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：
10200742
负责人：
Angela Robertson Bazzi
金额：
$ 75.19万
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/10200742
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 Structure 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).

项目摘要/摘要背景：注射毒品的人（PWID）持续存在约10％的新美国艾滋病毒感染。提供无菌注射器（通过注射器服务程序[SSP]和药房）有助于防止注射 - 相关的HIV传播；但是，在许多位置以及大多数PWID的注射器访问不足体验与性和注射相关的重叠性艾滋病毒风险。就像在几个地理区域美国东北部的注射量增加了阿片类药物，兴奋剂和其他药物对艾滋病毒传播的重新担忧，疾病预防控制中心宣布与注射药物使用有关HIV爆发。尽管暴露前预防（PREP）和美国预防服务工作队具有公认的有效性建议提供准备艾滋病毒感染风险的PWID，对这种社会边缘化的吸收人口仍然受到严格限制。提案概述：当前的提案是广泛的高潮初步研究，包括（a）在东北社区的PWID的（a）深入的定性研究受卵毒素使用和艾滋病毒的影响，记录了高艾滋病毒风险和低预期知识但兴趣高的兴趣，（b）与预备提供者，SSP员工和其他主要利益相关者的关键信息者访谈，他们提供了特定的利益相关者准备干预内容和交付策略的建议，以及（c）两个试点随机对照试验（RCT）的（RCT）提供高风险人群的行为干预措施，包括使用我们提议的药物和PWID证明了可行性，可接受性和初步效率方法。这项广泛的研究导致了“健康准备”干预的发展。概念模型：“健康准备”是一项简短的多组分行为干预措施嵌入在SSP中的训练有素的预备导航器，试图改善预备力（主要结果）通过增加艾滋病毒和准备知识，改善艾滋病毒风险感知和准备好和动力，培养准备使用自我有效和行为技巧，并减少准备使用的结构障碍。研究设计概述：我们提出在劳伦斯和马萨诸塞州劳伦斯/波士顿/剑桥的两个SSP中测试“健康准备”的效率受注射相关的艾滋病毒传播的严重影响。我们将同样将200个PWID随机化以接收（a）“健康准备”干预措施，其中包括导航员分配，理论知觉的艾滋病毒和准备教育，动机访谈，解决问题和计划以及持续的准备导航（n = 100）或（b）护理标准（信息和推荐； n = 100）。我们将评估成功的准备摄取（通过医疗/药房记录），依从性（通过头发的药物水平）和持久性（通过医疗/药房记录）超过12个月。我们还将研究通过特定的概念介体（例如，准备知识，动机，自我效能感），并且根据假设的主持人（例如，年龄，性别，性风险）。