biostudies-literatureEckhardt BNCATS NIH HHSNIDA NIH HHS494-502https://www.ebi.ac.uk/biostudies/studies/S-EPMC8922207biostudies-literatureUnknown182(5)<h4>Importance</h4>To achieve hepatitis C elimination, treatment programs need to engage, treat, and cure people who inject drugs.<h4>Objective</h4>To compare a low-threshold, nonstigmatizing hepatitis C treatment program that was colocated at a syringe service program (accessible care) with facilitated referral to local clinicians through a patient navigation program (usual care).<h4>Design, setting, and participants</h4>This single-site randomized clinical trial was conducted at the Lower East Side Harm Reduction Center, a syringe service program in New York, New York, and included 167 participants who were hepatitis C virus RNA-positive and had injected drugs during the prior 90 days. Participants enrolled between July 2017 and March 2020. Data were analyzed after all patients completed 1 year of follow-up (after March 2021).<h4>Interventions</h4>Participants were randomized 1:1 to the accessible care or usual care arm.<h4>Main outcomes and measures</h4>The primary end point was achieving sustained virologic response within 12 months of enrollment.<h4>Results</h4>Among the 572 participants screened, 167 (mean [SD] age, 42.0 [10.6] years; 128 (77.6%) male, 36 (21.8%) female, and 1 (0.6) transgender individuals; 8 (4.8%) Black, 97 (58.5%) Hispanic, and 53 (32.1%) White individuals) met eligibility criteria and were enrolled, with 2 excluded postrandomization (n = 165). Baseline characteristics were similar between the 2 arms. In the intention-to-treat analysis, 55 of 82 participants (67.1%) in the accessible care arm and 19 of 83 participants (22.9%) in the usual care arm achieved a sustained virologic response (P < .001). Loss to follow-up (12.2% [accessible care] and 16.9% [usual care]; P = .51) was similar in the 2 arms. Of the participants who received therapy, 55 of 64 (85.9%) and 19 of 22 (86.3%) achieved a sustained virologic response in the accessible care and usual care arms, respectively (P = .96). Significantly more participants in the accessible care arm achieved all steps in the care cascade, with the greatest attrition in the usual care arm seen in referral to hepatitis C virus clinician and attending clinical visit.<h4>Conclusions and relevance</h4>In this randomized clinical trial, among people who inject drugs with hepatitis C infection, significantly higher rates of cure were achieved using the accessible care model that focused on low-threshold, colocated, destigmatized, and flexible hepatitis C care compared with facilitated referral. To achieve hepatitis C elimination, expansion of treatment programs that are specifically geared toward engaging people who inject drugs is paramount.<h4>Trial registration</h4>ClinicalTrials.gov Identifier: NCT03214679.JAMA internal medicineAccessible Hepatitis C Care for People Who Inject Drugs: A Randomized Clinical Trial.PMC8922207UL1 TR002384K01 DA048172T32 DA007233Smith MMateu-Gelabert PMarks KMFong CAponte-Melendez YKapadia SEdlin BREckhardt BfalseAccessible Hepatitis C Care for People Who Inject Drugs: A Randomized Clinical Trial.<h4>Importance</h4>To achieve hepatitis C elimination, treatment programs need to engage, treat, and cure people who inject drugs.<h4>Objective</h4>To compare a low-threshold, nonstigmatizing hepatitis C treatment program that was colocated at a syringe service program (accessible care) with facilitated referral to local clinicians through a patient navigation program (usual care).<h4>Design, setting, and participants</h4>This single-site randomized clinical trial was conducted at the Lower East Side Harm Reduction Center, a syringe service program in New York, New York, and included 167 participants who were hepatitis C virus RNA-positive and had injected drugs during the prior 90 days. Participants enrolled between July 2017 and March 2020. Data were analyzed after all patients completed 1 year of follow-up (after March 2021).<h4>Interventions</h4>Participants were randomized 1:1 to the accessible care or usual care arm.<h4>Main outcomes and measures</h4>The primary end point was achieving sustained virologic response within 12 months of enrollment.<h4>Results</h4>Among the 572 participants screened, 167 (mean [SD] age, 42.0 [10.6] years; 128 (77.6%) male, 36 (21.8%) female, and 1 (0.6) transgender individuals; 8 (4.8%) Black, 97 (58.5%) Hispanic, and 53 (32.1%) White individuals) met eligibility criteria and were enrolled, with 2 excluded postrandomization (n = 165). Baseline characteristics were similar between the 2 arms. In the intention-to-treat analysis, 55 of 82 participants (67.1%) in the accessible care arm and 19 of 83 participants (22.9%) in the usual care arm achieved a sustained virologic response (P < .001). Loss to follow-up (12.2% [accessible care] and 16.9% [usual care]; P = .51) was similar in the 2 arms. Of the participants who received therapy, 55 of 64 (85.9%) and 19 of 22 (86.3%) achieved a sustained virologic response in the accessible care and usual care arms, respectively (P = .96). Significantly more participants in the accessible care arm achieved all steps in the care cascade, with the greatest attrition in the usual care arm seen in referral to hepatitis C virus clinician and attending clinical visit.<h4>Conclusions and relevance</h4>In this randomized clinical trial, among people who inject drugs with hepatitis C infection, significantly higher rates of cure were achieved using the accessible care model that focused on low-threshold, colocated, destigmatized, and flexible hepatitis C care compared with facilitated referral. To achieve hepatitis C elimination, expansion of treatment programs that are specifically geared toward engaging people who inject drugs is paramount.<h4>Trial registration</h4>ClinicalTrials.gov Identifier: NCT03214679.2022-01-01T00:00:00Z2022 May2026-05-09T13:57:12.037Z2025-02-19T00:13:17.117ZS-EPMC89222073528585110.1001/jamainternmed.2022.0170