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

Not Applicable

Recruiting

• Conditions: Hepatitis C

• Registration Number: NCT06179498
• Lead Sponsor: University of California, San Francisco

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).

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 Timeline

• Study First Submitted: 2023-12-12
• Study First Submitted QC: 2023-12-12
• Study First Posted: 2023-12-22
• Study Start: 2024-03-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13
• Primary Completion: 2027-03-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intervention efficacy	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.

Secondary Outcome Measures

Name	Time	Method
HCV Treatment Completion	Point of HCV treatment initiation up to 3 years	The proportion of participants who complete treatment, by randomized group
Change in Partner Support (Intervention mechanism)	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.
Sustained Virologic Response at 12 weeks post treatment completion (SVR12)	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

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States