Advanced Care Coordination and Enhanced Linkage and Retention Among Transitional Re-Entrants

Not Applicable

Recruiting

• Conditions: Hepatitis C

• Registration Number: NCT04701437
• Lead Sponsor: Montefiore Medical Center

Brief Summary

The overarching goal of this study is to develop a peer-based care coordination intervention for individuals with Hepatitis C Virus (HCV) who were recently released from correctional settings to promote linkage to and retention in HCV care. The investigators will assess the existing barriers and facilitators of HCV treatment initiation, HCV treatment completion, and sustained virologic response among individuals recently released from a U.S. jail or prisons in a randomized control trial. This study will assess the feasibility and process measures of a peer-enhanced HCV care coordination intervention among recently incarcerated individuals.

Detailed Description

The proposed 2-year study will be a block stratified, randomized controlled trial. Once consented and enrolled, participants will be randomly assigned to either the peer-enhanced intervention or referred to standard clinical care. The investigators will enroll 80 former inmates with chronic HCV who have been released from incarceration within the past 6 months. It is expected that enrollment will be completed by the fourth quarter of the first year. This will allow sufficient time for HCV treatment uptake, completion, determination of Sustained Virologic Response (SVR), and assessment of reinfection. Individual participant follow-up will be 3 months on average for treatment, 3 months for SVR, and 3 months to assess for reinfection.

Elucidating the barriers and facilitators in the re-entry care cascade (as well as how they may be overcome) will be critical in designing sustainable models of care for HCV-infected former inmates. The investigators hypothesize that a peer-enhanced strategy will be more effective than standard referral in improving linkage to, and retention in, HCV care among individuals recently released from correctional settings.

Study Timeline

• Study First Submitted: 2020-11-17
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-08
• Study Start: 2021-12-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-17
• Primary Completion: 2025-12-30
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• currently incarcerated or recently released from a U.S. jail or prison (6 months)
• Chronic HCV with documented detectable viral load
• 18 years old
• Fluent in English or Spanish
• Resident of the Upstate area of South Carolina

Exclusion Criteria

• Unable to sign informed consent
• Life expectancy of less than 1 year
• Plans to relocate from the Upstate area of South Carolina in the next 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Linkage to care	6 months	A visit with an HCV treatment provider

Secondary Outcome Measures

Name	Time	Method
Reinfection	12 months after treatment completion	Determined by EMR
HCV cure	3 months after treatment completion	Achieving HCV cure, as determined by EMR
Treatment completion	up to 3 months after treatment initiation	Completing HCV treatment, as determined by EMR
HCV treatment initiation	up to 3 months after linkage to care	Initiating HCV treatment and the number of days following release from the correctional setting to initiation of HCV treatment

Trial Locations

Locations (1)

Prisma Health-Upstate; 🇺🇸 Greenville, South Carolina, United States