A Randomized Trial to Test the Efficacy of a Partner Navigation Intervention for HCV Treatment Among Young Adult People Who Inject Drugs
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hepatitis C
- Sponsor
- University of California, San Francisco
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Intervention efficacy
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- HCV Treatment Completion(Point of HCV treatment initiation up to 3 years)
- Change in Partner Support (Intervention mechanism)(1 week, 1 month, 3 months and 6-months after HCV infection disclosure visit)
- Sustained Virologic Response at 12 weeks post treatment completion (SVR12)(Point of HCV treatment initiation up to 3 years)