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350万人感染丙型肝炎病毒（HCV）。在美国，由于 随着阿片类药物流行，HCV病例增加，特别是在30岁以下的成年人中。然而，很少有年轻人 注射毒品者（PWID ≤30岁）--他们是美国HCV流行的中心--正在受益 治愈性HCV治疗。一个潜在的有希望的，但尚未开发的途径，增加丙型肝炎病毒治疗， PWID是他们的注入合作伙伴的杠杆作用，成功地导航之间的多重障碍， 诊断和治疗。我们的团队对二元体进行了广泛的研究，确定了一个潜在的行动点， 注入可以通过行为干预加以利用的伙伴关系。确定的定量结果 具体的注射相关的人际因素（即，信任，亲密，合作）与增加 注射伙伴关系的健康和安全。其次是定性结果， 人际因素，伙伴参与（即，情感、有形、深情和积极的社会支持） 增强合作伙伴协调行为的能力（二元能力）。与伴侣的人际因素 参与被发现可以克服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，我们开发了 合作伙伴导航干预是一个两阶段的注入合作伙伴关系干预，以增强二元 为年轻成人PWID启动HCV治疗的能力。拟定的研究是一项随机对照 研究（RCT），以评估第一次行为干预的有效性和作用机制，以增加 在年轻成人PWID中开始HCV治疗。与我们的社区HCV检测合作 组织（CBO），我们将随机选择最近诊断为HCV感染的年轻成年PWID（250 伙伴关系，n=500）和他们的主要注射伙伴干预或标准护理。可扩展性是核心 两阶段干预的设计。第1部分扩展了HCV感染诊断的标准治疗 咨询与辅导员主导的讨论与HCV阳性PWID，以确定情境和个人 HCV治疗的障碍，并确定一个注射伙伴，以帮助他们的HCV治疗导航。会话2 是年轻的成年PWID和他们的注射伴侣的二元会议。一位顾问促进了讨论 将制定战略，以应对已确定的HCV治疗启动障碍和伙伴关系实践 战略和具体计划，包括一个时间轴， 治疗导航中的潜在替代策略。在这两次会议上，顾问记录了关键 将讨论的信息记录到纸质讲义（合作伙伴导航图）中，作为干预工具。一 社区咨询委员会将指导实施和传播。拟议 这项研究将提高这一高度受影响人群的治愈率。我们的增强二元能力的战略 可以适用于其它健康行为的目标改变（例如，HCV预防）影响年轻PWID。