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

Hepatitis C Clinical Trial

— ACCELERATE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04701437
• Other study ID #: 2020-12458
• Secondary ID: 4R00DA043011
• Status: Recruiting
• Phase: N/A
• Start date: December 17, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: October 2023
• Source: Montefiore Medical Center
• Contact: Matthew Akiyama, MD
• Phone: 718-920-7175
• Email: makiyama[@]montefiore.org
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

Behavioral:
• Peer mentor
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.
• Standard of care
Passive referral to a HCV provider

Locations

Country	Name	City	State
United States	Prisma Health-Upstate	Greenville	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Montefiore Medical Center	National Institute on Drug Abuse (NIDA), Prisma Health-Upstate

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Linkage to care	A visit with an HCV treatment provider	6 months
Secondary	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
Secondary	Treatment completion	Completing HCV treatment, as determined by EMR	up to 3 months after treatment initiation
Secondary	HCV cure	Achieving HCV cure, as determined by EMR	3 months after treatment completion
Secondary	Reinfection	Determined by EMR	12 months after treatment completion