta GA 30333; (404) 639-2050.

Selected Citations:

Lindegren ML, Byers RH, Thomas P, Davis SF, et al. Trends in perinatal transmission of HIV/AIDS in the United States. JAMA. 282(6): 531-538, 1999.

Klevens RM, Diaz T, Fleming PL, Mays MA, et al. Trends in AIDS among Hispanics in the United States, 1991-1996. AJPH. 89(7): 1104-1106, 1999.

Klevens RN, Fleming PK, Neil JJ, Li J. Is there really a heterosexual AIDS epidemic in the United States? Findings from a multistate validation study, 1992-1995. American Journal of Epidemiology. 149(1): 75-84, 1999.

Chiasson MA, Berenson L, Li W, Schwartz S, et al. Declining HIV/AIDS mortality in New York City. JAIDS. 21(1): 59-64, 1999.

Neal JJ, Fleming P. Trends in heterosexually acquired AIDS in the United States, 1990 through 1996. International Conference on AIDS. 12: 1036 (Abstract No. 60201), 1998.

National Center for HIV, STD, and TB Prevention. HIV/AIDS Surveillance Report: US HIV and AIDS Cases Reported Through June 1998. 10(1): 1-40, 1998. Report updates may be obtained from the CDC home page: http://www.cdc.gov, select the topic “Publications, Software, & Products.”

Muthambi BR, Chiasson MA, Lehner T, Singh TP. Improved survival time after diagnosis with AIDS among adult in New York City (NYC), 1980-1994. Conference on Retroviruses and Opportunistic Infections. 80 (Abstract No. 9a), 1998.

Melvin G, Corson K, Malamud H, et al. Success in implementing public health service guidelines to reduce perinatal transmission of HIV- Louisiana, New Jersey, and South Carolina, 1993, 1995, and 1996. MMWR. 47(33) 688-691, 1998.

McFarland JW, Singh TP, Vasquez F, Forlenza SW. The increasing impact of injecting drug use (IDU) on the AIDS epidemic, New York City (NYC), the first 100,000 AIDS cases. Conference on Retroviruses and Opportunistic Infections. 103 (Abstract No. 128), 1998.

Forlenza SW, Vazquez F, Singh TP. Using multiple Department of Health (DOH) databases to optimize AIDS surveillance opportunities and pitfalls. International Conference of Emerging Infectious Diseases. (Abstract p. 82), 1998.

Division of HIV/AIDS Prevention-Surveillance and Epidemiology, National Center for HIV, STD, and TB Prevention, CDC. AIDS among persons aged > 50 years- United States, 1991-1996. 47(2): 21-27, 1998.

Denning P, Fleming P. Beyond clinical trials- population-based HIV viral load monitoring and antiretroviral therapy. Conference on Retroviruses and Opportunistic Infections. 81 (Abstract No. 11), 1998.

Dean-Gaitor H, Fleming PL, Ward JW. Trends in AIDS incidence among black persons- United States, 1990-1996. International Conference on AIDS. 12: 131-132 (Abstract No. 13230), 1998.

Chiasson MA, Berenson L, Li W, Schwartz S, et al. Accelerating decline in New York City AIDS mortality. Conference on Retroviruses and Opportunistic Infections. 80 (Abstract No. 9b), 1998.

Wortley PM, Fleming PL. AIDS incidence in women: recent trends. National Conference on Women and HIV. 108 (Abstract No. 106.2), 1997.

Denning P, Fleming PL. Estimating recent patterns of HIV infection among adolescents and young adolescents. Conference on Retroviruses and Opportunistic Infections. 133 (Abstract No. 375), 1997.

Database: Supplement to Routine HIV and AIDS Surveillance (SHAS) Project

Purpose Of The Database And Study Design: The objective of SHAS is to obtain additional descriptive information on persons newly reported to State/local health departments with HIV infection and AIDS. This information supplements data that are routinely collected by the HARS. The information obtained from this project is useful in improving understanding of a variety of epidemiologic and policy issues (e.g., minority issues related to the HIV epidemic); how to best target educational efforts and interventions (e.g., condom distribution) to prevent HIV transmission, and how to improve health care for HIV positive persons (e.g., assessing access to and utilization of health care). SHAS sites include Arizona, Colorado, Connecticut, Delaware, Florida, Georgia, Los Angeles County, Maryland (new in 2000), Michigan, Minnesota (new in 2000) New Jersey, New Mexico, South Carolina, Texas (new in 2000) and Washington.

Nature Of The Data Collected: Cross-sectional interviews

Unit Of Analysis: Newly reported adults with HIV or AIDS

Data Collection Methods: Persons at least 18 years of age and reported as having HIV or AIDS to collaborating health departments are eligible for inclusion in the study. The study protocol and questionnaire are routinely reviewed by the CDC Institutional Review Board (IRB) and State/local IRBs. Depending on the caseload in each participating jurisdiction, data are collected for patients at selected facilities, in specific metropolitan areas or counties, or statewide. Sampling is necessary in some jurisdictions. When feasible, personal physicians are consulted before a patient is contacted. Patients whose medical and/or psychiatric status is unstable are excluded from the study. Family members or other proxies for deceased patients are not contacted. Verbal or written consent is sought before interviews are conducted. A standardized interview form is administered by trained interviewers either during a routine medical visit or by interview at home or other mutually acceptable location; rarely, interviews may be conducted by telephone. As part of the interview process, patients are counseled about practices to avoid HIV transmission and are referred, as needed, to appropriate medical care, substance abuse treatment, or social service agencies. Because the database is an extension of routine surveillance, the representativeness of the interviewed sample compared to all cases reported in the jurisdiction conducting the study can be assessed. Data are routinely analyzed at the State/local level for HIV prevention community planning and publication. Data are also transmitted to CDC after identifiers have been removed. At the national level, data are analyzed for program purposes and scientific publications.

General Attributes: Data collection was begun in 1990 and is ongoing. To date, more than 22,000 SHAS interviews have been completed.

Major Data Constructs And Key Data Elements: Demographic and socioeconomic characteristics, drug use history (both injected and non-injected), sexual behavior history (including sexually transmitted diseases), access to and utilization of health care services, reasons and location for HIV testing; reproductive history of HIV positive women, disabilities, migration patterns, antiretroviral therapy and therapies to prevent AIDS opportunistic infections (OIs), and adherence to therapies. These data supplement the information gathered by routine case investigations and reported to the HARS.

Strengths And Weaknesses Of The Study Design And Database: SHAS gathers useful data that supplements the information routinely collected through HARS. The study establishes infrastructure at the State/local level to collect these data on a routine basis for local use, as well as at the national level. The sampling methods used to identify subjects may not derive a generalizable sample of newly reported cases within a jurisdiction or across the US. However, representativeness of the sample can be assessed because of the direct link to surveillance data. Therefore, the generalizability can be improved by adjusting the sample interviewed in each participating site. The large number of cases interviewed and the multi-site aspect of the study also contribute to its generalizability.

Gaps In The Data Collected And Factors Leading To The Gaps: None identified

Feasibility Of Linking With Other Databases: SHAS data are routinely linked to HIV/AIDS surveillance data. The data may also be linked at the local level to other databases (e.g., the Adult/Adolescent Spectrum of Diseases study). However, this may require additional informed consent procedures.

Process To Access The Database And Contact Person: For more information contact: Chief, Surveillance Branch, Division of HIV/AIDS Prevention, Surveillance, and Epidemiology, CDC, Mailstop E-47, 1600 Clifton Road, NE, Atlanta GA 30333; (404) 639-2050.

Selected Citations:

Denning P, Nakashima AK Wortley P, the SHAS Project Group. High risk sexual behaviors among HIV positive adolescents and young adults. Conference on Retroviruses and Opportunistic Infections. 1999.

Campsmith ML, Nakashima AK, Jones JL, Ward JW, the SHAS Project Group. Crack use after HIV diagnosis and impact on condom use.American Public Health Association. 1999.

Sullivan PS, Nakashima AK, Purcell D. Geographic differences in non-injection and injection substance use among HIV-seropositive men who have sex with men (MSM): western United States versus other regions. Journal of AIDS and Human Retrovirology. 19: 266-273, 1998.

Wohl AR, Lu S, Odem S. Sorvillo F, Pegues CF, Kerndt PR. Sociodemographic and behavioral characteristics of African-American women with HIV and AIDS in Los Angeles, 1990-1997. Journal of AIDS and Human Retrovirology. 19(4): 413-420, 1998.

CDC. Risks for HIV infection among persons residing in rural areas and small cities, 1995-1996. MMWR. 47: 974-978, 1998.

Davidson AJ, Bertram SL, Lezotte DC, Marine WN, Rietmeijer CA, Haggland BB, Cohn DL. Comparison of health status, socioeconomic characteristics, and knowledge and use of HIV-related resources between HIV positive men and women. Medical Care. 36: 1676-1684, 1998.

Nakashima AK, Jones JL, Burgess DA, Ward JW, the SHAS Project Group. Predictors of not currently receiving protease inhibitors.International Conference on AIDS. 1998.

Nakashima AK, Jones JL, Burgess DA, Ward JW, the SHAS Project Group. Adherence to currently prescribed antiretroviral therapies: results from a multi-site interview project. American Public Health Association. 1998.

Boyd DK, Brown C. Demographics and needle-sharing of injecting drug users in Arizona. International Conference on AIDS. 11(1): 127 (Abstract No. Mo.C.1418), 1996.

Diaz T, Chu SY, Conti L, Nahlen BL. Health insurance coverage among persons with AIDS: results from a multistate surveillance project.AJPH. 84(6): 1015-1018, 1994.

Fann SA, Conti L, Smith, D, et al. Risks for HIV infection among persons residing in rural areas and small cities- selected sites, Southern United States, 1995-1996. MMWR. 47(45): 974-978, 1998.

Chu SY, Diaz T, Schable B. Risk behaviors among women with HIV/AIDS who report sex with women. International Conference on AIDS. 10(1): 311 (Abstract No. PC0173), 1994.

Diaz T, Chu S. Bisexual men with AIDS: supplement to HIV/AIDS surveillance. International Conference on AIDS. 10(1): 699 (Abstract No. PO-C13-2890), 1993.

Database: Adult/Adolescent Spectrum of HIV Disease (ASD) Project

Purpose Of The Database And Study Design: ASD is a national surveillance project that collects demographic, clinical, behavioral, laboratory, health care use, and other related data on HIV positive individuals 13 years of age and older. ASD provides a method for monitoring the full spectrum of HIV-related illnesses and evaluating trends in those illnesses. Although advances in HIV/AIDS therapy are reducing the number of HIV positive persons advancing to AIDS, many non-AIDS-defining illnesses (e.g., pneumonia) continue to occur. ASD defines the spectrum and magnitude of those non-AIDS-defining illnesses, as well as AIDS-related illnesses.

Nature Of The Data Collected: Longitudinal medical record reviews conducted to study a natural cohort of HIV positive adults

Unit Of Analysis: Individual patients treated at hospital-based outpatient clinics and community-based clinical practices.

Data Collection Methods: ASD uses an observational cohort study design and is conducted through cooperative agreements with health departments in Los Angeles, New York City, Atlanta, Detroit, Denver, Houston, San Antonio, New Orleans, Seattle, and Puerto Rico. Cases are drawn from hospital inpatient and outpatient facilities, infectious disease practitioners specializing in HIV infection, private practice medical groups, HIV treatment facilities, and HMOs. About two-thirds of the cohort receive care in public facilities. ASD follows HIV/AIDS patients accessing care at participating sites to retrieve clinical, treatment, and laboratory data from medical records at six-month intervals, beginning with the entry of the patient into the ASD database and ending with the patient’s death or loss to follow-up. ASD provides risk information and provides surveillance of HIV-related illnesses. ASD data are recorded using standardized software. Information is sent to CDC without personal identifiers. Data analysis is performed at participating State and local health departments and at the CDC.

General Attributes: From the inception of ASD in 1990 to June 1999, over 47,000 patients diagnosed with HIV or AIDS have been observed.

Major Data Constructs And Key Data Elements: Demographic characteristics; mode of HIV exposure; AIDS-defining conditions; other clinical conditions, diagnostic, immunologic, and virologic test results; treatment and prophylaxis; hospitalization dates and discharge diagnoses; date and cause of death; and social data.

Strengths And Weaknesses Of The Study Design And Database: Since its inception, ASD has been the primary source of information for monitoring OIs; served as a sentinel surveillance system for new OIs; provided the data necessary to revise the AIDS case definition in 1993; provided the data necessary to develop the “smearing forward” method of evaluating immunologically-diagnosed AIDS cases over time; and contributed to CDC’s ability to statistically adjust incident AIDS diagnoses to account for the change in the AIDS case definition. The number of records and the diversity of the patient population contained in the database has made ASD data the primary source of information for current PHS HIV treatment guidelines by demonstrating the impact of various treatment regimens on changing patterns of morbidity in the HIV positive population. ASD data represent a diverse group of HIV positive individuals. The database, however, is facility-based and does not represent the HIV positive population in the US.

Gaps In The Data Collected And Factors Leading To The Gaps: CDC is now piloting an ASD-related, population-based surveillance project to monitor preventable OIs and access to care and treatment.

Feasibility Of Linking With Other Databases: Linkage is feasible at the local level.

Selected Citations:

Jones JL, Hanson DK, Dworkin MS, Alderton DL, et al. Surveillance for AIDS-defining opportunistic infections, 1992-1997. MMWR. 48(SS-2): 1-22, 1999.

Sullivan, PS, Hanson DL, Chu SY, Jones JL, et al. Epidemiology of anemia in human immunodeficiency virus (HIV)-infected persons: results from the multistate Adult and Adolescent Spectrum of HIV Disease Surveillance Project. Blood. 91: 301-308, 1998.

Smith D. The HIV Epidemiology Research Study, HIV Outpatient Study, and the Spectrum of Disease Studies. Journal of AIDS and Human Retrovirology. 17(Supple. 1): S17-S19, 1998.

McNaghten AD, Hanson DL, Jones JL, Dworkin MS, et al. The effects of antiretroviral therapy and year of AIDS diagnosis on survival.International Conference on AIDS. 10(1): 311 (Abstract No. PC0173), 1994.

Dworkin MS, Wan PC, Jones WJ. Recent patterns of antiretroviral prescriptions among HIV positive patients in care in the United States.International Conference on AIDS. 12: 146 (Abstract No. 13303), 1998.

Davidson AJ, Bertram SK, Lezotte DC, Marine WM, et al. Comparison of health status, socioeconomic characteristics, and knowledge and use of HIV-related resources between HIV positive women and men. Medical Care. 36(12): 1676-1684, 1998.

Database: Pediatric Spectrum of HIV Disease (PSD) Project

Purpose Of The Database And Study Design: The PSD is designed to monitor: trends in pediatric HIV-related care (e.g., treatment, prophylaxis for OIs, and immunologic and virologic testing); clinical course of HIV infection in children (e.g., occurrence of manifestations of HIV infection, hospitalizations, long-term outcomes, and death); and social circumstances of HIV positive children (e.g., changes in caretakers and school attendance).

Nature Of The Data Collected: Longitudinal medical record reviews conducted to study a natural cohort of HIV positive and HIV-exposed children

Unit Of Analysis: Individual patients treated at hospital-based outpatient clinics

Data Collection Methods: PSD has conducted active surveillance of pediatric HIV infection and perinatal HIV exposure since 1988 in multiple clinical facilities in eight geographic areas in the US. The project is currently conducted in six project sites (New York City, Puerto Rico, Los Angeles, District of Columbia, Texas, and Massachusetts) which coordinate data collection and analysis for their region. Eligible children are identified for Parts A and B through key care providers. Data abstractors supported by the project review all available medical records of eligible children in participating hospitals. All HIV positive children are eligible for enrollment in Part A, which is a long-term prospective medical record review study involving data abstraction at six month intervals. Both HIV-exposed and HIV positive children are eligible for enrollment in Part B, special studies which involve one-time abstraction of medical records of selected subgroups of children to address new research questions. For Part A, data entry occurs at each site into a data management system designed by CDC. For Part B, completed data forms are mailed to CDC for computer entry. Intensive training along with close coordination and supervision ensures accuracy and comparability of the data across sites.

General Attributes: In its tenth year of operation, PSD has enrolled more than 13,125 children, including 4,541 HIV positive children. Each site is currently monitoring between 265 and 1,000 HIV positive children for Part A. For Part B, a total of 1,200 HIV-exposed children born in 1995 were enrolled in a special study completed in FY 1997. In that study, implementation of PHS guidelines for preventing perinatal HIV infection was assessed.

Major Data Constructs And Key Data Elements: Demographic characteristics; mode of HIV exposure; birth history; AIDS-defining conditions; other clinical conditions (e.g., bacterial infections, nonspecific finding for greater than two months, progressive neurological disease, other infectious diseases, tuberculosis, and other possibly HIV-related diagnoses), diagnostic, immunologic, and virologic test results; treatment and prophylaxis, hospitalization dates and discharge diagnoses; date and cause of death; and social data.

Strengths And Weaknesses Of The Study Design And Database: PSD is one of the largest databases in the world for monitoring HIV-exposed and HIV positive children. More than ten years of follow-up has been undertaken for some HIV positive children. PSD provides the capacity to track trends in the pediatric HIV epidemic.

Gaps In The Data Collected And Factors Leading To The Gaps: Data are abstracted from pediatric medical records only, so information on maternal history and in utero exposures is limited. Social data may not be well documented in the medical record.

Feasibility Of Linking With Other Databases: Linkage is feasible.

Selected Citations:

Thomas P, Mundy T, Abrams EJ, Bornschlegel K, et al. Aging cohort of perinatally HIV positive children in New York City (NYC).International Conference on AIDS. 12: 159 (Abstract No. 175/13363), 1998.

Ortiz I, Lugo RG, Perez CM, Suarez E, et al. Decreasing trends in wasting syndrome and failure to thrive among perinatally HIV positive children in Puerto Rico. International Conference on AIDS. 12: 113 (Abstract No. 13237), 1998.

Maldonado Y, Hill DW, Castro M, Sullivan B, et al. Temporal patterns of prenatal HIV testing and perinatal treatment and intervention strategies. International Conference on AIDS. 12: 405 (Abstract No. 23317), 1998.

Frederick T, Mascola L, Thomas P, Hsu HW, et al. HIV positive children becoming adolescents: a descriptive study of older children in New York City, Los Angeles County, Massachusetts, and Washington DC. International Conference on AIDS. 12: 447-448 (Abstract No. 23529), 1998.

Frederick T, Mascola L, Jackson J, Shin YS, et al. Missed opportunities to reduce perinatal HIV transmission: maternal and neonatal zidovudine (ZDV) use in Los Angeles County (LAC). International Conference on AIDS. 12: 395 (Abstract No. 458/23273), 1998.

