Optimizing PrEP uptake & Adherence among MSWs using a 2-stage randomization design

优化 PrEP 的吸收

• 批准号: 9145451
• 负责人: Katie Brooks Biello
• 金额: $ 26.43万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-23 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9145451
• 关键词: AIDS prevention; Address; Adherence; Alcohol or Other Drugs use; Anal Sex; Behavior Therapy; Behavioral; Blood; Caring; Case Management; Client; Clinic; Clinical Trials; Cognitive; Cohort Studies; Complex; Counseling; Country; Data; Decision Making; Dose; Drops; Ensure; Epidemiology; Evaluation; Evidence based intervention; Face; Focus Groups; Future; Gays; Grant; HIV; HIV Infections; HIV risk; Hair; Homelessness; Hospitals; Individual; Injection of therapeutic agent; Internet; Intervention; Interview; Life; Life Experience; Link; Manuals; Marketing; Measures; Mental Depression; Meta-Analysis; Methods; Modality; Oral; Participant; Patient Self-Report; Pharmaceutical Preparations; Phase; Population; Populations at Risk; Prevalence; Preventive Intervention; Problem Solving; Procedures; Process; Professional counselor; Prophylactic treatment; Publishing; Questionnaires; Randomized; Randomized Controlled Trials; Research; Research Infrastructure; Research Personnel; Rhode Island; Risk; Sampling; Site; Staging; Subgroup; Surveys; Tenofovir; Testing; Time; Training; Unemployment; United States; United States National Institutes of Health; Universities; Victimization; Visit; Work; antiretroviral therapy; base; cisgender; clinical care; design; efficacy trial; emtricitabine; follow-up; high risk; innovation; male; male sex worker; men; men who have sex with men; peer; pill; pilot trial; pre-clinical; primary outcome; programs; psychosocial; public health relevance; secondary outcome; sex; skills training; standard of care; theories; transgender women; transmission process; treatment adherence; truvada; uptake; working men

 DESCRIPTION (provided by applicant): Background: Male sex workers (MSW), or men who exchange sex for money, drugs, or other items of value with other men, are at exceptionally high risk for HIV infection. Pre-exposure prophylaxis (PrEP, truvada) is effective for reducing HIV acquisition among HIV uninfected individuals, but its efficacy is highly dependent on uptake and excellent adherence, which can pose problems among certain groups. Providence, Rhode Island (RI) is primed to be a site for testing of a PrEP initiation and adherence intervention for MSW, as it has a sizeable market for MSW (>1,000 street and internet based MSW). Additionally, Providence is the site of the nation's first drop-in center for MSW, called Project Weber, and is the site of one of the first clinical PrEP programs in the country, led by our team at Miriam Hospital/Brown University. Overview: Informed by our abundance of formative research and programmatic work with MSWs in the US, our interdisciplinary investigator team designed the "PrEPare for Work" package that includes two components: 1) peer-led strengths-based case management (SBCM) for PrEP initiation and 2) a counseling and problem-solving PrEP adherence intervention that addresses individualized barriers to optimal use. We propose to pilot test the "PrEPare for Work" package in two phases, laying the groundwork for a future R01 efficacy trial. We will: (Phase 1) conduct an open phase evaluation of "PrEPare for Work". The intervention will be piloted with up to 10 MSW. Acceptability and feasibility data and participant exit interviews will be used to finalize all study procedures, questionnaire and intervention manual for use in the next phase; (Phase 2) conduct a pilot randomized controlled trial (RCT) of "PrEPare for Work" using a two-stage randomization design. Stage 1: 106 MSW will be equally randomized to receive either the peer-led SBCM or standard of care (i.e., referrals only) for engagement with our existing PrEP clinic. Stage 2: Those from stage 1 who initiate PrEP (n~44), regardless of stage 1 randomization condition, will then be equally randomized to either the "PrEPare for Work" adherence intervention or standard of care comparison condition. In stage 1, the primary outcome is PrEP initiation (initial prescription filled, time-to-PrEP initiation). In stage 2, the primary outcomes are PrEP adherence (% of truvada-blood levels, hair samples, self-report) and retention in PrEP care at 6 months. Major study assessment visits are: for stage 1, baseline and 1-month follow up; for stage 2, baseline, 3-, and 6- months. Innovation: Evidence-based interventions to enhance uptake and optimize adherence of PrEP among at risk populations with complex life experiences must be developed and tested. This will ensure that individuals, such as MSW, who are most in need of PrEP, can benefit from its application. The current study would be the first of its kind with respect to "packaging" PrEP for MSW. By linking MSW to our team's existing PrEP program for ongoing PrEP clinical care, we will leverage existing infrastructure-enhancing the sustainability of the "PrEPare for Work" package, if shown to be effective in an eventual R01 efficacy RCT.

