Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06953479

Implementing Low-Barrier HCV Treatment in a Jail Setting

Led by Lifespan · Updated on 2026-02-27

40

Participants Needed

1

Research Sites

111 weeks

Total Duration

On this page

Sponsors

L

Lifespan

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Implementing Low-Barrier HCV Treatment in a Jail Setting

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Incarcerated individual at Rhode Island Department of Corrections
  • Age 18 years or older
  • Awaiting trial (not sentenced)
  • English speaking
  • Diagnosis of active HCV with viral load over 1000 IU/mL within 90 days before study entry
  • No prior treatment for current HCV infection
  • No cirrhosis (FIB-4 Score less than 3.25 within 90 days before study entry)
  • Self-reported 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)
Not Eligible

You will not qualify if you...

  • Cirrhosis (FIB-4 Score greater than 3.25 within 90 days before study entry or clinical signs of cirrhosis)
  • Positive for Hepatitis B surface antigen
  • Actively pregnant or breastfeeding
  • Known allergy or sensitivity to components of the study drug
  • Acute or serious illness requiring hospitalization at enrollment
  • Documented severe persistent mental illness by RIDOC
  • History of hepatic decompensation (such as ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatorenal syndrome, or variceal bleeding)
  • HIV-positive with active or acute AIDS-defining opportunistic infection within 90 days

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Rhode Island Department of Corrections

Cranston, Rhode Island, United States, 02920

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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