A national HIV community cohort: design, baseline, and follow-up of the AmFAR Observational Database. American Foundation for AIDS Research Community-Based Clinical Trials Network.

This article describes the design, methodology, baseline distributions, and general follow-up characteristics of the American Foundation for AIDS Research (AmFAR) National Observational Database (ODB) Project including the benefits and limitations of collecting information on a large simple cohort in the HIV community setting. The study prospectively followed 15,611 HIV-positive men and women and collected longitudinal and cross-sectional data on demographics, medical conditions, drug therapies, laboratory parameters, and survival. Participants were followed between October 1990 and December 1993 by 252 community-based sites coordinated by 22 centers in the Community-Based Clinical Trials Network (CBCT Network) throughout the United States (including Puerto Rico) and Toronto, Canada. The ODB provided quantitative information on a national level needed to track the HIV epidemic and plan clinical trials conducted through the Network, and to provide sites with local databases to monitor patients and facilitate access to therapies in clinical trials. Overall, the ODB contains information on 1,925 women (12%) and 13,686 men (88%), 60% white, 20% African American, 17% Latino/Hispanic, with 56,254 baseline and follow-up forms, a median follow-up of about 12 months, a 16% loss-to-follow-up, and an 11% mortality rate. AmFAR plans to place the ODB in the public domain.