Implementing Low-Barrier HCV Treatment in a Jail Setting

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorLifespan

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.

Eligibility criteria

Qualifiers

Incarcerated individual at RIDOC

Age ≥ 18 years

Awaiting trial (i.e., not sentenced)

English speaking

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]
  • Community Health Worker

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators

Lifespan

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator