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

 描述（由申请人提供）：背景：男性性工作者（MSW），或与其他男性交换金钱，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感染艾滋病毒，但其疗效高度依赖于吸收和良好的依从性，这可能会在某些群体中造成问题。罗得岛的普罗维登斯（RI）准备成为测试城市固体废物PrEP启动和依从性干预的地点，因为它具有相当大的城市固体废物市场（> 1，000个街道和基于互联网的城市固体废物）。此外，普罗维登斯是全国第一个城市固体废物下降中心的所在地，称为韦伯项目，也是全国第一个临床PrEP项目之一的所在地，由我们在米里亚姆医院/布朗大学的团队领导。概述：根据我们在美国与MSW进行的大量形成性研究和项目工作，我们的跨学科研究团队设计了“PrEP工作”包，其中包括两个组成部分：1）同行领导的基于优势的病例管理（SBCM），用于PrEP启动和2）咨询和解决问题的PrEP依从性干预，解决个性化障碍，以实现最佳使用。我们建议分两个阶段试行“工作前健康保障”计划，为日后的R 01成效试验奠定基础。我们将：（第一阶段）对“PrEPare for Work”进行开放阶段评估。干预措施将在多达10个城市固体废物中进行试点。可接受性和可行性数据以及受试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;（2期）采用两阶段随机设计进行“PrEPare for Work”的试点随机对照试验（RCT）。第1阶段：106名MSW将被平等随机分配接受同行领导的SBCM或标准治疗（即，仅转介）与我们现有的PrEP诊所合作。第二阶段：那些从第1阶段开始PrEP的人（n~44），无论第1阶段的随机化条件如何，然后将被平等地随机分配到“PrEP工作”依从性干预或护理标准比较条件。在第1阶段，主要结局是PrEP启动（初始处方填写，开始PrEP的时间）。在第2阶段，主要结果是PrEP依从性（Truvada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。主要研究评估访视包括：第1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：必须制定和测试基于证据的干预措施，以提高具有复杂生活经历的风险人群对PrEP的吸收和优化坚持。这将确保最需要PrEP的个人，如MSW，可以从其应用中受益。目前的研究将是第一个关于“包装”城市固体废物的PrEP。通过将MSW与我们团队现有的PrEP计划联系起来，以进行持续的PrEP临床护理，如果在最终的R 01疗效RCT中证明有效，我们将利用现有的基础设施来增强“PrEPare for Work”包的可持续性。

 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.