Bertolli J, Simonds RJ, Thomas P, Melville S, et al. Implementation of recommendations for the medical care of HIV-exposed infants in the first year of life, USA. International Conference on AIDS. 12: 394-395 (Abstract No. 171/23269), 1998.

Shakarishvili A, Schulte J, Levine W, Kreitner S, et al. Lack of timely prenatal care among women infected with HIV: implications for prevention of perinatal HIV transmission in the United States. International Conference on AIDS. 11(2): 158 (Abstract No. We.C.3585), 1996.

Barnhart HX, Caldwell MB, Thomas P, Mascola L, et al. Natural history of human immunodeficiency virus disease in perinatally infected children: an analysis from the Pediatric Spectrum of Disease Project. Pediatrics. 97(5): 710-716, 1996.

Database: HIV Epidemiologic Research Study (HERS)

In collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)

Purpose Of The Database And Study Design: The purpose of HERS is to: (1) determine the impact of HIV infection on the physical, social, and behavioral health of American women; (2) characterize gender-specific and other manifestations of HIV infection in women; and (3) identify the determinants of HIV disease progression in a multi-racial, multi-risk cohort of women.

Nature Of The Data Collected: Longitudinal semiannual interviews, physical examinations, medical record reviews, and specimen collection for testing and repository with centralized data management

Unit Of Analysis: Individual study subjects

Data Collection Methods: Beginning in 1993, a cohort of 1,310 women has been followed at four research centers in the US. The centers are located in New York City, Detroit, Baltimore, and Providence. All study subjects are seen every six months, and women with fewer than 100 CD4 cells are seen every three months. Interviewers, physical examiners, and medical record abstractors were trained in the use of a common protocol which uses the same data collection and tracking instruments for all sites.

General Attributes: Interview, physical examination, and specimens have been collected on 1,310 women, including 871 HIV positive and 439 demographically and behaviorally matched uninfected women. Women were between 16 and 55 years old at enrollment and by design, about 50% reported ever injecting illicit drugs and about 25% report current injection drug use. At enrollment, 58% of the cohort was African-American, 24% white, 17% Hispanic, and less than 1% each Asian, Native American, or of undetermined race/ethnicity.

Major Data Constructs And Key Data Elements: Data collected during the interview include: demographic characteristics, intercurrent illness and symptomatology, medication use, health care utilization, psychosocial health (e.g., depression, adverse life events, social support, disclosure of HIV status), and current sexual and substance use risk behaviors. The physical examination includes a pelvic examination, colposcopy (as indicated), oral exam, skin exam, breast exam, and for patients with low CD4 counts, opthalmologic and neuropsychiatric examinations. Specimen collection includes serum, plasma cells, oral and vaginal smears, wet mounts, HPV assays and yeast cultures. Seronegative women have HIV antibody testing for intercurrent seroconversion and HIV seropositive women have determination of CD4 cell count and HIV viral load.

Strengths And Weaknesses Of The Study Design And Database: Study subjects have been identified at a small number of Northeastern and Midwestern sites: two of which used hospital/clinic based recruitment and two of which used community-based recruitment. Despite the multi-racial, multi-site nature of the sample, some results may not be generalizable to the entire population of at-risk and infected women. The inclusion of demographically and behaviorally matched HIV positive women allows determination of the independent effect of HIV infection on social and medical outcomes.

Gaps In The Data Collected And Factors Leading To The Gaps: None identified

Feasibility Of Linking With Other Databases: Linkage with other databases may be feasible with the consent of the patients and approval by local and CDC institutional review boards.

Selected Citations:

Moore J, Schuman P, Schoenbaum E. Severe adverse life events and depressive symptoms among women with, or at risk for, HIV infection in four cities in the United States of America. AIDS. (in press).

Zierler S, Mayer K, Moore J, Stein M. Sexual practices in a cohort of US women with and without human immunodeficiency virus: HIV Epidemiology Research Study (HERS). Journal of the American Medical Women’s Association. 54(2): 79-83, 1999.

Rompalo AM, Astemoborski J, Schoenbaum E. Comparison of clinical manifestations of HIV infection among women by risk group, CD4+ cell count, and HIV-1 plasma viral load. Journal of AIDS and Human Retrovirology. 20:448-454, 1999.

Klein RS, Flanigan T. Schuman P. The effect of immunodeficiency on cutaneous delayed-type hypersensitivity testing in HIV infected women with anergy: implications for tuberculin testing. International Journal of Tuberculosis and Lung Disease. 3(8): 681-688, 1999.

Cu-Uvin S, Hogan JW, Warren D. Prevalence of lower genital track infections among human immunodeficiency virus (HIV)-seropositive and high-risk HIV-seronegative women. Clinical Infectious Diseases. 29(11): 1145-1150, 1999.

Vlahov D, Wientge D, Flynn C. Violence among women with or at risk for HIV infection. AIDS and Behavior. 2(1): 53-60, 1998.

Solomon L. Stein M, Flynn C, Shuman P, et al. Health service use by urban women with or at risk for HIV-1 infection: the HIV Epidemiology Research Study (HERS). Journal of AIDS and Human Retrovirology. 17(3): 253-261, 1998.

Smith DK. The HIV Epidemiology Research Study, HIV Outpatient Study, and the Spectrum of Disease Studies. Journal of AIDS and Human Retrovirology. 17(Supple. 1): S17-S19, 1998.

Shuman P, Sobel JD, Ohmit SE, Mayer KH, et al. Mucosal candidal colonization and candidiasis in women with or at risk for human immunodeficiency virus infection: HIV Epidemiology Research Study (HERS). Clinical Infectious Diseases. 27(5) 1161-1167, 1998.

Shuman P, Ohmit SE, Sobel JD, Mayer KH, et al. Oral lesions among women living with or at risk for HIV infection: HIV Epidemiology Research Study (HERS) Group. American Journal of Medicine. 104(6): 559-564, 1998.

Rich JD, Astemborski J, Smith DK, Schoenbaum E, et al. Needle exchange programs: availability and participation among injection drug using women. Conference on Retroviruses and Opportunistic Infections. 104 (Abstract No. 134), 1998.

Ohmit S, Schuman P, Schoebbaum E, Rompaolo A, et al. Adherence to antiretroviral therapy (ART) among women in the HIV Epidemiology Research Study (HERS) and Women’s Inter-Agency HIV Study (WIHS). International Conference on AIDS. 12: 590 (Abstract No. 32347), 1998.

Ohmit S, Schuman P, Moore J, Schoenbaum E, et al. Utilization of mental health services by women living with or at risk for HIV.International Conference on AIDS. 12: 484 (Abstract No. 24226), 1998.

Flanigan T, Williams S, Flanigan TP, Cuuvin S, et al. HIV-specific antibody in serum and cervicovaginal lavage of HIV+ women.International Conference on AIDS. 12: 517 (Abstract No. 31111), 1998.

Flanigan T, Sheu M, Flanigan TP, Allsworth J, et al. Continuity of medical care and risk of incarceration in HIV+ and HIV- high risk women.International Conference on AIDS. 12: 604 (Abstract No. 502/32411), 1998.

Arthington-Skaggs B, Warren D, Klein RS, Sobel JD, et al. Emergency of fluconazole resistance among vaginal Candida albicans isolates from an HIV+ women. International Conference on AIDS. 12: 538 (Abstract No. 31216), 1998.

Smith DK, Warren DL, Vlahov D. Design and baseline participant characteristics of the Human Immunodeficiency Virus Epidemiology Research (HERS) Study: a prospective cohort study of human immunodeficiency virus infection in US women. American Journal of Epidemiology. 146(6): 459-469, 1997.

Database: HIV Outpatient Study (HOPS)

Purpose Of The Database And Study Design: To collect information about the demographic characteristics, symptoms, OIs, treatments, and laboratory values of a dynamic cohort of ambulatory HIV positive patients seen at eight to twelve clinics nationwide. The main objective of the project is to assess the efficacy, durability, and adverse effects of antiretroviral therapy in clinical practice.

Nature Of The Data Collected: Longitudinal medical record reviews conducted to study a natural cohort of HIV positive adults

Unit Of Analysis: Individual patients treated at predominantly hospital-based outpatient clinics

Data Collection Methods: Beginning in 1993, medical records at eight to twelve hospital-based HIV clinics are reviewed on an ongoing basis. Medical records are abstracted using a standardized abstraction tool, and the data are automated.

General Attributes: From 1993 to 1999, about 5,000 HIV positive patients were seen during approximately 70,000 visits to their HIV clinicians

Major Data Constructs And Key Data Elements: Demographic characteristics, source of payment, HIV risk group, tobacco and alcohol use, symptoms at the time of the visit, definitive and presumptive disease and conditions presented at the visit, and complete therapeutic drug histories (including start and stop dates and dosage).

Strengths And Weaknesses Of The Study Design And Database: The cohort is treated at a small number of sites and thus may not be generalizable to the larger HIV positive population. Patients may be treated at other sites during intervening periods. Data from those other treatment episodes are not collected.

Gaps In The Data Collected And Factors Leading To The Gaps: HOPS is a convenience sample.

Feasibility Of Linking With Other Databases: Not available.

Selected Citations:

Moorman AC, Holmberg SD, Marlowe SI, et al. Changing conditions and therapies of ambulatory HIV positive patients: the HIV Outpatient Study (HOPS). Annuals of Epidemiology. 9(6) 349-357, 1999.

Von Bargen JC, Moorman AC, Holmberg SD. How many pills do patients with HIV infection take? (letter) JAMA 280(1): 29, 1998.

Moorman AC, Von Bargen JC, Palella FJ, Holmberg SD. Pneumocystis carinii pneumonia incidence and chemoprophylaxis failure in an ambulatory HIV positive population. Journal of AIDS and Human Retrovirology. 19(2): 182-188, 1998.

Smith D. The HIV Epidemiology Research Study, HIV Outpatient Study, and the Spectrum of Disease Studies. Journal of AIDS and Human Retrovirology. 17(Supple. 1): S17-S19, 1998.

Palella FR, Delaney KM, Moorman AC, et al. Declining mortality and morbidity in HIV positive ambulatory patients. NEJM. 17:253-261, 1998.

Holmberg SD, Moorman AC, Von Bargen JS, et al. Possible effectiveness of clarithromycin and rifabutin for Cryptosporidiosiumchemoprophylaxis in HIV positive patients. JAMA. 279:384-386, 1998.

Moorman A, Von Bargen J, Palella F, Holmberg S. Determinants of “breakthrough” Pneumocystis carinii pneumonia (PCP) in the HIV Outpatient Study (HOPS). Conference on Retroviruses and Opportunistic Infections. 118 (Abstract No. 294), 1997.

Loveless M, Delaney K, Moorman A, McCabe r. Quantification of pain syndromes in the HIV Outpatient Study (HOPS). Conference on Retroviruses and Opportunistic Infections. 128 (Abstract No. 350), 1997.

Fisher D, Fuhrer J, Moorman A, Pathak D. Resource utilization in HIV patients diagnoses with CMV. Conference on Retroviruses and Opportunistic Infections. 121 (Abstract No. 307), 1997.

Ward DJ, Fisher DJ, Holmberg SD, Delaney K, et al. Experience with MAC prophylaxis in the HIV Outpatient Study (HOPS). Conference on Retroviruses and Opportunistic Infections. 85, 1996.

Moorman AC, Holmberg SD, Fuhrer J, Loveless M, et al. The HIV Outpatient Study (HOPS): description and initial findings. International Conference on AIDS. 11(2):100 (Abstract No. We.B.3253, 1996.

Moorman AC, Ward DJ, Brown KM, Fisher DJ, et al. Differential antiretroviral use in the HIV Outpatient Study (HOPS). National Conference on Human Retroviruses and Related Infections. 105, 1995.

Database: National School-Based Youth Risk Behavior Survey (YRBS)

Purpose Of The Database And Study Design: The YRBS is an epidemiologic surveillance system that was established by the CDC to monitor the prevalence of youth behaviors that most influence health. The YRBS focuses on priority health-risk behaviors established during youth that result in the most significant mortality, morbidity, disability, and social problems during both youth and adulthood. Such behaviors include: unintentional and intentional injuries; tobacco use; alcohol and other drug use; sexual behaviors that result in HIV infection, other sexually transmitted diseases, and unintended pregnancies; and physical activity. Survey results are used by the CDC to: monitor how priority health-risk behaviors among high school students increase, decrease, or remain the same over time; evaluate the impact of broad national, State, and local efforts to prevent priority health-risk behaviors; monitor progress in achieving relevant national health objectives for the year 2000; and help focus programs and policies for comprehensive school health education on the priority health-risk behaviors.

Nature Of The Data Collected: Self-recorded survey

Unit Of Analysis: Individual survey respondents

Data Collection Methods: The YRBS uses a three-stage cluster sample design to produce a nationally representative sample of ninth through twelfth grade students in the US. The target population is all public, parochial, and other private school students in ninth through twelfth grade in the fifty States and the District of Columbia, with the exception of Louisiana. In Stage 1 in 1997, a total of 1,719 PSUs consist of large counties or groups of smaller, adjacent counties. Fifty-four PSUs were selected from sixteen strata formed on the basis of urbanization and the relative percentage of African-American and Hispanic students in the primary sampling unit (PSU). PSUs were classified as urban if they were in one of the 60 largest metropolitan statistical areas (MSAs) in the US, otherwise they were considered non-urban. PSUs were selected without replacement with probabilities proportional to school enrollment size. In Stage 2, 191 schools were selected with probability proportional to school enrollment size. Schools with substantial numbers of African-American and Hispanic students were sampled at relatively higher rates than all other schools. In Stage III, a sample was randomly selected within each chosen school at each grade, one or two intact classes of a required subject (e.g., English or social studies). All students were eligible to participate. Trained data collectors administered an 88-item questionnaire in the classroom. Students recorded responses on computer scannable answer sheets. Parental consent was obtained prior to sample administration. Individual responses were weighted.

General Attributes: In 1997, there were 16,262 interviews completed.

Major Data Constructs And Key Data Elements: HIV-related items measure sexual history, condom use, alcohol and drug use during sex, drug use history (including injection drug use), HIV education received and source of the education, and use of birth control pills. Other measures include: demographic, educational, and physical characteristics; geographic location; parental educational level; and other health-risk behaviors and frequency of those behaviors.

Strengths And Weaknesses Of The Study Design And Database: The YRBS is a nationally representative survey.

Gaps In The Data Collected And Factors Leading To The Gaps: None identified

Feasibility Of Linking With Other Databases: This is an anonymous survey so linking is not possible.

Process To Access The Database And Contact Person: A public use data set is available. For more information contact: Chief, Surveillance and Evaluation Branch, CDC, Mailstop K-33, 1600 Clifton Road, NE, Atlanta GA 30333; (770) 488-3259.

Selected Citations:

CDC. Trends in HIV-related sexual risk behaviors among high school students- selected US cities, 1991-1997. MMWR. 48(21): 440-443, 1999.

Kann L, Lowry R, Kinchen S, Collins J. Eight-year trends in HIV risk behaviors among US youth. International Conference on AIDS. 12: 204 (Abstract No. 14110), 1998.

Kann L, Kinchen SA, Williams BI, Ross JG, et al. Youth Risk Behavior Surveillance- United States, 1997. Journal of School Health. 68(9): 355-369, 1998.

Garofalo R, Cameron Wolf R, Kessel S, et al. The association between health risk behaviors and sexual orientation among a school-based sample of adolescents. Pediatrics. 101: 8954-902, 1998.

CDC. Trends in sexual risk behaviors among high school students- United States, 1991-1997. MMWR. 47(36): 749-752, 1998.

Shrier LA, Emans J, Woods ER, Durant RH. The association of sexual risk behaviors and problem drug behaviors in high school students.Journal of Adolescent Health. 20(5): 377-383, 1997.

Hou SI, Basen-Engquist K. Human immunodeficiency virus risk behavior among white and Asian/Pacific Islander high school students in the United States: does culture make a difference? Journal of Adolescent Health. 20(1): 68-74, 1997.

CDC. Trends in sexual risk behavior among high school students- United States, 1990, 1991, and 1993. MMWR. 44(7): 124-125, 131-132, 1995.

Lowry R, Holtzman D, Truman BI, Kann L, et al. Substance use and HIV-related sexual behaviors among US high school students: are they related? AJPH. 84(7): 1116-1120, 1994.

Centers for Disease Control and Prevention (CDC), National Center for Chronic Disease Prevention

Database: Behavioral Risk Factor Surveillance System (BRFSS)

Purpose Of The Database And Study Design: In the early 1980s, CDC worked with States to develop the BRFSS. This State-based system gathers information on the prevalence of risk behaviors among Americans and their perceptions and practices related to a variety of health issues. The BRFSS was implemented initially in 1984 by 15 states. By 1994, all US States, the District of Columbia, and three territories were participating in the BRFSS. State and local health departments rely on the BRFSS to: determine priority health issues and identify populations at highest risk; develop strategic plans and target prevention programs; monitor the effectiveness of intervention strategies and progress toward achieving prevention goals; educate the public, health care providers, and policymakers about disease prevention; and support community policies that promote health and prevent disease.

Nature Of The Data Collected: Cross-sectional telephone survey responses

Unit Of Analysis: Survey respondents

Data Collection Methods: States conducting statewide monthly data collection for the BRFSS use a three-stage cluster sampling technique based on the Mitofsky-Waksberg method of random-digit dialing. In that sampling design, as adapted for the BRFSS, telephone numbers are randomly selected from blocks of 100 telephone numbers generated from the set of all existing area codes and prefixes in the state. In Stage 1, selected blocks of 100 randomly ordered numbers are screened to determine the household status of the first number in each block. Blocks remain in the sample only if a residence is reached. In Stage 2, the 100 numbers in the accepted block are randomly dialed to identify additional households. In Stage 3, individual respondents are randomly selected from all adults age 18 or older living in a household. They are interviewed in accordance with the BRFSS protocol until the target number of interviews is completed. Interviews are conducted by trained interviewers using a standardized interview form. The questionnaire has a core component (a fixed core, a rotating core, and emerging issues questions), optional modules, and State-added questions. For comparability, many of the questions in the BRFSS are taken from national surveys such as the National Health Interview Survey (NHIS) and the National Health and Nutrition Examination Survey (NHANES). Most States use a computer-assisted telephone interviewing (CATI) software program. At the end of the interviewing cycle each month, the States use software provided by CDC to edit their data. They then send their data to CDC for final editing. Results are compiled annually. CDC provides each State with an aggregate data set.

