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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06179498
• Other study ID #: 1R01DA053325-01A1
• Secondary ID: 1R01DA053325-01A
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: University of California, San Francisco
• Contact: Meghan D Morris, MPH, PhD
• Phone: 415-574-0651
• Email: meghan.morris[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2027
• Est. primary completion date: July 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 week, 1 month, 3 months and 6-months after HCV infection disclosure visit
Secondary	HCV Treatment Completion	The proportion of participants who complete treatment, by randomized group	Point of HCV treatment initiation up to 3 years
Secondary	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	Point of HCV treatment initiation up to 3 years