NCT04701437

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
BEHAVIORAL	Peer mentor	Peer mentors will contact participants within 72 hours of enrollment to discuss the early release period, gauge their readiness for HCV treatment, and identify ancillary needs. They will also accompany the participant to their first medical appointment with an HCV provider and any future appointments if requested by the participant. Peer mentors will offer participants social support throughout the 6 months they are enrolled in the study.
BEHAVIORAL	Standard of care	Passive referral to a HCV provider

Timeline

• Start date: 2021-12-17
• Primary completion: 2026-02-02
• Completion: 2026-08-01
• First posted: 2021-01-08
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States