COMMUNITY OPINION LEADER INTERVENTION TRIAL--RAKAI UGAND

Rakai项目研究小组(RPRG)建议与NIMH/ACTS/DCC合作，在乌干达Rakai农村地区实施一项以社区为基础的随机意见领袖干预试验。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项行为、流行病学和干预研究，产生了所需的详细人口统计学、行为和性传播疾病/艾滋病毒数据或试验设计。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，并实现了较高的登记遵从性和超过75%的延长跟踪。超过80%的非洲人口是农村人口，他们面临着感染艾滋病毒的巨大风险。在Rakai，大约13%的大于或等于13岁的成年人是HIV+。我们建议以30个社区中所有12-49岁的居民为目标并招募所有同意的人，并随机将社区分配到干预和控制部门。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，包括促进一致使用避孕套和减少性伴侣的数量。鉴于Rakai的性行为改变和避孕套的使用受到以下因素的限制：性伴侣之间缺乏关于性问题的沟通、艾滋病患者之间不和谐的婚姻、生育欲望、支配年轻女孩和老年男性之间性关系的交易因素、酗酒和强迫性行为，我们建议在人种学研究的指导下，在OL干预信息中解决这些因素。OL干预将通过在所有研究社区的家庭中进行的12个月和24个月的基线和两次跟踪调查来评估。我们将测量中间行为变量(避孕套使用、报告的伴侣数量、其他行为)和STD/HIV终点，包括滴虫的患病率和发病率，以及HIV和HSV-2的患病率和发病率。我们还将比较人种学研究的结果与网络调查的结果，以此作为识别OL、监测OL更替和评估信息提供强度是否随时间保持稳定的一种手段。这些数据将有助于今后在方案中复制OL干预措施。如果整个OL协作研究的设计或多个站点的数据荟萃分析需要，研究设计、目标人群和消息可以修改(例如：包括Rakai交易中心的条形图)。

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.