Partner Navigation Intervention for Hepatitis C Treatment Among Young People Who Inject Drugs
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Partner Navigation Intervention.
- Who it may be relevant to
- Registry conditions: Hepatitis C. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized Trial to Test the Efficacy of a Partner Navigation Intervention for HCV Treatment Among Young Adult People Who Inject Drugs
Overview
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
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.
Interventions
- Behavioral Partner Navigation Intervention
A two-session, disclosure counselor-led, behavioral intervention to enable the injecting partner to support and navigate the adult PWID to start HCV treatment.
Primary outcome measures
- Intervention efficacy [Time frame: 6 months, 12 months, and 24 months after HCV infection disclosure visit.]
Secondary outcome measures (3)
- Change in Partner Support (Intervention mechanism) [Time frame: 1 week, 1 month, 3 months and 6-months after HCV infection disclosure visit]
- HCV Treatment Completion [Time frame: Point of HCV treatment initiation up to 3 years]
- Sustained Virologic Response at 12 weeks post treatment completion (SVR12) [Time frame: Point of HCV treatment initiation up to 3 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- University of California, San Francisco — San Francisco
Publications
- Morris MD, Tan JY, McDonell CC, Scarpetta M, Nguyen TN, Price JC, Neilands TB. A single-site randomized controlled trial of partner navigation to HCV treatment for people who inject drugs: a study protocol for the You're Empowered for Treatment Initiation (YETI) partner trial. Trials. 2025 Jan 22;26(1):26. doi: 10.1186/s13063-024-08662-0. PMID 39844334
Identifiers
NCT: NCT06179498 · 1R01DA053325-01A1 · 1R01DA053325-01A1