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

 描述(申请人提供)：背景：男性性工作者(MSW)，或与其他男性进行性交易以换取金钱、药物或其他有价值的物品的男性，感染艾滋病毒的风险极高。暴露前预防(PrEP，Truvada)对于减少未感染艾滋病毒的个人获得艾滋病毒是有效的，但其有效性高度依赖于吸收和良好的依从性，这可能在某些群体中造成问题。罗德岛州普罗维登斯(RI)准备成为垃圾PrEP启动和遵守干预测试的地点，因为它拥有相当大的MSW市场(基于1,000条街道和互联网的MSW)。此外，普罗维登斯是全国第一个MSW收容中心的所在地，名为Project Weber，也是全国首批临床PrEP项目之一，由我们在Miriam医院/布朗大学的团队领导。概述：受我们与美国MSW的大量形成性研究和项目工作的启发，我们的跨学科研究团队设计了包括两个组成部分的“为工作做准备”套餐：1)针对PrEP启动的同行主导的基于优势的案例管理(SBCM)；2)咨询和解决问题的PrEP遵从性干预，解决最佳使用的个性化障碍。我们建议分两个阶段对“准备工作”方案进行试点测试，为未来的R01疗效试验奠定基础。我们将：(第一阶段)进行“准备工作”的公开阶段评估。这项干预将在最多10个城市垃圾中进行试点。将使用可接受性和可行性数据以及参与者退出访谈来最终确定所有研究程序、问卷和干预手册，以供下一阶段使用；(第二阶段)使用两阶段随机设计进行“准备工作”的试点随机对照试验(RCT)。第一阶段：106名MSW将被同等随机地接受同行主导的SBCM或标准护理(即仅转介)，以便参与我们现有的PrEP诊所。阶段2：从阶段1开始进行PrEP(n~44)的患者，无论阶段1的随机化条件如何，随后将被同等随机地分配到“为工作做准备”坚持干预或护理标准比较条件。在第一阶段，主要结果是PrEP启动(初始处方填满，PrEP启动时间)。在第二阶段，主要结果是PrEP依从性(特鲁瓦达-血液水平、头发样本、自我报告的百分比)和在6个月时保留在PrEP护理中。主要的研究评估访问是：对于阶段1，基线和1个月的随访；对于阶段2，基线，3个月和6个月。创新：必须开发和测试循证干预措施，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，如MSW，可以从它的应用中受益。目前的研究将是关于城市生活垃圾“包装”PrEP的第一次此类研究。通过将MSW与我们团队现有的PrEP计划相关联，以进行持续的PrEP临床护理，我们将利用现有的基础设施-如果在最终的R01疗效随机对照试验中被证明是有效的，那么我们将增强“准备工作”方案的可持续性。

 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.