Efficacy of a community-based PrEP uptake intervention for people who inject drugs in the US Northeast

项目摘要/摘要 背景：美国持续约10%的新艾滋病毒感染发生在注射吸毒者(PWID)中。 提供无菌注射器(通过注射器服务计划和药房)有助于防止注射- 与艾滋病毒传播有关；然而，在许多地方，获得注射器的机会不足，大多数PWID 性行为和注射相关的艾滋病毒风险有很大的重叠。就像在几个地理区域 在美国东北部，阿片类药物、兴奋剂和其他药物的注射增加正在造成 随着疾控中心宣布与注射吸毒有关的艾滋病毒爆发，人们对艾滋病毒传播再次感到担忧。 尽管暴露前预防(PrEP)和美国预防服务工作组已证明有效 建议向有艾滋病毒感染风险的PWID提供PrEP，在这个被社会边缘化的群体中 人口仍然受到严格的限制。提案概述：目前的提案是广泛的 初步研究，包括：(A)对东北社区进行深入的定性研究 受阿片类药物使用和艾滋病毒的影响，记录了高艾滋病毒风险和低PrEP知识，但兴趣很高，(B) 与PrEP提供商、SSP员工和其他提供具体信息的关键利益相关者进行的关键线人访谈 关于PrEP干预内容和提供策略的建议，以及(C)两个试点随机对照试验 PrEP Navigator为高危人群提供的行为干预(RCT)，包括 使用具有可行性、可接受性和初步疗效的药物和PWID 接近。这种广泛的研究导致了“PrEP for Health”干预措施的发展。 概念模型：“PrEP for Health”是为PWID提供的一种简短的多成分行为干预 SSP中嵌入了训练有素的PrEP导航器，旨在提高PrEP的摄入量(主要成果) 通过增加HIV和PrEP在PWID中的PrEP依从性和持久性(次要结果) 知识，提高HIV风险认知和PrEP兴趣和动机，培养PrEP使用自我效能 和行为技能，以及减少PrEP使用的结构性障碍。研究设计概述：我们建议 “PrEP for Health”在劳伦斯和马萨诸塞州波士顿/剑桥两个SSP的效果测试 受与注射有关的艾滋病毒传播的严重影响。我们将平均随机选择200个PWID来接收 (A)“PrEP for Health”干预措施，包括导航仪提供的、理论上知情的艾滋病毒和PrEP 教育、激励性访谈、解决问题和规划，以及持续的PrEP导航(n=100)，或 (B)护理标准(信息和转诊；n=100)。我们将评估成功的PrEP摄取(通过 医疗/药房记录)、依从性(通过头发中的药物水平)和持久性(通过医疗/药房 记录)超过12个月。我们还将检查干预效果发生的程度通过 具体的概念中介变量(如PrEP知识、动机、自我效能感)，并根据 假设的主持人(例如，年龄、性别、性风险)。

PROJECT SUMMARY/ABSTRACT Background: A persistent ~10% of new U.S. HIV infections occur among people who inject drugs (PWID). Provision of sterile syringes (via syringe service programs [SSPs] and pharmacies) helps prevent injection- related HIV transmission; however, syringe access is insufficient in many locations, and the majority of PWID experience substantial overlapping sexual and injection-related HIV risks. As in several geographic regions of the United States, in the Northeast, increasing injection of opioids, stimulants, and other drugs is causing renewed concerns about HIV transmission, with CDC declaring HIV outbreaks connected to injection drug use. Despite the proven efficacy of pre-exposure prophylaxis (PrEP) and U.S. Preventive Services Task Force recommendation that PrEP be offered to PWID at risk for HIV acquisition, uptake in this socially marginalized population remains severely limited. Overview of Proposal: The current proposal is a culmination of extensive preliminary research, including (a) in-depth qualitative research with PWID across Northeastern communities affected by opioid use and HIV that documented high HIV risk and low PrEP knowledge but high interest, (b) key informant interviews with PrEP providers, SSP staff, and other key stakeholders who provided specific suggestions for PrEP intervention content and delivery strategies, and (c) two pilot randomized controlled trials (RCTs) of PrEP Navigator-delivered behavioral interventions with high risk populations including people who use drugs and PWID that demonstrated the feasibility, acceptability, and preliminary efficacy of our proposed approach. This extensive research has led to the development of the “PrEP for Health” intervention. Conceptual Model: “PrEP for Health” is a brief, multi-component behavioral intervention delivered to PWID by highly trained PrEP Navigators embedded within SSPs that seeks to improve PrEP uptake (primary outcome) and PrEP adherence and persistence (secondary outcomes) among PWID by increasing HIV and PrEP knowledge, improving HIV risk perceptions and PrEP interest and motivation, cultivating PrEP use self-efficacy and behavioral skills, and reducing structural barriers to PrEP use. Overview of Study Design: We propose testing efficacy of “PrEP for Health” in two SSPs in Lawrence and Boston/Cambridge, Massachusetts, areas heavily affected by injection-related HIV transmission. We will equally randomize 200 PWID to receive either (a) the “PrEP for Health” intervention, which includes Navigator-delivered, theory-informed HIV and PrEP education, motivational interviewing, problem-solving and planning, and ongoing PrEP navigation (n=100), or (b) standard of care (information and referrals; n=100). We will evaluate successful PrEP uptake (via medical/pharmacy records), adherence (via drug levels in hair), and persistence (via medical/ pharmacy records) over 12 months. We will also examine the degree to which intervention efficacy occurs through specific conceptual mediators (e.g., PrEP knowledge, motivation, self-efficacy) and differs according to hypothesized moderators (e.g., age, gender, sexual risk).