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

Primary Purpose

Hepatitis C

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer mentor
Standard of care
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring recently incarcerated, Hepatitis C, peer mentor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Recently released from a NYC jail or NYS prison (6 months)
  • Chronic HCV with documented detectable viral load
  • 18 years old
  • Fluent in English or Spanish

Exclusion Criteria:

  • Unable to sign informed consent
  • Life expectancy of less than 1 year

Sites / Locations

  • Prisma Health-UpstateRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Peer-enhanced intervention

Standard of care

Arm 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.

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

Outcomes

Primary Outcome Measures

Linkage to care
A visit with an HCV treatment provider

Secondary Outcome Measures

HCV treatment initiation
Initiating HCV treatment and the number of days following release from the correctional setting to initiation of HCV treatment
Treatment completion
Completing HCV treatment, as determined by EMR
HCV cure
Achieving HCV cure, as determined by EMR
Reinfection
Determined by EMR

Full Information

First Posted
November 17, 2020
Last Updated
October 9, 2023
Sponsor
Montefiore Medical Center
Collaborators
Prisma Health-Upstate, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04701437
Brief Title
Advanced Care Coordination and Enhanced Linkage and Retention Among Transitional Re-Entrants
Acronym
ACCELERATE
Official Title
HCV-ACCELERATE Advanced Care Coordination and Enhanced Linkage and Retention Among Transitional Re-Entrants
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 17, 2021 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
Collaborators
Prisma Health-Upstate, National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
recently incarcerated, Hepatitis C, peer mentor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peer-enhanced intervention
Arm Type
Experimental
Arm 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.
Arm Title
Standard of care
Arm Type
Placebo Comparator
Arm Description
If randomized to the standard of care intervention, the participant will only receive passive referral to HCV-care.
Intervention Type
Behavioral
Intervention Name(s)
Peer mentor
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard of care
Intervention Description
Passive referral to a HCV provider
Primary Outcome Measure Information:
Title
Linkage to care
Description
A visit with an HCV treatment provider
Time Frame
6 months
Secondary Outcome Measure Information:
Title
HCV treatment initiation
Description
Initiating HCV treatment and the number of days following release from the correctional setting to initiation of HCV treatment
Time Frame
up to 3 months after linkage to care
Title
Treatment completion
Description
Completing HCV treatment, as determined by EMR
Time Frame
up to 3 months after treatment initiation
Title
HCV cure
Description
Achieving HCV cure, as determined by EMR
Time Frame
3 months after treatment completion
Title
Reinfection
Description
Determined by EMR
Time Frame
12 months after treatment completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Akiyama, MD
Phone
718-920-7175
Email
makiyama@montefiore.org
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsey Riback, MPH
Phone
201-372-4089
Email
lindsey.riback@einsteinmed.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Akiyama, MD
Organizational Affiliation
Montefiore Medical Center/Albert Einstein College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alain Litwin, MD
Organizational Affiliation
Prisma Health-Upstate
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prisma Health-Upstate
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain Litwin, MD
Email
Alain.Litwin@prismahealth.org
First Name & Middle Initial & Last Name & Degree
Morgan Davis, MS
Email
morgan.davis9@prismahealth.org

12. IPD Sharing Statement

Plan to Share IPD
No

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

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