Enhancing PrEP in Community Settings (EPIC)

描述(由申请人提供)：男男性行为者(MSM)在全球范围内感染艾滋病毒/艾滋病的比例不成比例。最近的3期临床试验(Iprex)显示，每天口服恩曲他滨/替诺福韦预防艾滋病毒的口服(PrEP)为高危未感染艾滋病毒的MSM提供了44%的额外保护。生物标本中较高水平的粘附性和药物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PrEP。促进遵守和减少风险行为将是在实施计划中支持使用PrEP的个人的核心。支持遵守的多模式方法可能会带来最大和最持久的好处。两种相辅相成的干预措施作为联合遵守干预措施的组成部分特别有希望。首先，下一步咨询，一种以客户为中心，以情境为导向的咨询方法，在Iprex研究结束时被证明是可行和可接受的。我们最近开发了集成的下一步咨询(INSC)，融合了风险降低和遵从性支持咨询，以允许在社区环境中更流畅地提供服务。第二种方法，短信系统(SMS)支持，已被证明可以提高非洲艾滋病毒感染者的抗逆转录病毒依从率和降低艾滋病毒病毒载量。除了遵守支持外，在社区环境中监控PrEP使用情况的易用、廉价和准确的工具将是至关重要的。2011年年中，旧金山公共卫生部将在400名男男性接触者中启动为期18个月的PrEP示范项目。在这个项目的第一阶段，我们建议在一个由城市赞助的示范项目中，确定接受PrEP的未感染HIV的MSM的依从性和危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有效性。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使用者的遵守和降低风险。在这项研究的第二阶段，我们将在旧金山市政STD诊所进行的随机临床试验中，评估iNSC+SMS干预在促进PrEP依从性和减少危险行为方面的有效性。EPIC研究(在社区环境中增强PrEP)的长期目标是优化对MSM在社区环境中使用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.