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Taking people in United StatesPhase 4

Easier hepatitis C treatment for adults awaiting trial in jail

Tests a simplified hepatitis C treatment program for adults held in jail.

Key facts

Who runs it
Lifespan
Where
Cranston, United StatesSee the site
Trial code
Registry title
Implementing Low-Barrier HCV Treatment in a Jail Setting
Status
Recruiting
Phase
Phase 4
People taking part
40 people, planned
Started
11 Jun 2025
Expected to end
Aug 2027
Type of study
Interventional
Treatments tested
  • Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]
  • Community Health Worker
Record updated
27 February 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults held at the Rhode Island Department of Corrections (RIDOC) jail, awaiting trial, with active hepatitis C. They must also report injection drug use. All will get a 12-week course of Sofosbuvir/Velpatasvir (Epclusa).

Age
18 years or older
Sex
All sexes
Disease stage
Active hepatitis C without cirrhosis (scarring of the liver), with a FIB-4 Score <3.25 within 90 days before entry.
Earlier treatment
No earlier treatment for the current hepatitis C infection.
Biomarker or test result
HCV RNA >1000 IU/mL within 90 days before entry.

Main reasons for not taking part

  • Cirrhosis, or any past liver failure signs such as fluid in the belly or bleeding veins
  • Positive test for Hepatitis B surface antigen
  • Pregnant or breastfeeding
  • Severe persistent mental illness recorded by RIDOC, or serious illness needing hospital care at enrolment
  • HIV with an active AIDS-related infection within 90 days, or allergy to the study drug

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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
  • 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
  • Actively pregnant or breastfeeding

Where in United States

  • Rhode Island Department of CorrectionsCranston, United StatesContact: Jessica MigliaccioTaking people

About the trial

What the trial wants to find out

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 full original descriptionShow less

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.

The group in the trial

  • MINMON-JTreatment being tested

    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.

    Treatment: Sofosbuvir / Velpatasvir Oral Tablet [Epclusa] and Community Health Worker

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
MINMON-J: An Effectiveness Implementation Pilot Study Evaluating a Low-barrier Hepatitis C Treatment Model in a Jail Setting
Plain-language title
Easier hepatitis C treatment for adults awaiting trial in jailGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
27 February 2026