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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-25

Study Completion Date

2027-06-01

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).

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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.

Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Behavioral intervention: two counseling based sessions

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

Partner Navigation Intervention

Intervention Type 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.

Control

Standard of care HCV disclosure. This staff-facilitated session follows the California HIV/HCV test counselor certification protocol with the Index alone.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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