Low-barrier hepatitis C treatment program in jail
MINMON-J: An Effectiveness Implementation Pilot Study Evaluating a Low-barrier Hepatitis C Treatment Model in a Jail Setting
This project tests whether a simplified 12-week Epclusa treatment with community health worker support helps adults in jail with active hepatitis C start and finish therapy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lifespan Academic / other |
| Locations | 1 site (Cranston, Rhode Island) |
| Trial ID | NCT06953479 on ClinicalTrials.gov |
What this trial studies
This is a pilot hybrid effectiveness-implementation study (MINMON-J) delivering a simplified, minimal‑monitoring HCV treatment model inside the Rhode Island Department of Corrections. Forty adults awaiting trial with active HCV will receive a full 12‑week course of sofosbuvir/velpatasvir (Epclusa) with no routine on‑treatment lab monitoring, and those released before completion will be given take‑home medication. Community health workers will provide postrelease adherence support and help arrange follow‑up testing. Researchers will measure cure (SVR12) and implementation outcomes including feasibility, acceptability, fidelity, and maintenance using the PRISM/RE‑AIM framework.
Who should consider this trial
Good fit: Ideal participants are adults (≥18) incarcerated at the Rhode Island Department of Corrections who are awaiting trial, English speaking, have active HCV RNA, are treatment‑naïve, have no cirrhosis, report injection drug use, and are willing to be contacted after release.
Not a fit: People with cirrhosis, hepatitis B surface antigen positivity, pregnancy or breastfeeding, documented severe persistent mental illness, prior hepatic decompensation, or those unwilling/unable to continue medication or follow up after release are not expected to benefit from this low‑barrier approach.
Why it matters
Potential benefit: If successful, this approach could allow more people in jail to start and complete curative hepatitis C treatment with fewer clinic visits and less monitoring.
How similar studies have performed: Minimal‑monitoring direct‑acting antiviral programs have cured HCV in community settings, but applying this low‑barrier model within jail populations is novel and less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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 this trial is running
Cranston, Rhode Island
- Rhode Island Department of Corrections — Cranston, Rhode Island, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.