CULTURAL FEASIBILITY STUDIES IN PREPARATION FOR CLINICAL-TRIALS TO REDUCE MATERNAL-INFANT HIV TRANSMISSION IN HAITI

A cultural feasibility study is defined as one that investigates scien tific as well as ethical, behavioral, and social issues in the design of clinical trials. The value of-such a broadly defined assessment is illustrated through the presentation of two case studies conducted to prepare for clinical trials to reduce maternal-infant HIV transmission in Cite Soleil, Haiti. The first study addressed issues surrounding a trial of breast-feeding and exclusive bottle-feeding among HIV seropo sitive mothers. The second study focused on the implementation of a do uble-blind trial of HIV immune globulin and standard immune globulin t o be administered to infants of seropositive mothers shortly after bir th. Both cases used focus group interviews with mothers and in-depth i nterviews with key informants to investigate AIDS-related beliefs, acc eptability of trial participation, risks to subjects, and community re actions and repercussions to the trial. Findings point to the difficul ties posed by attempts to conduct trials involving complex research de signs in socially disadvantaged populations. Recommendations highlight the need to consider the community-wide impact of a trial, and the ne ed to undertake extensive educational preparation of participants to e nsure informed consent and adherence to protocols.