Low-barrier hepatitis C treatment program in jail
Official title: MINMON-J: An Effectiveness Implementation Pilot Study Evaluating a Low-barrier Hepatitis C Treatment Model in a Jail Setting
Run by Lifespan · NCT06953479 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Lifespan Academic / other |
| Locations | 1 site (Cranston, Rhode Island) |
| Status | Recruiting |
| Started | June 11, 2025 |
| Main results expected | January 2027 |
| Study ends | August 2027 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT06953479 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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Rhode Island Department of Corrections
Cranston, Rhode Island, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.