Efficacy of a PrEP uptake & Adherence Intervention among male sex workers using a 2-stage randomization design

项目总结/摘要 背景：男性性工作者（MSWs），或以性换取金钱、商品、毒品或其他物品的男性 与其他男性有价值的女性感染艾滋病毒的风险特别高。暴露前预防（PrEP） 有效地减少艾滋病毒感染者中的艾滋病毒感染，但其疗效高度依赖于 吸收和优异的粘附性。然而，在那些可能受益的人中， 使用PrEP（如MSWs）的最大可能性仍然不是最佳的。成功的PrEP摄取和依从性 包装必须响应并适合于MSW独特的心理社会和背景情况。 提案概述：目前的提案是对这一人群进行10多年研究的结果， 包括定性研究、流行病学评估和方案工作。这些形成性数据导致 到NIMH资助的R34（MPI：Biello，Mimiaga，Chan），这使得我们的跨学科团队， 社区合作伙伴合作开发和试点测试基于理论的干预措施- “PrEPare for Work”-解决1）通过实力在当地PrEP诊所/提供者获得和吸收PrEP- 基于案例管理使用动机访谈的原则（例如，专注于价值观、优势和 改变的努力，使反思和同情的声明），和2）提供认知行为疗法- 知情的PrEP依从性咨询（例如，解决问题的能力建设），并提供个性化的日常文本 消息提醒，以优化医务工作者之间的PrEP依从性。试点RCT证明了可行性， “PrEPare for Work”的可接受性和初步有效性。概念模型：“工作准备” 干预是基于社会认知疗法（SCT），它规定了一套核心机制， 影响健康行为，主要强调自我调节和自我反思，包括自我效能。 研究设计概述：我们现在建议在研究中测试“PrEPare for Work”包的有效性。 大普罗维登斯地区和洛杉矶县采用两阶段随机化设计。第一阶段：500人 MSW将被随机分配接受“PrEPare for Work Stage 1干预”（基于强度） 病例管理和促进PrEP联系）或标准护理，以评估成功的PrEP吸收 （通过实时替诺福韦尿液分析验证;处方数据）。阶段2：启动PrEP的人 （n~156; ~55%来自第1阶段干预组，~20%来自第1阶段SOC组）将进行均等重新随机化 到“PrEPare for Work Stage 2干预”（1对1技能培训，解决问题和激励 访谈依从性咨询和个性化的每日短信提醒）或SOC评估PrEP 坚持（头发样本中的替诺福韦浓度）和保留在PrEP护理（预约出席）超过12 个月我们还将研究在何种程度上改善PrEP吸收和坚持发生在 概念中介的背景（例如，PrEP动机，自我效能）和主持人（例如，种族/民族， 物质使用，感知的艾滋病毒风险）的干预。将评估干预的成本效益。

PROJECT SUMMARY/ABSTRACT Background: Male sex workers (MSWs), or men who exchange sex for money, goods, drugs, or other items of value with other men, are at exceptionally high risk for HIV infection. Pre-exposure prophylaxis (PrEP) is effective at reducing HIV acquisition among HIV uninfected individuals, but its efficacy is highly dependent on uptake and excellent adherence. However, uptake of and adherence to PrEP among those who might benefit the most from using PrEP, such as MSWs, remains suboptimal. A successful PrEP uptake and adherence package must be responsive and tailored to MSWs’ distinct psychosocial and contextual circumstances. Overview of Proposal: The current proposal is a culmination of over 10 years of research with this population, including qualitative research, epidemiological assessments and programmatic work. These formative data led to an NIMH-funded R34 (MPIs: Biello, Mimiaga, Chan), which allowed our interdisciplinary team and community partners to collaborate on the development and pilot testing of a theory-based intervention— “PrEPare for Work”—to address 1) access to and uptake of PrEP at local PrEP clinics/providers via strength- based case management using principles of motivational interviewing (e.g., focusing on values, strengths and change efforts, making reflective and empathetic statements), and 2) provide cognitive-behavioral therapy- informed PrEP adherence counseling (e.g., problem-solving skill-building) with personalized, daily text message reminders to optimize PrEP adherence among MSWs. The pilot RCT demonstrated the feasibility, acceptability and preliminary efficacy of “PrEPare for Work”. Conceptual Model: The “PrEPare for Work” intervention is based on Social Cognitive Therapy (SCT), which specifies a core set of mechanisms that influence health behavior with a primary emphasis on self-regulation and self-reflection, including self-efficacy. Overview of Study Design: We now propose to test the efficacy of the “PrEPare for Work” package in the Greater Providence area and in Los Angeles County using a two-stage randomization design. Stage 1: 500 MSW will be equally randomized to receive either the “PrEPare for Work Stage 1 intervention” (strength-based case management and facilitated PrEP linkage) or standard of care to evaluate successful PrEP uptake (verified by real-time tenofovir urinalysis; prescription data) within 2 months. Stage 2: those who initiate PrEP (n~156; ~55% from Stage 1 intervention arm and ~20% from Stage 1 SOC arm) will be equally re-randomized to the “PrEPare for Work Stage 2 intervention” (1-on-1 skills training, problem solving, and motivational interviewing adherence counseling and personalized, daily text messaging reminders) or SOC to assess PrEP adherence (tenofovir concentration in hair sample) and retention in PrEP care (appointments attended) over 12 months. We will also examine the degree to which improvements in PrEP uptake and adherence occur in the context of the conceptual mediators (e.g., PrEP motivation, self-efficacy) and moderators (e.g., race/ethnicity, substance use, perceived HIV risk) of the intervention. Intervention cost-effectiveness will be assessed.