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

Montefiore Medicine Academic Health System

Status: Enrolling

Conditions: Hepatitis C

Treatments: Behavioral: Peer mentor; Behavioral: Standard of care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04701437

4R00DA043011 (U.S. NIH Grant/Contract)

2020-12458

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups, including a placebo group

Peer-enhanced intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Peer mentor

Standard of care

Placebo Comparator group

Description:

If randomized to the standard of care intervention, the participant will only receive passive referral to HCV-care.

Treatment:

Behavioral: Standard of care