RecruitingPhase 4NCT06953479

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

Sponsor

Lifespan

Enrollment

40 participants

Start Date

Jun 11, 2025

Study Type

INTERVENTIONAL

Conditions

Implementation Science Incarceration Injection Drug Use Hepatitis C (HCV)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether people held in jail awaiting trial can successfully complete treatment for Hepatitis C (HCV) — a liver infection spread through blood — before they are released. Participants will receive a standard 12-week oral medication and researchers will follow up to see if the treatment is completed and effective. **You may be eligible if...** - You are 18 or older, currently incarcerated at RIDOC (Rhode Island) and awaiting trial (not yet sentenced) - You have been diagnosed with active Hepatitis C (confirmed by a blood test within the past 90 days) - You have not been treated for Hepatitis C before - You report injection drug use - You are willing and able to be contacted after release and to continue taking medication once released **You may NOT be eligible if...** - You have cirrhosis (severe liver scarring) or signs of advanced liver disease - You also have Hepatitis B or HIV with active complications - You are pregnant or breastfeeding - You have a severe mental illness on record - You are allergic to the study medication (Sofosbuvir/Velpatasvir) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSofosbuvir / Velpatasvir Oral Tablet [Epclusa]

Individuals will receive a full course (i.e., 84 tablets) of Sofosbuvir / Velpatasvir 400/100mg tablets.

OTHERCommunity 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.