RECRUITINGPhase 4INTERVENTIONAL

Implementing Low-Barrier HCV Treatment in a Jail Setting

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

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.

Locations (1)

Rhode Island Department of Corrections

Cranston, Rhode Island, United States