Partner Navigation Intervention for Hepatitis C Treatment Among Young People Who Inject Drugs
- Conditions
- Hepatitis C
- Interventions
- Behavioral: Partner Navigation Intervention
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Partner Navigation 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.
- 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