Pilot Study of a Simplified Hepatitis C Treatment Using SofosbuvirVelpatasvir in a Jail Setting Support from Community Health Workers for Medication and Follow-Up Evaluating Feasibility and Cure Rates in Adults Awaiting Trial

What this Trial Is About

Researchers are evaluating a simplified, low-barrier hepatitis C virus HCV treatment program designed for adults with active HCV who are incarcerated and awaiting trial at the Rhode Island Department of Corrections. This study aims to determine whether this approach is feasible, acceptable, and effective in a jail setting, especially for people who inject drugs. It is a pilot study assessing if the treatment can be completed and if participants are cured of HCV using this method, potentially informing future expansion of HCV treatment in correctional facilities. Participants will receive a 12-week course of the medication sofosbuvirvelpatasvir Epclusa without the need for lab monitoring during treatment. If released before completing treatment, participants will take remaining doses with them and receive support from Community Health Workers CHWs. These CHWs will assist with medication adherence, community re-entry, and coordination of follow-up lab work. The study includes one experimental arm where all participants receive the full treatment and CHW support. During the study, participants will be tracked for cure rates of HCV between 12 and 24 weeks after treatment completion. Researchers will also assess how easy the program is to deliver, how well participants follow the treatment plan, and how acceptable the program is to both participants and staff. Additional data collected includes participant demographics, adherence to medication inside and outside jail, program costs, and qualitative feedback from participants and staff. The study will help determine if this treatment model can be maintained and scaled in other jail settings.

Implementing Low-Barrier HCV Treatment in a Jail Setting