General Attributes: Sample sizes vary by state

Major Data Constructs And Key Data Elements: HIV-related questions address: HIV education for school age children, condom use among sexually active teens, self-assessed risk of becoming infected with HIV, blood donation, and HIV testing experience. Other items include: demographic characteristics, household composition, health status, health care access, chronic disease control, tobacco and alcohol consumption, women’s health, immunization, colorectal cancer screening, and injury control. Optional modules cover a range of topics including additional chronic disease, diet, preventive services, health care coverage and utilization.

Strengths And Weaknesses Of The Study Design And Database: The BRFSS provides substantial flexibility to pose questions to the public. Telephone surveys exclude indigent populations that do not have telephones. Response rates for telephone surveys have been declining in recent years.

Gaps In The Data Collected And Factors Leading To The Gaps: The sexual behavior module is optional and many States do not use it. Respondents age 65 years and older are not asked the HIV-related questions; respondents age 50 years and older are not asked the sexual behavior questions. There is a limited number of HIV-related behavioral questions asked on the BRFSS and a low prevalence of risk behaviors are reported. As a telephone survey of the general population, it may be more useful to obtain data on knowledge, beliefs, and attitudes that are the focus of national, State, or local prevention programs than to try to obtain prevalence estimates of risk behavior.

Feasibility Of Linking With Other Databases: Because BRFSS does not collect identifying information, linkage is not feasible. However, the use of comparable questions from other surveys allows comparison of the results.

Process To Access The Database And Contact Person: Information is available through the BRHSS website at:http://www.cdc.gov/nccdphp/brfss. Public use datasets are available on CD-ROM.

Selected Citations:

Sy F, Smith D, Thompson S, Jackson K. The association of perceived risk for HIV infection and self-reports of HIV antibody testing in a predominantly rural US Southern State. International Conference on AIDS. 12: 870 (Abstract No. 43118), 1998.

Liu KL, Mayer KH, Loberti PG, Hesser JE. Factors associated with prior HIV testing from the behavioral risk factor survey in Rhode Island.International Conference on AIDS. 12: 876 (Abstract No. 43145), 1998.

Nebot M, Celentano DD, Burwell L, Davis A, et al. AIDS and behavioral risk factors in women in inner city Baltimore: a comparison of telephone and face to face surveys. Journal of Epidemiology and Community Health. 48: 412-418, 1994.

Vincent AL, Ganguly R, Sanders L, Sinnott JT, et al. A BRFSS-based survey of AIDS education and perceptions in Florida, USA.International Conference on AIDS. 12: 267 (Abstract No. PC0439), 1994.

CDC National Center for Health Statistics (NCHS)

National Health Examination Statistics Surveys (NHANES IV)

The NHANES is conducted by the NCHS, to provide national statistics on the health and nutritional status of the non-institutionalized civilian population through household interviews, standardized physical examinations, and collection of blood samples in special mobile examination centers. The present NHANES, started in March 1999, will be a continuous survey of 5,000 persons per year from 15 randomly selected locations throughout the US. The survey includes 18 components that measure the general health of the civilian non-institutionalized population and 74 laboratory analyses in addition to the HIV assay. Additional information and reports may be obtained from the NCHS web page at: www.cdc.gov/nchs.

Selected Citations:

McQuillan GM, Khare M, Karon JM, Schable CA, et al. Update on the human immunodeficiency virus in the United States household population: NHANES III, 1988-1994. Journal of AIDS and Human Retrovirology. 14(4): 355-360, 1997.

McQuillan GM, Khare M, Ezzati-Rice, Karon JM, et al. The seroepidemiology of human immunodeficiency virus in the United States household population: NHANES III, 1988-1991. Journal of AIDS and Human Retrovirology. 7(11): 1195-1201, 1994.

McQuillan GM, Khare M, Ezzati TM, Schable CA, et al. The seroepidemiology of human immunodeficiency virus in the United States household populations: NHAMES III, 1988-1991. National Conference on Human Retroviruses and Related Infections. 59, 1993.

State and Local Area Integrated Telephone Survey (SLAITS)

As part of the State and Local Area Integrated Telephone Survey (SLAITS), NCHS is conducting a two-phase effort to evaluate HIV-related behavior questions developed by the Behavioral Surveillance Working Group. In Phase 1, questions deemed most sensitive were assessed by four focus groups. A report was prepared and sent to the Working Group and modifications were made to the questionnaire. In Phase 2, a 200 case pilot study will be conducted as a test of the questionnaire administered by telephone with the most sensitive behavioral questions answered using a touch-tone collection methodology. Based on the findings of this pilot, recommendations will be made regarding future implementation of HIV-related behavior questions on random digit dialing telephone surveys of the general population.

National Survey of Family Growth (NSFG)

The National Survey of Family Growth, or NSFG, was conducted in 1973, 1976, 1982, 1988, and 1995. During that time, it has been a survey of women 15 to 44 years of age, designed to produce estimates of sexual activity, marriage and divorce, infertility, contraceptive use, and use of health services that will shed light on birth and pregnancy rates in the US. The survey has been designed to produce estimates for subgroups by age, region, race, education, income and other variables. In the 2001 NSFG (also known as Cycle 6), the NSFG will include a national sample of men 15 to 49 years of age in addition to a national sample of women. HIV funding is being used specifically for the sample of males and for the operations necessary to obtain large samples of black, Hispanic, and 15 to 24-year-old men and women. In addition, the content of the survey is being upgraded to include more HIV-related data, including anal intercourse as well as vaginal intercourse, same-gender sexual activity, condom use for disease prevention, risk behaviors including substance use, exchanging money or drugs for sex, non-voluntary sex, and sexually transmitted disease history. Because most of this HIV-related content is very sensitive for the general population, much of it is administered with Audio Computer-Assisted Self-Interviewing (Audio CASI).

The survey schedule is also being accelerated. Cycle 6 is scheduled for 2001, Cycle 7, for 2004, and Cycle 8, for 2007.

Additional information and reports may be obtained from the NCHS web page at: http://www.cdc.gov/nchs.

National Health Interview Survey (NHIS)

The NHIS is an annual population based survey designed to collect information on the health status and health care utilization of the non-institutionalized, civilian population of the U.S. through personal interviews in about 40,000 households per year. The NHIS has been fielded continuously since the late 1950's. The sample is designed to be representative of the U.S. and of the four main regions of the country. The current design includes an oversample of both the Black and Hispanic populations to improve the ability of NCHS to make reliable health estimates for these two groups. The NHIS includes sets of questions which are asked every year to allow monitoring of trends in basic health measures such as insurance status, prevalence of chronic conditions, injuries, and smoking. In addition, the survey includes supplemental questionnaires to gather information on other important health topics. In 1997, the NHIS underwent a major redesign in both the content and the mode of data collection. The redesigned NHIS continues to cover most aspects of health but focuses on describing the health and health care utilization of individuals. Data are now collected using computer-assisted methodology; this will greatly improve the timeliness of NHIS data.

Information on AIDS knowledge, HIV testing, and general perceptions of risk were collected from adult NHIS respondents with supplements to the NHIS from 1987 to 1995. The NHIS is unique in its ability to provide estimates of all individuals tested for HIV including those who are tested because of blood donation or who seek testing from their private health care provider. In 1997, questions on HIV testing and risk were added to the annual component of the redesigned NHIS. For 2000, the AIDS component will be expanded to collect information on knowledge and risk for tuberculosis, prevalence of sexually transmitted diseases, and additional questions on HIV testing. Thus the NHIS AIDS component provides annual data to monitor the use of HIV testing, general risk behaviors, and basic information on tuberculosis awareness and STD prevalence. This data can also be examined by the other demographic and health information collected in the NHIS. The large annual sample size of the NHIS makes it possible to examine small population subgroups; data from several years can also be combined to further increase analytic possibilities.

Selected Citations:

Tao G, Branson BM, Kassler WJ, Cohen RA. Rates of receiving HIV test results: data from the US National Health Interview Survey for 1994 and 1995. JAIDS. 22(4): 395-400, 1999.

Anderson JE, Hardy AM, Cahill K, Aral S. HIV antibody testing and posttest counseling in the US: data from the 1989 National Health Interview Survey. AJPH. 82(11): 1533-1535, 1992.

Hardy AM, Dawson DA. HIV antibody testing among adults in the US: data from 1988 NHIS. AJPH. 80(5): 586-589, 1990.

National Vital Statistics System (NVSS)

The National Vital Statistics System, conducted by NCHS in partnership with 54 States and vital registration offices, provides complete coverage of all births and deaths in the United States. This program is used to track HIV infection mortality by age, race, Hispanic origin, and sex for the United States, each State, county, and cities of 10,000 or more population from 1987 to the present (currently 1997 data year). This program also includes information on decedents by educational attainment, marital status, place of death (hospital, residence, nursing home, and other places), occupation and industry (for selected States), and State or country of birth.

HIV infection mortality data are available on public use data tapes, CD-ROMS (1991-1996), and in National Vital Statistics Reports (formerly Monthly Vital Statistics Reports), and Vital Statistics of the United States, Volume II, Mortality (annually through 1992 data year). Additional information and reports can be obtained from the NCHS web page at: http://www.cdc.gov/nchswww/products.

Selected Citations:

National Center for Health Statistics. Births and Deaths: Preliminary Data For 1997. 47(4), (PHS) 99-1120, 1998.

Buehler JW, Hanson DL, Chu SY. The reporting of HIV/AIDS deaths in women. AJPH. 82(11): 1500-1505, 1992.

National Death Index (NDI)

The NDI is a central, computerized index of death record information compiled under contract to the NCHS by the State vital statistics programs. Magnetic tapes (beginning with deaths occurring in 1979) contain a standard set of identifying data for each decedent. The data are used to search the NDI to identify and locate death records filed in the State offices. NDI assists researchers to determine if persons in their studies may have died. If so, the NDI provides the names of the States where the deaths occurred, the corresponding death certificate numbers, and the death dates. The NDI user can them arrange with the appropriate State vital statistics office to obtain copies of death certificates or specific statistical information such as cause of death.

Selected Citations:

Dannenberg A, McNeil J, Brundage J. Mortality among 2419 HIV-positive military service applicants: an update. International Conference on AIDS. 7(1): 46 (Abstract No. M.C.94), 1991.

Dannenberg A, McNeil J, Brundage J. Mortality among 1862 HIV positive persons in a geographically dispersed US population: preliminary results. International Conference on AIDS. 125 (Abstract No. WAP31), 1989.

National Health Care Survey (NHCS)

The NHCS is an integrated program of health care provider and establishment surveys and inventories conducted by the National Center for Health Statistics to provide national data on the provision and utilization of health care resources for the major sectors of the health care delivery system. These data are used to monitor health care use, the impact of medical technology, and the quality of care provided to the US population. Currently active NHCS components include the following national probability surveys: the National Hospital Discharge Survey (NHDS), the National Survey of Ambulatory Surgery (NSAS), the National Ambulatory Medical Care Survey (NAMCS), the National Home and Hospice Care Survey (NHHCS), and the National Nursing Home Survey (NNHS).

HIV data needs are addressed through each of the NHCS components through the collection and provision of diagnostic and other information related to HIV. These data describe the utilization of the major sectors in the health care delivery system and the impact of treating HIV on the health system. Specifically, NHDS reports have been published addressing trends in hospital use for HIV. The NAMCS and the NHAMCS provide data on visits to physicians’ offices, and hospital emergency and outpatient departments, respectively, and also collect data on visits at which HIV serology tests were ordered or provided. The NHHCS provides data on the patients receiving care and services received from home health agencies and hospices.

National Hospital Discharge Survey (NHDS)

The National Hospital Discharge Survey (NHDS) is the principal source of information on inpatient utilization of hospitals and is based on a sample of discharges from non-federal, short-stay and general hospitals. The NHDS provides data on the characteristics of inpatients, diagnoses, surgical procedures, expected source of payment, length of stay and on the size, location, and ownership of hospitals. Data from the NHDS are used for tracking specific diseases, the introduction of new technologies, and the impact of changes in financing systems. The NHDS has been conducted annually since 1965.

National Survey of Ambulatory Surgery (NSAS)

The National Survey of Ambulatory Surgery (NSAS) complements the NHDS by providing data on the increasing variety of surgical and diagnostic treatments performed outside the inpatient setting. The NSAS provides data on visits to freestanding and hospital-based ambulatory surgery centers. Data include patient demographic characteristics, diagnoses, surgical operations, and diagnostic procedures performed, patient disposition, and expected sources of payment. The NSAS was conducted from 1994 to 1996.

National Ambulatory Medical Care Survey (NAMCS)

The National Ambulatory Medical Care Survey (NAMCS) is based on a sample of visits to non-federal, office-based physicians who are primarily engaged in direct patient care. Physicians in the specialties of anesthesiology, pathology, and radiology are excluded. Data are obtained on the patient’s demographic characteristics, symptoms, physicians' diagnoses, and medications ordered or provided, and services provided, including information on diagnostic procedures, patient management, and planned future treatment. The NAMCS was conducted annually from 1974 to 1981, in 1985, and annually since 1989.

National Hospital Ambulatory Medical Care Survey (NHAMCS)

The National Hospital Ambulatory Medical Care Survey (NHAMCS) is based on a sample of visits to the emergency departments and outpatient departments of non-federal, short-stay and general hospitals. Data are obtained on the demographic characteristics of patients, expected source(s) of payment, patients' complaints, physician’s diagnoses, diagnostic/screening services, procedures, medication therapy, disposition, types of health care professionals seen, causes of injury where applicable, and certain characteristics of the hospital, such as type of ownership. The NHAMCS has been conducted annually since 1992.

National Home and Hospice Care Survey (NHHCS)

The National Home and Hospice Care Survey (NHHCS) is a continuing series of surveys of home health and hospice care agencies, regardless of whether they are Medicare certified or licensed. Data are collected about agencies that provide home and hospice care and about their current patients and discharges. Home health care is provided to individuals and families in their place of residence for the purpose of promoting, maintaining, or restoring health or for maximizing the level of independence while minimizing the effects of disability and illness, including terminal illness. Hospice care is defined as a program of palliative and supportive care services providing physical, psychological, social, and spiritual care for dying persons, their families, and other loved ones. Hospice services are available in both home and inpatient settings. Data are collected on demographic characteristics, referral and length of service, diagnoses, number of visits, patient charges, health status, reason for discharge, and types of services provided. The NHHCS has been conducted in 1992-1994, 1996, and 1998.

National Nursing Home Survey (NNHS)

The National Nursing Home Survey (NNHS) is a continuing series of surveys of nursing homes, their residents, and their staff. Recent surveys have included nursing homes that were freestanding or were nursing care units of hospitals, retirement centers, or similar institutions where the unit maintained financial and resident records separate from those of the larger institutions. Board and care homes and homes with fewer than three beds were excluded. The NNHS provides information from two perspectives: that of the provider of services and that of the recipient. Data about the facilities include characteristics such as size, ownership, Medicare/Medicaid certification, occupancy rate, days of the care provided, and expenses. For recipients, data are obtained on demographic characteristics, health status, and services received. The NNHS was conducted in 1973 to 1974, 1977, 1985, 1995, and 1997, and will be conducted in 1999.

Health Care Financing Administration(now known as Centers for Medicare and Medicaid Services(CMS)) (HCFA(now known as CMS))

Database: Medicaid Statistical Information System (MSIS)

Purpose Of The Database And Study Design: MSIS was established by HCFA(now known as CMS) in 1984 as a voluntary system for States and was mandated nationally for FY 1999 to standardize the content and structure of Medicaid eligibility and claims files among State Medicaid Programs. Early Medicaid eligibility and claims files (1984-1998) may vary somewhat but contain most of the variables maintained in the 1999 MSIS files.

Nature Of The Data Collected: Longitudinal administrative records regarding Medicaid eligibility and claims submitted for reimbursement by the Medicaid program

Unit Of Analysis: The unit of analysis in eligibility records is the Medicaid beneficiary. The unit of analysis in claim files is the claim. Episodes of care and provider-focused files may also be constructed.

Data Collection Methods: MSIS files are organized in five major groups: Medicaid eligibility, inpatient claims, long-term care, other claims/encounters, and pharmacy claims/encounters. Each set of files contains the recipient’s unique identifier that allows linkage across all files to construct person-based analysis files. The unique identifier may be a Social Security Number or other unique number that is issued only once to a recipient and not reused.

Eligibility records are maintained in the eligibility portion of the MSIS. Eligibility data are recorded by local departments of public welfare. Eligibility files are usually updated on a weekly basis. The eligibility record contains several types of root fields: fixed variables that do not change during enrollment in the Medicaid account (e.g., sex); non-fixed variables that may be overwritten when a change occurs (e.g., ZIP code), and additive variables where longitudinal changes are recorded (e.g., eligibility periods).

Health care providers submit automated or hardcopy claims to the State Medicaid program for processing and payment. Claims files are commonly updated on a weekly basis. MSIS uses four distinct claims file structures: inpatient claims, long-term care claims, outpatient claims, and prescription drug claims. The claim file tape must contain one record for each claim of the appropriate type paid or encounters processed during the reporting period. Each claim file must include: one record for each line item that is separately adjudicated; all fully adjudicated claims that have completed the State’s processing cycle for which the State has determined that it has liability to reimburse the provider; adjudicated claims that have passed all the State’s automated edits, but which resulted in a zero liability because of payments by responsible third parties; claim records representing capitated payments or fees paid to capitated plans; encounter claims, to the extent that they are routinely received by the State; and Medicare/Medicaid crossover claims.

Effective for FY 1999 data, claims files may contain several types of records: current fee-for-service claims for medical services, capitated payments, and encounter claims. Encounter or “pseudo-claims” simulate claims that would have been generated for members of HMOs and health insuring organizations (HIOs), patients in prepaid health plans (PHP), and recipients in primary care case management (PCCM) if their claims were billed on a fee-for-service basis. Some States also use “service-tracking claims” for special purposes, such as tracking individual services covered in a lump-sum billing. Adjustment claims are identified and categorized by the Adjustment indicator field. Another claim type identifies supplemental payment above the capitation fee or above the negotiated rate, such as in the case of Federally Qualified Health Center (FQHC) additional reimbursement.

The inpatient file includes any service claim billed as an inpatient hospital service. This file also includes records for services billed by religious non-medical institutions. Inpatient psychiatric services provided in a separately administered psychiatric wing or psychiatric hospital are not considered acute and are not included in the inpatient file. Psychiatric hospital claims are included in the long term care claims file.

The long term care file includes Title XIX claims for long-term care services received in an institution such as: nursing facilities (NFs), intermediate care facilities for the mentally retarded (ICF-MRs), psychiatric hospitals, and independent freestanding psychiatric wings of acute care hospitals.

The drug claim file records identify Title XIX claims for prescription drugs, durable medical equipment, and supplies provided by a pharmacist under a prescription. Injectibles and other drugs dispensed as a bundled service are reported for the provider administering the service (e.g., physician-administered inoculations are reported on the outpatient file as a physician service).

