Hepatitis CACCELERATENCT04701437

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

A study testing Peer mentor in people with Hepatitis C, run by Montefiore Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C
What is being tested?: Peer mentor
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteUnited States
Study dates: 17 Dec 2021to Aug 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Prisma Health-Upstate
Greenville, South Carolina, 29605

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Hepatitis C
Being tested: Peer mentor, Standard of care
Keywords: recently incarcerated, Hepatitis C, peer mentor
Medical subject headings: Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Peer mentorBehavioural
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 careBehavioural
Passive referral to a HCV provider

Study groups in NCT04701437
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months

Secondary outcomes (7)

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.
Measured: 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.
Measured: Up to 3 months after treatment initiation
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.
Measured: 12 months after treatment completion
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 24 weeks (~6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Dec 2021Aug 2026

First posted8 Jan 2021
Study start17 Dec 2021
Primary completion2 Feb 2026
Study completionAug 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Hepatitis CStudies of the same condition, open and under way.
More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04701437
Sponsor's protocol ID: 2020-12458
Other IDs: 4R00DA043011, 19-PRS-438-01, MMC-10898
Acronym: ACCELERATE
Status last verified: Apr 2026
First submitted: 17 Nov 2020
Last updated: 20 Apr 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Varan AK, Mercer DW, Stein MS, Spaulding AC. Hepatitis C seroprevalence among prison inmates since 2001: still high but declining. Public Health Rep. 2014 Mar-Apr;129(2):187-95. doi: 10.1177/003335491412900213.
PubMed 24587554
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.
PubMed 26466657
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.
PubMed 41192754

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
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People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
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All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: HCV-ACCELERATE Advanced Care Coordination and Enhanced Linkage and Retention Among Transitional Re-Entrants
ClinicalTrials.gov ID: NCT04701437
Acronym / sponsor ID: ACCELERATE / 2020-12458
Conditions: Hepatitis C
Keywords: recently incarcerated, Hepatitis C, peer mentor
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 80 participants (estimated)
Lead sponsor: Montefiore Medical CenterUniversity, hospital or other
Collaborators: Prisma Health-Upstate, National Institute on Drug Abuse (NIDA), New York City Department of Homeless Services
Study start: 17 Dec 2021 (actual)
Primary completion: 2 Feb 2026 (actual)
Study completion: Aug 2026 (estimated)
First posted: 8 Jan 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Peer-enhanced intervention	Experimental	Behavioral: Peer mentorThose 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.
Standard of care	Placebo comparator	Behavioral: Standard of careIf randomized to the standard of care intervention, the participant will only receive passive referral to HCV-care.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Peer mentorPeer 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.	Behavioural	Peer-enhanced intervention
Standard of carePassive referral to a HCV provider	Behavioural	Standard of care

Primary outcome

Linkage to Care
Time frame: 6 months
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.

7 secondary outcomes

Time to HCV Treatment Initiation
Time frame: Up to 3 months after linkage to care
Time to HCV Treatment completion
Time frame: Up to 3 months after treatment initiation
Number of Participants with Detectable Hepatitis C Virus (HCV) Reinfection
Time frame: 12 months after treatment completion
Sustained Virologic Response (SVR)
Time frame: 3 months after treatment completion
Reincarceration Rate
Time frame: Up to 24 weeks (~6 months)
Emergency Department (ED) Utilization
Time frame: Up to 24 weeks (~6 months)
Hospitalizations
Time frame: Up to 24 weeks (~6 months)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
Background: PubMed 24587554Varan AK, Mercer DW, Stein MS, Spaulding AC. Hepatitis C seroprevalence among prison inmates since 2001: still high but declining. Public Health Rep. 2014 Mar-Apr;129(2):187-95. doi: 10.1177/003335491412900213.
Background: PubMed 26466657Vizuete 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.
BackgroundAkiyama 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.
Derived from this study: PubMed 41192754Riback 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.
Individual participant dataSharing planned: No

Related trials for Hepatitis C

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
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Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Matthew Akiyama, MD principal investigator

Montefiore Medical Center/Albert Einstein College of Medicine

Alain Litwin, MD principal investigator

Prisma Health-Upstate

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Peer mentor in people with Hepatitis C, run by Montefiore Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Linkage to Care (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04701437, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.