MINMON-J: An Effectiveness Implementation Pilot Study Evaluating a Low-barrier Hepatitis C Treatment Model in a Jail Setting
Lifespan
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. 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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 withi…
Interventions
- DrugSofosbuvir / Velpatasvir Oral Tablet [Epclusa]
Individuals will receive a full course (i.e., 84 tablets) of Sofosbuvir / Velpatasvir 400/100mg tablets.
- OtherCommunity 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.
Location
- Rhode Island Department of CorrectionsCranston, Rhode Island