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: 10630059
• 负责人: Meghan D Morris
• 金额: $ 70.71万
• 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/10630059
• 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; Evidence based program; Family; Foundations; Friends; Goals; Health; Health Promotion; Health Resources; Health behavior; Health behavior and outcomes; Hepatitis C; Hepatitis C Therapy; Hepatitis C virus; Homelessness; Individual; Infection; Injecting drug user; Intervention; Intervention Studies; 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; Translating; Trust; United States; Visit; Work; acceptability and feasibility; behavior change; clinical diagnosis; cohort; comparison intervention; curative treatments; design; distrust; efficacy evaluation; efficacy testing; epidemic virus; experience; group intervention; improved; indexing; intimate behavior; marginalization; member; novel; opioid epidemic; programs; randomized trial; randomized, controlled study; response; social; social relationships; standard of care; success; timeline; 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 在全球范围内，超过350万人感染了丙型肝炎病毒（HCV）。在美国，由于 Oopioid流行病，HCV病例有所增加，尤其是在30岁以下的成年人中。但是，很少有年轻人 谁在美国HCV流行病的中心注射药物（PWID≤30岁）正在受益 从治愈性HCV疗法中。潜在的承诺，但尚未开发的大道，用于增加HCV治疗 PWID是他们注入合作伙伴成功驾驶多个障碍的利用 诊断和治疗。我们团队与二元组的广泛研究确定了其中一个潜在的动作点 可以通过行为干预来利用的伙伴关系。确定的定量发现 与增加有关 注射伙伴关系的健康和安全。其次是定性结果 人际关系因素，伴侣参与（即情感，有形，深情和积极的社会支持） 增强了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 发现参与可以克服HCV治疗的障碍。 在我们广泛的二元研究和二元行为改变理论的基础上，我们发展了 合作伙伴导航干预措施两次注射伙伴关系干预以增强二元 HCV治疗计划的年轻成人PWID的能力。拟议的研究是一项随机控制的 研究（RCT）评估第一种行为干预措施增加的效率和作用机理 年轻成人PWID中的HCV治疗计划。与我们基于社区的HCV测试合作 组织（CBO），我们将与最近被诊断为HCV感染的年轻成人PWID随机（250 合作伙伴关系，n = 500）及其主要注入干预或护理标准的合作伙伴。可伸缩性是核心 进行两项干预的设计。第1节扩展了护理标准HCV感染诊断 通过辅导员主导的辅导与HCV积极的PWID进行讨论，以确定情况和个人 HCV治疗的障碍并确定注射伙伴以帮助其HCV治疗导航。会议2 是与年轻的成人PWID及其注射伙伴的二元课程。辅导员准备的讨论 将制定策略以应对已确定的HCV治疗计划障碍和伙伴关系实践 策略并传达一个计划，涉及两个合作伙伴解决障碍，包括时间表和 治疗导航的潜在替代策略。在这两个课程中，辅导员记录密钥 在纸质讲义上讨论的信息（合作伙伴导航图）用作干预工具。一个 社区咨询委员会年轻的成人PWID将指导实施和传播。提议 研究将提高这种高度影响的人群的治愈率。我们增强二元能力的策略 可以适应其他影响年轻PWID的其他健康行为（例如，HCV预防）的目标变化。