All other claims not included in the other specific claims groups are in the outpatient file. The outpatient claims file includes: provider claims for all non-institutional Medicaid services (e.g., office-based physician visits, hospital-based ambulatory claims, etc.); provider claims for services received in hospitals, NFs, and ICF/MRs that are not billed as part of the inpatient or long-term care claims (e.g., physician visits in those facilities, services of private duty nurses, encounters); capitated payments; and claims for medical and non-medical services received under a Title XIX waiver. Outpatient records may contain bills for multiple service units (e.g., several physician visits for the same illness, multiple laboratory tests conducted on the same day).

General Attributes: MSIS data files will vary substantially among State Medicaid programs, reflecting the number of Medicaid enrollees and the number of claims processed.

Major Data Constructs And Key Data Elements: Eligibility fixed field variables include: MSIS identification number (a unique identification number used to identify a Medicaid recipient in MSIS), birth date, death date, sex, race/ethnicity, county of residence, ZIP code, dual eligible flag, and Medicare Health Insurance Claim. Monthly fields completed for each month of eligibility include: days of eligibility, eligibility group, maintenance assistance status, basis of eligibility, health insurance, Temporary Assistance to Needy Families (TANF) cash flag, restricted benefits flag, up to four managed care plan types under which the recipient is covered during the month, and State Children’s Health Insurance Program (S-CHIP) code.

Inpatient variables include: program type, Medicaid amount paid, beginning and end service dates, provider identification number, amount charged, other third party payment, Medicaid-covered inpatient days, Medicare deductible payment, Medicare coinsurance payment, up to nine diagnosis codes (ICD-9-CM), up to six procedure codes (ICD-9-CM procedure or CPT codes), admission and discharge dates, patient status, DRG, and up to 23 UB Revenue Codes

Long term care variables include: Medicaid amount paid, beginning and end service dates, provider identification number, amount charged, other third party payment, Medicare deductible payment, Medicare coinsurance payment, five diagnosis codes, admission and discharge date, patient status, ICF-MR days, leave days, nursing facility days, and patient liability.

Prescription drug variables include: Medicaid amount paid, date prescribed, provider identification number, amount charged, other third party payment, quantity (e.g., number of units of a prescription that were filled), days supply, National Drug Code (NDC), prescription fill date, and prescribing physician identification number.

Outpatient variables include: type of claim, date of payment, Medicaid amount paid, beginning and end dates of service, provider identification, amount charged, other third party payment, quantity of service, Medicare deductible payment, Medicare coinsurance payment, two diagnosis codes, place of service, specialty code, service (e.g., CPT-4, ICD-9-CM, and HCPCS), UB-92 revenue code, and provider identification number.

Strengths And Weaknesses Of The Study Design And Database: MSIS is being restructured as a national database for FY 1999, as described above. The system in place prior to 1999 has different variable names, but the design is similar to FY 1999 files. State participation was optional and included approximately 30 States by FY 1998. MSIS eligibility and claims files are useful in conducting a variety of observational studies of HIV positive individuals. The files have substantial limitations, however. They are large and complex and require substantial experience in their use to accurately construct and use analysis files.

There are no direct identifiers for HIV positive Medicaid beneficiaries. Indirect methods must be used, such as the application of ICD-9-CM, NDC, and State-generated specialty HIV rate coding nets. These nets, however, have varying degrees of predictive value, sensitivity, and specificity. Once identified, no direct clinical marker data (e.g., CD4 count or viral load) are available to stage HIV positive beneficiaries. Claims files may not completely identify services received by Medicaid beneficiaries, only those services for which a Medicaid claim was submitted for payment. Moreover, Medicaid beneficiaries may be enrolled in other insurance programs (e.g., Medicare, VA, commercial insurance) or receive services through clinical trials or other sources. Other design factors associated with MSIS make its use complex.

Gaps In The Data Collected And Factors Leading To The Gaps: Clinical marker data, date of HIV infection, death date (often missing from the MSIS eligibility file or delayed in recording), and other sources of payment and care.

Feasibility Of Linking With Other Databases: To study persons with HIV and AIDS, Medicaid eligibility and claims files have been linked to a variety of other databases. Some of these databases include: HARS, Medicare, other insurance claims files, administrative records, observational databases, clinical trial databases, and the NDI.

Process To Access The Database And Contact Person: HCFA(now known as CMS) Center for Medicaid and State Operations, Data and Systems Group, Division of Information, Analysis, and Technical Assistance, (410) 786-0780.

Selected Citations:

Turner BJ, Newshaffer CJ, Cocroft J, Fanning T. Improved birth outcomes among HIV positive women with enhanced Medicaid prenatal care.AJPH. 90(1): 85-91, 2000.

Turner, BJ, Cocroft J, Newschaffer CJ, Hauck WW, Fanning TR. Sources of prenatal care data and their association with birth outcomes of HIV positive women. AJPH. 20: 118-121, 2000.

Wutoh A, Hidalgo J, Rhee W, Bareta J, et al. Survival differences associated with treatment of cytomegalovirus retinitis in Maryland patients with AIDS, 1987-1994. American Journal of Health-System Pharmacy. 56: 1314-1318, 1999.

Wutoh A, Hidalgo J, Rhee W, Bareta J. A characterization of older AIDS patients in Maryland. Journal of the National Medical Association. 90(6): 369-373, 1998.

Walkup J, Sambamoorthi U, Crystal S. Characteristics of persons with mental retardation and HIV/AIDS infection in a statewide Medicaid population. American Journal of Mental Retardation. 104(4): 356-363, 1999.

Walkup J, Crystal S, Sambamoorthi U. Schizophrenia and major affective disorder among Medicaid recipients with HIV/AIDS in New Jersey.AJPH. 89(7): 1101-1103, 1999.

Gebo KA, Chaisson RE, Folkemer JG, Bartlett JG, Moore RD. Costs of HIV medical care in the era of highly active antiretroviral therapy.AIDS. 13(8): 963-969, 1999.

Laine C. Markson LE, McKee LH, Hauck WW, et al. The relationship of clinic experience with advanced HIV and survival of women with AIDS. AIDS. 12: 417-424, 1998.

Turner BJ, Hauck WW, Fanning TR, Markson LE. Cigarette smoking and maternal-child HIV transmission. Journal of AIDS and Human Retrovirology. 14:327-337, 1997.

Turner BJ, Markson LE, Taroni F. Estimation of survival after AIDS diagnosis: CD4 T-lymphocyte count versus clinical severity. Journal of Clinical Epidemiology. 49:59-65, 1996.

Turner BJ, McKee L, Silverman NS, Hauck WW, et al. Prenatal care and birth outcomes of a cohort of HIV positive women. Journal of AIDS and Human Retrovirology. 12:259-267, 1996.

Friedman L, Hidalgo J, Bartnyska L, Turner B. Analyzing survival of adults using a severity classification system for AIDS hospitalizations.Medical Care, 34(2): 178-189, 1996.

Turner BJ, Markson LE, Hauck WW, Cocroft J, et al. Prenatal care of HIV positive women: analysis of a large New York State cohort.Journal of AIDS and Human Retrovirology. 9:371-378, 1995.

Fanning TR, Turner BJ, Cosler LE, et al. Quality of Medicaid data for HIV/AIDS research: examination of a statewide database. AIDS and Public Policy. 10: 39-47, 1995.

Bartnyska L, Schactman M, Hidalgo J. Patterns in Maryland Medicaid enrollment among persons with AIDS. Inquiry. 32: 184-195, 1995.

Markson LE, Cosler LE, Turner BJ. Implications of generalists’ slow adoption of zidovudine in clinical practice. Archives of Internal Medicine. 154: 1497-1504, 1994.

Moore R, Hidalgo J, Bareta J, Chaisson RE. Zidovudine therapy and health resources utilization in AIDS. JAIDS, 7(4): 349-354, 1994.

Moore R, Hidalgo J, Sugland B, Chaisson R. Zidovudine and the natural history of the Acquired Immunodeficiency Syndrome, NEJM. 324(20): 1412-1416, 1991.

Agency: Health Care Financing Administration(now known as Centers for Medicare and Medicaid Services(CMS)) (HCFA(now known as CMS))

Database: Medicare

Purpose Of The Database And Study Design: Medicare files are used to administer the beneficiary eligibility and claims processing responsibilities of the Medicare program. Medicare databases record information regarding all services billed on behalf of Medicare beneficiaries under its hospital (Part A) and supplemental (Part B) insurance plans. Part A covers acute care hospitalizations and stays in skilled nursing facilities (SNFs) for all Medicare beneficiaries. Part B covers physician, outpatient hospital, home health, and other medical services, such as diagnostic radiology and laboratory testing, for those individuals wishing to purchase supplemental coverage.

Nature Of The Data Collected: Longitudinal administrative records regarding Medicare eligibility and claims submitted for reimbursement by the Medicare program

Unit Of Analysis: The unit of analysis in the eligibility or Denominator File is the Medicare beneficiary. The unit of analysis in the claim files is the claim. Episodes of care and provider-focused files may also be constructed.

Data Collection Methods, Major Data Constructs And Key Data Elements: Eligibility files are maintained in the Denominator File. Demographic data in the Denominator File include beneficiary demographic characteristics, geographic data, date of death, enrollment date, HMO enrollment, Medicaid buy-in, if the beneficiary was enrolled in Medicare due to disability or other enrollment criteria, and other related eligibility data. The Denominator File is a sub-set of the Health Insurance Master File that maintains Medicare benefits data for all individuals eligible to receive Medicare benefits. Due to its size, the Health Insurance Master File is not commonly used for analytic purposes.

Several types of Medicare claims files are maintained. Each claim record includes summary beneficiary demographic characteristics. The Part A Medicare Provider Analysis and Review (MEDPAR) file has summary claims records that condense the services billed for an inpatient stay into a single claim. Data included in MEDPAR claims include: institutional provider number, admission and discharge date, length of stay, admission type, discharge destination, days covered by Medicare, coinsurance amount, inpatient deductible, lifetime reserve days, date that SNF benefits were exhausted, total charges, covered charges, amount reimbursed, service-specific charges (e.g., intensive care unit), up to five ICD-9-CM diagnostic codes, up to three ICD-9-CM procedure codes, dates of procedures, and DRG.

The Part B Medicare Annual Data Beneficiary File IV (BMAD-IV) has separate records for each claim to which selected provider and beneficiary data are attached. Data included in the BMAD-IV claims include: individual provider number, provider type, provider specialty, assignment/participation indicator, submitted charge, allowed charge, reimbursed charge, one CPT-4 procedure code, type of service, place of service, date of service, and units of service.

Outpatient Bill Records include: institutional provider number, dates of first and last service, total charges, covered charges, reimbursed amount, professional charges, up to five ICD-9-CM codes, up to three ICD-9-CM procedure codes, and CPT-4 code.

Hospice and Home Health Agency Bill Records include: provider number, date care began and ended, total visits, total charges, charge per unit, number of visits, reimbursement amount, and ICD-9-CM code.

The Institutional Provider of Services file summarizes the characteristics of inpatient facilities providing care to Medicare beneficiaries. The file includes: provider category, total beds, geographic location, residency programs, affiliations, accreditation, administrative control, service provided, number of salaried physicians, residents, nurses, and total staff.

General Attributes: The size of the files will vary based on the years and populations studied.

Strengths And Weaknesses Of The Study Design And Database: Medicare beneficiary and claims files may be useful in conducting a variety of observational studies of HIV positive individuals. The files have substantial limitations, however. They are large and complex and require substantial experience in their use to accurately construct and use analysis files. There are no direct identifiers for HIV positive Medicare beneficiaries. Indirect methods must be used, such as the application of ICD-9-CM coding nets. Since Medicare does not cover pharmaceuticals, coding nets must rely solely on diagnostic coding. Such coding may undercount HIV positive beneficiaries due to the stigmatization that may be related to being identified as being infected. Coding nets that rely solely on ICD-9-CM codes have relatively poor predictive value, sensitivity, and specificity. Once identified, no direct clinical marker data (e.g., CD4 count or viral load) are available to stage HIV positive beneficiaries. Claims files may not completely identify services received by Medicare beneficiaries, only those services for which a Medicare claim was submitted for payment. Moreover, Medicare beneficiaries may be enrolled in other insurance programs (e.g., Medicaid, Veterans Affairs, commercial insurance) or receive services through clinical trials or other sources. Other design factors associated with Medicare files make their use complex.

Gaps In The Data Collected And Factors Leading To The Gaps: Clinical marker data, date of HIV infection, and other sources of payment and care.

Feasibility Of Linking With Other Databases: To study persons with HIV and AIDS, Medicare eligibility and claims files have been linked to a variety of other databases. Some of these databases include: HARS, Medicaid, other insurance claims files, administrative records, observational databases, clinical trial databases, and the NDI.

Process To Access The Database And Contact Person: HCFA(now known as CMS) Office of Information Services, Enterprise Database Group, Division of Data Liaison and Distribution, (410) 786-3673.

Selected Citations:

Fasciano N, Cherlow A, Turner B, Thornton C. Profile of Medicare beneficiaries with AIDS: application of an AIDS case definition system.Health Care Financing Review, 19(3), 19-38, 1998.

Riley GF, Potosky AL, Lubitz JD, Kessler LG. Medicare payments from diagnosis to death for elderly cancer patients by stage at diagnosis.Medical Care. 33(8): 828-841, 1995.

Mitchell JB, Cromwell J. Impact of Medicare payment reductions on access to surgical services. Health Services Research. 30(5): 635-655, 1995.

Davis MH, Burner ST. Three decades of Medicare: what the numbers tell us. Health Affairs. 14(4): 231-243, 1995.

Gornick M, McMillan A, Lubitz J. A longitudinal perspective on patterns of Medicare payments. Health Affairs. 140-150, 1993.

Gaumer GL, Stavins J. Medicare use in the last ninety days of life. Health Services Research. 26(6): 725-742, 1992.

Health Resources and Services Administration (HRSA), HIV/AIDS Bureau (HAB)

Database: AIDS Drug Assistance Program (ADAP) Monthly Report

Purpose Of The Database And Study Design: The ADAP Monthly Report allows the HAB to routinely monitor the fiscal status of ADAPs across the US, trends in enrollment in those programs, and other developments that may have an impact on the ability of HIV positive low-income individuals to access life sustaining and enhancing therapeutics.

Nature Of The Data Collected: Cross-sectional administrative data

Unit Of Analysis: Individual State ADAPs

Data Collection Methods: Reports are submitted electronically or on hardcopy. HAB contractors enter data into an administrative database.

General Attributes: ADAP Monthly Reports were initiated in February 1998 and are submitted by all 50 States, the District of Columbia, Puerto Rico, and US territories. As of April 1999, State submission of ADAP monthly reports is a condition of grant award.

Major Data Constructs And Key Data Elements: Data reported include: funds received by the ADAP by source of funding; monthly enrollment data; methods used to directly measure or estimate enrollment; expenditures by type of drug; unit prices paid by type of drug; changes in key aspects of the program (e.g., financial eligibility, drug formularies, and clinical guidelines issued in the State); and other related data.

Strengths And Weaknesses Of The Study Design And Database: Timeliness of report submissions varies among grantees due to inherent variation in State systems. ADAPs may impute some data (e.g., enrollment) using a variety of methods. Such imputation may result in variation in reliability of the data among ADAPs.

Gaps In The Data Collected And Factors Leading To The Gaps: Additional detailed antiretroviral data are needed. HAB staff is considering adding these elements to the report.

Feasibility Of Linking With Other Databases: ADAP monthly reports may be linked to other State-specific databases. The reports are considered confidential, however, due to confidential funding information provided in the reports.

Process To Access The Database And Contact Person: This is not a database accessible to the public. For more information contact: Paul Mahanna, Public Health Analyst, HRSA, HAB, Division of Service Systems at (301) 443-4063.

Selected Citations: Additional information also may be obtained from the HAB web site: http://www.hrsa.gov/hab

Database: Annual Administrative Report (AAR)

Purpose Of The Database And Study Design: The AAR provides standardized data regarding providers and clients participating in Titles I or II of the Ryan White CARE Act for administrative and fiscal monitoring purposes. The Resource Allocation Report provides data on the amount of funds allocated for various types of health and support services. Title I of the CARE Act provides formula and supplemental grants to Eligible Metropolitan Areas (EMAs) that are disproportionately impacted by the HIV epidemic. Grants are awarded to the chief elected official of the city or county that administers the health agency providing services to the greatest number of HIV positive individuals in the EMA. Title II of the Ryan White CARE Act provides formula grants to States, the District of Columbia, Puerto Rico, and eligible US territories to fund health care and support services for HIV positive individuals. The goal of the AAR is to provide uniformly collected data that shows what populations are being reached and what types and amounts of services are being provided. The AAR is designed to provide information on the number and characteristics of clients who are served by agencies funded by Titles I or II, the types and amount of services they receive, and the agencies from which they receive those services. The Resource Allocation Report supplements the AAR by identifying funds allocated to different types of services, aggregated at the grantee level.

Nature Of The Data Collected: Cross-sectional administrative data

Unit Of Analysis: Providers or programs receiving Titles I or II funds

Data Collection Methods: Providers are required to submit AAR reports annually using standardized reporting forms. The Standard AAR is completed by most providers and includes service counts for contracting agencies and their subcontractors. Providers either submit hardcopy aggregate reports or electronically stored data obtained from their automated files. Title II grantees must report summary fiscal and client data for the ADAPs using the AIDS Pharmaceutical Assistance Program AAR. Local providers that implement pharmaceutical assistance programs must also complete these data. Providers are responsible for developing a data collection system that reports all required data, including unduplicated client counts. Providers are responsible for obtaining and reporting AAR data from subcontractors, completing their aggregate reports, and submitting them to the grantee. Health Insurance Continuation Programs (HICP) must complete a HICP AAR. Titles I or II grantees are responsible for collecting AARs from their providers and subcontractors on a calendar year basis. They must also prepare the AIDS Pharmaceutical Assistance and HICP AARs. The grantees are responsible for ensuring compliance with AAR reporting requirements and providing training and technical assistance to contract providers. Grantees must edit the AARs for completeness and accuracy and forward them to HAB in March of each year. HAB disseminates aggregate data to each grantee and produces national tabular data that summarizes the submissions of grantees. Grantees are required to submit Resource Allocation Reports twice annually by fiscal year, using an Office of Management and Budget (OMB) approved form to report on anticipated allocations 90 days after grant award and then final allocations with their final grant progress report.

