Partner Navigation Intervention for Hepatitis C Treatment Among Young People Who Inject Drugs

March 11, 2025 updated by: University of California, San Francisco

A Randomized Trial to Test the Efficacy of a Partner Navigation Intervention for HCV Treatment Among Young Adult People Who Inject Drugs

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

After an initial ramp-up phase to ensure intervention materials and protocols meet the needs of the target population and organizational setting, we will apply a stratified randomized design to enroll 250 adult PWID with recently diagnosed HCV infection ("index") and their primary injecting partner("partner") into a randomized control efficacy trial of a two-session partner navigation intervention, compared to standard of care. The primary endpoint is starting HCV treatment. Recruitment will over sample PWID between 18-30 years of age.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Self report injecting drugs in the past month
  • Self report a primary injecting partner (currently inject drugs together)
  • HCV infection identified at partnering community-based clinical site

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Partner Navigation Intervention
A two-session, disclosure counselor-led, behavioral intervention to enable the injecting partner to support and navigate the adult PWID to start HCV treatment.
No Intervention: Control
Standard of care HCV disclosure. This staff-facilitated session follows the California HIV/HCV test counselor certification protocol with the Index alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention efficacy
Time Frame: 6 months, 12 months, and 24 months after HCV infection disclosure visit.
Assessed by comparing the proportion of those enrolled in the intervention group who initiated treatment to the proportion of those enrolled in the control group who initiated treatment at 6 months, 12 months, and 24 months after HCV infection disclosure visit.
6 months, 12 months, and 24 months after HCV infection disclosure visit.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HCV Treatment Completion
Time Frame: Point of HCV treatment initiation up to 3 years
The proportion of participants who complete treatment, by randomized group
Point of HCV treatment initiation up to 3 years
Sustained Virologic Response at 12 weeks post treatment completion (SVR12)
Time Frame: Point of HCV treatment initiation up to 3 years
Proportion of participants who achieve sustained virologic response at 12 weeks post treatment (SVR12), by randomized group
Point of HCV treatment initiation up to 3 years
Change in Partner Support (Intervention mechanism)
Time Frame: 1 week, 1 month, 3 months and 6-months after HCV infection disclosure visit
Self-reported level of partner support measured at baseline, 1 week, 1 month, 3 months, and 6 months. Partner support is measured with a validated survey scale (range 1-5) where the higher the value the higher the partner support.
1 week, 1 month, 3 months and 6-months after HCV infection disclosure visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Meghan D Morris, MPH, PhD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

December 12, 2023

First Submitted That Met QC Criteria

December 12, 2023

First Posted (Actual)

December 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01DA053325-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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