Recruiting

Sofosbuvir/Velpatasvir

Sponsor:

Lifespan

Code:

NCT06953479

Conditions

HEPATITIS C (HCV)

Incarceration

Injection Drug Use

Implementation Science

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]

Community Health Worker

Study Details

Brief 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.

Conditions

HEPATITIS C (HCV)

Incarceration

Injection Drug Use

Implementation Science

Study ID

NCT06953479

Start date

Jun 11, 2025

Status verified date

Feb, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MINMON-J

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.

Interventions

Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]

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

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.

Primary outcome measure

  • HCV Cure Rate [ Time Frame: Between 12 and 24 weeks after completion of HCV treatment ]

Central Contacts and Locations

Locations

Rhode Island Department of Corrections

Recruiting

Cranston, Rhode Island, United States, 02920

Contacts

Jessica Migliaccio

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

Principal Investigator:

Justin Berk, MD MPH MBA

More Information

Sponsor

Lifespan

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lifespan on 2026-02-27.