General Attributes: AAR data have been submitted by grantees for the period between 1994 and 1999. Summary AAR reports have been completed through 1998, with 1999 data to be available by Fall 2000. A total of 51 Title I grantees and 54 Title II grantees currently submit AAR forms. Resource Allocation Reports were instituted in FY 1996 as a requirement of OMB and approved as a revised AAR. Summary reports and trend analyses have been completed for FY 1996 to 1999. A total of 51 Title I grantees and 54 Title II grantees currently submit Resource Allocation Reports as a condition of grant award and as part of their final progress report.

Major Data Constructs And Key Data Elements: AAR data provided by grantees include provider information (for agencies receiving funds to deliver direct services), the type and units of service provided, and summary client demographic data. The AAR collects data on all clients who receive at least one service in a calendar year that is eligible for Title I or II funding. Resource allocation data can be used to provide amounts, percentages, and trends in increases/decreases of the use of Title I and II funds for various service categories.

Strengths And Weaknesses Of The Study Design And Database: Data are aggregated at the grantee level. Clients often use more than one provider and patient level files with a unique client ID are not submitted to the grantee. Most providers report all services and clients eligible for Titles I or II funding, not just services and clients funded by the Ryan White CARE Act. Although this strategy provides a more complete assessment of the HIV-related services delivered by Ryan White CARE Act providers, the data report over estimates the number of individuals served by Titles I or II. Resource allocation data provide an aggregate description of the use of funds, but they do not represent the actual expenditure of funds by providers.

Gaps In The Data Collected And Factors Leading To The Gaps: In addition to duplicate counts of patients by multiple providers, longitudinal person-based clinical data are not collected. Clinical outcomes cannot be linked to interventions due to lack of longitudinal databases. Provider performance and quality data are inadequately recorded.

Feasibility Of Linking With Other Databases: The provider data reported in the AAR might be linked to other databases. Client data are reported in the aggregate and cannot be linked due to the lack of unique identifiers. A cross-Title AAR prototype is in development.

Process To Access The Database And Contact Person: This is not a database accessible to the public. For more information on the AAR contact: John Milberg, Deputy Branch Chief, HRSA HAB Office of Science and Epidemiology at (310) 443-6560. For the information on the Resource Allocation Report contact: Richard Conviser, PhD, Chief, Evaluation Branch, HRSA HAB Office of Science and Epidemiology at (310) 443-6560

Selected Citations:

HIV/AIDS Bureau, Trends in Ryan White CARE Act Title I and II Allocations for HIV Services: FY 1996-1999. Rockville: HRSA, 2000.

HIV/AIDS Bureau. 1997 Annual Administrative Report: Ryan White CARE Act Title I and Title II National Data Tables. Rockville: HRSA, 1999.

HIV/AIDS Bureau. 1996 Annual Administrative Report: Ryan White CARE Act Title I and Title II National Data Tables. Rockville: HRSA, 1998.

McKinney MM, Wieland MK, Bowen GS, et al. States’ responses to Title II of the Ryan White CARE Act. Public Health Report. 108(1): 4-11, 1993.

Bowen GS, Marconi K, Kohn S, Bailey DM, et al. First year of AIDS services delivery under Title I of the Ryan White CARE Act. Public Health Reports. 107(5): 491-499, 1992.

Database: Uniform Reporting System (URS) Client Data Demonstration Project

Purpose Of The Database And Study Design: In 1994, HRSA initiated the URS to demonstrate the feasibility of collecting client demographic and service data on HIV/AIDS infected/affected clients across a network of service providers and the usefulness of these data for planning and evaluation purposes at both the local and national levels. Through this system, HRSA sought to overcome the limitations of the AAR, the national reporting system for the Ryan White CARE Act. The AAR collects data aggregated at the grantee level and has duplicated counts of clients.

Nature Of The Data Collected: Demographic information, service use, and health indicators are collected.

Unit Of Analysis: Clients of providers funded by Title I or Title II of the Ryan White CARE Act

Data Collection Methods: Demographic information, service utilization, and health indicators of all clients receiving services at providers funded by the Ryan White CARE Act are collected by service providers every six months and sent to their Title I or Title II grantee. The grantees process the data from all of their providers and send these data to HRSA. Also, they continually monitor the quality of the data they receive from their providers and immediately address any problems that arise with the submission of data from their providers. Continuing clients may be followed longitudinally through the use of a unique identifier.

General Attributes: TheURS is a voluntary program, established in 1994 to collect information from several Title I and Title II grantees and their subcontracted service providers about their individual clients. In 1997, through a competitive process, HRSA awarded seven contracts including five Title I sites and two Title II sites, one of which was a new grantee. HRSA supports, both financially and technically, the implementation and collection of the URS data at these seven sites. Although it was originally designed to include clients who received services from Title I and Title II providers, a number of the participating providers also receive funding from Titles III and IV of the Ryan White CARE Act. Therefore, the URS provides a relatively complete picture of all Ryan White CARE Act clients at these seven sites.

Major Data Constructs And Key Data Elements: Client demographics, service utilization, and health status indicators are collected.

Strengths And Weaknesses Of The Study Design And Database: One strength of the database is that an unique identifier is used to protect the anonymity of the clients, and as a further safeguard, this unique identifier is encrypted before it is sent to HRSA. Another strength is that grantees provide technical assistance to all their providers regarding the appropriate and accurate collection and entry of relevant data.

Gaps In The Data Collected And Factors Leading To The Gaps: Althoughclient-level clinical data are not currently collected, HAB is in the process of changing the database to include several outcome measures relating to medical outcomes and whether standards of care are being followed at Ryan White CARE Act providers.

Feasibility Of Linking With Other Databases: Linkages might be achieved through encoding of unique identifiers of other databases using the same algorithm as the systems used for the URS.

Process To Access The Database And Contact Person: Gaining access to the database will be determined on a case by case basis. For more information, please contact Jill M. Jacobsen, PhD, Statistician, HRSA, HAB, Office of Science and Epidemiology at (301) 443-6560.

Selected Citations:

Marconi K, Durbin RC, Niemcryk SJ, Baitty RL. Retention in primary health care of clients diagnosed with HIV by Ryan White CARE Act health care providers over a 30-month period. International Conference on AIDS. 12: 854 (Abstract No. 42402), 1998.

Database: Grantee Applications, Titles I and II of the Ryan White CARE Act

Purpose Of The Database And Study Design: Applications for funding systematically gather data annually that are used for administrative and fiscal monitoring and to confirm conformance with statutory provisions set forth in the Ryan White CARE Act. Special studies have also been conducted.

Nature Of The Data Collected: Cross-sectional administrative, clinical, and psychosocial service data

Unit Of Analysis: Title I and Title II grantees.

Data Collection Methods: Data are aggregated from administrative records, automated data systems, or hardcopy records. Grantees submit data using a standardized tabular format.

General Attributes: Automated data for selected tables is available for 1998 and 1999 application submissions for 49 Title I grantees and 54 Title II grantees.

Major Data Constructs And Key Data Elements: For Title I grantees data include: local HIV epidemiologic data by demographic group, HIV exposure, and other categories; Planning Council membership; Planning Council areas of interest/expertise; summary of the previous year’s expenditures by service area; progress in implementing previous year’s goals; qualitative assessment of populations with special needs; other sources of funding; HIV-related collaboration and coordination activities; and implementation plans. For Title II grantees data include: the previous year’s allocations by service area (i.e., Home and Community-Based Care, Health Insurance Continuation Program, ADAP, HIV Care Consortia, and Administration/Planning/Evaluation), the previous year’s disbursement and expenditures by program category; other sources of HIV-related funding; proposed implementation plans; detailed consortium information by program category; and the demographic characteristics of clients served within consortium region by program category.

Strengths And Weaknesses Of The Study Design And Database: The applications provide useful summary information regarding the processes undertaken to plan, allocate, and deliver HIV services. The quality and completeness of the data provided, however, vary among grantees.

Gaps In The Data Collected And Factors Leading To The Gaps: Unique client service utilization data are not available.

Feasibility Of Linking With Other Databases: Grantee identifiers (e.g., name of the jurisdiction) may be linked to other databases.

Process To Access The Database And Contact Person: This is not a database accessible to the public. For more information contact Richard Conviser, PhD, Chief, Evaluation Branch, HRSA HAB Office of Science and Epidemiology at (310) 443-6560.

Selected Citations:

Hines R, Rosenberg L, Nelson J, Marconi K. Changes in the composition of Ryan White CARE Act Title I Comprehensive Health Services Planning Councils from 1993 to 1996. Meeting of the Association of Health Services Research. 14: 279, 1997.

Database: Ryan White CARE Act Title III Program Data Report

Purpose Of The Database And Study Design: Title III of the Ryan White CARE Act funds outpatient HIV early intervention services for low-income, medically underserved individuals in established primary care systems. Data from Title III Program Data Reports are used for administrative and programmatic monitoring and to confirm conformance with statutory provisions set forth in Title III of the Ryan White CARE Act.

Nature Of The Data Collected: Cross-sectional unduplicated administrative, demographic, clinical, and psychosocial service data

Unit Of Analysis: Agency receiving Title III funding

Data Collection Methods: Grantees submit aggregate data on an annual, calendar year basis using standardized reporting forms. Submissions are commonly mailed in on a fax-to-data form or submitted electronically using the Internet.

General Attributes: A total of 165 grantees submit data on an annual basis. Reporting was initiated on a voluntary basis for FY 1992 and 1993 (with about 50% of grantees submitting data). Mandatory reporting was initiated inFY 1994. 174 projects will be reporting on CY 1999 activities and approximately 23 more will be added in FY 2000.

Major Data Constructs And Key Data Elements: Reports from grantees include: summary grantee data; counseling and testing services provided to clients; primary health care services provided to clients; referrals; case management and/or eligibility assistance services provided; outreach services provided; demographic characteristics and health status of clients; fiscal data related to the Title III award; and summary service utilization among grantee clients. The scope of data reported by the Title III grantee spans all patients, clients, or other individuals served by the agency, as well as services provided by the agency, regardless of the source of funding.

Strengths And Weaknesses Of The Study Design And Database: The quality of the data varies substantially among grantees. Title III grantees are asked to report data that spans all services provided and clients served by the agency, regardless of the funding source. Discretion is given to the grantee to define their Title III program. The actual number of clients served may be under-estimated and that estimation may vary among grantees because data reported may not include services provided through subcontractors.

Gaps In The Data Collected And Factors Leading To The Gaps: Insufficient data systems used by grantees; Title III program data report does not collect direct service utilization data.

Feasibility Of Linking With Other Databases: There are no identifiedlinks to other databases. A cross-Title AAR prototype is in development.

Process To Access The Database And Contact Person: This is not a database accessible to the public. For more information contact:Betty Gramley, Project Officer, HRSA HAB Title III Program, Division of Community Based Programs at (301) 443-0735.

Selected Citations:

HIV/AIDS Bureau, 1996 Program Data Report: Title III Early Intervention Services Ryan White CARE Act. Rockville: HRSA, 1998.

Database: Ryan White CARE Act Title IV Data Reporting System

Purpose Of The Database And Study Design: Title IV of the Ryan White CARE Act funds the development and operation of primary care and social services for children, youth, and women living with HIV, as well as their families. The Title IV program supports comprehensive, community-based, coordinated services that integrate both health and social services. Title IV programs must also develop strategies to effectively link with HIV research studies funded by the National Institutes of Health (NIH) and other entities. The Title IV program actively collaborates with the NIH in the Reaching for Excellence in Adolescent Care and Health (REACH) project. Data from the Title IV Data Reporting System are used for administrative and fiscal monitoring and to confirm conformance with statutory provisions set forth in Title IV of the Ryan White CARE Act. Additionally, the Title IV Data Reporting System is designed to assist HAB to describe to Congress and other policymakers the unique characteristics of service delivery to HIV positive children and their families, as well as prevention of HIV transmission to women and children at-risk.

Nature Of The Data Collected: Cross-sectional administrative, clinical, and support service data

Unit Of Analysis: Program grantees and their subcontractors

Data Collection Methods: Tabular reports must be completed annually by Title IV grantees and their subcontractors. Grantees are responsible for the quality of data reported by sub-contractors and for ensuring that the data reported represent unique, unduplicated client counts. Detailed criteria are provided to the grantees regarding the definition of enrolled clients, family members, and other sub-populations that may be served by the Title IV program.

General Attributes: A total of 53 grantees currently submit annual reports to HAB; five additional adolescent specific grantees will initiate data reporting in FY 2000

Major Data Constructs And Key Data Elements: Data collected include: organizational structure of the grantee and their subcontractors; demographic characteristics and clinical status of clients who are enrolled in the Title IV program; housing/living arrangements; primary caregiver; source of reimbursement for basic medical services; rates of utilization of services by service type; and prevention, outreach, and education activities conducted by the program, including the characteristics of the individuals reached by these services and the frequency with which the services were provided.

Strengths And Weaknesses Of The Study Design And Database: Title IV programs may not have centralized automated information systems that support the data reporting. Client counts may be duplicated due to lack of a centralized information system. Frequency of service use within a Title IV program may be under-counted due to inadequate service tracking systems. Title IV programs vary significantly in design and the array of services provided; those differences may not be accurately reflected in the organization data submitted to the Reporting System. The validity and reliability of the data reported may also be highly variable.

Gaps In The Data Collected And Factors Leading To The Gaps: Minimal clinical data are recorded in the Reporting System.

Feasibility Of Linking With Other Databases: Linkage with other databases is feasible at the local programmatic level. No client identifiers are transmitted to HAB. A cross-Title AAR prototype is in development.

Process To Access The Database And Contact Person: This is not a database accessible to the public. For more information contact: Ivana Williams, HRSA HAB, Deputy Branch Chief, Title IV Programs, Division of Community Based Programs at (301) 443-9051.

Selected Citations:

HIV/AIDS Bureau. Ryan White CARE Act Title IV: Summary Presentation and Comparisons of Selected 1995 and 1996 Data Elements Reported by Grantees. Rockville: HRSA, 1998.

Teitelbaum M, Toland G, Saulsbury K. Ryan White CARE Act Title IV Grant Program: Summary Presentation and Comparisons of Selected 1995 and 1996 Data Elements Reported By Grantees. Cambridge: Abt Associates, Inc., 1994.

Teitelbaum M, Saulsbury K. Ryan White Title IV Grant Program: Summary Presentation and Comparison of 1994 and 1995 Data Elements. Cambridge: Abt Associates, Inc., 1994.

Palinecek J, Hidalgo J, Hutton N, Weiss B. Impact of on-site social work services on the documentation of client and family-centered information: The experience of Ryan White CARE Act (Title IV) pediatric programs in Maryland. Pediatric AIDS and HIV Infection: Fetus to Adolescent. 7(5): 337-345, 1996.

Database: Ryan White CARE Act, Special Projects of National Significance (SPNS) Program

Purpose Of The Database And Study Design: The SPNS Program is supported by Part F of the Ryan White CARE Act to develop innovative models of HIV/AIDS care. These models are designed to address special care needs of HIV positive individuals in minority and hard-to-reach populations. The SPNS projects are designed to be replicable in other parts of the US and to have strong evaluation components. SPNS projects focus on a variety of topics including: managed care, infrastructure development among care providers, access to care through reduction of barriers for specific populations, housing (in collaboration with the Department of Housing and Urban Development), legal advocacy, comprehensive primary care, integration of mental health and primary care, and services for inmates.

Nature Of The Data Collected: Varies by SPNS project

Unit Of Analysis: Varies by SPNS project

Data Collection Methods: Reflecting the unique nature of each SPNS project, data collection methods vary substantially. The data collected is dependent upon the project’s design and the services provided. Several groups of SPNS projects use standardized data collection instruments developed to uniformly capture programmatic, fiscal, client demographic characteristics and health status, and service delivery data.

General Attributes: In Federal Fiscal Year 1999, 87 SPNS grantees were funded.

Major Data Constructs And Key Data Elements: Data elements vary among grantees and are based on the service model used and the scope of the project.

Strengths And Weaknesses Of The Study Design And Database: Given the unique nature of many of the SPNS projects, the study designs and data collection methods vary substantially. The timeliness of reporting and the content of reporting also vary widely among projects.

Gaps In The Data Collected And Factors Leading To The Gaps: Gaps vary among grantees.

Feasibility Of Linking With Other Databases: The feasibility of linkage with other databases varies, based on the data collection strategies used by the project. Some projects rely on clinical, administrative, and insurance claims files that might be linked to other databases at the program level. Unique identifiers are not provided to HAB so linkage at the federal level is not feasible.

Process To Access The Database And Contact Person: These are not databases generally accessible to the public. For more information contact: Barbara Aranda-Naranjo, PhD, Chief, Demonstration Project Development and Evaluation Branch, HRSA HAB, Office of Science and Epidemiology, Special Projects of National Significance Program at (301) 443-9976.

Selected Citations:

Huba GJ, Melchior LA, De Veauuse NF, Hillary K, et al. A national program of innovative AIDS care projects and their evaluation. Home Health Care and Services Quarterly. 17(1): 3-30, 1998.

Gamliel S, Singer B, Marconi K. HIV healthcare delivery and managed care: applications and implications from the Special Projects of National Significance Program. Home Health Care and Services Quarterly. 17(1): 101-109, 1998.

Brady RE, Singer B, Marconi KM. Special Projects of National Significance Program: ten models of adolescent HIV care. Journal of Adolescent Health. 23 (2 Suppl): 1-4, 1998.

Melchior L, Feudo R, Greenberg B, Hodgins A. et al. Outreach to adolescent women with or at high risk for HIV: a report from ten innovative service models. National Conference on Women and HIV. 179 (Abstract No. P2.25), 1997.

Huba G, Hodgins A, Woods E, Kipke M, et al. A profile of adolescent women with or at high risk for HIV: personal and service needs.National Conference on Women and HIV. 178 (Abstract No. P2.24), 1997.

Huba G, Larson T, Marconi K, Melchoir L, et al. Cooperative information sharing, evaluation, and management model for 27 HIV service projects: first year results. International Conference on AIDS. 11(2): 407 (Abstract No. ThD. 50008), 1996.

Database: Ryan White CARE Act AIDS Education and Training Centers (AETCs)

Purpose Of The Database And Study Design: The AETC program is funded by Part F of the Ryan White CARE Act. The AETC program is a national network of centers that undertake targeted, multi-disciplinary education and training programs for health care workers in designated geographic areas. A goal of the AETC program is to expand the number of health care workers who are trained and motivated to counsel, diagnose, treat, and manage the care of HIV positive individuals, as well as help reduce high-risk behaviors that may lead to HIV infection. AETCs collaborate with providers funded by the Ryan White CARE Act, educational institutions, hospital and community-based providers, and professional associations to coordinate and conduct training. AETC projects and their subcontractors maintain several databases. The Individual Program Data Record is completed by participating grantees twice annually. Pertinent information forms are distributed at AETC training sessions to capture data regarding participants.

