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

基于社区的 PrEP 摄取干预对美国东北部注射吸毒者的效果

基本信息

批准号：
10403430
负责人：
Angela Robertson Bazzi
金额：
$ 73.2万
依托单位：
BROWN UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-07-01 至 2025-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10403430
关键词：
AIDS prevention Adherence Advisory Committees Affect Age Anti-Retroviral Agents Appointment Area Behavior Therapy Behavioral Boston Centers for Disease Control and Prevention (U.S.)Characteristics Collaborations Communities Community Health Data Development Disease Outbreaks Drug user Education Enrollment Epidemiologist Equation Evaluation Gender Geographic Locations HIV HIV Infections HIV risk Hair Health Heterogeneity Heterosexuals Incidence Injecting drug user Injections Intervention Interview Knowledge Letters Location Maintenance Massachusetts Mediator of activation protein Medical Modeling Monitor Motivation National Institute of Drug Abuse Needle-Exchange Programs Oral Participant Pharmaceutical Preparations Pharmacy facility Population Populations at Risk Positioning Attribute Preventive service Problem Solving Provider Public Health Qualitative Research Randomized Randomized Controlled Trials Recommendation Records Research Research Design Risk Risk Behaviors Sampling Scientist Self Efficacy Sexual Partners Site Sterility Stimulant Suggestion Syringes Tenofovir Testing Training Treatment Efficacy United States Woman Work base biobehavior community setting efficacy testing experience high risk high risk population improved informant injection drug use interest intervention effect marginalized population men who have sex with men motivational enhancement therapy multiple drug use opioid injection opioid use pre-exposure prophylaxis prevent preventive intervention primary outcome recruit risk perception secondary outcome skills social standard of care stimulant use substance use substance user theories transmission process uptake

项目摘要

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).

项目概要/摘要背景：美国新增艾滋病毒感染者中持续约 10% 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 [SSP] 和药房）有助于防止注射 - 相关的艾滋病毒传播；然而，许多地方注射器的使用不足，而且大多数注射吸毒者正如在美国的几个地理区域一样，他们经历了大量重叠的性行为和注射相关的艾滋病毒风险。在美国东北部，阿片类药物、兴奋剂和其他药物的注射量不断增加，导致疾病预防控制中心宣布艾滋病毒爆发与注射吸毒有关，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已证实有效建议向有感染艾滋病毒风险的吸毒者提供 PrEP，在这个社会边缘化的地区人口仍然受到严重限制。提案概述：目前的提案是广泛的成果。初步研究，包括 (a) 与注射吸毒者一起在东北部社区进行深入的定性研究受阿片类药物使用和 HIV 影响，记录了 HIV 风险高和 PrEP 知识低但兴趣高，(b) 对 PrEP 提供者、SSP 工作人员和其他提供具体信息的主要利益相关者进行关键知情人访谈关于 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 Navigator 对高危人群（包括以下人群）提供行为干预的随机对照试验 (RCT)：使用证明了我们提议的可行性、可接受性和初步功效的药物和注射吸毒者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、多成分的行为干预，由注射吸毒者提供训练有素的 PrEP 导航员嵌入 SSP 中，旨在提高 PrEP 的采用率（主要成果）通过增加 HIV 和 PrEP 来提高吸毒者的 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，并减少 PrEP 使用的结构性障碍：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”的功效我们将同等随机地随机分配 200 名受注射相关 HIV 传播影响的吸毒者。 (a) “PrEP for Health”干预措施，其中包括导航仪提供的、基于理论的 HIV 和 PrEP 教育、动机性访谈、问题解决和规划以及持续的 PrEP 导航 (n=100)，或 (b) 护理标准（信息和转诊；n=100）我们将评估 PrEP 的成功采用（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）我们还将检查干预效果在 12 个月内发生的程度。具体的概念中介（例如，PrEP 知识、动机、自我效能）并且根据不同的情况而有所不同消除调节因素（例如年龄、性别、性风险）。