Actively Recruiting
Led by University of California, San Francisco · Updated on 2025-03-13
500
Participants Needed
1
Research Sites
13 weeks
Total Duration
U
University of California, San Francisco
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
Researchers are evaluating a behavioral intervention called the Partner Navigation Intervention to increase hepatitis C (HCV) treatment initiation among adults who inject drugs. This randomized controlled trial focuses on people who inject drugs (PWID) with recently diagnosed HCV, enrolling 250 adult participants along with their primary injecting partners. The study particularly targets young adults between 18 and 30 years old to understand how partner support can impact treatment start rates. Participants will be randomly assigned to either the intervention group or the standard care group. Those in the intervention group receive two counseling sessions: the first session occurs immediately after HCV results disclosure, focusing on setting treatment goals and engaging the injecting partner to support treatment initiation. The second session, one week later, includes both the participant and their partner working together to create a personalized "navigation map" to guide the treatment process. The control group receives standard HCV results disclosure following the usual counseling protocol. During the study, researchers will monitor participants at multiple time points up to 24 months after HCV results disclosure, assessing outcomes such as treatment initiation, partner support changes, treatment completion, and sustained virologic response. Participants will be evaluated through counseling sessions, interviews, and follow-up assessments. The study aims to understand the effectiveness and mechanism of this behavioral intervention in helping PWID start and complete HCV treatment, with ongoing safety monitoring throughout the trial period.
CONDITIONS
Partner Navigation Intervention for Hepatitis C Treatment Among Young People Who Inject Drugs
You may qualify if you...
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants in the intervention group attend two counseling sessions to support and navigate HCV treatment initiation with their injecting partner.
2 visits (in-person)
Duration - Up to 3 years
Participants are monitored for treatment initiation, partner support changes, treatment completion, and sustained virologic response over several months to years.
Assessments at 1 week, 1 month, 3 months, 6 months, 12 months, 24 months, and up to 3 years after HCV infection disclosure visit
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
M
Meghan D Morris, MPH, PhD
C
Claire McDonell, MS
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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Meghan D Morris, Judy Y Tan, Claire C McDonell...
https://pubmed.ncbi.nlm.nih.gov/39844334