Abstract

Background: Telemedicine removes geographic and temporal obstacles to healthcare access. Few randomized trials have evaluated telemedicine effectiveness for underserved populations. We compared sustained virological response (SVR12) rates for hepatitis C virus (HCV) infection among persons with opioid use disorder through facilitated telemedicine (FTM) versus offsite liver specialist referral (usual care or UC).

Methods: We conducted a prospective, cluster randomized trial utilizing the stepped wedge design to compare SVR12 rates between FTM onsite in opioid treatment programs (OTPs) to UC. Between 3/1/17 and 2/29/20, we enrolled 602 participants at 12 OTPs throughout New York State. All OTPs began with UC and every 9 months, 4 sites, randomly selected, transited from UC to FTM during 3 steps. We followed participants for two years to assess for reinfection. Participant inclusion criteria required six months enrollment in the OTP and active insurance. Multiple imputation was used to handle missing data (5.8% missingness). To estimate the intervention effect, we used a robust, non-parametric, within-period, cluster-level method. To assess for heterogeneity of treatment effects, we utilized generalized linear mixed effects models.

Results: A total of 602 participants (FTM [n=290] and UC [n=312]) with mean age of 48.1 ± 13.0 years, 61.3% male, 30.7% Hispanic, 49.2% African American or other races, 28.1% with anxiety/depression, and 23% with cirrhosis. In FTM, 268/290 (92.4%) participants initiated treatment while 126/312 (40.4%) UC participants initiated treatment. The overall SVR12 was 90.7% in FTM compared to 35.2% in referral. The period specific intervention effect, computed as the difference between the SVR12 rate cluster-period summaries for FTM and UC is 0.596 (p <0.0001, 95% CI: (.237, .955)). We did not identify heterogeneity of treatment for fibrosis, urban/rural, or mental health (anxiety/depression) conditions. We found that drug use decreased significantly (p=<.0001) among cured participants, regardless of intervention arm between the first and SVR12 visits. Minimal (n=13) reinfections occurred, resulting in an HCV reinfection incidence of 2.42 per 100 person-years of observation. Participants reported very high healthcare delivery satisfaction, equivalent between arms.

Conclusion: HCV treatment through FTM integrated into OTPs results in significantly higher SVR12 compared with offsite referral. Drug use also declined significantly, and the response was durable with minimal HCV reinfections over two years. FTM integrates HCV management into OTPs, increasing access of underserved populations to high-quality HCV care with high patient satisfaction. FTM should be considered an approach to expand healthcare access as part of HCV elimination approaches.