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

项目总结/摘要 背景：持续约10%的美国新发HIV感染发生在注射毒品（PWID）人群中。 提供无菌注射器（通过注射器服务计划[SSP]和药房）有助于防止注射- 然而，在许多地方，注射器的使用不足，大多数艾滋病毒感染者 艾滋病毒感染风险与性行为和注射相关的艾滋病毒感染风险存在很大重叠。在几个地理区域， 在美国东北部，越来越多的阿片类药物，兴奋剂和其他药物的注射正在引起 美国疾病控制和预防中心宣布艾滋病毒爆发与注射毒品有关，这再次引起了人们对艾滋病毒传播的担忧。 尽管暴露前预防（PrEP）和美国预防服务工作组（U.S. Preventive Services Task Force）的有效性已得到证实， 建议向有艾滋病毒感染风险的PWID提供PrEP， 人口仍然非常有限。提案概述：目前的提案是广泛的 初步研究，包括（a）在东北社区进行深入的PWID定性研究 受阿片类药物使用和艾滋病毒影响，记录了高艾滋病毒风险和低PrEP知识，但兴趣高，（B） 与PrEP提供者，SSP工作人员和其他提供具体信息的关键利益相关者进行了关键线人访谈 PrEP干预内容和实施策略的建议，以及（c）两项试点随机对照试验 PrEP导航器提供的行为干预与高风险人群（包括以下人群）的随机对照试验（RCT） 使用药物和PWID，证明我们提出的可行性，可接受性和初步疗效 approach.这项广泛的研究导致了“PrEP for Health”干预措施的发展。 概念模型：“PrEP for Health”是一种简短的多组分行为干预，由 在SSP中嵌入训练有素的PrEP导航员，旨在改善PrEP吸收（主要结局） 和PrEP依从性和持久性（次要结局）通过增加艾滋病毒和PrEP 知识，提高艾滋病毒风险认知和PrEP兴趣和动机，培养PrEP使用自我效能 和行为技能，并减少PrEP使用的结构性障碍。研究设计概述：我们建议 在马萨诸塞州劳伦斯和波士顿/剑桥地区的两个SSP中测试“PrEP for Health”的功效 受注射相关艾滋病毒传播的严重影响。我们将同样随机分配200个PWID， (a)“PrEP for Health”干预措施，其中包括导航器提供的，理论知情的艾滋病毒和PrEP 教育、动机访谈、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吸收（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。我们还将研究干预效果发生的程度， 特定的概念中介（例如，PrEP知识，动机，自我效能），并根据 假设的调节器（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).