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Implementing Low-Barrier HCV Treatment in a Jail Setting

NCT06953479 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-02-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Lifespan

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-11
Primary Completion
2027-01-31
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06953479 on ClinicalTrials.gov