Rapid hepatitis C test and treat with peer support at opioid treatment programs (RAPID HCV): a hybrid effectiveness-implementation type 1 randomized control trial

IF 9.1 Q1 HEALTH CARE SCIENCES & SERVICES

Lancet Regional Health-Americas Pub Date : 2026-05-01 Epub Date: 2026-03-24 DOI:10.1016/j.lana.2026.101439

Oluwaseun Falade-Nwulia , Jennifer C. Price , Jordan J. Feld , Ellen Eaton , Ricardo A. Franco , Brittany Barnaba , Diane Brown , Sarah Hussain , Tarfa Verinumbe , Catherine Wren , Hamidreza Karimi-Sari , Kyoko Hirose , Chris Cavacuiti , Stephen T. O'rear , Camelia Capraru , Karin Tobin , Dhananjay Vaidya , Sheree Schwartz , Mark Sulkowski

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引用次数: 0

Abstract

Background

People who use drugs (PWUD) face persistent barriers to hepatitis C virus (HCV) treatment, threatening HCV elimination goals. Integrating HCV testing and treatment into opioid treatment programs (OTPs) may increase access and uptake. We evaluated the effectiveness and implementation outcomes of an onsite HCV test and treat model delivered within OTPs.

Methods

RAPID HCV was a multicenter, open label randomized controlled trial conducted at five OTPs in the United States and Canada. PWUD with a reactive antibody test were randomized (1:1) to onsite OTP-delivered HCV test and treat with peer support (RAPID HCV) or referral to offsite specialist care. Randomization was computer generated with concealed allocation. Following randomization, participants underwent clinical eligibility assessment for glecaprevir/pibrentasvir. The primary outcome was HCV treatment initiation within 12 weeks among treatment eligible participants (modified intention-to-treat [mITT]). The trial is registered at clinicaltrials.gov (NCT04677153).

Findings

Between August 2021, and November 2023, 182 participants were randomized; 58 were ineligible for treatment and two were administratively excluded, yielding 122 in the mITT population. Median age was 49 years (IQR 38–58), 73 (60%) were male, and 85 (70%) had an illicit substance detected in urine at baseline. Treatment initiation occurred in 59 of 66 (89% [95% Confidence Interval 79–95]) RAPID HCV participants compared with 12 of 56 (21% [95% CI 13–34]) referred participants (p < 0.001). No serious adverse events related to study procedures or HCV treatment were observed.

Interpretation

Onsite HCV test and treat with peer support delivered by OTP staff significantly increased HCV treatment initiation compared with offsite referral. Integrating HCV care into OTPs is an effective strategy to advance HCV elimination among PWUD.

Funding

AbbVie.

查看原文本刊更多论文

快速丙型肝炎检测和阿片类药物治疗项目同伴支持治疗（Rapid HCV）：一项混合有效性-实施型随机对照试验

药物使用者（PWUD）面临丙型肝炎病毒（HCV）治疗的持续障碍，威胁到消除HCV的目标。将丙型肝炎病毒检测和治疗纳入阿片类药物治疗方案（OTPs）可能会增加获取和吸收。我们评估了现场HCV测试和治疗模式在OTPs内的有效性和实施结果。方法：rapid HCV是一项多中心、开放标签随机对照试验，在美国和加拿大的5家OTPs进行。有反应性抗体检测的PWUD被随机（1:1）分配到现场otp提供的HCV检测和同伴支持治疗（RAPID HCV）或转诊到场外专科护理。随机化是由计算机生成的，采用隐藏分配。随机分组后，参与者接受glecaprevir/pibrentasvir的临床资格评估。主要结局是符合治疗条件的参与者在12周内开始HCV治疗（修改意向治疗[mITT]）。该试验已在clinicaltrials.gov注册（NCT04677153）。在2021年8月至2023年11月期间，182名参与者被随机分配；58例不符合治疗条件，2例行政排除，在mITT人群中产生122例。中位年龄为49岁（IQR 38-58）， 73名（60%）为男性，85名（70%）在基线时尿液中检测到非法物质。66名快速丙型肝炎患者中有59名（89%[95%可信区间79-95]）开始治疗，而56名患者中有12名（21%[95%可信区间13-34]）开始治疗（p < 0.001）。未观察到与研究程序或HCV治疗相关的严重不良事件。解释：与非现场转诊相比，现场HCV检测和由OTP工作人员提供的同伴支持治疗显著增加了HCV治疗的起始率。将HCV治疗纳入otp是促进pwud人群消除HCV的有效策略。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Lancet Regional Health-Americas Multiple-

CiteScore

8.00

自引率

0.00%

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期刊介绍： The Lancet Regional Health – Americas, an open-access journal, contributes to The Lancet's global initiative by focusing on health-care quality and access in the Americas. It aims to advance clinical practice and health policy in the region, promoting better health outcomes. The journal publishes high-quality original research advocating change or shedding light on clinical practice and health policy. It welcomes submissions on various regional health topics, including infectious diseases, non-communicable diseases, child and adolescent health, maternal and reproductive health, emergency care, health policy, and health equity.