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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hepatitis C

Intervention / Treatment
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* Behavioral: Peer mentor
* Behavioral: Standard of care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peer-enhanced intervention<br>Those randomized to the peer-enhanced intervention group will be contacted by a peer mentor within 72 hours of enrollment to discuss the early release period, readiness for HCV treatment, and identify ancillary needs. Individuals randomized to this arm will be provided a study cell phone. | Behavioral: Peer mentor<br>* 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.<br>|
| Placebo Comparator: Standard of care<br>If randomized to the standard of care intervention, the participant will only receive passive referral to HCV-care. | Behavioral: Standard of care<br>* Passive referral to a HCV provider<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linkage to care | A visit with an HCV treatment provider | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, recently incarcerated, peer mentor