Hepatitis C
Conditions
Keywords
Young people who inject drugs
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).
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
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.
Sponsors
National Institute on Drug Abuse (NIDA)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Behavioral intervention: two counseling based sessions
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention efficacy | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Partner Support (Intervention mechanism) | 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. |
| HCV Treatment Completion | Point of HCV treatment initiation up to 3 years | The proportion of participants who complete treatment, by randomized group |
| Sustained Virologic Response at 12 weeks post treatment completion (SVR12) | 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 |
Countries
United States
Contacts
Primary ContactMeghan D Morris, MPH, PhD
Backup ContactClaire McDonell, MS
Outcome results
None listed