Enhancing PrEP in Community Settings (EPIC)

加强社区环境中的 PrEP (EPIC)

• 批准号: 8512792
• 负责人: Albert Ying-Hwa Liu
• 金额: $ 45.11万
• 依托单位: PUBLIC HEALTH FOUNDATION ENTERPRISES
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-06 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8512792
• 关键词: AIDS prevention; AIDS/HIV problem; Address; Adherence; Affect; Africa; Anti-Retroviral Agents; Biological; Biological Markers; Blood; Cities; Client; Clinic; Clinic Visits; Clinical; Communities; Counseling; Cues; Data; Detection; Drug usage; Effectiveness; Ensure; Evaluation; Financial compensation; Funding; Goals; HIV; HIV Infections; HIV prevention trial; Hair; Health; Human immunodeficiency virus test; Incidence; Individual; Infection; Institute of Medicine (U.S.); Intervention; Lead; Literature; Measures; Methods; Monitor; Observational Study; Oral; Patients; Pattern; Phase; Phase III Clinical Trials; Population; Prevention; Prevention strategy; Prophylactic treatment; Public Health; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Reporting; Research; Research Personnel; Resistance development; Risk; Risk Behaviors; Risk Reduction; Sampling; San Francisco; Specimen; Spottings; Support System; System; Telephone; Tenofovir; Testing; United States; Validation; Viral Load result; base; clinical practice; clinical research site; community setting; cost; drug testing; effective intervention; emtricitabine; high risk; improved; men; men who have sex with men; multi-component intervention; novel; novel strategies; pill; prevent; prevention service; programs; protective effect; sex; sexually active; standard of care; tool; uptake

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.

描述（由申请人提供）：全球范围内，男男性行为者（MSM）受到艾滋病毒/艾滋病的影响不成比例。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）为未感染艾滋病毒的高危MSM提供了44%的额外保护。较高水平的粘附性和生物样本中的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PrEP是否可以在社区环境中提供。促进依从性和减少风险行为将是支持个人在实施计划中使用PrEP的核心。支持遵约的多模式方法可能会产生最大和最持久的效益。两个互补的干预措施是特别有前途的一个组合的依从性干预措施的组成部分。首先，下一步咨询，一个以客户为中心，情境驱动的咨询方法被证明是可行的，并在iPrEx研究结束时被接受。我们最近开发了集成的下一步咨询（iNSC），合并风险降低和依从性支持咨询，以允许在社区环境中更简化的交付。第二种办法，即短信系统支助，已证明可提高非洲艾滋病毒感染者坚持抗逆转录病毒治疗的比率，并降低艾滋病毒载量。除了坚持支持，易于使用，廉价和准确的工具，监测PrEP使用在社区环境将是至关重要的。2011年年中，旧金山弗朗西斯科公共卫生部将在400名男男性行为者中开展为期18个月的PrEP示范项目。在这个项目的第一阶段，我们建议确定的模式和相关性的遵守和风险行为之间的艾滋病毒未感染的男男性接触者接受PrEP在一个城市赞助的示范项目。我们还将评估两种新的生物学标记物的遵守其效用在监测遵守在临床设置。第一阶段的数据将为多模式干预的完善和部署提供信息，以促进MSM PrEP用户的依从性和降低风险。在本研究的第二阶段，我们将在旧金山弗朗西斯科市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）的长期目标是优化在社区环境中使用PrEP的MSM的支持。