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

ConditionHepatitis C
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Partner Navigation Intervention

    Behavioral

    A 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

500 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months, 12 months, and 24 months after HCV infection disclosure visit.

Secondary outcomes

1

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
2

HCV Treatment Completion

The proportion of participants who complete treatment, by randomized group

Time frame
Point of HCV treatment initiation up to 3 years
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator