COMMUNITY OPINION LEADER INTERVENTION TRIAL RAKAI-UGANDA

Rakai项目研究小组（RPRG）建议与NIMH/ACTs/DCC合作，在乌干达Rakai农村地区实施一项意见领袖（OL）干预的随机社区试验。 Rakai为试验提供了一个独特的环境：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，从而获得了所需的详细人口统计学，行为和STD/HIV数据或试验设计。 我们在结合社区行为数据和生物标本采集方面拥有丰富的经验，并且已经实现了高入组依从性和超过75%的长期随访。 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岁以上的成年人中约有13%是艾滋病毒阳性。我们建议以30个社区的12-49岁居民为目标，将所有同意的人登记，并随机将社区分配到干预和控制组，在实施干预之前，我们将在干预组进行人种学和社交网络研究，以确定舆论领袖和制定干预信息，包括促进坚持使用避孕套和减少性伴侣数量。 鉴于性行为的改变和安全套的使用，在Rakai的限制缺乏沟通的合作伙伴之间的性问题，艾滋病毒不和谐的个人之间的婚姻，生育的愿望，交易的因素，年轻女孩和老年男子之间的性关系，酒精的使用和胁迫性行为，我们建议解决这些因素的OL干预消息，指导的民族志研究。将通过在所有研究社区的家中进行的基线调查和12个月和24个月时的两次随访调查来评价OL干预。 我们将测量中间行为变量（安全套使用，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。 我们还将比较民族志研究的结果，网络调查作为一种手段，以确定OL，监测OL营业额，并评估是否强度的消息提供保持稳定，随着时间的推移。 这些数据将有助于今后按方案复制其他职等的干预措施。如果整体OL协作研究的设计或多个研究中心数据的元分析需要，可以修改研究设计、目标人群和消息（例如：在Rakai交易中心纳入酒吧）。

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.