Mobile Telemedicine for Treating Chronic Hepatitis C Among Rural People Who Inject Drugs: A Randomized Clinical Trial.

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.