Implementation of Site-Specific Hepatitis C Virus Treatment Workflows for Vulnerable, High-Risk Populations: A Prospective Single-Arm Trial

Introduction: Hepatitis C virus (HCV) treatment with pan-genotypic direct acting antivirals is highly effective, given an evidence-based simplified treatment algorithm. Yet access to treatment is limited among vulnerable populations. Objective: We assessed the effectiveness of site-specific HCV treatment workflows on HCV care for vulnerable populations in Austin, Texas. Methods: Patients diagnosed with chronic hepatitis C enrolled in care at a study site were eligible for this prospective, single-arm clinical trial. We assessed the proportion of participants that: (1) were prescribed treatment, (2) initiated treatment, (3) completed treatment, (4) were assessed for cure, and (5) achieved cure. We also evaluated implementation using the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework. Results: Of 62 participants, 89% had ever experienced homelessness and 94% had ever used drugs. An estimated 66% (95% CrI, 42%-84%) were prescribed treatment and 49% (95% CrI, 26%-70%) initiated treatment. An estimated 38% (95% CrI, 20%-58%) completed treatment, 14% (95% CrI, 4%-44%) were assessed for cure, and 10% (95% CrI, 2%-35%) achieved cure. Conclusions: We identified gaps along the HCV care cascade between: (1) enrolled to prescribed treatment and (2) completed treatment to assessed for cure. Site-specific HCV treatment workflows were insufficient to engage participants in care and avoid treatment delays. Novel approaches are needed and these may include patient outreach, patient navigation, test-and-treat protocols, and removing financial or payor barriers to medication access. Trial Registration: Registered on ClinicalTrials.gov on July, 14, 2022. Identifier: NCT05460130. https://clinicaltrials.gov/ct2/show/NCT05460130.