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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hepatitis C
• Intervention / Treatment: Behavioral: Peer mentor; Behavioral: Standard of care

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Prisma Health-Upstate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peer-enhanced intervention; 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; 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.
Placebo Comparator: Standard of care; If randomized to the standard of care intervention, the participant will only receive passive referral to HCV-care.	Behavioral: Standard of care; Passive referral to a HCV provider

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to HCV Treatment Initiation	For participants who initiate HCV treatment, time to HCV treatment initiation will be determined by the number of days following release from the correctional setting to HCV treatment initiation. Results will be summarized by study arm using descriptive statistics.	Up to 3 months after linkage to care
Time to HCV Treatment completion	Time to HCV treatment completion will be sourced from electronic medical record data and will be defined as the number of days following release from the correctional setting to completion of HCV treatment. Results will be summarized by study arm using descriptive statistics.	Up to 3 months after treatment initiation
Sustained Virologic Response (SVR)	The number/percentage of participants who achieve HCV cure (i.e., the virus is undetectable in the blood at 12 weeks), as determined by electronic medical records, will be summarized by study arm using basic descriptive statistics.	3 months after treatment completion
Reincarceration Rate	Reincarceration rate will be determined using public correctional facility inmate lookup systems to confirm instances of re-incarceration. Results will be summarized by study arm. If a participant is reincarcerated after being enrolled, they will remain as part of the study throughout the study period. During the reincarceration period, the research team will not be in contact with the participant, nor will any research-related activities be conducted until the participant is released back into the community.	Up to 24 weeks (~6 months)
Emergency Department (ED) Utilization	ED utilization will be assessed by the number of documented health-care related visits to an ED facility. ED utilization will be sourced via REDCap participant interviews and electronic medical records. Results will be summarized by study arm.	Up to 24 weeks (~6 months)
Hospitalizations	Hospitalizations will be determined by the number of inpatient hospital admissions up to 24 weeks. Hospitalization data will be sourced via REDCap patient interviews and electronic medical records. The number/percentage of participants who are hospitalized will be summarized by study arm.	Up to 24 weeks (~6 months)
Number of Participants with Detectable Hepatitis C Virus (HCV) Reinfection	HCV reinfection will be assessed based upon a review of electronic medical records. HCV reinfection will be defined as the return of detectable Hepatitis C virus in the blood at 12 weeks after a previously confirmed clearance. Results will be summarized by study arm.	12 months after treatment completion

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: National Institute on Drug Abuse (NIDA); Prisma Health-Upstate; New York City Department of Homeless Services
• Investigators: Principal Investigator: Matthew Akiyama, MD, Montefiore Medical Center/Albert Einstein College of Medicine; Principal Investigator: Alain Litwin, MD, Prisma Health-Upstate

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2021
• Primary Completion (Actual): February 2, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Hepatitis C; peer mentor; recently incarcerated
• Additional Relevant MeSH Terms: Blood-Borne Infections; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; Flaviviridae Infections; Hepatitis; Hepatitis C; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 2020-12458; 4R00DA043011 (U.S. NIH Grant/Contract); 19-PRS-438-01 (Other Identifier: Biomedical Research Alliance of New York (BRANY)); MMC-10898 (Other Identifier: National Institutes of Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No