Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04701437
Recruitment Status : Recruiting
First Posted : January 8, 2021
Last Update Posted : February 14, 2022
Sponsor:
Information provided by (Responsible Party):
Montefiore Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 the New York City (NYC) jails or New York State (NYS) 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.

Condition or disease Intervention/treatment Phase
Hepatitis C Behavioral: Peer mentor Behavioral: Standard of care Not Applicable

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. Those eligible will also be over the age of 18 and fluent in English or Spanish. If they have a life expectancy of less than one year they will be deemed ineligible. During the first year the investigators will recruit and enroll 80 former inmates of the NYC jails or NYS prisons with chronic HCV into the HCV-ACCELERATE intervention. 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.

Our primary outcome, linkage to care, will be defined as a visit with an HCV treatment provider. Secondary outcomes will include time to HCV treatment initiation (# of days following release from the correctional setting), treatment completion, sustained virologic response (SVR), HCV risk behaviors/substance use as determined by ACASI (Audio Computer Assisted Self Interview) interviews, re-incarceration (as determined by Department of Corrections, DOC, inmate lookup system), ED utilization, and hospitalizations. 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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: HCV-ACCELERATE Advanced Care Coordination and Enhanced Linkage and Retention Among Transitional Re-Entrants
Actual Study Start Date : December 17, 2021
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Linkage to care [ Time Frame: 6 months ]
    A visit with an HCV treatment provider


Secondary Outcome Measures :
  1. HCV treatment initiation [ Time Frame: up to 3 months after linkage to care ]
    Initiating HCV treatment and the number of days following release from the correctional setting to initiation of HCV treatment

  2. Treatment completion [ Time Frame: up to 3 months after treatment initiation ]
    Completing HCV treatment, as determined by EMR

  3. HCV cure [ Time Frame: 3 months after treatment completion ]
    Achieving HCV cure, as determined by EMR

  4. Reinfection [ Time Frame: 12 months after treatment completion ]
    Determined by EMR


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04701437


Contacts
Layout table for location contacts
Contact: Matthew Akiyama, MD 718-920-7175 makiyama@montefiore.org
Contact: Lindsey Riback, MPH 201-372-4089 lindsey.riback@einsteinmed.org

Locations
Layout table for location information
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Matthew Akiyama, MD    718-920-7175    makiyama@montefiore.org   
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Matthew Akiyama, MD Montefiore Medical Center/Albert Einstein College of Medicine
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT04701437    
Other Study ID Numbers: 2020-12458
First Posted: January 8, 2021    Key Record Dates
Last Update Posted: February 14, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Montefiore Medical Center:
recently incarcerated
Hepatitis C
peer mentor
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections