Partner Navigation for Hepatitis C

Recruiting in Palo Alto (17 mi)

Overseen by Meghan D Morris, MPH, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, San Francisco

Disqualifiers: Non-injecting drug users, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The Partner Navigation Intervention Study is a randomized controlled study (RCT) to assess the efficacy and mechanism of action of the first behavioral intervention to increase hepatitis C (HCV) treatment initiation among adult people who inject drugs (PWID).

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 data supports the effectiveness of the Partner Navigation Intervention treatment 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 treatment, with high cure rates. In one study, 91% of patients who began treatment achieved a sustained virologic response, indicating the treatment's success. ^{1 2 3 4 5}

How does the Partner Navigation treatment for Hepatitis C differ from other treatments?

The Partner Navigation treatment for Hepatitis C is unique because it involves patient navigators who help patients overcome barriers to care by providing education, treatment readiness support, and medication coordination, which is especially beneficial for high-need patients. This approach has shown high success rates in real-world settings, particularly for underserved populations, by improving treatment initiation and adherence. ^{1 2 3 6 7}

Research Team

Meghan D Morris, MPH, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

Trial Timeline

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)

Treatment Details

Interventions

• Partner Navigation Intervention (Behavioural 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.

Participant Groups

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+

Suresh Gunasekaran

University of California, San Francisco

Chief Executive Officer since 2022

MBA from Southern Methodist University

Dr. Lukejohn Day

University of California, San Francisco

Chief Medical Officer

MD from Stanford University School of Medicine

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

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]

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]

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]

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]

References

1. United States 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. [2022]

2. United States 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. [2020]

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

Patient Navigation Increases Linkage to Care and Receipt of Direct-acting Antiviral Therapy in Patients with Hepatitis C. [2023]

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

Multidisciplinary managed care networks-Life-saving interventions for hepatitis C patients. [2018]

5. United States 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. [2017]

6. Switzerland 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. [2020]

7. 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]