Enhancing PrEP in Community Settings (EPIC)

描述（由申请人提供）：在全球范围内，男男性行为者（MSM）感染艾滋病毒/艾滋病的比例过高。最近的一项3期临床试验（iPrEx）显示，每日口服恩曲他滨/替诺福韦预防艾滋病毒的口服（PrEP）对未感染艾滋病毒的高风险男男性行为者提供了44%的额外保护。生物标本中较高水平的药物粘附和检测与保护作用密切相关。卫生部门目前正在规划示范项目，以评估是否可以在社区环境中提供预防措施。促进依从性和减少风险行为将是支持个人在实施规划中使用预防措施的核心。支持依从性的多模式方法可能会产生最大和最持久的效益。作为联合依从性干预的组成部分，两种互补的干预措施特别有希望。首先，下一步咨询，一种以客户为中心、情境驱动的咨询方法，在iPrEx研究结束时进行了试点，证明是可行和可接受的。我们最近开发了综合下一步咨询（iNSC），将降低风险和坚持治疗支持咨询结合起来，以便在社区环境中更有效地提供服务。第二种方法，即短信系统支持，已被证明可提高非洲艾滋病毒感染者的抗逆转录病毒依从率并降低艾滋病毒载量。除了依从性支持外，用于监测社区环境中PrEP使用情况的易于使用、廉价和准确的工具也至关重要。2011年年中，旧金山公共卫生部将在400名男男性行为者中开展一项为期18个月的预防PrEP示范项目。在该项目的第一阶段，我们建议在一个城市资助的示范项目中确定接受PrEP的未感染艾滋病毒的男男性接触者的依从性和风险行为的模式和相关性。我们还将评估两种新的依从性生物标志物在临床环境中监测依从性的效用。第一阶段的数据将为改进和部署多模式干预措施提供信息，以促进MSM PrEP使用者的依从性并降低风险。在本研究的第二阶段，我们将在旧金山市性病诊所进行一项随机临床试验，评估iNSC+SMS干预在促进PrEP依从性和减少风险行为方面的有效性。EPIC研究（加强社区环境中的PrEP）的长期目标是在社区环境中优化对男男性行为者利用PrEP的支持。

DESCRIPTION (provided by applicant): Men who have sex with men (MSM) are disproportionately affected by HIV/AIDS globally. A recent phase 3 clinical trial (iPrEx) showed that oral (PrEP) for HIV prevention with daily oral emtrictabine/tenofovir provided 44% additional protection to high-risk HIV-uninfected MSM. Higher levels of adherence and detection of drug in biological specimens was strongly associated with protective effect. Health departments are currently planning demonstration projects to evaluate whether PrEP can be delivered in community settings. Promoting adherence and reducing risk behaviors will be central to supporting individuals using PrEP in implementation programs. Multi-modal approaches to supporting adherence will likely have the largest and most sustained benefit. Two complementary interventions are particularly promising as components of a combined adherence intervention. First, Next Step Counseling, a client-centered, context-driven counseling approach proved feasible and acceptable when piloted at the end of the iPrEx study. We have recently developed integrated Next Step Counseling (iNSC), merging risk reduction and adherence support counseling, to allow more streamlined delivery in community settings. A second approach, short message system (SMS) support, has been shown to improve antiretroviral adherence rates and lower HIV viral load among HIV-infected patients in Africa. In addition to adherence support, easy-to-use, inexpensive, and accurate tools for monitoring PrEP use in community settings will be critical. In mid 2011, the San Francisco Department of Public Health will launch an 18-month PrEP demonstration project among 400 MSM. In the first phase of this project, we propose to determine the patterns and correlates of adherence and risk behaviors among HIV-uninfected MSM receiving PrEP in a city-sponsored demonstration project. We will also evaluate two novel biological markers of adherence for their utility in monitoring adherence in clinical settings. Data from this first phase will inform the refinement and deployment of a multimodal intervention to promote adherence and reduce risk among MSM PrEP users. In the second phase of this study, we will evaluate the effectiveness of the iNSC+SMS intervention in promoting PrEP adherence and reducing risk behaviors in a randomized clinical trial conducted at the municipal STD clinic in San Francisco. The long term goal of the EPIC study (Enhancing PrEP in Community Settings) is to optimize support of MSM utilizing PrEP in community settings.