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

项目摘要/摘要 背景：男性性工作者(MSW)，即以性换取金钱、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极高。暴露前预防(PrEP)是 有效地减少未感染艾滋病毒的人感染艾滋病毒，但其有效性高度依赖于 摄取和出色的粘附性。然而，那些可能受益的人对PrEP的接受和坚持 使用PrEP的最大好处，如MSW，仍然是次优的。一次成功的PrEP吸收和坚持 包装必须做出响应，并针对MSW的不同心理社会和背景情况量身定做。 提案概述：目前的提案是对这一人群进行了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 NIMH资助的R34(MPI：Biello，Mimiaga，Chan)，这使得我们的跨学科团队和 社区合作伙伴协作开发和试点基于理论的干预措施- “为工作做准备”--解决1)通过加强当地PrEP诊所/提供者获得PrEP和吸收PrEP的问题- 使用激励性访谈原则的基于案例的管理(例如，关注价值观、优势和 改变努力，发表反思性和感同身受的声明)，以及2)提供认知行为疗法-- 知情的PrEP遵守咨询(例如，解决问题的技能培养)，提供个性化的日常文本 消息提醒优化MSW中的PrEP遵从性。试点RCT论证了可行性， “为工作做准备”的可接受性和初步效度。概念模型：“为工作做准备” 干预是基于社会认知疗法(SCT)的，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省，包括自我效能。 研究设计概述：我们现在建议测试“为工作做准备”方案在 大普罗维登斯地区和洛杉矶县采用两阶段随机设计。第一阶段：500人 城市生活垃圾将被同等随机地分为两组，一组接受“准备工作第一阶段干预”(基于强度的干预 病例管理和促进PrEP链接)或评估成功采用PrEP的护理标准 (通过实时替诺福韦尿液分析验证；处方数据)在2个月内。阶段2：发起PrEP的人 (N~156；阶段1干预组约55%，阶段1 SOC组约20%)将进行同样的重新随机 准备工作阶段2干预(一对一技能培训、解决问题和激励 约谈遵从性咨询和个性化的每日短信提醒)或SOC以评估PrEP 坚持(头发样本中的替诺福韦浓度)和保留PrEP护理(参加预约)超过12 月份。我们还将检查PrEP摄取和依从性在多大程度上有所改善 概念中介变量(例如PrEP动机、自我效能)和调节变量(例如种族/民族， 药物使用、感知的艾滋病毒风险)。将对干预成本效益进行评估。

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.