REACH

Reaching for Excellence in Adolescent Care and Health: 1996 - 2000

Basic Science and Clinical Science Groups Adolescent Medicine HIV/AIDS Research Network

Abstract: The Reaching for Excellence in Adolescent Care and Health (REACH) Project was an observational study designed to better understand HIV disease progression and co-morbidity in adolescents, with the ultimate goal of improving the health care management of adolescents living with HIV. The study sample includes both HIV infected adolescents and high-risk HIV uninfected adolescents, between the ages of 12 through 18 years, who were recruited from clinics throughout the United States during the late 1990s. The study utilized five primary methods of data collection: 1) direct face-to-face interview, 2) Audio Computer-Assisted Self-Administered Interview (ACASI), 3) medical record abstraction, 4) physical examinations, and 5) laboratory examinations. REACH includes data on 578 adolescents who were observed for an average of one and a half years, providing unique opportunities to study extensive biomedical, behavioral and psychosocial outcomes. Examples of topics covered in this data set include:

Sampling procedure: Recruitment for the REACH Project occurred from February 1996 through November 1999. Both HIV infected adolescents and high-risk HIV uninfected adolescents, between the ages of 12 through 18 years, were recruited from 16 clinics serving general adolescent populations and some that provided exclusive HIV care. These clinics were located throughout the United States and included the following: four sites in the New York/New Jersey area, three sites in the Mid-Atlantic, six sites in the Southeast, one in Chicago, and one in Los Angeles.

Evidence of HIV infection through vertical transmission, contaminated blood products, or early childhood sexual abuse was an exclusion criterion. Initially, all HIV infected adolescents who met the criteria were enrolled at a 2:1 ratio to the HIV uninfected adolescents and were matched as well as possible. The characteristics of the control group consisting of HIV- negative adolescents were required to be similar to those of the seropositive participants for the following characteristics: age, sex, race, ethnicity, drug-taking behaviors, and by clinical site or region as appropriate. Additionally, all participants in the control group must have initiated sexual activity. With the study and control populations similar in most aspects except for HIV infection, the effect of HIV itself on biologic morbidity could be more accurately examined. Youth received IRB-approved levels of compensation for study visits at the majority of REACH sites.

Instruments: Direct face-to-face interviews were administered at clinical visits by study coordinators. Most items had specific "question by question" (Q x Q) narratives to facilitate accurate and reliable data collection and were refined periodically as experience grew. Prescribed antiretroviral therapy (ART) adherence was assessed by self-report at each visit for the HIV infected participants. Questions in the last two years of the study also assessed reasons for nonadherence to ART regimens. Direct questioning for depression and suicidal ideation was conducted so that interventions could be implemented if deemed necessary.

The ACASI was used to obtain sensitive information while providing complete confidentiality, promoting validity, engaging youth, and obviating effects of illiteracy through a talking computer and highlighted mouse-driven responses. A timeline was used with the ACASI to assist the adolescents and orient them to the timeframe for certain scales. Aside from the validated behaviorally related assessment scales, the two main areas of data collection in the ACASI were focused on drug taking and sexual activity risk behaviors.

The sexual activity risk behaviors of interest included number and gender of partners, sexual activity practices including oral, anal, and vaginal sex, frequency of sexual practices over 3-month intervals, and use of protection during sexual activities. Questions relating to risk behaviors of the three most recent partners were also asked. In addition, validation of the participant's self-report of illicit drug taking in the ACASI was done using urine drug screening results.

Ongoing medical chart abstraction was used to ascertain health service utilization, medications, and targeted incident medical conditions. The study was specifically interested in the occurrence of sexually transmitted infections (STIs), Center for Disease Control and Prevention (CDC) AIDS-defining conditions and Category B symptomatic conditions. Specific diagnostic criteria for each of these conditions were developed to enhance specificity and were coded as: 1) definitive, 2) presumptive, 3) clinical, or 4) insufficiently documented. Source documentation for all AIDS-defining conditions was reviewed on routine semiannual site monitoring visits.

Targeted, rather than full, physical examinations were required by the study protocol, although the study did collect diagnostic information indicated by history or current symptoms and uncovered by ancillary clinical examinations. The frequency of laboratory testing done as part of the REACH protocol was consistent with the Public Health Service guidelines for managem ent of HIV-infected adolescents and adults.

More about the data: The Adolescent Medicine HIV/AIDS Research Network has compiled a list of scientific publications that have been based on research using the REACH data. Exploring these publications will provide information on the types of research that have been done using the data and may help to guide your proposed research. Download the list of Scientifc Publications. In addition, two papers providing an overview about the data contents, means of data collection, and participant profiles are also available for download.

Acquiring the data: REACH participant data are available as standard and sensitive data files. Standard data files primarily include information collected via subject data collection forms, in addition to the majority of the laboratory results. Sensitive data files include confidential subject information such as urine drug screen results, the Health Behavior Questionnaire, the ACASI, and derived variables for such data. Separate ID numbers for the standard and sensitive data files were assigned and data from these files cannot be linked without access to the linkage file decoding data or the acquisition of the merged sensitive dataset files from Sociometrics. Additionally, biologic specimens collected by the study are available for analysis. Investigators who are interested in utilizing REACH sensitive data files and/or specimens are required to submit a research proposal and IRB correspondence to Sociometrics that approves the proposal with no concerns about identifiable information or conflicts with the data. See the documentation below for more information on how to acquire the data and specimens. The User's Guide included in the documentation packages below contains a list of the variables included in the dataset.

If you have any questions, require assistance in locating data or specimens, or would like help completing any forms, please contact socio@socio.com or 650-949-3282.

Documents to Request the REACH Data

REACH Standard Data

REACH Standard Data
Standard data files primarily include information collected via subject data collection forms and the majority of the laboratory results. These data can be acquired by submitting a request and data transfer agreement. See the documentation packet for details.
Download documentation packet

REACH Sensitive Data

REACH Sensitive Data
The sensitive dataset package includes all of the standard data and additional sensitive data. Sensitive data include confidential subject information such as urine drug screen results, the Health Behavior Questionnaire, the ACASI, and derived variables for such data. Acquisition of these data require IRB approval and a data transfer agreement. See the documentation packet for details.
Download documentation packet

REACH Specimen Data

REACH Biorepository Specimens
Biologic specimens collected by the study are available for analysis. Acquisition of specimens requires IRB and NICHD approval, and a materials transfer agreement. See the documentation packet for details.
Download documentation packet

REACH Specimen and Sensitive Data

REACH Sensitive Data and Biorepository Specimens
This option allows for acquisition of the sensitive data (includes standard data), and biologic specimens. This requires IRB and NICHD approval and data and material transfer agreements. See the documentation packet for details.
Download documentation packet