Partner Navigation for Hepatitis C

Overseen By Claire McDonell, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Non-injecting drug users, others

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

Compensation: Varies

Number of Visits: 2

Duration: Up to 3 years

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help people who inject drugs start treatment for hepatitis C (HCV). The goal is to determine if a supportive program, called Partner Navigation, can encourage participants to begin their treatment. The program includes two counseling sessions that focus on setting goals and using a "navigation map" to plan the treatment journey with a partner's help. Suitable candidates for this trial are adults who have injected drugs in the past month, have a primary injecting partner, and have been diagnosed with hepatitis C. As an unphased trial, this study offers a unique opportunity to contribute to innovative strategies that could improve treatment access and outcomes for people with hepatitis C.

Do I need to stop my current medications for this trial?

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

What prior data suggests that the Partner Navigation Intervention is safe for people who inject drugs?

Research has shown that the Partner Navigation Intervention is a support strategy designed to help people start hepatitis C treatment. This method includes counseling sessions to assist people who inject drugs in beginning their treatment. While specific safety data for this intervention is not available, it is entirely behavioral. This means it involves talking and planning rather than taking new medications or undergoing medical procedures. Generally, behavioral interventions are considered very safe because they focus on support and communication instead of making physical changes to the body. Therefore, participants are unlikely to face medical risks from the intervention itself. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Partner Navigation Intervention for Hepatitis C because it emphasizes a collaborative approach to treatment. Unlike standard care, which typically involves solo counseling sessions, this intervention includes two sessions that actively engage both the patient and their injecting partner. This method not only helps the patient set treatment goals but also involves their partner in supporting those goals through a tool called a "navigation map." This personalized plan enhances communication and coordination, potentially increasing the likelihood of successful treatment initiation and adherence, which could be a game-changer in managing Hepatitis C.

What evidence suggests that the Partner Navigation Intervention is effective for increasing hepatitis C treatment initiation among people who inject drugs?

In this trial, participants in the intervention arm will receive the Partner Navigation Intervention. Research shows this approach can help people start and complete their Hepatitis C treatment. Past studies demonstrated that support from a partner increases the number of people who begin treatment. The intervention includes two counseling sessions focused on setting treatment goals and creating a personalized treatment plan. These sessions aim to improve communication and ensure the partner provides helpful support. Overall, the Partner Navigation Intervention is designed to make starting Hepatitis C treatment easier and more successful for participants. ^{2 3 5 6 7}

Who Is on the Research Team?

Meghan D Morris, MPH, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults who have used injection drugs in the past month, share their injecting activities with a primary partner, and have been diagnosed with hepatitis C at a community-based clinical site.

Inclusion Criteria

Self report a primary injecting partner (currently inject drugs together)

Self report injecting drugs in the past month

HCV infection identified at partnering community-based clinical site

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Two-session partner navigation intervention to increase HCV treatment initiation

1 week

2 visits (in-person)

Treatment

Participants initiate and complete HCV treatment

Up to 3 years

Follow-up

Participants are monitored for sustained virologic response and partner support

6 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Partner Navigation Intervention

Trial Overview The study is testing a 'Partner Navigation Intervention' to see if it helps people who inject drugs start treatment for hepatitis C. It's an RCT, meaning participants are randomly assigned to either receive the intervention or not.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

In addition to standard HCV results disclosure for the comparator arm, intervention participants will have two counseling sessions: Session 1: Immediately after HCV results disclosure, a staff-facilitated session with the index to (1) Establish HCV Treatment Goals, fostering commitment, and (2) Engage the Injecting Partner, identifying ways to support treatment initiation. Session 2: One week later, involving both the index and injecting partner, to (1) Enhance Partner Support with specific strategies for HCV treatment initiation and (2) Collaborative Navigation Mapping, using a "navigation map" tool. By Session 2's end, both will have a completed navigation map, a visual guide for the HCV treatment journey. Both sessions stress communication and dyadic coordination. The "navigation map" tool ensures a personalized plan for the index's treatment initiation and the partner's supportive navigator role.

Group II: Control Active Control 1 Intervention

Standard of care HCV disclosure. This staff-facilitated session follows the California HIV/HCV test counselor certification protocol with the Index alone.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

The Check Hep C program successfully enrolled 388 participants, with 33% initiating treatment for Hepatitis C, and 91% of those who started treatment achieving sustained virologic response (SVR), indicating high cure rates.

