The use of an educational video during informed consent in an HIV clinical trial in Haiti
The use of an educational video during informed consent in an HIV clinical trial in Haiti
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DOI：
10.1097/01.qai.0000229998.59869.05
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发表时间：
2006-08-15
影响因子：
3.6
通讯作者：
Fitzgerald, Daniel W.
中科院分区：
文献类型：
--
作者：
Joseph, Patrice;Schackman, Bruce R.;Fitzgerald, Daniel W.
背景：来自发展中国家的参加艾滋病毒临床试验的研究志愿者可能是文盲，不熟悉医学研究的进行。对志愿者进行有关同意书内容的教育是必要的，但可能会很困难和耗时。我们评估了在海地太子港进行的一项HIV临床试验的知情同意过程中使用教育视频的可行性和有效性。方法：招募HIV血清阴性志愿者进入纵向队列，研究高危性行为和HIV-1感染的发生率。在登记前，所有志愿者在两次教育会议期间收到了关于同意书的信息。在第一次会议上，由5至10名志愿者组成的小组观看了关于同意书基本要素的教育视频。在第二次活动中，志愿者们与一名社会工作者进行了一对一的会面。然后通过16个对错题和4个开放式问题对志愿者的理解能力进行口头评估。结果：250名志愿者接受了教育，186人(74%)通过了第一次评估。高学历是通过第一次评估的显著预测因素(优势比为1.60；95%可信区间为1.05-2.44)。在失败的中，47人回来进行了重复的一对一教育课程和第二次评估。在这47人中，39人(83%)通过，8人(7%)第二次评估不合格。总体而言，250人中有225人(90%)通过了第一次或第二次评估，并有资格参加研究。结论：使用教育视频的知情同意确保了大多数志愿者的良好理解。对于一些教育水平较低的参与者，可能需要额外的教育课程。
Background: Research volunteers from developing countries who enroll in HIV clinical trials may be illiterate and unfamiliar with the conduct of medical research. Educating volunteers about the contents of the consent form is essential but can be difficult and time consuming. We evaluated the feasibility and effectiveness of an educational video during the informed consent process for an HIV clinical trial conducted in Port-au-Prince, Haiti.Methods: HIV-seronegative volunteers were recruited into a longitudinal cohort to study rates of high-risk sexual behavior and incidence of HIV-1 infection. Before enrollment, all volunteers received information about the consent form during 2 educational sessions. In the first session, groups of 5 to 10 volunteers viewed an educational video on the essential elements of the consent form. In the second, the volunteers met one-on-one with a social worker. Volunteers' comprehension was then evaluated orally by 16 true-false questions and 4 open-ended questions. Volunteers who failed the first evaluation received additional education and had a second evaluation.Results: Two hundred fifty volunteers received education, and 186 (74%) passed the first evaluation. Higher formal education was a significant predictor of passing the first evaluation (odds ratio, 1.60; 95% confidence interval, 1.05-2.44). Of the 64 who failed, 47 returned for a repeat one-on-one education session and a second evaluation. Among these 47, 39 (83%) passed, and 8 (7%) failed the second evaluation. In total, 225 (90%) of 250 individuals passed either the first or second evaluation and were eligible to enroll in the study.Conclusions: Informed consent using an educational video ensured good comprehension in most of the volunteers. Additional educational sessions may be necessary for some participants with lower educational level.