NCT06179498

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Mar 2024Jun 2027

First Submitted

Initial submission to the registry

December 12, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 22, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

March 25, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

2.9 years

First QC Date

December 12, 2023

Last Update Submit

March 11, 2025

Conditions

Hepatitis C

Keywords

Young people who inject drugs

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in Partner Support (Intervention mechanism)

    1 week, 1 month, 3 months and 6-months after HCV infection disclosure visit

  • HCV Treatment Completion

    Point of HCV treatment initiation up to 3 years

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

    Point of HCV treatment initiation up to 3 years

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Partner Navigation InterventionBEHAVIORAL

A two-session, disclosure counselor-led, behavioral intervention to enable the injecting partner to support and navigate the adult PWID to start HCV treatment.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

RECRUITING

Related Publications (1)

  • 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: 39844334DERIVED

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Meghan D Morris, MPH, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Meghan D Morris, MPH, PhD

CONTACT

415-574-0651meghan.morris@ucsf.edu

Claire McDonell, MS

CONTACT

claire.mcdonell@ucsf.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Behavioral intervention: two counseling based sessions
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2023

First Posted

December 22, 2023

Study Start

March 25, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)