Morris Meghan D, Tan Judy Y, McDonell Claire C, Scarpetta Maia, Nguyen Tiffany N, Price Jennifer C, Neilands Torsten B
Department of Epidemiology & Biostatistics, University of California, San Francisco, USA.
Cancer Research Center for Health Equity, Division of Population Sciences, Department of Biomedical Sciences, Cedars-Sinai Medical Center, Los Angeles, USA.
Trials. 2025 Jan 22;26(1):26. doi: 10.1186/s13063-024-08662-0.
Disparities persist in testing and treatment for hepatitis C virus (HCV), leaving socially marginalized populations, including people who inject drugs (PWID), less likely to benefit from curative treatment. Linkage services are often insufficient to overcome barriers to navigating the medical system and contextual factors.
The You're Empowered for Treatment Initiation (YETI) Partner trial is a single-site randomized controlled trial evaluating the efficacy of a two-session behavioral intervention that engages injecting partners as peer navigators for HCV treatment. We aim to recruit 250 PWID and their primary injecting partners in San Francisco, California, randomizing them 1:1 to either a control or intervention group. The primary outcome is the initiation of HCV treatment, with secondary outcomes including treatment completion and sustained virologic response 12 weeks post-treatment. Data will be collected through questionnaires and electronic health records and analyzed using intention-to-treat and mixed-effects models.
This trial will provide evidence of a new HCV treatment linkage intervention leveraging the support of primary injecting partners to initiate HCV treatment. If successful, the intervention could inform public health strategies and policies to address HCV in marginalized populations.
ClinicalTrials.gov NCT06179498. Registered on December 22, 2023.
丙型肝炎病毒（HCV）检测和治疗方面的差距依然存在，包括注射吸毒者（PWID）在内的社会边缘化人群从治愈性治疗中获益的可能性较低。转诊服务往往不足以克服医疗系统和背景因素带来的障碍。
“你有权开始治疗”（YETI）伙伴试验是一项单中心随机对照试验，评估一项为期两阶段的行为干预措施的效果，该干预措施让注射吸毒者的伙伴作为同伴导航员参与HCV治疗。我们的目标是在加利福尼亚州旧金山招募250名注射吸毒者及其主要注射伙伴，将他们按1:1随机分为对照组或干预组。主要结局是开始HCV治疗，次要结局包括治疗完成情况以及治疗后12周的持续病毒学应答。数据将通过问卷调查和电子健康记录收集，并使用意向性分析和混合效应模型进行分析。
这项试验将提供证据，证明一种新的HCV治疗转诊干预措施利用主要注射伙伴的支持来启动HCV治疗。如果成功，该干预措施可为解决边缘化人群HCV问题的公共卫生战略和政策提供参考。
ClinicalTrials.gov NCT06179498。于2023年12月22日注册。
