RESUMEN
A cultural feasibility study is defined as one that investigates scientific 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 on Cité Soleil, Haiti. The first study addressed issues surrounding a trial of breast-feeding and exclusive bottle-feeding among HIV seropositive mothers. The second study focused on the implementation of a double-blind trial of HIV immune globulin and standard immune globulin to be administered to infants of seropositive mothers shortly after birth. Both cases used focus group interviews with mothers and in-depth interviews with key informants to investigate AIDS-related beliefs, acceptability of trial participation, risks to subjects, and community reactions and repercussions to the trial. Findings point to the difficulties posed by attempts to conduct trial involving complex research designs in socially disadvantaged populations. Recommendations highlight the need to consider the community-wide impact of a trial, and the need to undertake extensive educational preparation of participants to ensure informed consent and adherence to protocols.
PIP: Cultural feasibility studies use ethnographic methods to explore ethical, behavioral, and social issues inherent in the design of proposed clinical trials. This approach was applied in advance of clinical trials aimed at reducing maternal-infant HIV transmission in Cite Soleil, Haiti. The first focused on conditions that would be necessary to conduct a trial of breast feeding versus exclusive bottle feeding by HIV-positive mothers; the second investigated the feasibility of a double-blind trial of administration of a high- titer antibody preparation--HIV immune globulin (HIVIG)--to infants of seropositive mothers shortly after birth. Study methods included focus group discussions with mothers and in-depth interviews with key informants about AIDS-related beliefs, acceptability of trial participation, risks to subjects, and community repercussions. Concerns identified included the potential negative effect on breast feeding promotion efforts in Haiti, the scarcity of economic means to sustain safe bottle feeding, the risk of being labeled HIV-positive by virtue of study participation, the potential for the HIVIG trial to reinforce the misconception that a vaccine effective against AIDS exists, and problems explaining the concept of a double-blind study and accepting random assignment to treatment and control groups. As a result of these studies, it was decided to conduct the infant feeding study in a community with higher rates of exclusive bottle feeding and lower infant mortality than exist in Cite Soleil. The HIVIG trial could be conducted, but only after extensive community education to ensure informed consent. An objective assessment of subject comprehension was developed for this purpose.