A Randomized Trial to Test the Efficacy of a Partner Navigation Intervention for HCV Treatment among Young Adult People who Inject Drugs

一项随机试验，测试伴侣导航干预对年轻注射吸毒者丙型肝炎治疗的有效性

• 批准号: 10364060
• 负责人: Meghan D Morris
• 金额: $ 72.67万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-01 至 2027-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10364060
• 关键词: Action Potentials; Address; Adult; Affect; Age; Behavior; Behavior Therapy; Clinical; Communities; Control Groups; Counseling; County; Data; Diagnosis; Discrimination; Dissemination and Implementation; Emotional; Epidemic; Evidence based program; Family; Fibrinogen; Foundations; Friends; Goals; Health; Health Promotion; Health Resources; Health behavior; Health behavior outcomes; Hepatitis C; Hepatitis C Therapy; Hepatitis C virus; Homelessness; Individual; Infection; Injecting drug user; Intervention; Intervention Studies; Logistics; Maps; Medical; Paper; Partnership Practice; Personal Satisfaction; Persons; Population; Poverty; Prevention; Probability; Professional counselor; Randomized; Records; Research; Risk; Role; Safety; San Francisco; Site; Social Network; Social support; System; Testing; Theory of Change; Time; TimeLine; Translating; Trust; United States; Visit; Work; base; behavior change; clinical diagnosis; cohort; comparison intervention; curative treatments; design; distrust; efficacy testing; experience; group intervention; improved; indexing; intimate behavior; member; novel; opioid epidemic; programs; randomized controlled study; randomized trial; response; social; social exclusion; social relationships; standard of care; success; tool; young adult

PROJECT ABSTRACT Globally, more than 3.5 million people are infected with hepatitis C virus (HCV). In the United States, due to the opioid epidemic, HCV cases have increased, especially among adults under 30. However, few young people who inject drugs (PWID ≤30 years old) – who are at the center of the HCV epidemic in the US – are benefiting from curative HCV therapy. A potentially promising, yet untapped avenue for increasing HCV treatment among PWID is the leveraging of their injecting partners to successfully navigate the multiple obstacles between diagnosis and treatment. Our team’s extensive research with dyads identified a potential action-point within injecting partnerships that can be harnessed through behavioral intervention. Quantitative findings identified specific injecting related interpersonal factors (i.e., trust, intimacy, cooperation) associated with increased health and safety for injecting partnerships. Followed by qualitative results that in combination with interpersonal factors, partner involvement (i.e., emotional, tangible, affectionate, and positive social support) enhances a partnership’s ability to coordinate behavior (dyadic capacity). Interpersonal factors with partner involvement was found to overcome barriers to HCV treatment. Building on our extensive foundation of dyadic research and dyadic behavior change theories, we developed the Partner Navigation Intervention a two-session injecting partnership intervention to enhance dyadic capacity for HCV treatment initiation for young adult PWID. The proposed study is a randomized controlled study (RCT) to assess the efficacy and mechanism of action of the first behavioral intervention to increase HCV treatment initiation among young adult PWID. In partnership with our community-based HCV testing organizations (CBOs), we will randomize young adult PWID with recently diagnosed HCV infection (250 partnerships, n=500) and their primary injecting partner to intervention or standard of care. Scalability was core to the design of the two-session intervention. Session 1 expands on standard-of-care HCV infection diagnosis counseling with counselor-led discussion with the HCV positive PWID to identify situational and personal barriers to HCV treatment and identify an injecting partner to aid in their HCV treatment navigation. Session 2 is a dyad session with both the young adult PWID and their injecting partner. A counselor facilitated discussion will develop strategies to respond to the identified HCV treatment initiation barriers and partnerships practice strategies and concretize a plan involving both partners for addressing barriers, including a timeline and potential alternative strategies in treatment navigation. During both sessions the counselor records key information discussed onto a paper handout (Partner Navigation Map) serving as the intervention tool. A community advisory board young adult PWID will guide implementation and dissemination. The proposed study will improve the cure rate in this highly impacted population. Our strategy of enhancing dyadic capacity may be adapted for targeted change of other health behaviors (e.g., HCV prevention) affecting young PWID.

项目摘要 全球有超过 350 万人感染丙型肝炎病毒 (HCV)。在美国，由于 阿片类药物流行，丙型肝炎病毒病例增加，尤其是 30 岁以下的成年人。然而，很少有年轻人 注射吸毒者（注射吸毒者≤30岁）——处于美国HCV流行中心的人——正在受益 来自治愈性 HCV 治疗。增加 HCV 治疗的潜在有前途但尚未开发的途径 PWID 是利用他们的注射伙伴成功地克服了之间的多重障碍 诊断和治疗。我们的团队对二元组进行了广泛的研究，确定了其中的一个潜在行动点 注入可以通过行为干预来利用的伙伴关系。确定的定量结果 与注射相关的特定人际因素（即信任、亲密、合作）与增加相关 注射伙伴关系的健康和安全。接下来是定性结果，结合 人际因素、伴侣参与（即情感、有形、深情和积极的社会支持） 增强伙伴关系协调行为的能力（二元能力）。与伴侣的人际关系因素 研究发现参与可以克服丙型肝炎治疗的障碍。 基于我们广泛的二元研究和二元行为改变理论基础，我们开发了 合作伙伴导航干预 两次注射合作伙伴干预以增强二元关系 青年吸毒者开始丙型肝炎治疗的能力。拟议的研究是一项随机对照研究 研究（RCT）评估第一个行为干预措施的功效和作用机制，以增加 年轻成年吸毒者开始丙肝治疗。与我们基于社区的 HCV 检测合作 组织 (CBO)，我们将随机分配最近诊断出 HCV 感染的年轻成年吸毒者 (250 伙伴关系，n = 500）及其主要注射伙伴进行干预或标准护理。可扩展性是核心 两次会议干预的设计。第 1 场会议扩展了 HCV 感染诊断的标准护理 由辅导员主导与 HCV 阳性吸毒者进行讨论，以确定情况和个人情况 HCV 治疗的障碍并确定注射伙伴以帮助他们进行 HCV 治疗导航。第二节 是与年轻的注射吸毒者及其注射伙伴的二人会议。辅导员主持讨论 将制定策略来应对已确定的丙型肝炎治疗启动障碍和伙伴关系实践 战略并具体化一项涉及双方合作伙伴的解决障碍的计划，包括时间表和 治疗导航中潜在的替代策略。在两次会议期间，辅导员都会记录关键信息 将讨论的信息记录在作为干预工具的纸质讲义（合作伙伴导航图）上。一个 社区咨询委员会青年吸毒者将指导实施和传播。拟议的 研究将提高这一受影响严重人群的治愈率。我们增强双元能力的战略 可针对影响年轻注射吸毒者的其他健康行为（例如丙型肝炎预防）进行有针对性的改变。