Peter D. Friedmann, Donna Wilson, David de Gijsel, Kerry Nolte, Jean Dejace, Randall Hoskinson, Lizbeth M. Del Toro-Mejías, Elyse Bianchet, Patrick F. Dowd, William E. Soares, Thomas J. Stopka
Conclusions and Relevance: In this randomized clinical trial, telemedicine for chronic HCV treatment integrated with syringe services on a mobile van was associated with improved access to HCV treatment initiation and cure for people with a history of drug injection in rural communities where HCV treatment services are scarce, suggesting optimal strategies in rural areas should include convenient,
Importance: Persons who inject drugs in the rural US have high rates of chronic hepatitis C virus (HCV) infection and poor access to HCV testing, direct-acting antiviral (DAA) treatment, and syringe services. Effective approaches to test and treat this population are needed to achieve national HCV elimination goals. Objective: To test whether a mobile telemedicine-based HCV treatment intervention increases HCV treatment initiation and viral clearance and decreases sharing of injection equipment among rural persons who inject drugs. Design, Setting, and Participants: This open-label, randomized, parallel-group clinical trial compared mobile telemedicine care (MTC) for HCV treatment with enhanced usual care (EUC), both integrated with van-based syringe services, from April 21, 2022, to September 13, 2024. Participants were persons aged 18 years or older with a history of drug injection and chronic HCV infection from 3 rural counties in New Hampshire and Vermont. Intervention: MTC consisted of DAA treatment for HCV via telemedicine along with on-demand syringe services, all on a mobile van. EUC consisted of treatment referral by van staff, with care navigation to a local or regional clinician. Main Outcomes and Measures: Primary outcomes were the proportion of participants who (1) initiated DAA treatment for HCV, (2) achieved viral clearance at the 12-week follow-up, and (3) reported no injection equipment sharing at any point after the expected treatment completion visit. Results: Of 503 prescreened individuals, 169 were eligible and 150 were randomized to MTC (n = 75) or EUC (n = 75). Participants had a mean (SD) age of 38.1 (8.1) years, 103 (68.7%) were male, 105 (70.0%) experienced homelessness, and 97 (64.7%) reported drug injection in the past 30 days. MTC participants were more likely than EUC participants to initiate DAA treatment (43 [57.3%] vs 20 [26.7%]; relative risk [RR], 2.15 [95% CI, 1.41-3.28]) and to achieve viral clearance (28 [37.3%] vs 14 [18.7%]; RR, 2.00 [95% CI, 1.15-3.49]). No effect was detected on abstention from sharing of syringes or other injection equipment at follow-up (RR, 0.95; 95% CI, 0.68-1.32). Conclusions and Relevance: In this randomized clinical trial, telemedicine for chronic HCV treatment integrated with syringe services on a mobile van was associated with improved access to HCV treatment initiation and cure for people with a history of drug injection in rural communities where HCV treatment services are scarce, suggesting optimal strategies in rural areas should include convenient, low-threshold telemedicine treatment. Trial Registration: ClinicalTrials.gov Identifier: NCT05466331.