Effectiveness of combination HIV preventive interventions for young Thai MSM

描述(由申请人提供)：这项泰美合作申请旨在开发和进行一项多水平组合艾滋病毒预防干预的非随机有效性和成本效益研究，在泰国曼谷的男男性接触者(YMSM)中，使用和不使用每日口服替诺福韦/恩曲他滨(Truvada)暴露前预防(PrEP)和基于手机的短信依从性支持(PrEP)。尽管目前采取了预防和治疗措施，但泰国基督教男青年会(18-26岁男子)目前艾滋病毒流行的特点是艾滋病毒发病率很高(5-12/100Py)，而且在18-21岁的最年轻男子和卖淫的青年男同性恋者中感染率最高。拟议的联合干预将包括个人层面的组成部分：频繁的艾滋病毒检测、降低风险咨询、避孕套和润滑剂分发以及行为改变咨询；社区意识和动员；以及开放标签提供PrEP和短信(FrontlineSMS)遵守支持。参与者将包括从事性工作或最近(过去12个月)有出卖性行为史的泰国基督教男同性恋者。这项拟议的研究将由约翰霍普金斯大学、马希多尔大学和埃默里大学进行；泰国MOPH-美国疾病控制与预防中心合作(TUC)及其Silom社区诊所@trop Med(SCC)；以及社区合作伙伴，包括性工作者赋权和健康促进组织Swing；LGBT健康和权利组织彩虹天空；以及亚太MSM社区APCOM。该小组结合了在这种高度流行的背景下与YMSM合作的独特专业知识、途径和经验。这项研究将包括一个形成阶段，使用定性和社区参与方法来完善干预措施；试点；开放标签干预措施，评估在有和没有PrEP和SMS坚持支持的情况下对艾滋病毒感染终点的组合干预的有效性；以及成本计算和成本效益评估，其中将衡量与联合干预相关的成本、通过使用PrEP避免的感染人数、节省的折扣治疗成本，并评估干预方案是否节省成本、成本效益和非成本效益。有效性研究基于PrEP和非PrEP的人员时间比较，并将使用倾向评分方法来减少自我选择设计中固有的潜在偏差。总而言之， 这项研究建议招募1240名YMSM，620名选择PrEP，620名不选择PrEP。

DESCRIPTION (provided by applicant): This Thai-US collaborative application seeks to develop and conduct a non-randomized effectiveness and cost-effectiveness study of a multi-level combination HIV preventive intervention with and without daily oral Tenofovir/Emtricitabine (Truvada) pre-exposure prophylaxis (PrEP) with mobile phone-based SMS adherence support among young men who have sex with men (YMSM) in Bangkok, Thailand. The current epidemic of HIV among Thai YMSM (men aged 18-26) is marked by high HIV incidence (5-12/100py) despite current prevention and treatment efforts, and rates are highest among the youngest men, aged 18-21, and among the subset of YMSM who sell sex. The proposed combination intervention will include individual level components: frequent HIV testing, risk reduction counseling, condom and lubricant distribution, and behavior change counseling; community awareness and mobilization; and an open label offer of PrEP with SMS (FrontlineSMS) adherence support. Participants will include Thai YMSM engaged in sex work or with a history of recent (in the previous 12 months) selling sex. The proposed study will be conducted by Johns Hopkins, Mahidol, and Emory Universities; The Thai MOPH-US CDC Collaboration (TUC) and its Silom Community Clinic @ Trop Med (SCC); and community partners including SWING, a sex worker empowerment and health promotion group; Rainbow Sky, an LGBT health and rights group; and APCOM, the Asia-Pacific Community of MSM. This group combines unique expertise, access, and experience in working with YMSM in this hyper-epidemic context. The study will include a formative phase using qualitative and community engagement methods to refine the intervention; a pilot; the open label intervention assessing effectiveness of combination interventions with and without PrEP and SMS adherence support with an HIV infection endpoint; and a costing and cost-effectiveness assessment which will measure the costs associated with the combined intervention, the number of infections averted through PrEP use, discounted treatment costs save, and assess whether the intervention packages are cost- saving, cost effective, or not cost-effective. The effectiveness study has been powered on the comparison of person time on PrEP versus not on PrEP and will employ propensity score methods to reduce the potential bias inherent in the self-selection design. In all the study proposes to enroll 1240 YMSM, 620 who choose PrEP and 620 who do not choose PrEP.