J. Coreil et al., CULTURAL FEASIBILITY STUDIES IN PREPARATION FOR CLINICAL-TRIALS TO REDUCE MATERNAL-INFANT HIV TRANSMISSION IN HAITI, AIDS education and prevention, 10(1), 1998, pp. 46-62
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.