Participants who received on-site clinical care were more likely to start treatment compared to those linked to off-site care, highlighting the importance of accessible healthcare services in improving treatment initiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From Care to Cure: Demonstrating a Model of Clinical Patient Navigation for Hepatitis C Care and Treatment in High-Need Patients. Ford, MM., Johnson, N., Desai, P., et al.[2022]

In a study of 824 patients referred to an HCV clinic from 2014 to 2018, 76% successfully linked to care, demonstrating the effectiveness of a nurse navigator model in facilitating access to treatment despite barriers like high uninsured rates.

Disparities in linkage to care were identified, with higher rates among women and those with cirrhosis, while younger individuals and the uninsured had lower rates, highlighting the need for targeted interventions to improve access for these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disparities in Hepatitis C Linkage to Care in the Direct Acting Antiviral Era: Findings From a Referral Clinic With an Embedded Nurse Navigator Model. Sherbuk, JE., McManus, KA., Kemp Knick, T., et al.[2020]

The HERO study, involving 754 people who inject drugs (PWID), aims to evaluate the effectiveness of two patient-centered treatment models—patient navigation (PN) and modified directly observed therapy (mDOT)—in improving HCV treatment initiation, adherence, and achieving sustained virologic response (SVR).

This research is crucial as it seeks to provide evidence-based strategies to enhance HCV care for marginalized populations, addressing barriers to treatment uptake and adherence, which are often assumed to be problematic in PWID.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of a randomized pragmatic trial of patient-centered models of hepatitis C treatment for people who inject drugs: The HERO study. Litwin, AH., Jost, J., Wagner, K., et al.[2020]

A patient navigation program significantly improved linkage to hepatitis C virus (HCV) care and treatment initiation among 1353 socioeconomically disadvantaged patients, with odds ratios of 3.7 and 3.2 respectively within 6 months.

Despite the increased access to care, the patient navigation intervention did not lead to a significant difference in sustained virologic response rates between the navigation and usual care groups, indicating that while access improved, treatment effectiveness remained similar.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Navigation Increases Linkage to Care and Receipt of Direct-acting Antiviral Therapy in Patients with Hepatitis C. Strebe, J., Rich, NE., Wang, L., et al.[2023]

The implementation of a multidisciplinary managed care network significantly improved access to hepatitis C treatment, with the percentage of patients accessing treatment services within one year of diagnosis rising from 26.3% to 72.9% over two decades.

The study also showed a remarkable decrease in all-cause mortality among HCV-positive patients, from 33.7% to 4.5%, indicating that effective care pathways not only enhance treatment initiation but also lead to better overall survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary managed care networks-Life-saving interventions for hepatitis C patients. Tait, JM., Wang, H., Stephens, BP., et al.[2018]

Implementing a nurse-driven evidence-based pathway for hepatitis C treatment significantly improved the 4-week treatment completion rate from 94.9% to 100% and increased adherence scores from 2.46 to 2.92.

The pathway also reduced the mean lag time to treatment initiation by 26 days, indicating enhanced efficiency in patient care and overall satisfaction among healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Project P.E.A.C.H. (Pathway and Education Toward Adherence and Completion in Hepatitis C Therapy): A Nurse-Driven Evidence-Based Protocol. Redulla, RR., Reddy, KR., Faust, TW., et al.[2017]

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/39844334/

A single-site randomized controlled trial of partner ... - PubMed A single-site randomized controlled trial of partner navigation to HCV treatment ... The primary outcome is the initiation of HCV treatment, with secondary ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06179498

Partner Navigation Intervention for Hepatitis C Treatment ... The Partner Navigation Intervention Study is a randomized controlled study (RCT) to assess the efficacy and mechanism of action of the first behavioral ...

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08662-0

A single-site randomized controlled trial of partner navigation ... This trial will provide evidence of a new HCV treatment linkage intervention leveraging the support of primary injecting partners to initiate HCV treatment.

4. withpower.com withpower.com/trial/phase-hepatitis-11-2023-fc275

Partner Navigation for Hepatitis C Research shows that patient navigation programs, like the Check Hep C initiative, have been effective in helping patients start and complete Hepatitis C ...

5. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06179498

Partner Navigation Intervention for Hepatitis C Treatment ... The Partner Navigation Intervention Study is a randomized controlled study (RCT) to assess the efficacy and mechanism of action of the first ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11753105/

A single-site randomized controlled trial of partner ... This trial will provide evidence of a new HCV treatment linkage intervention leveraging the support of primary injecting partners to initiate HCV treatment.

7. ctv.veeva.com ctv.veeva.com/study/partner-navigation-intervention-for-hepatitis-c-treatment-among-young-people-who-inject-drugs

Partner Navigation Intervention for Hepatitis C Treatment ... The Partner Navigation Intervention Study is a randomized controlled study (RCT) to assess the efficacy and mechanism of action of the first ...