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NCT Number: NCT06179498

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

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).

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94158, United States

Location status: Recruiting

Location contact

Claire McDonell, MS

CONTACT

[email protected]

Meghan D Morris, MPH, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Partner Navigation Intervention

Behavioral

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 outcomes

  1. Intervention efficacy

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

    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.

Secondary outcomes

  1. Change in Partner Support (Intervention mechanism)

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

    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.

  2. HCV Treatment Completion

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

    The proportion of participants who complete treatment, by randomized group

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

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Claire McDonell, MS

CONTACT

[email protected]

Meghan D Morris, MPH, PhD

CONTACT

[email protected]

415-574-0651

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

A Randomized Trial to Test the Efficacy of a Partner Navigation Intervention for HCV Treatment Among Young Adult People Who Inject Drugs

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 22, 2023
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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