RECRUITING

Implementing Low-Barrier HCV Treatment in a Jail Setting

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-11
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06953479

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Incarcerated individual at RIDOC
  2. * Age ≥ 18 years
  3. * Awaiting trial (i.e., not sentenced)
  4. * English speaking
  5. * Diagnosis of active HCV (HCV RNA \>1000 IU/mL within 90 days prior to study entry)
  6. * Treatment-naïve for current HCV infection
  7. * No cirrhosis (FIB-4 Score \<3.25 within 90 days prior to study entry)
  8. * Self-report of injection drug use
  9. * Ability and willingness to be contacted after jail release
  10. * Verbal commitment to continue medication after discharge
  11. * Desire to receive Sofosbuvir/Velpatasvir (Epclusa)
  1. * Cirrhosis (FIB-4 Score \>3.25 within 90 days prior to study entry and/or clinical signs of cirrhosis)
  2. * Positive for Hepatitis B surface antigen
  3. * Actively pregnant or breastfeeding
  4. * Known allergy/sensitivity to study drug components
  5. * Acute or serious illness requiring hospitalization at enrollment
  6. * Documented severe persistent mental illness (SPMI) by RIDOC
  7. * Any clinical history of hepatic decompensation (e.g., ascites, SBP, HE, HRS, variceal bleeding)
  8. * HIV-positive with active or acute AIDS-defining opportunistic infection within 90 days

Contacts and Locations

Study Locations (Sites)

Rhode Island Department of Corrections
Cranston, Rhode Island, 02920
United States

Collaborators and Investigators

Sponsor: Lifespan

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 Registration Dates

Study Start Date2025-06-11
Study Completion Date2027-08

Study Record Updates

Study Start Date2025-06-11
Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

  • hepatitis c
  • incarceration
  • jail
  • injection drug use
  • minimal monitoring
  • MINMON
  • implementation science

Additional Relevant MeSH Terms

  • HEPATITIS C (HCV)
  • Incarceration
  • Injection Drug Use
  • Implementation Science