Cultural feasibility studies in preparation for clinical trials to reduce maternal-infant HIV transmission in Haiti. NLM AIDSLINE Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.

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Cultural feasibility studies in preparation for clinical trials to reduce maternal-infant HIV transmission in Haiti.

AIDS Educ Prev. 1998 Feb;10(1):46-62. Unique Identifier : AIDSLINE MED/98165996
Coreil J; Losikoff P; Pincu R; Mayard G; Ruff AJ; Hausler HP; Desormeau J; Davis H; Boulos R; Halsey NA; College of Public Health, University of South Florida, Tampa 33612,; USA.

Abstract: 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 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 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.
Keywords: *Clinical Trials/STANDARDS *Disease Transmission, Vertical/PREVENTION & CONTROL *HIV Infections/TRANSMISSION *Pregnancy Complications, InfectiousKWDclinicaltrials/standardsKWDdiseasetransmission,vertical/prevention&controlKWDhivinfections/transmissionKWDpregnancycomplications,infectious
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