Intervention to Enhance PrEP Uptake and Adherence in a Community-Based Setting

描述（由申请人提供）：暴露前预防（PrEP）是指每日或间歇口服抗逆转录病毒药物，旨在保护高危HIV阴性患者 个人感染。由于PrEP是目前最有希望的生物医学艾滋病毒预防工具，疾病控制和预防中心（CDC）于2011年1月发布了医疗保健提供者的临时指南，预计不久将发布详细的公共卫生指南。然而，为了使PrEP成为一种有效的预防工具，必须解决三个关键因素：a）可接受性，即，将从PrEP中受益的个人 必须知道它并愿意接受它; B）坚持，即，选择PrEP作为预防策略的个人必须按规定服用药丸;以及c）实施，即，必须制定流程和协议，以允许以可行、可扩展和现实的方式将PrEP交付和计划整合到真实的世界环境中。拟议的项目是一个两阶段的研究，与纽约市最大的LGBT社区卫生服务提供者合作进行。该项目将侧重于三个具体目标：1）确定可能影响PrEP实施的社会和行为因素，接受，以及纽约市MSM的使用/遵守，包括个人，社区和组织层面的因素;（二）检查与纽约市男同性恋者获得预防和护理服务的差异相关的社会和行为因素，这些因素可能直接影响PrEP实施计划和政策;和3）评估干预措施，其中PrEP被引入，提供和支持作为社区卫生中心提供的预防包的一部分。为了实现这些目标，该项目将招募高风险的男男性接触者，以测试两阶段的行为干预。首先，合格的参与者将被随机分配接受有关PrEP可用性的基本信息或旨在增加PrEP吸收的针对性干预措施。其次，接受PrEP的参与者（无论病情如何）将被随机分配接受基本依从性信息或增强PrEP依从性干预。参与者将在12个月内每季度接受一次随访。结果变量将包括：PrEP吸收，PrEP持久性，PrEP依从性（通过自我报告和生物措施测量），STI发病率和自我报告的风险行为。该项目特别具有创新性，因为它结合了功效和有效性试验，测试了一种新的干预措施， 将最可行地交付，并开创了一种新的方法，以社区为基础的合作和研究设计，可以加快实施科学的步伐。拟议的项目有可能不仅对PrEP干预措施对男男性行为者的有效性产生持续和强大的影响，而且还对社区环境内有针对性的干预措施的传播和可扩展性产生影响，并减少获取方面的差距，最大限度地提高文化能力和可接受性。 暴露前预防（PrEP）是预防艾滋病毒的一种新的生物医学方法，有可能成为一种强大的工具。本研究确定了可能影响MSM中PrEP可接受性和依从性的社会和行为因素，并与社区卫生中心合作，评估了两阶段干预措施，以改善PrEP的吸收，持久性和依从性。研究结果有可能影响在社区环境中有针对性的PrEP干预措施的传播和可扩展性，并以减少获取差异和最大限度地提高文化能力和可接受性的方式。

DESCRIPTION (provided by applicant): Pre-exposure prophylaxis (PrEP) refers to daily or intermittent oral administration of antiretroviral drugs designed to protect high-risk HIV-negative individuals from infection. As PrEP is, at present, the most promising biomedical HIV prevention tool, the Centers for Disease Control and Prevention (CDC) released interim guidance for health care providers in January 2011, and is expected to soon release detailed public health guidelines for its use. However, in order for PrEP to become an effective prevention tool, three critical factors must be addressed: a) acceptability, i.e., individuals who would benefit from PrEP must know about it and be willing to take it; b) adherence, i.e., individuals who choose to PrEP as a prevention strategy must take the pills as prescribed; and c) implementation, i.e., processes and protocols must be developed to allow for the integration of PrEP delivery and programs into real world settings in a way that is feasible, scalable, and realistic. The proposed project is a two-phase study, conducted in collaboration with the largest LGBT community health provider in New York City (NYC). This project will focus on three specific aims: 1) Identifying social and behavioral factors that are likely to influence PrEP implementation, acceptance, and use/adherence by MSM in NYC, including factors at individual-, community-, and organizational-levels; 2) Examining social and behavioral factors associated with disparities in access to prevention and care services among MSM in NYC that might directly impact PrEP implementation programs and policies; and 3) Evaluating an intervention in which PrEP is introduced, provided, and supported as part of a prevention package delivered in an community health center. To achieve these aims, the project will enroll high-risk MSM to test a two-stage behavioral intervention. First, eligible participants will be randomized to receive either basic information about PrEP availability or a targeted intervention designed to increase PrEP uptake. Second, participants who accept PrEP (regardless of condition) will be randomized to receive either basic adherence information or an enhanced PrEP adherence intervention. Participants will be followed quarterly for 12 months. Outcome variables will include: PrEP uptake, PrEP persistence, PrEP adherence (measured through self-report and biological measures), STI incidence, and self-reported risk behavior. The project is particularly innovative in that it combines an efficacy and effectiveness trial, testing a new intervention in the setting in which it would most feasibly be delivered, and pioneering a new approach to community-based collaboration and study design that can accelerate the pace of implementation science. The proposed project has the potential to exert a sustained and powerful influence not only on the effectiveness of PrEP interventions for MSM, but also on dissemination and scalability of a targeted intervention within community-based settings and in a manner that reduces disparities in access and maximizes cultural competence and acceptability. PUBLIC HEALTH RELEVANCE: Pre-exposure prophylaxis (PrEP) is a new biomedical approach to HIV prevention with the potential to become a powerful tool. This study identifies social and behavioral factors likely to influence PrEP acceptability and adherence among MSM, and collaborates with a community health center to evaluate a two- stage intervention to improve PrEP uptake, persistence, and adherence. Study findings have the potential to influence dissemination and scalability of a targeted PrEP intervention within community-based settings and in a manner that reduces disparities in access and maximizes cultural competence and acceptability.