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

在社区环境中加强 PrEP 的采用和依从性的干预措施

• 批准号: 8891315
• 负责人: Sarit A Golub
• 金额: $ 60.83万
• 依托单位: HUNTER COLLEGE
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-01 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8891315
• 关键词: AIDS prevention; Address; Adherence; Amendment; Anti-Retroviral Agents; Behavior Therapy; Behavioral; Biological; Caring; Centers for Disease Control and Prevention (U.S.); Clinical Protocols; Collaborations; Communities; Community Health; Community Health Centers; Data; Development; Drug Design; Effectiveness; Enrollment; Ethnic Origin; Guidelines; HIV; Health; Health Personnel; Health Services Accessibility; Incidence; Individual; Infection; Intervention; Lesbian Gay Bisexual Transgender; Measures; New York City; Oral Administration; Oral Contraceptives; Outcome; Participant; Patient Self-Report; Patients; Pharmaceutical Preparations; Phase; Plasma; Policies; Population; Population Heterogeneity; Prevention; Prevention strategy; Process; Prophylactic treatment; Protocols documentation; Public Health; Race; Randomized; Research Design; Risk; Risk Behaviors; Role; Services; Socioeconomic Status; Staging; Testing; Time; Tuberculosis; United States; base; cultural competence; design; disorder prevention; effectiveness trial; efficacy trial; eligible participant; high risk; implementation science; improved; innovation; interest; men who have sex with men; models and simulation; novel strategies; open label; pill; prevention service; programs; social; therapy design; tool; transmission process; uptake

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.

描述（由申请人提供）：暴露前预防（PREP）是指旨在保护高风险HIV阴性的抗逆转录病毒药物的每日或间歇性口服给药 感染的人。正如当前PREP是最有前途的生物医学预防工具一样，疾病控制与预防中心（CDC）于2011年1月发布了卫生保健提供者的临时指南，预计将很快发布详细的公共卫生指南。但是，为了成为有效的预防工具，必须解决三个关键因素：a）可接受性，即，将从准备中受益的个人 必须知道它并愿意接受； b）遵守，即选择准备作为预防策略的个人必须服用规定的药物； c）实施，即必须开发过程和协议，以允许以可行，可扩展和现实的方式将准备交付和程序集成到现实世界中。拟议的项目是一项两阶段的研究，与纽约市（NYC）最大的LGBT社区健康提供商合作进行。该项目将侧重于三个具体目标：1）确定可能影响PrAPE的实施，接受和使用/遵守纽约市的社会和行为因素，包括个人，社区和组织级别的因素； 2）检查纽约市MSM之间与访问预防和护理服务差异相关的社会和行为因素，这可能直接影响PREP实施计划和政策； 3）评估作为在社区健康中心提供的预防软件包的一部分，在其中引入，提供和支持的干预措施。为了实现这些目标，该项目将注册高危MSM，以测试两阶段的行为干预。首先，符合条件的参与者将被随机地接收有关预备可用性的基本信息或旨在增加预备摄取的目标干预措施。其次，接受PREP的参与者（无论条件如何）将被随机分配以接收基本依从性信息或增强的准备依从性干预措施。参与者将每季度遵循12个月。结果变量将包括：准备摄取，预备持续性，依从性（通过自我报告和生物学措施衡量），STI发病率和自我报告的风险行为。该项目尤其是创新的，因为它结合了功效和有效性试验，在其环境中测试了新的干预措施 将最可行的交付，并开创一种基于社区的协作和研究设计的新方法，该方法可以加速实施科学的步伐。拟议的项目有潜力不仅对MSM的准备干预措施的有效性产生持续和强大的影响力，而且还可以在基于社区的环境中进行有针对性干预的传播和可扩展性，并以降低访问权限并最大程度地提高文化能力和可接受性和可接受性的方式。