Care Coordination with Peer Support for Hepatitis C

(ACCELERATE Trial)

Recruiting at 1 trial location

Overseen By Matthew Akiyama, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Disqualifiers: Life expectancy < 1 year, others

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assist individuals with Hepatitis C who have recently been released from jail or prison. It focuses on using peer mentors to support these individuals in starting and adhering to their Hepatitis C treatment. One group will receive guidance and assistance from a peer mentor, while the other group will receive usual care without additional support. Eligible participants should have chronic Hepatitis C, speak English or Spanish, and reside in the Upstate area of South Carolina. As an unphased trial, this study provides a unique opportunity to contribute to innovative support strategies for Hepatitis C treatment.

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 prior data suggests that this peer-based care coordination intervention is safe for individuals with Hepatitis C?

Research shows that people generally have a positive experience with peer mentor support for Hepatitis C. Studies indicate that participants are very satisfied with this support, finding it helpful and easy to accept. For instance, one study found that participants valued advice and assistance from peers who had already completed Hepatitis C treatment. However, specific negative effects of peer mentoring remain largely undocumented.

In similar programs, peer mentors play a crucial role in offering emotional support and helping people access the care they need. Although detailed safety information is not yet available, positive feedback from past studies suggests that peer mentor support is a safe and helpful approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the peer mentor approach for hepatitis C because it offers a fresh angle on patient support and treatment readiness. Unlike the standard of care, which often involves passive referrals, this method actively engages patients through personal interaction with a peer mentor. This peer-enhanced intervention is designed to help patients navigate the early stages post-enrollment, assess their readiness for hepatitis C treatment, and address additional needs. By providing a study cell phone for direct communication, it aims to improve patient outcomes through enhanced support and engagement, which could potentially increase treatment adherence and success rates.

What evidence suggests that this peer-enhanced intervention is effective for Hepatitis C care coordination?

Research has shown that peer support can help patients with chronic Hepatitis C (HCV) stay engaged with healthcare services. In this trial, participants in the peer-enhanced intervention arm will receive support from a peer mentor, which studies have found increases the likelihood of starting HCV treatment. This support also results in more people getting tested for HCV and beginning treatment. Peer educators enhance understanding and involvement in HCV care. Overall, these findings suggest that a peer mentor can effectively encourage HCV treatment and care, especially for those recently released from prison. Meanwhile, participants in the standard of care arm will receive passive referral to HCV care. ^{6 7 8 9 10}

Who Is on the Research Team?

Alain Litwin, MD

Principal Investigator

Prisma Health-Upstate

Matthew Akiyama, MD

Principal Investigator

Montefiore Medical Center/Albert Einstein College of Medicine

Are You a Good Fit for This Trial?

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)

Exclusion Criteria

I am unable to understand or sign the consent form.

Life expectancy of less than 1 year

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Peer mentor
• Standard of care

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.

How Is the Trial Designed?

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+

Prisma Health-Upstate

Collaborator

Trials

91

Recruited

47,500+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34808487/

Validation of a tool to assess effectiveness of peer-recruitment ... Validation of a tool to assess effectiveness of peer-recruitment for hepatitis C testing and linkage to care among people who inject drugs.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6442435/

a randomised controlled trial of a peer support intervention In conclusion, our findings indicate that peer support can improve the engagement of patients with chronic HCV with healthcare services. The ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871621006724

Validation of a tool to assess effectiveness of peer- ... Peer-driven interventions offer a promising approach to increasing HCV treatment among people who inject drugs (PWID).

4. sciencedirect.com sciencedirect.com/science/article/pii/S258953702500166X

Community engagement and chronic viral hepatitis public ... This review indicated that community-engaged interventions significantly improved HBV vaccine completion, HBV/HCV test uptake, HBV/HCV linkage to care, HBV/HCV ...

5. harmreductionjournal.biomedcentral.com harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-017-0192-8

Perceived benefits of the hepatitis C peer educators Previous studies have found that peer educators can help increase knowledge and engagement with HIV and HCV care [25,26,27,28,29] and that peer- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11806898/

Peer-assisted telemedicine hepatitis-C treatment for ... Results. Quantitative data (n = 78) indicated patients had high levels of satisfaction with and support from the peers. Three themes were ...

7. academic.oup.com academic.oup.com/ofid/article/12/2/ofaf056/7998417

Enhancing Hepatitis C Virus Testing, Linkage to Care, and ... Structured peer mentor support program where mentors previously successfully treated for HCV ... outcomes due to insufficient data.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2949875924002224

Peer-Assisted Telemedicine for Hepatitis C (PATHS) We report development and programmatic evaluation of Peer-Assisted Telemedicine for Hepatitis C (PATHS), which utilizes State Opioid Response (SOR) funding.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6488268/

A Randomized Controlled Trial of Cash Incentives or Peer ... We evaluated the impact of peer-mentors and cash incentives on linkage to HCV treatment and cure in persons with HIV-HCV coinfection who had not ...

10. hepctrust.org.uk hepctrust.org.uk/wp-content/uploads/2022/11/Leave-no-one-behind.-Jan-2020-report.pdf

LEAVE NO ONE BEHIND Peer. Mentors will support the Peer Support Lead in delivering awareness campaigns using their own lived experience and may also support individuals to access ...