COMMUNITY OPINION LEADER INTERVENTION TRIAL RAKAI-UGANDA

Rakai项目研究组（RPRG）提议与NIMH/ACTs/DCC合作，在乌干达Rakai农村地区实施一项随机的、基于社区的意见领袖（OL）干预试验。Rakai为试验提供了独特的环境：自1989年以来，我们在该地区进行了多次行为、流行病学和干预研究，得出了所需的详细人口统计、行为和性病/艾滋病数据或试验设计。我们在结合社区行为数据和生物标本收集方面拥有丰富的经验，并取得了很高的注册依从性和超过75%的延长随访。超过80%的非洲人口生活在农村，面临着感染艾滋病毒的巨大风险。在Rakai，所有13岁以上或等于13岁的成年人中约有13%是艾滋病毒阳性。我们建议针对30个社区的所有12-49岁的居民，并随机分配社区到干预和控制部门。在实施干预之前，我们将在干预部门进行人种学和社会网络研究，以确定意见领袖并制定干预信息，包括促进一贯使用避孕套和减少性伴侣数量。鉴于Rakai的性行为改变和安全套使用受到伴侣之间缺乏性问题沟通、艾滋病毒不和谐个体之间的婚姻、生育欲望、控制年轻女孩和年长男性之间性关系的交易因素、酒精使用和强迫性行为的限制，我们建议在民族志研究的指导下，在OL干预信息中解决这些因素。OL干预将通过基线和12个月和24个月的两次随访调查进行评估，在所有研究社区的家中进行。我们将测量中间行为变量（避孕套的使用，报告的性伴侣数量，其他行为）和性病/艾滋病终点，包括滴虫的流行和发病率，HIV和HSV-2的流行和发病率。我们还将比较人种学研究的结果与网络调查的结果，作为识别OL的一种手段，监测OL的周转，并评估信息提供的强度是否随时间保持稳定。这些数据将有助于今后在方案上复制OL的干预措施。研究设计、目标人群和信息可以修改（例如：包括Rakai交易中心的酒吧），如果需要设计整体OL协作研究或来自多个站点的数据元分析。

The Rakai Project Research Group (RPRG) proposes to collaborate with the NIMH/ACTs/DCC by implementing a randomized, community-based trial of the Opinion Leaders (OL) intervention in rural Rakai District, Uganda. Rakai provides a unique setting for the trial: we have conducted multiple behavioral, epidemiological, and intervention studies in the district since 1989, resulting in detailed demographic, behavioral and STD/HIV data needed or trial design. We have extensive experience in combining behavioral data and biological specimen collection in the community, and have achieved high enrolment compliance and extended follow up greater than 75 percent. Over 80 percent of the African population is rural, and faces substantial risk of HIV. In Rakai, approximately 13 percent of all adults greater than or equal to age 13 years are HIV+. We propose to target and enrol all consenting persons aged 12-49 resident in 30 communities and to randomly assign communities to an intervention and control arm. Prior to implementing the intervention, we will conduct ethnographic and social networks research in the intervention arm to identify opinion leaders and develop intervention messages, including promotion of consistent condom use and reductions in numbers of sexual partners. Given that sexual behavior change and condom use in Rakai are constrained by lack of communication about sexual matters between partners, marriage between HIV discordant individuals, fertility desires, transactional factors governing sexual relations between young girls and older men, alcohol use and coercive sex, we propose to address such factors in the OL intervention messages, as guided by the ethnographic research. The OL intervention will be evaluated via a baseline and two follow up surveys at 12 and 24 months, conducted in the home in all study communities. We will measure intermediate behavioral variables (condom use, reported numbers of partners, other behaviors) and STD/HIV endpoints, including trichomonas prevalence and incidence, and HIV and HSV-2 prevalence and incidence. We will also compare the results of ethnographic research to network surveys as a means of identifying OLs, monitor OL turnover, and assess whether the intensity of message provision remains stable over time. Such data will assist in future programmatic replications of the OL intervention. The research design, target population and messages can be modified (ex: to include bars in Rakai trading centers) if desirable for the design of the overall OL collaborative study or for metanalysis of data from multiple sites.