Nature Of The Data Collected: Cross-sectional administrative and training data

Unit Of Analysis: AETC grantees and subcontractors and providers participating in AETC training sessions

Data Collection Methods: Pertinent information forms are distributed at each training session supported by the AETC program. Attendees complete the forms and return them to the grantees for batching and submission to a centralized site for editing, automation, data analysis, and report development. The Individual Program Data Record reflects aggregate data collected on the submitted information forms, as well as additional programmatic data collected by the grantee and their performance sites.

General Attributes: Currently 15 centers and 75 local subcontractors participate in the program.

Major Data Constructs And Key Data Elements: Information forms include demographic, discipline, and training characteristics of the attendees at the training sessions. Additionally, information is collected regarding the attendees’ site of practice, the patient characteristics, the nature of HIV care they provide, and their training needs. The Individual Program Data Record summarizes the training sessions conducted by the grantee and their performance sites, collaborating organizations, number of sessions offered by level of the training sessions, summary characteristics of the attendees of their training sessions, and summary characteristics of patients seen by the attendees.

Strengths And Weaknesses Of The Study Design And Database: HAB is revising their data collection instruments. Revised forms will be introduced in 2000.

Gaps In The Data Collected And Factors Leading To The Gaps: HAB staff members have identified gaps in the data being collected and items that require updating to reflect new treatment and service modalities.

Feasibility Of Linking With Other Databases: Linkage might be feasible at the grantee or sub-contractor level. Unique identifiers of training session attendees are not recorded so linkage with other databases is not feasible.

Process To Access The Database And Contact Person: This is not a database accessible to the public. For more information contact: Juanita Koziol, Deputy Branch Chief, HRSA, HAB, AIDS Education and Training Center Program, Division of Training and Technical Assistance at (301) 443-6364.

Selected Citations: Additional information also may be obtained from the HAB web site: www.hrsa.gov/hab.

Database: Ryan White CARE Act HIV/AIDS Dental Reimbursement Program

Purpose Of The Database And Study Design: The HIV/AIDS Dental Reimbursement Program assists accredited dental schools and post-doctoral dental programs with uncompensated costs resulting from provision of oral health care to HIV positive patients. The Commission on Dental Accreditation must accredit these institutions. Eligible institutions must document uncompensated costs of oral health care for HIV positive persons. Reimbursement levels reflect the number of patients served by each applicant institution and their unreimbursed oral health care costs, compared to the total number of patients served and total costs incurred across all eligible applicants. In Federal Fiscal Year 1997, 103 institutions received funding through this program.

Nature Of The Data Collected: Cross-sectional administrative and clinical data

Unit Of Analysis: Individual institutions applying for reimbursement

Data Collection Methods: Applicants received a standardized data collection form in March 1999 for reporting of aggregate patient and billing data for the period between July 1997 and June 1998.

General Attributes: Data are collected annually from each institution applying for reimbursement. Methods used to obtain the data submitted in the Dental Reimbursement Program Application vary among applicants.

Major Data Constructs And Key Data Elements: Data collected by the 1999 Program Application include: number of HIV positive patients treated by the applicant institution, method used to estimate the number of patients treated, demographic characteristics of the patients, reimbursement sources, amount of Ryan White CARE Act funds received, numbers of patients who received types of treatment services, estimated unreimbursed costs, methods used to estimate those costs, activities to be funded with the reimbursed costs, and narrative describing the institutions’ collaboration with Ryan White CARE Act planning councils, consortia, and other CARE Act-funded programs, as well as participation in outreach to persons with HIV and to other providers of HIV services.

Strengths And Weaknesses Of The Study Design And Database: The Program Application form was recently revised to gather more complete and accurate data. Detailed instructions for completing the Program Application form are included.

Gaps In The Data Collected And Factors Leading To The Gaps: None identified

Feasibility Of Linking With Other Databases: Individual institutions are identified in the Program Application. Linkage with other institution-specific data is feasible.

Process To Access The Database And Contact Person: This is not a database accessible to the public; functionally, the database is a contact database used by HRSA’s contractor to enter and verify submitted data. It is not currently formatted in a way that would allow easy access, or that allows searches/finds/sorts etc. as a typical database would. For further information contact: Barry H. Waterman, DMD, HRSA, HAB, Dental Reimbursement Program, Division of Community Based Services at (301) 443-1434.

Selected Citations:

There are two documents being prepared for publication in 2000. One is a Report of Aggregate Program Data for the 1998 reporting year; the other is an evaluation of the Dental Reimbursement Program conducted by a consultant/contractor.

Schneider DA, Hardwick KS, Marconi KM, Niemcryk SJ, et al. Delivery of oral health care through the Ryan White CARE Act to people infected with HIV. Journal of Public Health Dentistry. 53(4): 258-264, 1993.

National Institutes of Health (NIH)

Database: Adult AIDS Clinical Trial Group (AACTG)

National Institutes of Allergy and Infectious Diseases (NIAID)

Purpose Of The Database And Study Design: The AACTG, the largest HIV clinical trials organization in the world, plays a major role in setting standards of care for HIV infection and opportunistic diseases related to HIV/AIDS in the US and the developed world. The AACTG has been pivotal in providing the data necessary for the approval of therapeutic agents, as well as the treatment and prevention strategies, for many OIs and malignancies. The AACTG is composed of, and directed by, leading clinical scientists in HIV/AIDS therapeutic research.

Nature Of The Data Collected: Baseline and followup data collected for efficacy evaluations of HIV therapies within large-scale, multi-site clinical trials. Endpoints may include clinical outcomes, CD4 cell counts, or HIV RNA load.

Unit Of Analysis: HIV positive adults

General Attributes: Studies typically include several hundred subjects in each treatment arm.

Major Data Constructs And Key Data Elements: Through innovative hypothesis-based and pathogenesis-oriented studies of the treatment of HIV-1 infection and its sequelae, AACTG research focuses on:

Therapeutic interventions based on knowledge of disease pathogenesis;
Treatment strategies to limit replication of HIV-1 and improve disease-free survival among infected individuals;
Rapid development of agents that prevent or delay the complications of HIV-related disorders;
HIV-1 pathogenesis through advanced laboratory investigation;
Recruitment and retention of clinical trial participants who reflect the changing demographics of the AIDS epidemic;
Therapeutic approaches that improve quality of life for persons with HIV-1 infection.

Strengths And Weaknesses Of The Study Design And Database: Not available.

Gaps In The Data Collected And Factors Leading To The Gaps: None identified.

Feasibility Of Linking With Other Databases: Study subject names are strictly confidential and no identifying information is available.

For more information see the AACTG web site at: aactg.s-3.com. The following NIAID AACTG data sets have been submitted to NTIS for public use:

ACTG 002

The Efficacy & Safety of a Lower Dose of Zidovudine in the Treatment of Patients with AIDS-Associated Pneumocystis Carinii Pneumonia: A Randomized Controlled Trial. NTIS PB 93506087

ACTG 019

Safety and Efficacy of Zidovudine for Asymptomatic HIV Infected Individuals (CD4+cell counts above 500/mm3). NTIS PB 96502661

ACTG 019

Safety and Efficacy of Zidovudine for Asymptomatic HIV Infected Individuals (CD4+cell counts below 500/mm3). NTIS PB 94501871 (diskette and protocol)

ACTG 021

Trimethoprim-Sulfamethazole Versus Aerosolized Pentamidine For Secondary Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients Receiving Zidovudine: AIDS Clinical Trial Group Protocol NTIS PB95500229 (diskette and protocol) NTIS PB 500574 (protocol only)

ACTG 051

A Double-Blind, Placebo Controlled Trial to Evaluate Intravenous Gamma Globulin in Children with Symptomatic HIV Infection Receiving Zidovudine NTIS PB-97501258 (diskette and protocol), NTIS PB97-116867 (protocol only)

ACTG 076

Phase III Randomized Placebo-Controlled Trial to Evaluate the Efficacy, Safety and Tolerance of Zidovudine for the Prevention of Maternal-Fetal HIV Transmission NTIS Accession number pending, Submitted September 1997

ACTG 081

A Randomized Trial of Three Anti-Pneumocystis Agents plus ZDV for the Primary Prevention of Serious Infections in Patients with Advanced HIV Infection. NTIS PB 96-502141

ACTG 116A

Zidovudine Compared with Didanosine in Patients With Advanced HIV Type 1 Infection and Little or No Previous Experience With Zidovudine NTIS PB 97-503171

ACTG 116B/117A

Controlled Trial Comparing Continued ZDV with ddI in Human Immunodeficiency NTIS PB94-504099GEI

ACTG 155

Randomized, Double Blind Comparative Study of Dideoxycytidine (ddC) Alone or ddC/ZDV Combination Versus Zidovudine (ZDV) Alone in Patients with HIV Infections Who Have Received Prior ZDV Therapy. NTIS PB96502695 (diskette and protocol) NTIS PB96184056 (protocol only)

ACTG 175

A Randomized, Double-Blind Comparative Study of dideoxycytidine (ddC) Alone or ddC/ZDV Combination versus Zidovudine (ZDV) Alone in Patients With HIV Infection Who Have Received Prior ZDV Therapy. NTIS PB 98172539 (protocol only) and PB 99500159 (diskette)

ACTG 320

Randomized, Double-Blind, Phase III Study of Indinavir Sulfate (IDV) with Open-Label ZDV or Stavudine (d4T) and Lamivudine (3TC) in Subjects with HIV Infection with CD4 Cell Counts < 200 cells/mm3 and > 3 Months of Zidovudine Experience. NTIS PB 98502560 (diskette)

Selected Citations:

Bakshi S. Evaluation of pharmacokinetics, safety, tolerance, and activity of combination zalcitabine and zidovudine (ZDV) in stable, ZDV-treated, pediatric patients with HIV infection. Journal of Infectious Diseases. 175:1039-1050, 1997.

Boucher F. Phase I evaluation of zidovudine administered to infants exposed at birth to the human immunodeficiency virus. Journal of Pediatrics. 122(1): 137-144, 1993.

Brady M. Randomized study of the tolerance and efficacy of high versus low dose zidovudine in HIV positive children with mild to moderate symptoms (ACTG 128). Journal of Infectious Diseases. 173(5): 1097-1106, 1996.

Connor E. Reduction of maternal-infant transmission of human immunodeficiency virus 1 with zidovudine treatment: results of AIDS Clinical Trial Group Protocol 076. NEJM. 331(18): 1173-1180, 1994.

England J. Zidovudine, didanosine, or both as the initial treatment for symptomatic HIV positive children. NEJM. 336(24) 1704-1712, 1997.

Kline M. A randomized comparative trial of stavudine (d4T) versus zidovudine (ZDV, AZT) in children with human immunodeficiency virus infection. Pediatrics. 101(2): 214-220, 1998.

Luzuriaga K. Phamacokinetics, safety, and activity of nevirapine in HIV Type 1 infected children. Journal of Infectious Diseases. 174: 713-721, 1996.

Luzuriaga K. Combination treatment with zidovudine, didanosine, and nevirapine in infants with human immunodeficiency virus Type 1 infection. NEJM. 336(19): 1343-1349, 1997.

McKinney R. Safety and tolerance to intermittent intravenous and oral zidovudine therapy in human immunodeficiency virus-infected pediatric patients. Journal of Pediatrics. 116(4): 640-647, 1990.

McKiney R. A multicenter trial of oral zidovudine in children with advanced human immunodeficiency virus disease. NEJM. 324(15): 1018-1025, 1991.

O’Sullivan M. The pharmacokinetics and safety of zidovudine in the third trimester of pregnancy for women infected with human immunodeficiency virus and their infants: Phase I Acquired Immunodeficiency Syndrome Clinical Trials Group Study (Protocol 082).American Journal of Obstetrics and Gynecology. 168(5): 1510-1516, 1993.

Shearer W. Transport of recombinant human CD4-immunoglobulin G across the human placenta: pharmakinetics and safety in six mother-infant pairs in AIDS Clinical Trials Group Protocol 146. Clinical and Diagnostic Laboratory. 2(3) 281-285, 1995.

Spector S. A controlled trial of intravenous gamma globulin for prevention of serious bacterial infections in children receiving zidovudine for advanced human immunodeficiency virus infection. NEJM. 331(18): 1181-1187, 1994.

Database: AIDS Link to the Intravenous Experience (ALIVE)

NIAID

Purpose Of The Database And Study Design: The ALIVE cohort is an ongoing prospective study of HIV disease in out-of-treatment drug users residing in Baltimore. The cohort was recruited and screened for HIV infection in 1987 and 1988, 1994, and 1998. The objectives of the study are to: determine the course of HIV infection by characterizing the rate of progression to AIDS, immunosuppression, specific disease outcomes, and HIV-related mortality; identify markers of progression to clinical outcomes and levels of immunosuppression; identify the effect of HIV progression on drug use and sexual behaviors; evaluate the impact of specific gynecological conditions on progression in women; identify survival times from clinical and laboratory endpoints and factors associated with rapid progression and long-term survival; and collaborate using the ALIVE cohort for additional studies.

Nature Of The Data Collected: Longitudinal collection of physical examination, clinical specimens, and interview data

Unit Of Analysis: HIV positive and uninfected adolescent study subjects

Data Collection Methods: Injecting drugs users in Baltimore were recruited to participate in the study through dissemination of information about the study by a variety of community-based organizations. Eligibility for enrollment in the study included being 18 years of age or older, a history of injecting illicit drugs at any time within the previous 11 years, and being free of an AIDS-defining condition at baseline. At the baseline visit, eligible and consenting injecting drug users were enrolled and assigned a unique identifier on data collection instruments. After blood samples were taken, each participant received a face-to-face interview. A standardized baseline interview obtained demographic characteristics, medical history, and history of drug injection and sexual practices. All HIV seropositive subjects and a sample of seronegatives were enrolled in a longitudinal follow-up arm of the study. HIV seronegative study subjects were encouraged to return every six months for screening and an interview. At each six-month follow-up interview, HIV seronegative subjects were interviewed about their injecting drug use behavior and sexual practices during the past six months. HIV positive subjects were interviewed and given physical examinations at six-months intervals.

General Attributes: A total of 2,921 participants have enrolled in the study.

Major Data Constructs And Key Data Elements: Data collected at six-month intervals includes: demographic characteristics, signs and symptoms of HIV-related disease, licit and illicit drug use behaviors, use of HIV-related therapeutics, sexual history and practices, and frequency of condom use. A physical and brief neurological examination is conducted. Pap smears and pelvic examinations are conducted on women and cervical specimens obtained by cervico-vaginal lavage. At each visit, blood is drawn for serologic and immunologic testing.

Strengths And Weaknesses Of The Study Design And Database: The ALIVE cohort represents a long-standing, well-studied group of injecting drug users.

Gaps In The Data Collected And Factors Leading To The Gaps: None identified.

Feasibility Of Linking With Other Databases: Other databases have been linked to the ALIVE database including the HARS and Medicaid eligibility and claims files.

Process To Access The Database And Contact Person:

Selected Citations:

Solomon L, Vlahov D, Astemborski J, Galai N, et al. Factors associated with initiation of zidovudine in a cohort of injection drug users.Journal of Drug Issues. 25(1): 225-233, 1995.

Vlahov D, Munoz A, Solomon L, Astemborski J, et al. Comparison of clinical manifestations of HIV infection between male and female injecting drug users. AIDS. 8(6): 819-923, 1994.

Vlahov D, Astemborski J, Solomon L, Nelson KE. Field effectiveness of needle disinfection among injecting drug users. Journal of AIDS. 7(7): 760-766, 1994.

Astemborski J, Vlahov D, Warren D, Solomon L, et al. The trading of sex for drugs or money and HIV seropositivity among female intravenous drug users. AJPH. 84(3): 382-387, 1994.

Solomon L, Astemborski J, Warren D, Munoz A, et al. Differences in risk factors for human immunodeficiency virus type 1 seroconversion among male and female intravenous drug users. American Journal of Epidemiology. 137(8): 892-898, 1993.

Database: Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA) Observational Data Base (ODB)

NIAID

Purpose Of The Database And Study Design: CPCRA was established in 1989 to broaden the scope of the HIV research effort of NIAID to include clinical trials conducted in community-based settings. The main goal of the CPCRA is to obtain evidence to properly inform health care providers and people living with HIV about the most appropriate use of available HIV therapies in diverse populations across the spectrum of HIV disease.

The CPCRA is a network of community-based health care providers who have integrated scientific research into primary care. It now includes 15 research units, a statistical center, and an operations center. Research units are based in a variety of primary care settings, including private practices, community clinics, university outpatient departments, and VA hospitals. Located in 14 cities across the US, these 15 units and their patient base represent diverse geographic, racial, and risk groups. The CPCRA offers access to a large number of patients whose demographic characteristics reflect those of the evolving HIV epidemic. The CPCRA has established clinician/patient relationships that enhance patient retention and compliance in clinical studies and allow for long-term follow-up.

The scientific agenda for the CPCRA focuses on answering key clinical management questions that face providers and patients every day. The agenda is constructed around a core of antiretroviral treatment trials. CPCRA trials are designed with nested substudies aimed at understanding the pathogenesis of HIV infection and the public health implications of its treatment. These trials are complemented with substudies and other trials focused on issues of current interest. Antiretroviral and immunomodulatory research focuses on studies designed to determine the durability of virologic suppression of initial drug regimens and evaluate the virologic changes caused by second- and third-line regimens, as well as analyze the clinical consequences of the entire treatment sequence. The CPCRA plans to investigate the clinical outcome of patients with early HIV infection who receive an immunomodulator, as well as investigate various treatment combinations and sequences in this patient population.

The CPCRA studies how the spectrum of complication of HIV disease is changing and whether OI prophylaxis and treatment strategies should be modified. In addition, the CPCRA is interested in nutritional and metabolic disregulation and their effects on the pathogenesis, treatment, and clinical course of HIV disease.

The ODB is a data file of baseline and disease incidence information on 5,104 HIV positive patients enrolled between September 1990 and November 1992. Baseline variables include demographic characteristics, treatments, CD4 count, and HIV risk factors. Follow-up data through July 1, 1994 are included for 44 different incident opportunistic events and death.

Process To Access The Database And Contact Person: For additional information contact: Jonathan Kagan, MD, Therapeutics Research Program, DAIDS, NIAID, (301) 402-0131. Information regarding the CPCRA studies listed below may be obtained from the NTIS.

Study #	Title	NTIS Reference #
001	A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV positive Individuals with Serologic Evidence.	PB95-503405GEI (diskette and protocol) PB95-19151 (documentation only)
002	A Prospective, Randomized Open-Label, Comparative Trial of Dideoxyinosine versus Dideoxycytidine in HIV positive Patients Who Are Intolerant of or Who Failed Zidovudine Therapy.	PB95-503413GEI (diskette and protocol) PB95-191169 (documentation only)
CPCRA Observational Data Base		PB96-500897
CPCRA Cross-Study Data Base		PB96-500889

Selected Citations:

Please refer to the CPCRA webpage for a complete and up-to-date listing of abstracts and publications: http://www.cpcra.org/publications/.

