Your session is about to expire
← Back to Search
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
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.
Find a Location
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,607 Previous Clinical Trials
3,329,685 Total Patients Enrolled
46 Trials studying Hepatitis C
22,288 Patients Enrolled for Hepatitis C
University of California, San FranciscoLead Sponsor
2,593 Previous Clinical Trials
14,887,700 Total Patients Enrolled
16 Trials studying Hepatitis C
3,867 Patients Enrolled for Hepatitis C
Meghan D Morris, MPH, PhDPrincipal InvestigatorUniversity of California, San Francisco