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

描述(申请人提供)：由于生物、行为和结构性危险因素，女性性工作者感染和传播艾滋病毒的风险较高。在肯尼亚海岸省，也是性工作的热点地区，性工作者和嫖客占新增艾滋病毒感染人数的18.2%，男男性行为者，包括性交易者(MSW)，占20.5%。这些数据表明，目前针对这些高危人群的大多数艾滋病毒预防举措是不够的。很少有艾滋病毒预防干预措施全面处理性工作者、客户和性交易环境的交叉社会世界。在全球范围内，大多数以场所为基础的性服务干预措施都是在妓院或其他专门从事性工作的场所实施的。很少有在酒吧/俱乐部进行的、以客户和MSW为目标的、在非洲进行的。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，通过对160名性服务工作者、160名MSW和160名男性客户进行干预前后的独立横断面调查，以及从2个干预和2个对照酒吧/夜总会场所招募的80名FSWs、80名MSW和80名男性客户的队列，来评估干预的可行性。这项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；降低风险的障碍和促进者；以及通过形成性研究在25名男性客户、25名MSW和25名FSWs中对干预信息的反应，以告知在第二阶段(第一阶段)将完善的干预内容；(2)与当地主要知情人士合作，根据理论和我们以前的工作，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及性传播感染护理、蒙巴萨酒吧和夜总会的经理会议(第二阶段)；(3)测试在第二阶段制定的干预方案的可行性、可接受性，以及参与者通过流程措施在控制点暴露和干预污染的水平；以及(4)测试未来研究中使用的干预评估设计(在第三阶段)的可行性，方法是：(A)开发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FSW、MSW和客户的纵向队列的保留情况；(D)开发功率和样本量计算，以确定未来基于地点的联合预防试验的可行性；以及(E)比较衡量避孕套使用的不同方法：通过访谈和短信进行自我报告，以及SWS中的生物标记物，以确定在更大规模的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.