Burns DN, Hillman D, Neaton JD, Sherer R, Mitchell T, Capps L, Vallier WG, Thurnherr MD, Gordin FM. Cigarette smoking, bacterial pneumonia and other clinical outcomes in HIV-1 Infection. JAIDS, 13(4): 374-383, 1996.

Torres RA, Neaton JD, Wentworth D, Barr MR, Abrams D, Sherer R, Ward T, Sampson J. Acyclovir and survival in an observational cohort enrolled by the Community Programs for Clinical Research on AIDS (CPCRA). Clin Infect Dis, 26: 85-90, 1996.

Melnick SL, Sherer R, Louis TA, Hillman D, Rodriguez EM, Lackman, Capps L. Survival and disease progression according to gender of patients with HIV infection. JAMA. 272(24): 1915-1921, 1996.

Database: HIV Vaccine Clinical Trials Network (hvtn) and HIV Prevention Clinical Trials Network (hptn) - Formerly HIV Network for Prevention Trials (hivnet)

NIAID

Purpose Of The Database And Study Design: HIVNET was established in 1993 by the Division of AIDS (DAIDS), NIAID to be a multi-center, collaborative research network whose mission is to carry out HIV prevention efficacy trials. Its purpose was to evaluate the safety and effectiveness of promising interventions to prevent the transmission of HIV between sexual and/or needle-sharing partners, as well as from mother to baby during pregnancy and at birth. In most cases, the primary aim of these studies is to measure the effect of prevention interventions on reducing the number of new HIV infections.

The HIVNET has had a broad agenda that includes trials of vaccines, topical microbicides, treatment of sexually transmitted diseases, behavioral interventions, and approaches to prevent mother-to-infant transmission. It focuses primarily on efficacy trials (although it has carried out some Phase I and II studies) in an international multi-center network. Scientific collaborations with scientists in industry and academia, and NIAID staff constitute other key components of the program. The clinical research sites of the HIVNET are located in the US and abroad. Twenty-two research sites are currently located in eleven cities in the US. Eleven international sites are located in Asia, Africa, the Caribbean, and South America.

HIVNET's studies are often carried out in collaboration with other agencies that are involved in prevention research including NIMH, NIDA, the National Institute of Child Health and Human Development (NICHD), the National Institute on Alcohol Abuse and Alcoholism, Fogarty International Center, CDC, Walter Reed Army Institute of Research, the US Agency for International Development, the Population Council, the Contraceptive Research and Development Program, the United Nations AIDS program, and the World Health Organization.

In 1999, a plan for reconfiguration of the NIAID’s clinical prevention research and development program emerged from an eight-month process of evaluation and discussion involving a broad cross-section of the scientific and at-risk communities. The plan preserves important assets of the current program, minimizes disruption of ongoing and planned studies, ensures scientific and managerial continuity, creates greater opportunity for scientific creativity, and allows the possibility for institutions to participate in both areas of clinical research and development. The plan calls for the reconfiguration of HIVNET and the AIDS Vaccine Evaluation Group (AVEG) to create:

A comprehensive, clinically-based HIV Vaccine Clinical Trials Network (HVTN) with an expanded, integrated clinical research and development agenda including domestic and international components; and
A strengthened HIV Prevention Clinical Trials Network (HPTN) with a discreet scientific identity, a stable and predictable funding stream, and an integrated clinical research and development agenda with domestic and international components.

An orderly transition process has been undertaken to consolidate scientific responsibility for HIV vaccine research and development in the HVTN. Similarly, other areas of clinical prevention research currently under the purview of HIVNET will be consolidated in the HPTN. The transition will proceed through a two-stage process. The first stage will consist of establishing separate vaccine and prevention leadership core groups. The second stage will be the selection of the clinical sites.

Unit Of Analysis: Individuals at risk for HIV Infection

General Attributes: The Vaccine Preparedness Study (VPS) (HIVNET Protocol D01) was completed in January 1998. VPS had 4,892 participants from three groups at high risk for HIV: injection drug users, men who have anal intercourse (receptive or insertive) with other men, and women at high risk for HIV infection through heterosexual contact. In August 1997, an expansion of the VPS was launched with the recruitment of new groups of injection drug users at HIVNET sites in Philadelphia and New York City. The expansion continued in February 1998 with the start of recruitment of individuals in the three high risk groups at five pre-existing and three new HIVNET sites, in Baltimore, Los Angeles, and the Bronx.

Additional vaccine studies include: Safety Trial of Two HIV Vaccine Strategies in HIV-Negative Volunteers (HIVNET Protocol 014), HIV-Exposed But Uninfected Study (HIVNET Protocol D01.3), and the Infected Participant Cohort (IPC) (HIVNET Protocols D01.1 and 019).

Microbicide studies include: PMPA Gel Vaginal Microbicide Study (HIVNET Protocol 018), Phase 1 Rectal Microbicide Study (HIVNET Protocol 008), and the Vaginal Microbicide Study of Buffergel PRO 2000/5 Gel Study.

Behavioral studies include: HIV Early Detection Study (HEDS) (HIVNET D01.2), a trial of a behavioral intervention for men who have sex with men (HIVNET Protocol 015, "EXPLORE"), and an application of computer technology to assess risk behaviors among participants in the Vaccine Preparedness Study of HIVNET (HIVNET Protocol 005).

Strengths And Weaknesses Of The Study Design And Database: The HIVNET has a track record of carrying out important studies in the relevant areas of science and has made many significant contributions to the field of prevention research. It has had an active agenda and established systems and procedures. There is extensive integration of communities at-risk into the research program. There are well-established central laboratories and working structures for utilizing them and the data that are generated by them. The HIVNET funding structure is designed for the specific purpose of creating a network upon which a vaccine efficacy trial could be placed. It uses sites and "infrastructure" as its fundamental organizing principal, rather than science.

HIVNET has depended on additions to the infrastructure through incremental funding for particular clinical trials. This led to substantial variation in year-to-year funding levels and considerable difficulty in establishing scientific priorities when the funding base has been unpredictable. The "compartmentalization" of vaccine development, where Phase I and Phase II vaccine trials are in AVEG and Phase III in HIVNET, has made it difficult to ensure maximal efficiency and a "seamless" program of vaccine development. This has required coordination across two different organizations with varied scientific focus and priorities, laboratories, and data collection and analysis systems.

Feasibility Of Linking With Other Databases: None

Process To Access The Database And Contact Person: For additional information contact: Lawrence Corey, MD, Fred Hutchinson Cancer Research Center, University of Washington, (206) 667-6702. The HIVNET website is: http://www.hivnet.commed.net/.

Database: Multicenter AIDS Cohort Study (MACS)

NIAID

Purpose Of The Database And Study Design: MACS is a study of HIV infection in homosexual and bisexual men. Selected participants currently being followed include: HIV positive men who were enrolled in the study as seroprevalent cases or who have seroconverted while in the study; HIV-seronegative men at high risk of HIV-infection based on behavioral assessments, and a matched set of seronegative men who are at lower risk of HIV infection. NIAID plans to follow these subjects through at least 2005. MACS data have been used to conduct an array of HIV research including: clinical effects of therapy, trends in survival, and trends in HIV-related clinical events; correlation of host immune responses to the development of HIV disease; use of viral load as a predictor of outcome following seroconversion; use of viral factors including HIV phenotyping to determine disease outcome; trends in health service use; and HIV-related neuropsychological outcomes.

Nature Of The Data Collected: Longitudinal collection of clinical specimens and interview data

Unit Of Analysis: A matched cohort of HIV positive and seronegative men

Data Collection Methods: MACS subjects are followed at the clinical centers at six-month intervals. During their visits, they respond to a detailed health questionnaire, receive a physical examination, and have blood specimens taken. These specimens are processed and stored as frozen serum, plasma, and cells in the NIAID AIDS Specimen Repository. Additional samples of blood and other body fluids and tissues are collected for specific MACS pathogenesis protocols.

General Attributes: Over 5,500 men have participated in the MACS since the initial enrollment in 1984. MACS clinical centers include Baltimore, Pittsburgh, Chicago, and Los Angeles. Over one million specimens are housed in the NIAID AIDS Specimen Repository.

Major Data Constructs And Key Data Elements: Data collected include: immunologic, virologic, and other biologic determinants of disease progression, factors that are associated with HIV-mediated immune system destruction; and factors that might protect individuals from becoming HIV positive. Interview data include detailed questions regarding: sexual practices, HIV-related symptoms, use of health services, demographic and psychosocial characteristics, and quality of life.

Strengths And Weaknesses Of The Study Design And Database: MACS has experienced a high retention rate, with loss to follow-up of less than 20 percent among HIV positive men after ten years. MACS represents a repository of clinical specimens that cover the natural history of HIV infection and disease among a large cohort of at-risk individuals. The cohort has a disproportionately low number of minority homosexual and bisexual men participating. The MACS cohort also is not generalizable to segments of the newly HIV positive population who tend to have become HIV positive through injecting drug use or heterosexual transmission. The MACS cohort also is not generalizable to HIV positive women, a rapidly growing segment of the HIV positive population.

Gaps In The Data Collected And Factors Leading To The Gaps: None identified

Feasibility Of Linking With Other Databases: Feasibility is unclear. Public use tapes of accumulated MACS data are created biannually.

Process To Access The Database And Contact Person: Public use tapes may be obtained from NTIS. To order call (800) 553-6847 or through the NIAID website: http://www.niaid.nih.gov/research/aidsdata.htm.

Selected Citations:

Lyles RH, Tang AM, Smit E, Mellors JW, et al. Virologic, immunologic, and immune activation markers as predictors of HIV-associated weight loss prior to AIDS. JAIDS. 22(4): 386-394, 1999.

Saah AJ, Hoover DR, Peng Y, Phair JP, et al. Predictors of failure of Pneumocystis carinii pneumonia prophylaxis. JAMA. 273(15): 1197-1202, 1995.

Palenicek JP, Graham NMH, He YD, Hoover DA, et al. Weight loss prior to clinical AIDS as a predictor of survival. Journal of AIDS and Human Retrovirology. 10(3): 366-373, 1995.

Hoover, DR, Rinaldo C, He Y, Phair J, et al. Long-term survival without clinical AIDS after CD4+ cell counts fall below 200X10⁶/I. AIDS. 9:145-152, 1995.

Kirby AJ, Munoz A, Detels R, Armstrong JA, et al. Thrush and fever as measures of immunocompetence in HIV-1-Infected men. Journal of AIDS and Human Retrovirology. 7(12): 1242-1249, 1994.

Kass NE, Munoz A, Chen B, Zucconi SL, Bing EG, et al. Changes in employment, insurance, and income in relation to HIV status and disease progression. JAIDS. 7(1): 86-91, 1994.

Bacellar H, Munoz A, Hoover DR, et al. Incidence of clinical AIDS conditions in a cohort of homosexual men with CD4+ cell counts less than 100/mm3. Journal of Infectious Diseases. 170:1284-1287, 1994.

Munoz A, Schrager LK, Bacellar H, et al. Trends in the incidence of outcomes defining acquired immunodeficiency syndrome (AIDS) in the Multicenter AIDS Cohort Study. American Journal of Epidemiology. 137: 423-438, 1993.

Database: Reaching for Excellence in Adolescent Care and Health (REACH) Project

National Institute for Child Health and Human Development (NICHD)

Purpose Of The Database And Study Design: The REACH Project is designed to gain a better understanding of HIV disease progression and co-morbidity in adolescents to improve their health care management. Clinical science investigators participating in REACH must document two years experience caring for youth and must be affiliated with a clinical setting providing a wide array of adolescent health services to HIV positive youth. A total of 16 clinical sites in 13 cities participate in REACH, four sites in the New York/New Jersey area, three sites in the Mid-Atlantic area, six sites in the Southeast, one in Chicago, and one in Los Angeles.

Nature Of The Data Collected: A case-control design with HIV positive and uninfected sexually active adolescent study subjects is used. Longitudinal person-based clinical specimens, physical examination, and interview data are collected.

Unit Of Analysis: HIV positive and uninfected adolescent study subjects

Data Collection Methods: Several forms are used to collect data: direct face-to-face interviews, interactive computer interviewing (ICI), medical record abstraction, physical examination, and laboratory examination. Cases and controls are seen every three months, with data collected at each visit using all the data collection instruments except the ICI. The ICI is conducted every six months. Clinical investigators recruit study subjects at their clinical sites. Study coordinators are usually research nurses who have been centrally trained on both interviewing technique, as well as the intent of the questions. Clinicians and study coordinators are trained in protocol procedures, sample collection and processing, oral and skin examinations, and skinfold measurements.

General Attributes: Data gathered through the August 1997 database include baseline data on 225 subjects for the first 18 months of study accrual. Study recruitment and data collection are ongoing.

Major Data Constructs And Key Data Elements: Face-to-face interview measures include: demographic and educational characteristics, insurance coverage, living situation, and income, as well as a health history. The ICI gathers information regarding social support systems, depression, life-change events, HIV disclosure, coping, and sexual and drug-related behaviors. The physician examination includes standard measures, as well as the Tanner staging for sexual maturity, a gynecological and urogenital examination, and tuberculin test. Laboratory examinations include immunologic, virologic, hormonal, urinary drug screen, and sexually transmitted disease testing. A cerviocography is also conducted. The health-risk profile at entry into REACH includes a sexual history, condom use, smoking habits, and drug use. HIV testing, CD4 testing for HIV positive subjects, history of AIDS-related conditions, and use of antiretroviral treatment are also assessed at entry.

Strengths And Weaknesses Of The Study Design And Database: REACH is a well-established and documented cohort of HIV positive and uninfected adolescents.

Gaps In The Data Collected And Factors Leading To The Gaps: None identified.

Feasibility Of Linking With Other Databases: Linkage may be feasible with the consent of the study subjects.

Process To Access The Database And Contact Person: Audrey Rogers, PhD, NICHD, (301) 435-6873.

Selected Citations:

Rogers AS, Futterman DK, Moscicki AB, Wilson CM, et al. The REACH Project of the Adolescent Medicine HIV/AIDS Research Network: design, methods, and selected characteristics of participants. Journal of Adolescent Health. 22(4): 300-311, 1998.

Rogers AS, Futterman DK, Levin L, D’Angelo L. A profile of human immunodeficiency virus-infected adolescents receiving health care services at selected sites in the United States. Journal of Adolescent Health. 19(6): 401-408, 1996.

Database: Women’s Interagency HIV Study (WIHS)

NIAID, in collaboration with National Institute on Drug Abuse (NIDA), National Cancer Institute (NCI), National Institute on Dental Research and the CDC

Purpose Of The Database And Study Design: The WIHS is a multi-center, prospective study established in 1993 to carry out comprehensive investigations of the impact of HIV disease in women. WIHS was established in 1993 in tandem with a similar study, the HIV Epidemiology Research Study (HERS) coordinated by the CDC. The six WIHS sites are organized as a consortium. The sites are located in New York (two sites), the District of Columbia, Chicago, San Francisco, and Los Angeles. NIAID, NICHD, NIDA, NCI, and NIDR support various components of WIHS.

Nature Of The Data Collected: Longitudinal collection of physical examination, clinical specimen, and interview data

Unit Of Analysis: Study subjects are followed longitudinally

Data Collection Methods: Study subjects were recruited from HIV primary care clinics, hospital-based programs, and a variety of other community-based programs. To participate in WIHS, women must have been at least 13 years of age, provide informed consent to participate, be tested for HIV, complete an interview, participate in a baseline visit, and provide blood for laboratory testing. Study subjects participate in a baseline visit and follow-up visits every six months conducted by interviewers and examiners trained centrally. The baseline visit includes a physician and gynecological examination, oral examination, tuberculin and anergy skin testing, and laboratory specimen collection. Their medical records are also abstracted for all hospitalizations and HIV-related conditions.

General Attributes: A total of 2,641 women (2,066 HIV positive and 575 seronegative women) are under follow-up.

Major Data Constructs And Key Data Elements: The baseline visit interview gathers data regarding: demographic characteristics, medical and health history, obstetric and gynecologic history, drug use, sexual behavior, health care use, and psychosocial measures including quality of life. A baseline medical and gynecologic examination is conducted also. Similar data are collected at six-month intervals.

Strengths And Weaknesses Of The Study Design And Database: The generalizability of the groups studied is unclear.

Gaps In The Data Collected And Factors Leading To The Gaps: None identified

Feasibility Of Linking With Other Databases: Feasibility is unclear

Process To Access The Database And Contact Person:

Selected Citations:

Cejtin HE, Komaroff E, Massad LS, Korn A, et al. Adherence to colposcopy among women with HIV infection. JAIDS. 22(3): 247-252, 1999.

Weber K, Cohen M, Riester K, Holman S, et al. HIV research and women: what influences attrition? International Conference on AIDS. 12: 813 (Abstract No. 42202), 1998.

Levine AM, Melnick SL, Preston-Martin S, Silver S, et al. Use of mammography screening by HIV infected women: Women’s Interagency HIV Study (WIHS). International Conference on AIDS. 12: 590 (Abstract No. 32347), 1998.

Kovacs A, Chan L, Bremer J, Meyer WA, et al. Impact of plasma RNA on CD4 change and outcome for women in the Women’s Interagency HIV Study. International Conference on AIDS. 12: 803 (Abstract No. 42153), 1998.

Currier J, Richardson J, Masari L, Levine AM. Prevalence and determinants of non-use of antiretroviral therapy among women: Women’s Interagency HIV Study (WIHS). International Conference on AIDS. 12: 831 (Abstract No. 42288), 1998.

Database: Women and Infants Transmission Study (WITS)

NIAID, in collaboration with NICHD and NIDA

Purpose Of The Database And Study Design: WITS is a multi-site collaborative longitudinal study of US HIV positive women and their offspring. Inner-city women, children, and drug users are the particular focus of WITS and WITS II. Almost one-half (45 percent) of WITS/WITS II subjects are African-American and 37 percent are Hispanic. Study sites include: Brigham and Children’s Hospital, University of Illinois at Chicago, Columbia University, the State University of New York (SUNY) Brooklyn, and Baylor University in Houston. Enrollment sites include Chicago, Boston, New York City, and San Juan. Enrollment was initiated in 1989 to determine risk factors for perinatal transmission and disease progression. This initiative supports longitudinal clinical, virologic, and immunologic evaluations, as well as an extensive repository of maternal and infant blood specimens. WITS currently focuses on several critical topics in perinatal HIV research including: factors contributing to perinatal HIV transmission, pathogenic aspects of primary HIV infections in infants, early immunologic and viral markers of rapid versus more stable disease progression, role of maternal drug use on transmission risk and disease progression, and assessment of evidence for or against potential immune response to HIV exposure among uninfected infants, as well as the effects of perinatal exposure to antiretrovirals.

