Coreil J, Losikoff P, Pincu R, Mayard G, Ruff A J, Hausler H P, Desormeau J, Davis H, Boulos R, Halsey N A
College of Public Health, University of South Florida, Tampa 33612, USA.
AIDS Educ Prev. 1998 Feb;10(1):46-62.
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.
文化可行性研究被定义为一项在临床试验设计中调查科学以及伦理、行为和社会问题的研究。通过展示为在海地太阳城开展减少母婴艾滋病毒传播的临床试验而进行的两个案例研究，说明了这种广义评估的价值。第一项研究解决了围绕艾滋病毒血清阳性母亲中母乳喂养与完全瓶喂试验的相关问题。第二项研究重点是对艾滋病毒免疫球蛋白和标准免疫球蛋白进行双盲试验的实施，该试验将在出生后不久给予血清阳性母亲的婴儿。两个案例都采用了与母亲进行焦点小组访谈以及与关键信息提供者进行深入访谈的方式，以调查与艾滋病相关的信念、试验参与的可接受性、对受试者的风险以及社区对试验的反应和影响。研究结果指出了在社会弱势群体中尝试进行涉及复杂研究设计的试验所带来的困难。建议强调需要考虑试验对整个社区的影响，以及需要对参与者进行广泛的教育准备，以确保知情同意并遵守方案。
