Care Coordination with Peer Support for Hepatitis C

(ACCELERATE Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Alain Litwin, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Montefiore Medical Center

Disqualifiers: Life expectancy < 1 year, others

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of peer mentor treatment for hepatitis C?

Research shows that peer support can help more people start and complete hepatitis C treatment, especially in groups that might not usually seek care. Peer mentors, who have personal experience with the condition, can improve engagement with healthcare services and increase treatment uptake. ^{1 2 3 4 5}

Is peer support for hepatitis C treatment safe for humans?

The studies on peer support for hepatitis C treatment do not report any specific safety concerns, suggesting it is generally safe for humans. ^{1 2 3 4 5}

How does the peer mentor treatment for Hepatitis C differ from other treatments?

The peer mentor treatment for Hepatitis C is unique because it involves peer support, which helps patients engage with healthcare services more effectively, especially those who are marginalized or have difficulty accessing care. This approach is different from standard treatments as it focuses on using peer networks to improve linkage to care and adherence to treatment, rather than solely relying on medical interventions. ^{1 2 6 7 8}

Research Team

Alain Litwin, MD

Principal Investigator

Prisma Health-Upstate

Matthew Akiyama, MD

Principal Investigator

Montefiore Medical Center/Albert Einstein College of Medicine

Eligibility Criteria

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.

Inclusion Criteria

I have chronic Hepatitis C with a detectable virus level.

Recently released from a NYC jail or NYS prison (6 months)

I am 18 years old or older.

Exclusion Criteria

I am unable to understand or sign the consent form.

Life expectancy of less than 1 year

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HCV treatment and are monitored for treatment initiation and completion

3 months

Regular visits with HCV treatment provider

Sustained Virologic Response (SVR) Assessment

Participants are assessed for sustained virologic response after treatment completion

3 months

Reinfection Assessment

Participants are monitored for potential reinfection after achieving HCV cure

12 months

Treatment Details

Interventions

• Peer mentor (Behavioral Intervention)
• Standard of care (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: Peer-enhanced intervention Experimental Treatment 1 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 care Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Andrew D. Racine

Montefiore Medical Center

Chief Medical Officer since 1992

MD, PhD from New York University; Undergraduate degree from Harvard University

Philip O. Ozuah

Montefiore Medical Center

Chief Executive Officer since 2019

MD, PhD from New York University

Prisma Health-Upstate

Collaborator

Trials

91

Recruited

47,500+

Mark S. O’Halla

Prisma Health-Upstate

Chief Executive Officer since 2019

MBA

Patrice M. Weiss

Prisma Health-Upstate

Chief Medical Officer

MD

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Executive Officer since 2003

MD from National Autonomous University of Mexico

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Medical Officer since 2003

MD from National Autonomous University of Mexico

Findings from Research

In a randomized controlled trial involving 101 individuals with chronic hepatitis C, peer support significantly improved engagement with clinical services, with a 36.5% success rate compared to 18.4% in the standard care group, resulting in an 18.1% absolute increase.

The study found no serious adverse events associated with the peer support intervention, indicating it is a safe approach to enhance healthcare engagement for marginalized populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving engagement with healthcare in hepatitis C: a randomised controlled trial of a peer support intervention. Stagg, HR., Surey, J., Francis, M., et al.[2022]

The study found that peer support services significantly improved client engagement and satisfaction in hepatitis C care, with positive feedback from both clients and staff, indicating a successful integration of peer workers into the treatment process.

Peer workers not only helped clients prepare for treatment but also enhanced the overall clinic environment, making it more welcoming and supportive, which contributed to better access to additional services and a more positive experience for clients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of two community-controlled peer support services for assessment and treatment of hepatitis C virus infection in opioid substitution treatment clinics: The ETHOS study, Australia. Treloar, C., Rance, J., Bath, N., et al.[2022]

In a study analyzing 30,729 patients across 20 treatment networks, the presence of peer supporters significantly increased both the initiation (12% increase) and completion (145% increase) of hepatitis C therapy, suggesting that peer support can enhance treatment engagement.

Despite these positive outcomes, there was no significant change in the initiation of therapy among drug users or in the overall virological response, indicating that while peer support is beneficial for engagement, it may not directly impact treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of peer support in a hepatitis C elimination programme. Jugnarain, DV., Halford, R., Smith, S., et al.[2023]

A peer-based recruitment strategy effectively engaged people who inject drugs (PWID) in hepatitis C virus (HCV) testing and treatment, with 91% of participants completing a linkage to care appointment after being recruited.

Factors such as prior HCV treatment and daily injection drug use were positively associated with successful recruitment of network members, highlighting the importance of leveraging existing social networks for improving HCV care access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Network-based recruitment of people who inject drugs for hepatitis C testing and linkage to care. Falade-Nwulia, O., Ward, KM., McCormick, S., et al.[2022]

A peer-based integrated model of hepatitis C care was developed at a community drug and alcohol clinic, focusing on co-managing substance use and mental health issues alongside hepatitis C treatment.

Preliminary qualitative evaluations showed high patient acceptability of this model, indicating that integrating peer support with medical care can enhance treatment engagement among injecting drug users, the most affected group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The acceptability and feasibility of peer worker support role in community based HCV treatment for injecting drug users. Norman, J., Walsh, NM., Mugavin, J., et al.[2022]

Co-infection with HIV and hepatitis C virus (HCV) significantly increases the risk of severe liver disease, highlighting the urgent need for effective care strategies for this population.

The Care2Cure study is testing a nurse case management intervention aimed at improving access to HCV care for 70 adults co-infected with HIV, with the goal of enhancing linkage to care and reducing the time to treatment initiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Care2Cure: A randomized controlled trial protocol for evaluating nurse case management to improve the hepatitis C care continuum within HIV primary care. Starbird, LE., Han, HR., Sulkowski, MS., et al.[2020]

The HCV Peer Educator Program effectively enhances education and support for patients in opioid treatment programs, promoting engagement in hepatitis C virus (HCV) treatment.

By using peer educators under close supervision, the program shows potential in reducing barriers to HCV treatment for individuals who use drugs, suggesting a promising model for improving health outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing barriers to hepatitis C treatment among drug users: an integrated hepatitis C peer education and support program. Roose, RJ., Cockerham-Colas, L., Soloway, I., et al.[2022]

A qualitative study involving 23 adults with opioid use disorder revealed significant gaps in knowledge about Hepatitis C virus (HCV) prevention and treatment among people who use drugs, highlighting the need for better education and outreach.

Effective linkage to HCV care can be improved through enhanced communication between patients and healthcare providers, as well as by leveraging peer networks, indicating that integrated care approaches are crucial for addressing the needs of this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement in the Hepatitis C care continuum among people who use drugs. Tofighi, B., Lee, JD., Sindhu, SS., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Improving engagement with healthcare in hepatitis C: a randomised controlled trial of a peer support intervention. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of two community-controlled peer support services for assessment and treatment of hepatitis C virus infection in opioid substitution treatment clinics: The ETHOS study, Australia. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Role of peer support in a hepatitis C elimination programme. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Network-based recruitment of people who inject drugs for hepatitis C testing and linkage to care. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The acceptability and feasibility of peer worker support role in community based HCV treatment for injecting drug users. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Care2Cure: A randomized controlled trial protocol for evaluating nurse case management to improve the hepatitis C care continuum within HIV primary care. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Reducing barriers to hepatitis C treatment among drug users: an integrated hepatitis C peer education and support program. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Engagement in the Hepatitis C care continuum among people who use drugs. [2022]