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.
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.