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 in Cite 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 trials 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.
Mots-clés Pascal : Prévention, Transmission mère enfant, Essai clinique, SIDA, Virose, Infection, Haiti, Antilles, Amérique Centrale, Amérique, Homme, Faisabilité, Milieu culturel, Environnement socioculturel, Allaitement, Séropositivité, Immunoprophylaxie, Immunoglobuline, Immunopathologie, Immunodéficit, Femme, Femelle
Mots-clés Pascal anglais : Prevention, Mother to child transmission, Clinical trial, AIDS, Viral disease, Infection, Haiti, West Indies, Central America, America, Human, Feasibility, Cultural environment, Sociocultural environment, Breast feeding, Seropositivity, Immunoprophylaxis, Immunoglobulins, Immunopathology, Immune deficiency, Woman, Female
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 98-0129623
Code Inist : 002B05C02D. Création : 22/06/1998.