Hepatitis C Treatment in a Jail Setting

This study is looking at a new way to treat hepatitis C (HCV) for people who are in jail. The goal is to see if a simple treatment program can help people with HCV in jail start and finish their treatment more easily. You would receive a 12-week course of the medication sofosbuvir/velpatasvir (Epclusa) as an oral tablet. If you are released from jail during treatment, you will take the remaining medication with you. You will also get support from a Community Health Worker who can help with things like transportation, housing, and making sure you take your medication. The study wants to find out if this approach works and if people are cured of HCV. To join, you must be at least 18 years old, incarcerated at RIDOC, awaiting trial, speak English, and have active HCV without cirrhosis (severe liver scarring).

Study design
This is a pilot study involving 40 participants. All participants will receive the same treatment and support.
What's involved
You would take a daily oral tablet for 12 weeks. You would also receive support from a Community Health Worker.
Compensation
Not stated in the trial record.
Follow-up
Your HCV cure rate will be checked between 12 and 24 weeks after you finish treatment.

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NCT06953479

Implementing Low-Barrier HCV Treatment in a Jail Setting

Recruiting
PHASE4Ages 18+InterventionalTreatment
Lifespan
~40 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]Community Health Worker

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
HCV Cure Rate
Measured over Between 12 and 24 weeks after completion of HCV treatment
HEPATITIS C (HCV)
Incarceration
Injection Drug Use
Implementation Science
1 sites across 1 states
Rhode Island1

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Eligibility criteria

Inclusion

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

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
  • HCV Cure RateBetween 12 and 24 weeks after completion of HCV treatment

    HCV Cure Rate will be defined as achieving a Sustained Virological Response at 12 weeks after treatment completion (SVR12), assessed by an undetectable HCV RNA viral load measured via standard laboratory assay. An undetectable result indicates that the virus is no longer present in the blood and is considered the clinical definition of virologic cure.