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

NCT04701437 | Active Not Recruiting DMC

• 4 other identifiers: 2020-124584R00DA04301119-PRS-438-01MMC-10898
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Keywords

recently incarcerated; Hepatitis C; peer mentor

Outcome Measures

Primary Outcomes (1)

• Linkage to Care

  Linkage to care is defined as having a visit with an HCV treatment provider after release. Electronic Medical record (EMR) data will be extrapolated to evaluate this outcome. Results will be summarized by study arm using descriptive statistics.

  6 months

Secondary Outcomes (7)

• Time to HCV Treatment Initiation

  Up to 3 months after linkage to care

• Time to HCV Treatment completion

  Up to 3 months after treatment initiation

• Number of Participants with Detectable Hepatitis C Virus (HCV) Reinfection

  12 months after treatment completion

• Sustained Virologic Response (SVR)

  3 months after treatment completion

• Reincarceration Rate

  Up to 24 weeks (~6 months)

Study Arms (2)

Peer-enhanced intervention

EXPERIMENTAL

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

Standard of care

PLACEBO COMPARATOR

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

Behavioral: Standard of care

Interventions

Peer mentor BEHAVIORAL

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.

Peer-enhanced intervention

Standard of care BEHAVIORAL

Passive referral to a HCV provider

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• currently incarcerated or recently released from a U.S. jail or prison (6 months)
• Chronic HCV with documented detectable viral load
• years old
• Fluent in English or Spanish
• Resident of the Upstate area of South Carolina

You may not qualify if:

• 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

Sponsors & Collaborators

• Prisma Health-Upstate: collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• New York City Department of Homeless Services: collaborator
• Montefiore Medical Center: lead

Study Sites (1)

Prisma Health-Upstate

Greenville, South Carolina, 29605, United States

Location

Related Publications (4)

• Varan AK, Mercer DW, Stein MS, Spaulding AC. Hepatitis C Seroprevalence among Prison Inmates since 2001: Still High but Declining. Public Health Reports. 2014;129(2):187-195.

  BACKGROUND

• Vizuete J, Hubbard H, Lawitz E. Next-Generation Regimens: The Future of Hepatitis C Virus Therapy. Clin Liver Dis. 2015 Nov;19(4):707-16, vii. doi: 10.1016/j.cld.2015.06.009. Epub 2015 Jul 26.

  PMID: 26466657 BACKGROUND

• Akiyama M.J., MacDonald R, Jordan A, Laraque F, Columbus D, Maurantonio M, Schwartz J, Pham V, E. C. Hepatitis C in the Correctional-Community Continuum of Care: Poor Baseline Linkage Rates and Early Improvement with Care Coordination. IDSA; New Orleans, LA.

  BACKGROUND

• Riback LR, Davis M, King A, Boswell K, Moore C, Dendy B, Hoeflich C, Heo M, Litwin AH, Akiyama MJ. Rationale, design, and methodology of a randomized controlled trial evaluating the impact of peer-enhanced care coordination on linkage to HCV care among formerly incarcerated individuals. Contemp Clin Trials. 2025 Dec;159:108137. doi: 10.1016/j.cct.2025.108137. Epub 2025 Nov 3.

  PMID: 41192754 DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Matthew Akiyama, MD

  Montefiore Medical Center/Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

• Alain Litwin, MD

  Prisma Health-Upstate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: January 8, 2021
• Study Start: December 17, 2021
• Primary Completion: February 2, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)