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Care Coordination with Peer Support for Hepatitis C (ACCELERATE Trial)

N/A

Recruiting

Led By Alain Litwin, MD

Research Sponsored by Montefiore Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chronic HCV with documented detectable viral load

18 years old

Must not have

Unable to sign informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Summary

This trial will assess the feasibility of a peer-enhanced care coordination intervention for recently incarcerated individuals with HCV to promote linkage to and retention in HCV care.

Who is the study for?

This trial is for adults who have chronic Hepatitis C, were released from a NYC jail or NYS prison within the last 6 months, and can communicate in English or Spanish. They must be able to give informed consent and should not have a life expectancy of less than one year.

What is being tested?

The study is testing if having a peer mentor helps people with Hepatitis C get better care after they leave jail compared to just getting the usual healthcare services. It's looking at how well this works by randomly assigning participants to either the new approach with a mentor or standard care.

What are the potential side effects?

Since this trial involves social support rather than medication, there are no direct medical side effects. However, participants may experience emotional distress or discomfort when discussing their health condition with peers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have chronic Hepatitis C with a detectable virus level.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to understand or sign the consent form.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Linkage to care

Secondary study objectives

HCV cure

HCV treatment initiation

Reinfection

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Peer-enhanced interventionExperimental Treatment1 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.

Group II: Standard of carePlacebo Group1 Intervention

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

0 / 3Eligibility criteria met