Implementing Low-Barrier HCV Treatment in a Jail Setting

Part of paid clinical trials in Cranston, Rhode Island.

Sponsor
Lifespan
Study ID
NCT06953479
Phase
PHASE4
Status
Recruiting
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Conditions

  • HEPATITIS C (HCV)
  • Implementation Science
  • Incarceration
  • Injection Drug Use

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sofosbuvir / Velpatasvir Oral Tablet [Epclusa] — DRUG
    Individuals will receive a full course (i.e., 84 tablets) of Sofosbuvir / Velpatasvir 400/100mg tablets.
  • Community Health Worker — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jun 11, 2025
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Rhode Island Department of CorrectionsCranstonRhode Island02920
Jessica Migliaccio
[email protected]
(401) 462-3921
Justin Berk, MD MPH MBA (PRINCIPAL_INVESTIGATOR)

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By research site
Rhode Island Department of Corrections· Cranston, RI

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