Advanced Care Coordination and Enhanced Linkage and Retention Among Transitional Re-Entrants
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hepatitis C
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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. Those eligible will also be over the age of 18 and fluent in English or Spanish. If they have a life expectancy of less than one year they will be deemed ineligible. During the first year the investigators will recruit and enroll 80 former inmates of the NYC jails or NYS prisons with chronic HCV into the HCV-ACCELERATE intervention. 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. Our primary outcome, linkage to care, will be defined as a visit with an HCV treatment provider. Secondary outcomes will include time to HCV treatment initiation (# of days following release from the correctional setting), treatment completion, sustained virologic response (SVR), HCV risk behaviors/substance use as determined by ACASI (Audio Computer Assisted Self Interview) interviews, re-incarceration (as determined by Department of Corrections, DOC, inmate lookup system), ED utilization, and hospitalizations. 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.
Tracking Information
- NCT #
- NCT04701437
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Matthew Akiyama, MD Montefiore Medical Center/Albert Einstein College of Medicine