About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Partner Navigation Intervention
BehavioralA two-session, disclosure counselor-led, behavioral intervention to enable the injecting partner to support and navigate the adult PWID to start HCV treatment.
Treatment groups
Trial outcomes
Primary outcomes
Intervention 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.
Secondary outcomes
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.
HCV Treatment Completion
The proportion of participants who complete treatment, by randomized group
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
Sponsors and contacts
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University of California, San Francisco
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator