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: 8538874
• 负责人: Sarit A Golub
• 金额: $ 61.33万
• 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 2017-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8538874
• 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 Personnel; Health Services Accessibility; Incidence; Individual; Infection; Intervention; 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; public health relevance; 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）是指每天或间歇性口服抗逆转录病毒药物，旨在保护高危 HIV 阴性者 个人免受感染。由于 PrEP 是目前最有前途的生物医学 HIV 预防工具，美国疾病控制与预防中心 (CDC) 于 2011 年 1 月发布了针对医疗保健提供者的临时指南，并预计很快将发布详细的公共卫生使用指南。然而，为了使 PrEP 成为有效的预防工具，必须解决三个关键因素： a) 可接受性，即可以从 PrEP 中受益的个人 必须了解并愿意接受； b) 依从性，即选择 PrEP 作为预防策略的个人必须按规定服用药物； c) 实施，即必须制定流程和协议，以便以可行、可扩展和现实的方式将 PrEP 实施和计划整合到现实世界中。拟议项目是一项两阶段研究，与纽约市 (NYC) 最大的 LGBT 社区医疗服务提供者合作进行。该项目将重点关注三个具体目标： 1) 确定可能影响纽约市 MSM 实施、接受和使用/遵守 PrEP 的社会和行为因素，包括个人、社区和组织层面的因素； 2) 检查与纽约市 MSM 之间获得预防和护理服务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； 3) 评估将 PrEP 作为社区卫生中心预防包的一部分引入、提供和支持的干预措施。为了实现这些目标，该项目将招募高危 MSM 来测试两阶段行为干预。首先，符合条件的参与者将被随机接收有关 PrEP 可用性的基本信息或旨在提高 PrEP 吸收率的有针对性的干预措施。其次，接受 PrEP（无论病情如何）的参与者将被随机分配接受基本依从性信息或增强的 PrEP 依从性干预。参与者将每季度接受一次为期 12 个月的跟踪调查。结果变量包括：PrEP 摄入量、PrEP 持续性、PrEP 依从性（通过自我报告和生物学测量来衡量）、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，在其环境中测试新的干预措施 将最可行地交付，并开创一种基于社区的合作和研究设计的新方法，可以加快实施科学的步伐。拟议的项目有可能不仅对 MSM 的 PrEP 干预措施的有效性产生持续而强大的影响，而且对基于社区的环境中针对性干预措施的传播和可扩展性以及以减少获取差异和最大化的方式产生持续和强大的影响。文化能力和可接受性。