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

Abstract

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. 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). 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. 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. AbbVie.