Clinical trial NCT04701437: Advanced Care Coordination and Enhanced Linkage and Retention Among Transitional Re-Entrants
Official title: HCV-ACCELERATE Advanced Care Coordination and Enhanced Linkage and Retention Among Transitional Re-Entrants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatitis C
Keywords: recently incarcerated
Hepatitis C
peer mentor
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Prisma Health-Upstate
name: National Institute on Drug Abuse (NIDA)
First posted: 2021-01-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Linkage to care
timeFrame: 6 months
Secondary outcomes:
measure: HCV treatment initiation
timeFrame: up to 3 months after linkage to care
measure: Treatment completion
timeFrame: up to 3 months after treatment initiation
measure: HCV cure
timeFrame: 3 months after treatment completion
measure: Reinfection
timeFrame: 12 months after treatment completion
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Prisma Health-Upstate
state: South Carolina
Study officials:
affiliation: Montefiore Medical Center/Albert Einstein College of Medicine
name: Matthew Akiyama, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Prisma Health-Upstate
name: Alain Litwin, MD
role: PRINCIPAL_INVESTIGATOR
References: