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Clinical Trial Summary

The overarching goal of this study is to develop a peer-based care coordination intervention for individuals with 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.


Clinical Trial 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 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 Design


Related Conditions & MeSH terms


NCT number NCT04701437
Study type Interventional
Source Montefiore Medical Center
Contact Matthew Akiyama, MD
Phone 718-920-7175
Email makiyama@montefiore.org
Status Recruiting
Phase N/A
Start date December 17, 2021
Completion date March 31, 2024

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