ClinicalTrials.gg
RecruitingNCT06179498Updated Mar 13, 2025

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

An interventional study of Partner Navigation Intervention in Hepatitis C, sponsored by University of California, San Francisco. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-13.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Hepatitis C by University of California, San Francisco — 2 open to participants now, 2 under way, none of them phase 3. Hepatitis C · University of California, San Francisco.

Planned enrollment
2nd of 10
500 · median 95
Started
2024
the only one that year
No phase
5 of 12
2 open now
Registered
11th of 12
by date

Among the 12 studies in Hepatitis C by University of California, San Francisco, this one is the 2nd largest by planned enrollment of the 10 interventional ones, is the only one that started in 2024, is one of 5 with no phase, and was the 11th registered.

By phase

12 studies; the count open now beside each. This study's row is marked.

No phasethis study5 · 2 open
Phase 44 · 0 open
Observational2 · 0 open
Phase 11 · 0 open

By the year they started

First in 2000; this study’s year is marked. 1 started in 2024.

Size and results

Median enrollment 95 across the 10 interventional studies, 49 across the 2 observational. Of the 9 that completed or were terminated, 5 (56%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 12 studies in Hepatitis C by University of California, San Francisco, or all of them as a file.
02

Study 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).

Read the 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.

03

Conditions studied

  • Hepatitis C

Browse trials for

Keywords

  • Young people who inject drugs
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Self report injecting drugs in the past month
  • Self report a primary injecting partner (currently inject drugs together)
  • infection identified at partnering community-based clinical site
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Partner Navigation Intervention

  • No intervention
    Control

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

Interventions

  • BehavioralPartner 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.

06

What researchers measure

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.

    Time frame: 6 months, 12 months, and 24 months after HCV infection disclosure visit.

Secondary outcomes

  1. Change in Partner Support (Intervention mechanism)

    Self-reported level of partner support measured at baseline, 1 week, 1 month, 3 months, and 6 months. Partner support is measured with a validated survey scale (range 1-5) where the higher the value the higher the partner support.

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

  2. HCV Treatment Completion

    The proportion of participants who complete treatment, by randomized group

    Time frame: Point of HCV treatment initiation up to 3 years

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

    Proportion of participants who achieve sustained virologic response at 12 weeks post treatment (SVR12), by randomized group

    Time frame: Point of HCV treatment initiation up to 3 years

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2024 (actual). Primary completion is estimated for Mar 2027, 35 months after the start.

Of 150 non-industry interventional studies with no phase under Hepatitis C, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 42. This study's planned 35 months is above that.

Counting every sponsor, half of 153 studies reached it within 25 months; a quarter within 14 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 12, 2023
First posted
Dec 22, 2023
StartActual
Mar 25, 2024
Primary completionEst.
Mar 1, 2027
CompletionEst.
Jun 1, 2027
Last update
Mar 13, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06179498
Responsible party
Sponsor
First posted
Dec 22, 2023
Start date
Mar 25, 2024
Primary completion
Mar 1, 2027 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Mar 13, 2025

Study contacts

Meghan D Morris, MPH, PhD
Contact
meghan.morris@ucsf.edu
415-574-0651
Claire McDonell, MS
Contact
claire.mcdonell@ucsf.edu
Meghan D Morris, MPH, PhD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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