Integrated Hepatitis C-Opioid Use Disorder Care Through Facilitated Telemedicine: A Randomized Trial

Abstract

Importance: Facilitated telemedicine may promote hepatitis C virus elimination by mitigating geographic and temporal barriers.

Objective: To compare sustained virologic responses for hepatitis C virus among persons with opioid use disorder treated through facilitated telemedicine integrated into opioid treatment programs compared with off-site hepatitis specialist referral.

Design, setting, and participants: Prospective, cluster randomized clinical trial using a stepped wedge design. Twelve programs throughout New York State included hepatitis C-infected participants (n = 602) enrolled between March 1, 2017, and February 29, 2020. Data were analyzed from December 1, 2022, through September 1, 2023.

Intervention: Hepatitis C treatment with direct-acting antivirals through comanagement with a hepatitis specialist either through facilitated telemedicine integrated into opioid treatment programs (n = 290) or standard-of-care off-site referral (n = 312).

Main outcomes and measures: The primary outcome was hepatitis C virus cure. Twelve programs began with off-site referral, and every 9 months, 4 randomly selected sites transitioned to facilitated telemedicine during 3 steps without participant crossover. Participants completed 2-year follow-up for reinfection assessment. Inclusion criteria required 6-month enrollment in opioid treatment and insurance coverage of hepatitis C medications. Generalized linear mixed-effects models were used to test for the intervention effect, adjusted for time, clustering, and effect modification in individual-based intention-to-treat analysis.

Results: Among 602 participants, 369 were male (61.3%); 296 (49.2%) were American Indian or Alaska Native, Asian, Black or African American, multiracial, or other (ie, no race category was selected, with race data collected according to the 5 standard National Institutes of Health categories); and 306 (50.8%) were White. The mean (SD) age of the enrolled participants in the telemedicine group was 47.1 (13.1) years; that of the referral group was 48.9 (12.8) years. In telemedicine, 268 of 290 participants (92.4%) initiated treatment compared with 126 of 312 participants (40.4%) in referral. Intention-to-treat cure percentages were 90.3% (262 of 290) in telemedicine and 39.4% (123 of 312) in referral, with an estimated logarithmic odds ratio of the study group effect of 2.9 (95% CI, 2.0-3.5; P < .001) with no effect modification. Observed cure percentages were 246 of 290 participants (84.8%) in telemedicine vs 106 of 312 participants (34.0%) in referral. Subgroup effects were not significant, including fibrosis stage, urban or rural participant residence location, or mental health (anxiety or depression) comorbid conditions. Illicit drug use decreased significantly (referral: 95% CI, 1.2-4.8; P = .001; telemedicine: 95% CI, 0.3-1.0; P < .001) among cured participants. Minimal reinfections (n = 13) occurred, with hepatitis C virus reinfection incidence of 2.5 per 100 person-years. Participants in both groups rated health care delivery satisfaction as high or very high.

Conclusions and relevance: Opioid treatment program-integrated facilitated telemedicine resulted in significantly higher hepatitis C virus cure rates compared with off-site referral, with high participant satisfaction. Illicit drug use declined significantly among cured participants with minimal reinfections.

Trial registration: ClinicalTrials.gov Identifier: NCT02933970.

Figure 1.. Recruitment, Randomization, and Patient Follow-Up in the Stepped Wedge Cluster Randomized Opioid Treatment Program–Integrated Facilitated Telemedicine Trial

The number of sites randomized and individuals analyzed per period is illustrated at the bottom of the figure. Usual care is shown in dark shading and opioid treatment program–integrated facilitated telemedicine is shown in light shading. ART indicates antiretroviral therapy; HCV, hepatitis C virus.

Figure 2.. Distributions of Scores Obtained From the Drug Abuse Screening Test (DAST-10) at the Initial and Sustained Virologic Response Visits

The Tukey boxplot illustrates a significant decline in DAST-10 scores in individuals cured of hepatitis C virus infection in facilitated telemedicine (P < .001) and referral (P = .001). The box extends from the 25th to the 75th percentile, with the line in the middle of the box depicting the median. The lines extending from the top and bottom of the box depict the upper and lower values. For information on the components and scoring of the DAST-10, see the footnote in Table 1.

Figure 3.. Hepatitis C Virus Cure Subgroup Analysis

Dot and whisker plot of time-adjusted log(OR) with associated 95% CIs for various subgroups of interest. The level of α = .05 (2-tailed), and no adjustments for multiplicity were made. OR indicates odds ratio; SVR, sustained virologic response. ^aRace data were collected according to the 5 standard National Institutes of Health categories. Other races include American Indian or Alaska Native, Asian, multiracial, and other (ie, no race category was selected). ^bA normal distribution prior was used and the results were obtained with the blme R package, which encodes bayesian methods for fitting linear mixed models; priors were used for the model parameters.