Implementing Low-Barrier HCV Treatment in a Jail Setting (MINMON-J)

February 26, 2026 updated by: Justin Berk, Lifespan

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a hybrid effectiveness-implementation pilot study testing a simplified model of hepatitis C virus (HCV) treatment called MINMON-J, based on the successful "minimal monitoring" approach used in community settings. The study takes place at the Rhode Island Department of Corrections (RIDOC), a statewide unified jail and prison system. The goal is to assess whether low-barrier HCV treatment can be feasible, acceptable, and effective when started in jail, especially for individuals who inject drugs.

Participants will receive a full 12-week course of sofosbuvir/velpatasvir (Epclusa) with no lab monitoring required during treatment. Those released before completing treatment will be given take-home medication and supported by Community Health Workers (CHWs) post-release. CHWs will check in with participants, support medication adherence, and help coordinate follow-up testing.

The study will enroll 40 adults with active HCV who are awaiting trial and meet other medical and safety criteria. Implementation outcomes will be assessed using the PRISM/RE-AIM framework. These include:

Feasibility: Can the treatment be delivered as planned in the jail setting? Acceptability: Do participants and providers find the program acceptable? Fidelity: Do participants take the medication as prescribed? Effectiveness: Are participants cured of HCV (measured by SVR12)? Maintenance: Do participants remain engaged in care or avoid reinfection 6 months later?

Additional data will include participant demographics, adherence rates, and program costs (via the COINS framework). Participants and staff will also take part in qualitative interviews to understand their experience and identify ways to improve implementation. Results will inform a future larger trial and contribute to efforts to scale up HCV treatment in carceral settings as part of national HCV elimination efforts.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Cranston, Rhode Island, United States, 02920
        • Recruiting
        • Rhode Island Department of Corrections
        • Contact:
        • Principal Investigator:
          • Justin Berk, MD MPH MBA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]
Individuals will receive a full course (i.e., 84 tablets) of Sofosbuvir / Velpatasvir 400/100mg tablets.
Other: Community 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.
Other Names:
  • CHW

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HCV Cure Rate
Time Frame: Between 12 and 24 weeks after completion of HCV treatment
HCV Cure Rate will be defined as achieving a Sustained Virological Response at 12 weeks after treatment completion (SVR12), assessed by an undetectable HCV RNA viral load measured via standard laboratory assay. An undetectable result indicates that the virus is no longer present in the blood and is considered the clinical definition of virologic cure.
Between 12 and 24 weeks after completion of HCV treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implementation: Feasibility of Implementation Measure
Time Frame: Between 4 to 12 weeks post-implementation
The Feasibility of Implementation Measure (FIM) is a validated 4-item Likert-scale tool assessing provider perceptions of the feasibility of implementing a specific intervention. Each item is scored from 1 (completely disagree) to 5 (completely agree), with higher scores indicating greater perceived feasibility. The total score ranges from 4 to 20. Mean FIM scores will be reported across participants. This will be administered to participating stakeholders.
Between 4 to 12 weeks post-implementation
Fidelity: In-facility Treatment Adherence
Time Frame: From enrollment to the end of treatment at 12 weeks
Fidelity will be assessed by calculating the percentage of prescribed doses taken during the treatment period, based on in-facility medication dispensation data from the Rhode Island Department of Corrections (RIDOC) electronic medical record (EMR), Adherence will be reported both as a continuous variable (% of doses taken) and as a binary indicator (≥80% of prescribed daily doses taken during treatment). Missing doses will be quantified to assess treatment fidelity across care settings.
From enrollment to the end of treatment at 12 weeks
Fidelity: Community Treatment Adherence
Time Frame: From enrollment to the end of treatment at 12 weeks
Fidelity will be assessed by calculating the percentage of prescribed doses taken during the treatment period, based on community adherence data collected by community health workers (CHWs) using the Brief Adherence Rating Scale (BARS). Adherence will be reported both as a continuous variable (% of doses taken) and as a binary indicator (≥80% of prescribed daily doses taken during treatment). Missing doses will be quantified to assess treatment fidelity across care settings.
From enrollment to the end of treatment at 12 weeks
Implementation: Acceptability of Implementation Measure
Time Frame: Between 4 to 12 weeks post-implementation
Acceptability will be assessed using the validated 4-item Acceptability of Intervention Measure (AIM), which evaluates provider perceptions of how acceptable the intervention is. Each item is rated on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree). Total scores range from 4 to 20, with higher scores indicating greater acceptability.
Between 4 to 12 weeks post-implementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lifespan

Collaborators

National Institute on Drug Abuse (NIDA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

April 16, 2025

First Submitted That Met QC Criteria

April 23, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 2240400
  • R34DA061732 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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