Nature Of The Data Collected: Data collection has been conducted in two phases. In the first phase (1990 to 1993), three cohorts were enrolled: HIV positive pregnant women, their infants, and HIV positive non-pregnant women. In the second phase (1983 to present), HIV positive pregnant women and their infants were enrolled.

Unit Of Analysis: Longitudinal collection of clinical specimen, physical examination, and interview data

Data Collection Methods: Not available

General Attributes: About 1,800 pregnant women and 1,400 infants have enrolled.

Major Data Constructs And Key Data Elements: Adult specimens include blood and genital samples. Laboratory specimens are obtained from subjects at specified times throughout the study period. The content and timing of the laboratory testing varies depending upon the subject’s status (i.e., whether a woman or a child), the mother’s pregnancy status, and gestation at the time of enrollment.

Strengths And Weaknesses Of The Study Design And Database: None identified

Gaps In The Data Collected And Factors Leading To The Gaps: None identified

Feasibility Of Linking With Other Databases: No information provided

Process To Access The Database And Contact Person:

Selected Citations:

Hanson IC, Antonelli TA, Sperling RS, Oleske JM, et al. Lack of tumors in infants with perinatal HIV-1 exposure and fetal/neonatal exposure to zidovudine. Journal of AIDS and Human Retrovirology. 20(5): 463-367, 1999.

Rich KC, Siegal JN, Leurgans SE, Landay AL. Induced beta-chemokine and cytokine response in pregnant HIV-1 infected women and risk of perinatal transmission. International Conference on AIDS. 12: 397 (Abstract No. 23279), 1998.

Pacheco-Acosta E, Antonella T, Higgins A, Moroso NG, et al. Reproductive choices in the Women and Infant Transmission Study (WITS): pre and post ACTG 076 results. International Conference on AIDS. 12: 198 (Abstract No. 13565), 1998.

McIntosh K, FitzGerald G, Pitt J, Bremer JW, et al. A comparison of peripheral blood coculture versus 18- or 24-month serology in the diagnosis of human immunodeficiency virus infection in the offspring of infected women: Women and Infants Transmission Study. Journal of Infectious Disease. 178(2): 560-563, 1998.

Kalish LA, Diaz C, Rick KC, Shearer WT, et al. Virologic, immunologic, and clinical indicators of disease progression in a perinatal HIV cohort: the Women and Infants Transmission Study (WITS). International Conference on AIDS. 12: 160 (Abstract No. 13368), 1998.

Diaz C, Hanson C, Cooper ER, Read JS, et al. Disease progression in a cohort of infants with vertically acquired HIV infection observed from birth: the Women and Infant Transmission Study (WITS). Journal of AIDS and Human Retrovirology. 18(3): 221-228, 1998.

Cowles MK, Palumbo P, Virus detection, virus load, and disease progression in perinatally infected infants. . International Conference on AIDS. 12: 160-161 (Abstract No. 13369), 1998.

Kalish LA, Pitt J, Lew J, et al. Defining the time of fetal or perinatal acquisition of human immunodeficiency virus type 1 infection on the basis of age at first positive culture: Women and Infant Transmission Study (WITS). Journal of Infectious Disease. 175(3): 712-175, 1997.

Pitt J, Henrard D, Fitzgerald G, Lew J. et al. Association of HIV-1 antibodies (Ab) and ICD p24 antigen (Ag) with perinatal HIV-1 transmission. Conference on Retroviruses and Opportunistic Infections. 158 (Abstract No. 505), 1997.

Hanson IC, Pitt J, McIntosh K, Sherrieb K, et al. Standardized assessment of infants with indeterminate (IND) HIV-infection status followed in the Women and Infants Transmission Study (WITS). International Conference on AIDS. 11(2): 87 (Abstract No. We.B.3176), 1996.

Cooper ER, Hanson C, Diaz C, Abboud R, et al. Encephalopathy and HIV disease progression in a cohort of children with perinatally acquired HIV infection: the Women and Infants Transmission Study (WITS). International Conference on AIDS. 11(2): 26 (Abstract No. We.B.313), 1996.

Brambilla D, Leung S, Lew J, Shapiro D, et al. Interkit differences in plasma HIV-1 RNA levels in mothers enrolled in WITS/ACTG 076.Conference on Retroviruses and Opportunistic Infections. 178 (Abstract No. 616), 1997.

Center for Substance Abuse Treatment (CSAT) Program Evaluation Branch (PEB), Substance Abuse and Mental Health Administration (SAMSHA)

Database: HIV Outreach Demonstration Program

Purpose Of The Database And Study Design: The HIV Outreach Demonstration Program is designed to assess the treatment knowledge of injecting drug users and their sex and/or needle-sharing partners. The HIV Outreach Demonstration Program operates in twelve sites in the US. The cross-site evaluation is designed to pool local project implementation and operations data to determine if these projects reach national program goals and client treatment outcome objectives.

Nature Of The Data Collected: Cross-sectional and longitudinal data

Unit Of Analysis: Client and service program

Data Collection Methods: Survey instruments are used in the evaluation. Three discrete client data collection cycles are used: (1) anonymous outreach contacts recorded by outreach workers; (2) primary data collection at initial contact with the outreach program, data collected continually during the client’s tenure, and follow-up data collected following the HIV outreach intake; and (3) data collected for clients entering substance abuse treatment at intake and six-month follow-up

General Attributes: Process measures are collected within an evaluative framework

Major Data Constructs And Key Data Elements: Five types of data are collected: system-level measures, project-level measures, cost measures, client-level measures, and follow-up data. Systems-level data include organizational characteristics of project sites. Project-level measures include information about each organizational unit that provides client services including service delivery units (SDUs) and cost data for each organizational unit. SDU data includes information about the facilities, staff, types of care, therapeutic approach, and services provided. Cost measures include pace and nature of project/SDU expenditures, total and average service costs per client, and budget expenditures, and total costs per outreach project. Contact data includes the number of first or repeat outreach contacts including age, gender, and race/ethnicity of persons contacted, as well as the number of HIV risk reduction, drug treatment, and other materials distributed by outreach workers. Client-level data include: education, employment, income, criminal justice involvement, risk exposure categories, substance use patterns, HIV outreach services, substance abuse service use, and follow-up.

Strengths And Weaknesses Of The Study Design And Database: None identified

Gaps In The Data Collected And Factors Leading To The Gaps: None identified

Feasibility Of Linking With Other Databases: Uncertain

Process To Access The Database And Contact Person: Penny E. Dorsey, Calliber Associates, 10530 Rosehaven Street, Suite 400, Fairfax VA 22030, (703) 385-3200.

Selected Citations:

Center for Substance Abuse Treatment, HIV Outreach Demonstration Program Cross-Site Evaluation Second Annual Report. Rockville: Substance Abuse and Mental Health Administration, 1998.

Office of Disability

Database: Disability Claims: Title II, Title XVI Concurrent Determinations

Purpose Of The Database And Study Design: The SSA maintains State-by-State data on the number and approval rate of concurrent claims for Social Security Disability Insurance (SSDI) and/or Supplemental Security Income (SSI) programs by persons with HIV/AIDS.

Nature Of The Data Collected: Cross-sectional administrative records

Unit Of Analysis: Claims for SSDI and/or SSI

Data Collection Methods: Data maintained are generated from automated application materials submitted by applicants and administrative data maintained by SSA Office of Disability.

General Attributes: In FY 1999, a total of 29,572 new symptomatic HIV claims were submitted.

Major Data Constructs And Key Data Elements: The adjudication of the claim (allowance or denial). Other data elements are maintained by the SSA but were not made available to this project.

Strengths And Weaknesses Of The Study Design And Database: Information is unavailable

Gaps In The Data Collected And Factors Leading To The Gaps: Information is unavailable.

Feasibility Of Linking With Other Databases: Linkages have been made with other databases at the State level, including the HARS.

Process To Access The Database And Contact Person:

Veterans Health Administration

Database: Immunology Case Registry (ICR)

Purpose Of The Database And Study Design: The ICR module supports the maintenance of local and national registries for the tracking of HIV disease among VA patients. The module provides many capabilities for VA medical centers (VAMC) that provide care and treatment to HIV positive patients. ICR supports the identification and categorization of patients with HIV disease. It is used to generate reports for the CDC. The ICR automatically extracts data for inclusion in the VA national ICR. The Registry is used to provide VA-wide review of patient demographic characteristics, clinical aspects of HIV disease, and resource use involved in caring for patients. The Registry also supports national HIV-related research studies approved by the VA AIDS Program Office. The ICR also provides a variety of management reports for local use, including frequency of visits, as well as the number of laboratory tests and prescriptions per patient. The ICR produces several reports for the VAMCs including: categorization of patients according to severity of HIV disease; data necessary for AIDS case reporting to the CDC, automatic generation of CDC report forms on patients, and lists of patients that have not been seen at the VAMC for a specified length of time. The ICR provides several clinical and administrative reports for VAMC and headquarter's use. The ICR module retrieves several other local data files that contain information concerning diagnosis, prescriptions, surgical procedures, laboratory tests, radiology exams, dental care, patient demographic characteristics, hospital admissions, and clinical visits. This process allows identified clinical staff to take advantage of the wealth of data supported through local databases. The ICR creates a simple process for entering and tracking a patient through the ICR. Users need only identify the patient and determine the disease category for that patient. Virtually all other data employed by the ICR module is retrieved through other local database modules (e.g., Pharmacy, Laboratory, and Radiology). An extra level of security is provided by the VA to be consistent with VA laws and policies. Essential information is encrypted. Patient names and other identifying information (encrypted or not) are never transmitted to the national registry.

Nature Of The Data Collected: Longitudinal clinical and administrative records

Unit Of Analysis: Individual patient

Data Collection Methods: Data are entered by local staff at the VAMC as part of the creation and maintenance of the patients’ automated medical record. Data extracts are automatically conducted by the VA’s mainframe system.

General Attributes: ICR was fully implemented in 1992 across all the VAMCs and contains access to complete medical records including demographic information, diagnoses, resource utilization, pharmacy and laboratory data on over 45,000 patients.

Major Data Constructs And Key Data Elements: Patient demographic and military service characteristics, CD4 staging, numbers of outpatient visits, inpatient discharge summaries, inpatient surgical and other procedures, outpatient pharmacy data, laboratory and radiology data, dental care data, and information required to complete CDC AIDS case reports.

Strengths And Weaknesses Of The Study Design And Database: The ICR provides local and national tracking of HIV positive veterans by severity of the disease. Thus, ICR supplies patient level longitudinal information based on immune status and presence/absence of OIs.

Gaps In The Data Collected And Factors Leading To The Gaps: Unavailable

Feasibility Of Linking With Other Databases: Depending upon the objectives and study designs, linkages with other databases are feasible. These linkages can be achieved through encoding of unique identifiers of ICR and other databases by developing a third code that uses a common algorithmic table.

Process To Access The Database And Contact Person: Sophia Chang, MD, Director, Center for Quality Management, VA Palo Alto Health Care System, AIDS Service, (650) 493-5000 or (650) 849-0273.

Selected Citations:

Rahman A, Kendall S, Deyton LR, Rimland D, Simberkoff M, Goetz M. Trends in antiretroviral drug utilization for HIV/AIDS patients treated at US Department of Veterans Affairs (VA) medical centers. International Conference of Healthcare Resource Allocation for HIV/AIDS and Other Life-Threatening Illnesses, 1999.

Rahman A, Deyton LR, Goetz MB, Rimland D, Simberkoff MS. Inversion of inpatient/outpatient HIV service utilization: impact of improved therapies, clinical education, and case management in the US Department of Veterans Affairs. International Conference on AIDS. Abstract No. 443/42429, 12: 859, 1998.

McCollum M, McWhinney, S, Brown ER. Predictors of resource utilization in HIV/AIDS at a Veterans Affairs Medical Center. International Conference on AIDS. Abstract No. 60341, 12:1062, 1998.

Simberoff MS, Rabeneck L, Hartigan PM, Menke TJ, Wray NP. Progression data from the Department of Veterans Affairs’ HIV Registry are a model for use of administrative-clinical databases for study of disease. Meeting of the Association of Health Services Research. 14:309-310, 1997.

Douyou R, Guzman P, Romain G, Ireland SJ, Mendoza L, Lopez-Blanco M, Milanes F. Subtle neurological deficits and psychopathological findings in substance-abusing homeless and non-homeless veterans. Journal of Neuropsychiatry and Clinical Neuroscience. 10(2): 210-215, 1998.

Levine VR. Epidemiology of AIDS and tuberculosis among United States Veterans. International Journal of Tuberculosis and Lung Disease. 2(5): 405-412, 1998.

Rabeneck L, Hartigan PM, Huang IW, Souchek J, Wray NP. Predicting outcomes in HIV positive veterans: II. Survival after AIDS. Journal of Clinical Epidemiology. 50(11): 1241-1248, 1997.

Rabeneck L, Hartigan PM, Huang IW, Souchek J, Wray NP. Predicting outcomes in HIV positive veterans: I. progression to AIDS. Journal of Clinical Epidemiology. 50(11): 1231-1240, 1997

Hoff RA, Beam-Goulet J, Rosenheck RA. Mental disorder as a risk factor for human immunodeficiency virus infection in a sample of veterans. Journal of Nervous and Mental Disorders. 185(9): 556-560, 1997.

Bennett CL, Curtis JR, Achenbach C, Arno P, Bennett R, Fahs MC, Horner RD, Shaw-Taylor Y, Andrulus D. US hospital care for HIV positive persons and the role of public, private, and Veterans Administration hospitals. Journal of AIDS and Human Retrovirology. 13(5): 416-421, 1996.

Simberoff MS, Hartigan PM, Hamilton JD, Day PL, et al. Long-term follow-up of symptomatic HIV positive patients originally randomized to early versus later zidovudine treatment: report of a Veterans Affairs Cooperative Study. Journal of AIDS and Human Retrovirology. 11(2): 142-150, 1996.

O’Brien WA, Hartigan, PM, Martin D, Esinhart J, et al. Changes in plasma HIV-1 RNA and CD4+ lymphocyte counts and the risk of progression to AIDS. NEJM. 15:334(7): 426-431, 1996.

Bennett CL, Adams J, Bennett RL, Rodriquez D, George L, Cassileth B, Gilman SC. The learning curve for AIDS-related Pneumocystis carinii pneumonia: experience from 3,981 cases in Veterans Affairs Hospitals: 1987-1991. Journal of AIDS and Human Retrovirology. 8(4): 373-378, 1995.

(1) The federal government has also supported basic research and drug and vaccine development. These research topics are outside the scope of this project.

Topics

Prevention | Data Sources & Measurement | HIV & AIDS

An Inventory Of Federally Sponsored HIV And HIV-Relevant Databases

Introduction

Methods

Use Of Federally Supported HIV-Related Research

Filling Gaps in HIV-Related Research: Opportunities for Collaboration

Guide To Acronyms

Agency for Healthcare Research and Quality (AHRQ)

Database: AIDS Costs and Services Utilization Survey (ACSUS)

Database: Healthcare Cost and Utilization Project (HCUP-3)

Database: HIV Cost and Services Utilization Study (HCSUS)

Centers for Disease Control and Prevention (CDC), Division of HIV/AIDS Prevention, Surveillance, and Epidemiology

Database: HIV Counseling and Testing System (CTS)

Database: HIV/AIDS Reporting System (HARS)

Database: Supplement to Routine HIV and AIDS Surveillance (SHAS) Project

Database: Adult/Adolescent Spectrum of HIV Disease (ASD) Project

Database: Pediatric Spectrum of HIV Disease (PSD) Project

Database: HIV Epidemiologic Research Study (HERS)

Database: HIV Outpatient Study (HOPS)

Database: National School-Based Youth Risk Behavior Survey (YRBS)

Centers for Disease Control and Prevention (CDC), National Center for Chronic Disease Prevention

Database: Behavioral Risk Factor Surveillance System (BRFSS)

CDC National Center for Health Statistics (NCHS)

National Health Examination Statistics Surveys (NHANES IV)

State and Local Area Integrated Telephone Survey (SLAITS)

National Survey of Family Growth (NSFG)

National Health Interview Survey (NHIS)

National Vital Statistics System (NVSS)

National Death Index (NDI)

National Health Care Survey (NHCS)

National Hospital Discharge Survey (NHDS)

National Survey of Ambulatory Surgery (NSAS)

National Ambulatory Medical Care Survey (NAMCS)

National Hospital Ambulatory Medical Care Survey (NHAMCS)

National Home and Hospice Care Survey (NHHCS)

National Nursing Home Survey (NNHS)

Health Care Financing Administration(now known as Centers for Medicare and Medicaid Services(CMS)) (HCFA(now known as CMS))

Database: Medicaid Statistical Information System (MSIS)

Database: Medicare

Health Resources and Services Administration (HRSA), HIV/AIDS Bureau (HAB)

Database: AIDS Drug Assistance Program (ADAP) Monthly Report

Database: Annual Administrative Report (AAR)

Database: Uniform Reporting System (URS) Client Data Demonstration Project

Database: Grantee Applications, Titles I and II of the Ryan White CARE Act

Database: Ryan White CARE Act Title III Program Data Report

Database: Ryan White CARE Act Title IV Data Reporting System

Database: Ryan White CARE Act, Special Projects of National Significance (SPNS) Program

Database: Ryan White CARE Act AIDS Education and Training Centers (AETCs)

Database: Ryan White CARE Act HIV/AIDS Dental Reimbursement Program

National Institutes of Health (NIH)

Database: Adult AIDS Clinical Trial Group (AACTG)

Database: AIDS Link to the Intravenous Experience (ALIVE)

Database: Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA) Observational Data Base (ODB)

Database: HIV Vaccine Clinical Trials Network (hvtn) and HIV Prevention Clinical Trials Network (hptn) - Formerly HIV Network for Prevention Trials (hivnet)

Database: Multicenter AIDS Cohort Study (MACS)

Database: Reaching for Excellence in Adolescent Care and Health (REACH) Project

Database: Women’s Interagency HIV Study (WIHS)

Database: Women and Infants Transmission Study (WITS)

Center for Substance Abuse Treatment (CSAT) Program Evaluation Branch (PEB), Substance Abuse and Mental Health Administration (SAMSHA)

Database: HIV Outreach Demonstration Program

Office of Disability

Database: Disability Claims: Title II, Title XVI Concurrent Determinations

Veterans Health Administration

Database: Immunology Case Registry (ICR)

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