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HEPATITIS C (HCV)Phase 4MINMON-JNCT06953479

Implementing Low-Barrier HCV Treatment in a Jail Setting

A Phase 4 study testing Sofosbuvir / Velpatasvir Oral Tablet [Epclusa] and Community Health Worker in people with HEPATITIS C (HCV) and Incarceration, run by Lifespan at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sofosbuvir / Velpatasvir Oral Tablet [Epclusa] and Community Health Worker
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
11 Jun 2025to Aug 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • Rhode Island Department of Corrections

    Cranston, Rhode Island, 02920

    Jessica Migliaccio, (401) 462-3921, doc.planning@doc.ri.gov

    Justin Berk, MD MPH MBA

    Recruiting

Other trials in United States

About this study

Official title: 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:

Read more
  • 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.

Read the 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.

Being tested
Sofosbuvir / Velpatasvir Oral Tablet [Epclusa], Community Health Worker
Keywords
hepatitis c, incarceration, jail, injection drug use, minimal monitoring, MINMON, implementation science
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]Drug

    Individuals will receive a full course (i.e., 84 tablets) of Sofosbuvir / Velpatasvir 400/100mg tablets.

  • Community Health WorkerOther

    Also called CHW

    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.

Study groups in NCT06953479
Study groupRoleWhat they receive
MINMON-JExperimentalIndividuals 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.
Receives: Drug: Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]; Other: Community Health Worker

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HCV Cure Rate

    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.

    Measured: Between 12 and 24 weeks after completion of HCV treatment

Secondary outcomes (4)

  1. Implementation: Feasibility of Implementation Measure

    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.

    Measured: Between 4 to 12 weeks post-implementation

  2. Fidelity: In-facility Treatment Adherence

    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.

    Measured: From enrollment to the end of treatment at 12 weeks

  3. Fidelity: Community Treatment Adherence

    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.

    Measured: From enrollment to the end of treatment at 12 weeks

  4. Implementation: Acceptability of Implementation Measure

    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.

    Measured: Between 4 to 12 weeks post-implementation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2025
  2. Study start11 Jun 2025
  3. Primary completionJan 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Pilot Single-Arm Hybrid Implementation-Effectiveness Study; adaptation of "Minimal Monitoring" HCV treatment model
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06953479
Sponsor's protocol ID
IRB 2240400
Other IDs
R34DA061732
Acronym
MINMON-J
Status last verified
Feb 2026
First submitted
16 Apr 2025
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Berk J, Fu ES, Murphy M, Akiyama MJ, Sulkowski M, Rich JD, Frank HE. MINMON-J: a hybrid implementation pilot study evaluating a low-barrier hepatitis C treatment model in a jail setting. BMJ Open. 2025 Sep 30;15(9):e104839. doi: 10.1136/bmjopen-2025-104839.

    PubMed 41027703

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sofosbuvir / Velpatasvir Oral Tablet [Epclusa] and Community Health Worker in people with HEPATITIS C (HCV) and Incarceration, run by Lifespan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HCV Cure Rate (time frame: Between 12 and 24 weeks after completion of HCV treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06953479, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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