NCT06953479

Implementing Low-Barrier HCV Treatment in a Jail Setting

MINMON-J: An Effectiveness Implementation Pilot Study Evaluating a Low-barrier Hepatitis C Treatment Model in a Jail Setting

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Lifespan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a hybrid effectiveness-implementation pilot study testing a simplified model of hepatitis C virus (HCV) treatment called MINMON-J, based on the successful "minimal monitoring" approach used in community settings. The study takes place at the Rhode Island Department of Corrections (RIDOC), a statewide unified jail and prison system. The goal is to assess whether low-barrier HCV treatment can be feasible, acceptable, and effective when started in jail, especially for individuals who inject drugs. Participants will receive a full 12-week course of sofosbuvir/velpatasvir (Epclusa) with no lab monitoring required during treatment. Those released before completing treatment will be given take-home medication and supported by Community Health Workers (CHWs) post-release. CHWs will check in with participants, support medication adherence, and help coordinate follow-up testing. The study will enroll 40 adults with active HCV who are awaiting trial and meet other medical and safety criteria. Implementation outcomes will be assessed using the PRISM/RE-AIM framework. These include: Feasibility: Can the treatment be delivered as planned in the jail setting? Acceptability: Do participants and providers find the program acceptable? Fidelity: Do participants take the medication as prescribed? Effectiveness: Are participants cured of HCV (measured by SVR12)? Maintenance: Do participants remain engaged in care or avoid reinfection 6 months later? Additional data will include participant demographics, adherence rates, and program costs (via the COINS framework). Participants and staff will also take part in qualitative interviews to understand their experience and identify ways to improve implementation. Results will inform a future larger trial and contribute to efforts to scale up HCV treatment in carceral settings as part of national HCV elimination efforts.

Conditions

• HEPATITIS C (HCV)
• Incarceration
• Injection Drug Use
• Implementation Science

Interventions

Type	Name	Description
DRUG	Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]	Individuals will receive a full course (i.e., 84 tablets) of Sofosbuvir / Velpatasvir 400/100mg tablets.
OTHER	Community Health Worker	Participants will receive support from a Community Health Worker which may include assistance with basic needs (transportation, housing, employment, vital documents, insurance re-activation) as well as medication adherence, patient navigation, and peer recovery support.

Timeline

• Start date: 2025-06-11
• Primary completion: 2027-01-01
• Completion: 2027-08-01
• First posted: 2025-05-01
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study