Implementing Low-Barrier HCV Treatment in a Jail Setting

Recruiting now · Phase 4

Conditions studied: HEPATITIS C (HCV), Incarceration, Injection Drug Use, Implementation Science

In brief

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.

Key facts

Study ID

NCT06953479

Run by

Lifespan

People needed

40

Starts

2025-06-11

Expected to finish

2027-08-01

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Incarcerated individual at RIDOC
• Age ≥ 18 years
• Awaiting trial (i.e., not sentenced)
• English speaking
• Diagnosis of active HCV (HCV RNA >1000 IU/mL within 90 days prior to study entry)
• Treatment-naïve for current HCV infection
• No cirrhosis (FIB-4 Score <3.25 within 90 days prior to study entry)
• Self-report of injection drug use
• Ability and willingness to be contacted after jail release
• Verbal commitment to continue medication after discharge
• Desire to receive Sofosbuvir/Velpatasvir (Epclusa)

You may not qualify if…

• 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
• Acute or serious illness requiring hospitalization at enrollment
• Documented severe persistent mental illness (SPMI) by RIDOC
• Any clinical history of hepatic decompensation (e.g., ascites, SBP, HE, HRS, variceal bleeding)
• HIV-positive with active or acute AIDS-defining opportunistic infection within 90 days

Where it is running

• Rhode Island Department of Corrections — Cranston, Rhode Island, United States (enrolling)

Full record on ClinicalTrials.gov

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