PrEP and MOUD Rapid Access for Persons who Inject Drugs: the CHORUS+ Study

注射毒品者的 PrEP 和 MOUD 快速获取：CHORUS 研究

• 批准号: 10682181
• 负责人: Sabrina A Assoumou
• 金额: $ 95.29万
• 依托单位: BOSTON MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10682181
• 关键词: AIDS prevention; Acceleration; Address; Adherence; Adopted; Adoption; Affect; Automobile Driving; Behavior Therapy; Behavioral; Biometry; Blood; Boston; Buprenorphine; Caring; Cellular Phone; Clinic; Clinical Laboratory Improvement Amendments; Communicable Diseases; Communities; Control Groups; County; Data; Diphosphates; Dose; Drug user; Dryness; Effectiveness; Enrollment; Epidemic; Evaluation; Evidence based intervention; Foundations; Future; Goals; HIV; HIV risk; Home; Human; Human immunodeficiency virus test; Immunologic Deficiency Syndromes; Individual; Infection; Injecting drug user; Intervention; Laboratories; Measures; Medical; Medical center; Methadone; Methods; Mission; Modeling; National Institute of Drug Abuse; Opioid; Outcome; Overdose; Participant; Patients; Persons; Pharmaceutical Preparations; Pharmacy facility; Phase; Pilot Projects; Population; Populations at Risk; Prevention strategy; Privacy; Public Health; Qualitative Methods; Qualitative Research; Randomized; Randomized, Controlled Trials; Recommendation; Records; Recovery; Research; Research Methodology; Self Efficacy; Self Perception; Site; Social Behavior; Spottings; Substance Use Disorder; Tenofovir; Testing; Training; Treatment Efficacy; United States National Institutes of Health; Venous blood sampling; Walking; acceptability and feasibility; addiction; arm; care fragmentation; cocaine use; contextual factors; efficacy evaluation; evidence base; experimental study; heroin use; improved; improved outcome; informant; interest; long term recovery; medication for opioid use disorder; mortality; motivational enhancement therapy; motivational intervention; multidisciplinary; novel; opioid epidemic; opioid overdose; opioid use disorder; outreach; participant interview; peer; peer coaching; peer recovery; pilot test; point of care; pre-exposure prophylaxis; prevent; primary outcome; process evaluation; programs; rapid test; rapid testing; recruit; response; scale up; secondary outcome; self testing; skills; social stigma; substance use; syndemic; theories; therapy development; treatment as usual; trial design; uptake

PROJECT SUMMARY / ABSTRACT The US opioid overdose epidemic has been accompanied by an increase in human immunodeficiency (HIV) among persons who inject drugs. The co-occurrence of HIV and opioid use disorder (OUD) suggests that a comprehensive approach to OUD and its infectious complications has the potential to improve outcomes. HIV pre-exposure prophylaxis (PrEP) and medication for opioid use disorder (MOUD) are evidence-based approaches that are recommended for persons who inject drugs. Unfortunately, these measures have not been widely adopted in real-world settings or accessed by persons at-risk. Foundation for the Proposal: The CHORUS intervention (Comprehensive HIV and Opioid use disorder Response to the Unaddressed Syndemic) is informed by preliminary research, including: (a) quantitative and qualitative research with persons with substance use disorder, (b) a randomized controlled trial of a peer-delivered motivational intervention demonstrating effectiveness in reducing heroin and/or cocaine use, and (c) preliminary studies demonstrating the feasibility and acceptability of peer-delivered motivational interventions in non-traditional settings. During the CHORUS pilot phase, we uncovered that PrEP was initiated late in the intervention. Therefore, we are attempting to accelerate PrEP initiation by providing HIV self-testing (CHORUS +) at baseline. The CHORUS+ intervention includes HIV self-testing, rapid initiation of PrEP and MOUD, and a 6-month peer recovery coach to support adherence to these medications. Conceptual Model: CHORUS+ is a theory-based, peer-delivered, mobile phone-supported intervention focused on enhancing uptake and adherence to HIV PrEP (primary outcome), and receipt of MOUD (secondary outcome) among persons who inject opioids. CHORUS+ aims to improve behavioral skills and self-efficacy while addressing structural barriers. Summary: The current proposal seeks to determine the efficacy of a novel intervention to increase the uptake of evidence-based measures to prevent HIV and treat opioid use disorder. We will compare the CHORUS+ intervention to usual care (passive referral) among persons who inject opioids (aim 1). In addition, we will examine study implementation to facilitate potential future dissemination using a mixed-methods process evaluation of CHORUS+ (aim 2). The study will be performed at Boston Medical Center’s Faster Paths clinic, a low-barrier substance use disorder bridge clinic, and through Victory Programs, which utilizes a mobile outreach van. The proposed intervention will recruit from non-traditional settings in order to reach participants who might not be comfortable in office- based clinics. This project specifically addresses NIDA’s mission of developing effective socio-behavioral interventions to increase uptake of HIV prevention strategies, and accelerating the adoption of evidence-based interventions to address substance use and its infectious complications.

项目概要/摘要 美国阿片类药物过量流行伴随着人类免疫缺陷（HIV）的增加 HIV 和阿片类药物使用障碍 (OUD) 的同时出现表明， 治疗 OUD 及其感染并发症的综合方法有可能改善艾滋病毒的治疗结果。 暴露前预防 (PrEP) 和治疗阿片类药物使用障碍 (MOUD) 的药物是基于证据的 不幸的是，这些措施并未被推荐给注射吸毒者。 已在现实世界中广泛采用或被高危人群访问该提案的基金会： CHORUS 干预（针对未解决的症状的综合艾滋病毒和阿片类药物使用障碍反应） 通过初步研究提供信息，包括： (a) 对患有以下疾病的人进行定量和定性研究 物质使用障碍，(b) 同伴提供的动机干预的随机对照试验 证明在减少海洛因和/或可卡因使用方面的有效性，以及 (c) 初步研究证明 在非传统环境中同伴提供的激励干预的可行性和可接受性。 在 CHORUS 试点阶段，我们发现 PrEP 是在干预后期启动的。 尝试通过在基线时提供 HIV 自我检测 (CHORUS +) 来加速 PrEP 的启动。 干预措施包括 HIV 自我检测、快速启动 PrEP 和 MOUD 以及为期 6 个月的同伴康复教练 支持遵守这些药物的概念模型：CHORUS+ 是一个基于理论的、同行交付的、 移动电话支持的干预措施侧重于提高艾滋病毒暴露前预防措施的采用和依从性（初级 结果），并在注射阿片类药物的人中接受 MOUD（次要结果）。 提高行为技能和自我效能，同时解决结构性障碍。 旨在确定一种新的干预措施的有效性，以增加基于证据的措施的采用 预防艾滋病毒和治疗阿片类药物使用障碍 我们将比较 CHORUS+ 干预与常规护理（被动）。 注射阿片类药物的人中的推荐）（目标 1） 此外，我们将检查研究的实施情况 使用 CHORUS+ 的混合方法过程评估促进未来潜在的传播（目标 2）。 研究将在波士顿医学中心的 Faster Paths 诊所进行，这是一种低门槛物质使用障碍诊所 桥梁诊所，并通过胜利计划，利用移动外展车进行拟议的干预。 将从非传统环境中招募人员，以接触那些可能不适应办公室环境的参与者 该项目专门解决了 NIDA 发展有效社会行为的使命。 采取干预措施，以提高艾滋病毒预防策略的采用率，并加速采用基于证据的 解决药物使用及其感染并发症的干预措施。