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

描述（由申请人提供）：女性性工作者（FSW）由于生物、行为和结构性风险因素，感染和传播艾滋病毒的风险较高。在肯尼亚的海岸省，拟议的研究地点和性工作的热点，性工作者和客户占新的艾滋病毒感染的18.2%，男男性行为者，包括那些卖性（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解决性工作者、客户和性交易场所的交叉社会世界。全世界针对性工作者的大多数基于场所的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。很少在酒吧/俱乐部进行，以客户和医务工作者为目标，在非洲进行。因此，我们计划在肯尼亚蒙巴萨的夜总会/酒吧制定和试行多层次干预措施。我们将采用随机对照设计，通过对160名FSW、160名MSW和160名男性客户进行独立的干预前后横断面调查，以及从2个干预和2个对照酒吧/夜总会场所招募的80名FSW、80名MSW和80名男性客户的队列，评估干预的可行性。 本混合方法研究的具体目的是（1）通过形成性研究了解25名男性客户、25名MSWs和25名FSWs的风险行为的社会文化背景、对HIV和风险的信念/理解;降低风险的障碍和促进因素;以及对干预信息的反应，以告知第2阶段（第1阶段）将改进的干预内容;（2）与当地主要信息提供者合作，根据当地情况并参考理论和我们先前的工作，设计多层次的降低风险干预措施，包括同伴提供的个人和团体教育，分发男用和女用避孕套和润滑剂，“街头剧场”演示，现场“月光”艾滋病毒检测和咨询以及性传播感染护理，在蒙巴萨的酒吧和夜总会举行管理人员会议（第2阶段）;（3）测试第2阶段制定的干预措施的可行性、可接受性，以及通过过程措施在控制点的接触和干预污染的参与水平;（4）测试干预评价设计的可行性（在第3阶段）将用于未来的研究，通过：（a）开发和评估招募和数据收集程序;（B）确定安全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;（d）开发功效和样本量计算，为未来基于场所的组合预防试验提供可行性信息;以及（e）比较测量避孕套用途：通过访谈和短信进行自我报告，以及在SW中使用生物标志物，以确定最相关的测量方法，用于更大规模的试验。

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.