 描述（由申请人提供）： 背景：男性性工作者 (MSW)，或与其他男性以性换取金钱、毒品或其他有价值物品的男性，感染艾滋病毒的风险极高。暴露前预防（PrEP、truvada）可有效减少未感染艾滋病毒的个体中艾滋病毒的感染，但其功效高度依赖于吸收和良好的依从性，这可能会给某些群体带来问题。罗德岛州普罗维登斯 (RI) 已准备好成为 MSW 的 PrEP 启动和依从性干预测试的地点，因为它拥有相当大的 MSW 市场（> 1,000 个街道和互联网 MSW）。此外，普罗维登斯是美国第一个 MSW 临时中心（称为“韦伯计划”）的所在地，也是该国第一个临床 PrEP 项目之一的所在地，该项目由我们在米里亚姆医院/布朗大学的团队领导。概述：根据我们与美国 MSW 进行的大量形成性研究和计划性工作，我们的跨学科研究团队设计了“PrEPare for Work”一揽子计划，其中包括两个组成部分：1）用于 PrEP 启动的同行主导的基于优势的病例管理 (SBCM)；2) 咨询和解决问题的 PrEP 依从干预，以解决最佳使用的个体化障碍。我们建议分两个阶段对“PrEPare for Work”套餐进行试点测试，为未来的 R01 疗效试验奠定基础。我们将：（第一阶段）对“PrEPare for Work”进行公开阶段评估。该干预措施将在最多 10 名城市固体废弃物中进行试点。可接受性和可行性数据以及参与者退出访谈将用于最终确定下一阶段使用的所有研究程序、调查问卷和干预手册； （第二阶段）采用两阶段随机化设计进行“PrEPare for Work”试点随机对照试验（RCT）。第一阶段：106 名 MSW 将同样随机接受同行主导的 SBCM 或标准护理（即仅转诊），以便参与我们现有的 PrEP 诊所。第 2 阶段：从第 1 阶段开始启动 PrEP 的人员 (n~44)，无论第 1 阶段随机化条件如何，都将被同等随机分配到“PrEPare for Work”依从性干预或护理标准比较条件。在第一阶段，主要结果是 PrEP 启动（初始处方配药、PrEP 启动时间）。在第 2 阶段，主要结局是 PrEP 依从性（特鲁瓦达血液水平的百分比、头发样本、自我报告）和 6 个月时 PrEP 护理的保留率。主要研究评估访问包括： 第一阶段、基线和 1 个月随访；第 2 阶段、基线、3 个月和 6 个月。创新：必须开发和测试基于证据的干预措施，以提高具有复杂生活经历的高危人群对 PrEP 的吸收并优化其依从性。这将确保最需要 PrEP 的个人（例如 MSW）能够从其应用中受益。目前的研究将是首个针对城市固体废弃物“包装”PrEP 的研究。通过将 MSW 与我们团队现有的 PrEP 计划联系起来，进行持续的 PrEP 临床护理，如果在最终的 R01 功效随机对照试验中被证明有效，我们将利用现有的基础设施，增强“PrEPare for Work”包的可持续性。