Peer Support + Vouchers for Hepatitis C

Overseen By Mariana Gomez de la Espriella, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Carilion Clinic

Disqualifiers: Under 18, Prior HCV treatment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with Hepatitis C receive necessary treatment by offering support and resources. Participants receive assistance from a peer specialist and vouchers for phone service, transportation, and meals. The focus is on individuals who have tested positive for Hepatitis C, have ongoing substance use issues, and need support to stay on track with their treatment. The trial compares this new support approach with standard care to determine if it improves engagement and completion of treatment. As an unphased trial, this study provides a unique opportunity to access additional support resources that may enhance the treatment journey.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for engaging patients with Hepatitis C?

Research has shown that using peer support and vouchers in hepatitis C treatment is safe and effective. Studies indicate that peer support helps build trust, making it easier for people to start and continue their treatment. This method has not shown harmful effects, suggesting it is well-tolerated. Financial incentives, such as vouchers, have also been studied and found to boost patient involvement without causing safety issues. Overall, both components of this treatment have demonstrated positive results in terms of safety and effectiveness in past studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Peer Support + Vouchers approach for Hepatitis C because it goes beyond traditional medical treatments like antiviral medications. This method incorporates a peer specialist who provides personalized support, helping individuals navigate their treatment journey. Additionally, vouchers serve as incentives to encourage patients to complete their treatment regimen, which could potentially improve adherence rates and overall outcomes. By addressing the social and behavioral aspects of treatment, this approach aims to achieve better long-term success in managing Hepatitis C.

What evidence suggests that this trial's treatments could be effective for Hepatitis C?

Research has shown that peer support can significantly aid patients with chronic Hepatitis C in better utilizing healthcare services. One study found that all patients began treatment, and 92.3% completed it. Peer support has proven particularly beneficial for people who inject drugs, as they often encounter barriers to healthcare access. These programs assist patients in starting and completing their treatment more effectively. In this trial, one group will receive peer support along with resources such as transportation and meal vouchers, ensuring that people with Hepatitis C receive the necessary care. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a positive Hepatitis C antibody test and a history of substance use disorder. They must have an elevated Hepatitis C RNA indicating active infection but cannot have had prior treatment for Hepatitis C.

Inclusion Criteria

Elevated Hepatitis C RNA

Positive Hepatitis C antibody test

History of substance use disorder

Exclusion Criteria

I am under 18 years old.

I have been treated for Hepatitis C.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive peer specialist support and vouchers to facilitate linkage to care

6 months

Ongoing support throughout the study

Qualitative Study

Semi-structured interviews with participants and care providers to identify barriers and facilitators to HCV care

6 months

Interviews conducted throughout the study

Follow-up

Participants are monitored for attendance at the first treatment appointment and engagement in care

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Peer Specialist and Vouchers

Trial Overview The study tests whether support from peer specialists and vouchers for phone, transportation, and meals can help people with Hepatitis C engage better in their treatment process, potentially reducing the drop-off between diagnosis and care.

How Is the Trial Designed?

Group I: Peer specialist and Vouchers Experimental Treatment 1 Intervention

Intervention arm

Group II: Standard of care Active Control 1 Intervention

Who Is Running the Clinical Trial?

Carilion Clinic

Lead Sponsor

Trials

85

Recruited

15,400+

Virginia Polytechnic Institute and State University

Collaborator

Trials

162

Recruited

26,900+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Citations

1. harmreductionjournal.biomedcentral.com harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-022-00619-3

Peer-facilitated treatment access for hepatitis C: the Live Hep ... This commentary explores the lessons learned during implementation of a peer-facilitated hepatitis C virus (HCV) testing and treatment ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12435099/

Peer‐Delivered Outreach With Rapid Treatment Pathways for ... Treatment uptake was 100.0%, and known treatment completion was 92.3%. Treatment uptake within 2 weeks was 57.1%. Findings suggest that the co‐ ...

4. academic.oup.com academic.oup.com/jac/article/74/Supplement_5/v17/5645637

redefining the role of peers across the hepatitis C care ... Of these, 89 (85.6%) started treatment and 76 (85.4%) had a favourable outcome. Factors associated with not being approved for treatment were ...

5. 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).

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

Peer-assisted telemedicine hepatitis-C treatment for ... All participants reported that the Peer TeleHCV model built trust and eased barriers for PWUD initiating and remaining in HCV treatment. This ...

7. withpower.com withpower.com/trial/phase-substance-related-disorders-4-2022-aaae6

Peer Support + Vouchers for Hepatitis C · Info for Participants This N/A medical study run by Carilion Clinic needs participants to evaluate whether Peer Specialist and Vouchers will have tolerable side effects ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0955395924002469

Financial incentives to increase engagement across the ... We conducted a systematic review to assess evidence regarding the effectiveness of financial incentives to improve engagement and progression through the HCV ...