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).
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
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
500
A two-session, disclosure counselor-led, behavioral intervention to enable the injecting partner to support and navigate the adult PWID to start HCV treatment.
University of California, San Francisco
San Francisco, California, United States
RECRUITINGIntervention efficacy
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.
Time frame: 6 months, 12 months, and 24 months after HCV infection disclosure visit.
Change in Partner Support (Intervention mechanism)
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.
Time frame: 1 week, 1 month, 3 months and 6-months after HCV infection disclosure visit
HCV Treatment Completion
The proportion of participants who complete treatment, by randomized group
Time frame: Point of HCV treatment initiation up to 3 years
Sustained Virologic Response at 12 weeks post treatment completion (SVR12)
Proportion of participants who achieve sustained virologic response at 12 weeks post treatment (SVR12), by randomized group
Time frame: Point of HCV treatment initiation up to 3 years
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