About this trial
The goal of this clinical trial is to learn whether a low-barrier treatment program can help people with hepatitis C virus (HCV) who are in jail start and complete treatment more easily. This study focuses on adults at the Rhode Island Department of Corrections who have active HCV and are awaiting trial.
The study asks:
* Can a simplified, low-barrier HCV treatment program work in a jail setting? * Do participants finish treatment and get cured using this approach?
All participants will receive a 12-week course of the HCV medication sofosbuvir/velpatasvir (Epclusa). If they are released before completing treatment, they will take the remaining doses with them. Community Health Workers (CHWs) will help support participants after release, including reminding them to take medications and helping them get follow-up lab work.
Researchers will measure:
* Whether participants are cured of HCV * Whether the treatment approach is easy to use (feasible), acceptable, and followed correctly (fidelity) * Whether the program could be used in other jails or expanded in the future
This study may help bring HCV treatment to more people in jail, reduce community spread of the virus, and support national goals to eliminate HCV.
Eligibility criteria
Qualifiers
Incarcerated individual at RIDOC
Age ≥ 18 years
Awaiting trial (i.e., not sentenced)
English speaking
Disqualifiers
Cirrhosis (FIB-4 Score >3.25 within 90 days prior to study entry and/or clinical signs of cirrhosis)
Positive for Hepatitis B surface antigen
Actively pregnant or breastfeeding
Known allergy/sensitivity to study drug components
Trial design
Treatments tested in this trial
- Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]
- Community Health Worker
Treatment groups
Sponsors and collaborators
Lifespan
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator