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Partner Navigation for Hepatitis C

N/A

Recruiting

Led By Meghan D Morris, MPH, PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up point of hcv treatment initiation up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a new intervention to see if it can help more people with hepatitis C who use drugs to start treatment. It is a randomized controlled study, which means some participants will receive the intervention

Who is the study for?

This trial is for adults who have used injection drugs in the past month, share their injecting activities with a primary partner, and have been diagnosed with hepatitis C at a community-based clinical site.

What is being tested?

The study is testing a 'Partner Navigation Intervention' to see if it helps people who inject drugs start treatment for hepatitis C. It's an RCT, meaning participants are randomly assigned to either receive the intervention or not.

What are the potential side effects?

Since this trial focuses on behavioral intervention rather than medication, there may be no direct medical side effects. However, participants might experience stress or emotional discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ point of hcv treatment initiation up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~point of hcv treatment initiation up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and point of hcv treatment initiation up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Intervention efficacy

Secondary study objectives

Change in Partner Support (Intervention mechanism)

HCV Treatment Completion

Sustained Virologic Response at 12 weeks post treatment completion (SVR12)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 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 II: ControlActive Control1 Intervention

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

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