A Structural Intervention for Most-At-Risk Populations in Mombasa, Kenya

描述（由申请人提供）：由于生理、行为和结构上的风险因素，女性性工作者（FSWs）感染和传播艾滋病毒的风险较高。在肯尼亚海岸省，即拟议研究的地点和性工作的热点地区，性工作者和客户占新感染艾滋病毒的18.2%，而男男性行为者，包括卖淫者（MSW）占20.5%。这些数据表明，目前针对这些最危险人群的大多数艾滋病毒预防行动是不够的。很少有艾滋病预防干预措施全面解决了性工作者、客户和性交易场所等相互交叉的社会世界。在世界范围内，大多数针对性工作者的基于场所的干预措施都是在妓院或其他特定的性工作场所实施的。很少在酒吧/俱乐部进行，有针对性的客户和msw，并在非洲进行。因此，我们计划在肯尼亚蒙巴萨的夜总会/酒吧开发和试点多层次干预。我们将采用随机对照设计，通过独立的干预前和干预后横断面调查来评估干预的可行性，调查对象包括160名女服务员、160名女服务员和160名男性客户，以及从2个干预酒吧/夜总会和2个对照酒吧/夜总会招募的80名女服务员、80名女服务员和80名男性客户。这种混合方法研究的具体目的是：(1)了解风险行为的社会文化背景，对艾滋病毒和风险的信念/理解；减少风险的障碍和促进因素；通过形成性研究，对25名男性客户、25名msw和25名fsww对干预信息的回应，为第二阶段（第一阶段）的干预内容提供信息；(2)与当地关键信息人员合作，根据理论和我们之前的工作，设计适合当地情况的多层次降低风险干预措施，包括同伴提供的个人和团体教育，分发男女避孕套和润滑剂，“街头剧场”演讲，现场“月光”艾滋病毒检测和咨询以及性传播感染护理，以及在蒙巴萨酒吧和夜总会举行的经理会议（第二阶段）；(3)通过工艺措施测试第二阶段制定的干预方案的可行性、可接受性，以及控制点的参与者暴露水平和干预污染水平；(4)测试干预评估设计（在第三阶段）的可行性，以便在未来的研究中使用，方法是：(a)制定和评估招募和数据收集程序；(b)确定避孕套使用的潜在生物标志物的有用性；(c)评估废物固体废物、都市固体废物和客户的保留情况；(d)开发功率和样本量计算，为未来基于场地的联合预防试验提供可行性信息；(e)比较测量避孕套使用情况的不同方法：通过访谈和短信的自我报告，以及SWs中的生物标志物，以便确定在更大规模试验中使用的最相关措施。

DESCRIPTION (provided by applicant): Female sex workers (FSWs) are at heightened risk for acquiring and transmitting HIV infection because of biological, behavioral and structural risk factors. In Kenya's Coast Province, the site of the proposed study and a hotspot for sex work, sex workers and clients accounted for 18.2% of new HIV infections, and men who have sex with men, including those who sell sex (MSW), for 20.5%. These data suggest that most current HIV prevention initiatives for these most-at-risk populations are inadequate. Few HIV prevention interventions have addressed comprehensively the intersecting social worlds of sex workers, clients, and settings in which sex is transacted. The majority of venue-based interventions for SWs worldwide have been implemented in brothels, or other sex work-specific establishments. Few have been conducted in bars/clubs, have targeted clients and MSWs, and have been conducted in Africa. Therefore, we plan to develop and pilot a multi-level intervention in nightclubs/bars in Mombasa, Kenya. We will use a randomized controlled design to evaluate intervention feasibility via independent pre- and post-intervention cross-sectional surveys with 160 FSWs, 160 MSWs and 160 male clients, and cohorts of 80 FSWs, 80 MSWs and 80 male clients recruited from 2 intervention and 2 control bars/nightclubs venues. The specific aims of this mixed-methods study are to (1) understand the socio-cultural context of risk behavior, beliefs/understandings of HIV and risk; barriers to and facilitators of risk-reduction; and responses to intervention messages among 25 male clients, 25 MSWs, and 25 FSWs via formative research to inform intervention content to be refined in Phase 2 (Phase 1); (2) in collaboration with local key informants, design a multi-level risk-reduction intervention tailored o the local context and informed by theory and our prior work, that includes peer-delivered individual and group education, distribution of male and female condoms and lubricants, "street theater" presentations, on-site "moonlight" HIV testing and counseling and STI care, and manager meetings in Mombasa bars and nightclubs (Phase 2); (3) test the intervention package developed in Phase 2 for feasibility, acceptability, as well as participant level of exposure and intervention contamination at control sites via process measures; and (4) test the feasibility of an intervention evaluation design (in Phase 3) to be used in a future study, by: (a) developing and evaluating recruitment and data collection procedures; (b) determining the usefulness of potential biomarkers of condom use; (c) assessing retention of a longitudinal cohort of FSW, MSW, and clients; (d) developing power and sample size calculations to inform feasibility for a future venue-based combination prevention trial; and (e) comparing different ways of measuring condom use: self-report via interview and text messaging, and biomarkers among SWs so as to determine most relevant measures for use in a larger trial.