MINMON-J: a hybrid implementation pilot study evaluating a low-barrier hepatitis C treatment model in a jail setting.
Justin Berk, Emily S Fu, Matthew Murphy...
https://pubmed.ncbi.nlm.nih.gov/41027703Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID06953479
MINMON-J: Evaluating a Low-Barrier Hepatitis C Treatment Model in a Jail Setting to Support Treatment Completion and Cure
Led by Lifespan · Updated on 2026-02-27
40
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
L
Lifespan
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a simplified, low-barrier hepatitis C virus (HCV) treatment program designed for adults with active HCV who are incarcerated and awaiting trial at the Rhode Island Department of Corrections. This study aims to determine whether this approach is feasible, acceptable, and effective in a jail setting, especially for people who inject drugs. It is a pilot study assessing if the treatment can be completed and if participants are cured of HCV using this method, potentially informing future expansion of HCV treatment in correctional facilities. Participants will receive a 12-week course of the medication sofosbuvir/velpatasvir (Epclusa) without the need for lab monitoring during treatment. If released before completing treatment, participants will take remaining doses with them and receive support from Community Health Workers (CHWs). These CHWs will assist with medication adherence, community re-entry, and coordination of follow-up lab work. The study includes one experimental arm where all participants receive the full treatment and CHW support. During the study, participants will be tracked for cure rates of HCV between 12 and 24 weeks after treatment completion. Researchers will also assess how easy the program is to deliver, how well participants follow the treatment plan, and how acceptable the program is to both participants and staff. Additional data collected includes participant demographics, adherence to medication inside and outside jail, program costs, and qualitative feedback from participants and staff. The study will help determine if this treatment model can be maintained and scaled in other jail settings.
CONDITIONS
Brief Title
Implementing Low-Barrier HCV Treatment in a Jail Setting
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Incarcerated individual at Rhode Island Department of Corrections
- Age 18 years or older
- Awaiting trial (not yet sentenced)
- English speaking
- Diagnosis of active hepatitis C virus infection with HCV RNA >1000 IU/mL within 90 days prior to study entry
- Treatment-nafve for current HCV infection
- No cirrhosis with FIB-4 Score less than 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)
You will not qualify if you...
- Cirrhosis with FIB-4 Score greater than 3.25 within 90 days prior to study entry or clinical signs of cirrhosis
- Positive for Hepatitis B surface antigen
- Actively pregnant or breastfeeding
- Known allergy or sensitivity to study drug components
- Acute or serious illness requiring hospitalization at enrollment
- Documented severe persistent mental illness by RIDOC
- Any clinical history of hepatic decompensation such as ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatorenal syndrome, or variceal bleeding
- HIV-positive with active or acute AIDS-defining opportunistic infection within 90 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants receive a full 12-week course of sofosbuvir/velpatasvir (Epclusa) with support from a Community Health Worker to assist with medication adherence and community re-entry.
Visits as needed with Community Health Workers during treatment; medication provided at jail and take-home if released early
Follow-up
Duration - Up to 12 weeks after treatment completion
Participants are supported post-release with follow-up testing and adherence support to assess treatment effectiveness and engagement in care.
Community Health Worker check-ins and follow-up visits for testing
Trial Site Locations
Total: 1 location
1
Rhode Island Department of Corrections
Cranston, Rhode Island, United States, 02920
Actively Recruiting
Loading map...
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here