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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Trial to Test the Efficacy of a Partner Navigation Intervention for HCV Treatment Among Young Adult People Who Inject Drugs

Conditions
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Hepatitis C

Intervention / Treatment
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* Behavioral: Partner Navigation Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Behavioral: Partner Navigation Intervention<br>* A two-session, disclosure counselor-led, behavioral intervention to enable the injecting partner to support and navigate the adult PWID to start HCV treatment.<br>|
| No Intervention: Control<br>Standard of care HCV disclosure. This staff-facilitated session follows the California HIV/HCV test counselor certification protocol with the Index alone. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months, 12 months, and 24 months after HCV infection disclosure visit. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Partner Support (Intervention mechanism) | Self-reported level of partner support measured at baseline, 1 week, 1 month, 3 months, and 6 months | 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 | 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 | Point of HCV treatment initiation up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Young people who inject drugs