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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Rhode Island
Rhode Island Department of Corrections
RECRUITING
Cranston
Time Frame
Start Date: 2025-06-11
Estimated Completion Date: 2027-08
Participants
Target number of participants: 40
Treatments
Experimental: MINMON-J
Individuals in this arm will be provided the full-course treatment of sofosbuvir / velpatasvir for treatment of hepatitis C virus. They will also receive support from a Community Health Worker (CHW) to assist with community re-entry, medication adherence, and lab follow-up.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA)
Leads: Lifespan

This content was sourced from clinicaltrials.gov