Recruiting

Hepatitis C

Sponsor:

UCLA

Code:

NCT06179498

Conditions

Hepatitis C

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Partner Navigation Intervention

Study Details

Brief summary:

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).

Conditions

Hepatitis C

Study ID

NCT06179498

Start date

Mar 25, 2024

Status verified date

Mar, 2025

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Intervention efficacy [ Time Frame: 6 months, 12 months, and 24 months after HCV infection disclosure visit. ]

Central Contacts and Locations

Central contacts

Meghan D Morris, MPH, PhD

415-574-0651meghan.morris@ucsf.edu

Claire McDonell, MS

claire.mcdonell@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Meghan D Morris, MPH, PhD

meghan.morris@ucsf.edu

Claire McDonell, MS

claire.mcdonell@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

Mar 13, 2025

Last verified

Mar, 2025

Keywords

  • Young people who inject drugs

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2025-03-13.