- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04698629
Hepatitis C Pharmacy-based Strategy for Injectors (HepPSI)
Pilot Study of a Community-Pharmacy Model to Expand Access to Medications to Treat and Prevent Hepatitis C, Opioid Use Disorders, Overdose and HIV Among Persons Who Inject Drugs
Study Overview
Status
Conditions
Detailed Description
Single-arm, prospective observational study of 40 adult persons who inject drugs (PWID) who screen positive for hepatitis C virus (HCV) with a reactive antibody test at community sites who are offered facilitated linkage to community-pharmacy program through patient navigators. Individuals who are eligible and enroll will complete a baseline survey to assess sociodemographics, substance use, HIV risk behaviors, and awareness of and interest in HCV treatment. After the survey, the participants will be linked to the community-pharmacy program, via the patient navigator, where treatment for HCV and opioid use disorder (OUD), as well as pre-exposure prophylaxis (PrEP), Naloxone and vaccinations, will be offered to participants.
After 6 months, participants will complete a follow-up survey, which will include questions on: whether an evaluation for HCV occurred at the community pharmacy, whether HCV treatment was initiated since baseline visit, substance use, HIV risk behaviors, receipt of medications to treat HCV, opioid use disorder, Naloxone and PrEP receipt, medication adherence, and injecting network.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98104
- University of Washington
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- >18 years old
- Reports injecting drugs with 90 days of screening
- Positive HCV test documented (screening antibody test or viral load test)
- Not currently taking medications to treat HCV, and never previously treated with direct-acting antivirals (DAAs) for HCV
- Willing to undergo evaluation for HCV through a community pharmacy program and work with Patient Navigators
- Provides release of information (ROI) to access community pharmacy program records and/or other HCV treatment providers
Exclusion Criteria:
- People who plan to leave the Seattle area within 6 months
- Who do not wish to be treated for their HCV infection
- Who are known to be pregnant
- Who report impending incarceration that would disrupt clinical care
- Who are not comfortable reading and speaking English
- Who report being HIV-positive
- Who report having end-stage renal disease or require dialysis treatments
- Who report prior enrolled in (i.e. completed at least the initial intake appointment) the Kelley-Ross pharmacy program for hepatitis C treatment ("One Step Hep C Free")
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Community Pharmacy Program Successful Linkage
Time Frame: 6 months
|
The number/percent of participants who successfully link to the community pharmacy program and are seen for initial evaluation.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Initiation of HCV Treatment
Time Frame: 6 months
|
The number/percent who initiate medications for HCV.
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Substance Use
Time Frame: 6 months
|
Compare at baseline and 6-month follow-up the number of days of drug use within the past 30 days via self-report using the modified Addition Severity Index (ASI).
|
6 months
|
HIV Drug Risk Behaviors
Time Frame: 6 months
|
Compare at baseline and 6-month follow-up the number of injecting episodes using shared needle/syringe within the past 30 days via self-report using the modified Risk Behaviors Survey (RBS).
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6 months
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HIV Sex Risk Behaviors
Time Frame: 6 months
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Compare at baseline and 6-month follow-up the number of episodes of unprotected vaginal or anal sex within the past 30 days via self-report using the modified Risk Behaviors Survey (RBS).
|
6 months
|
Utilization of Other Community Pharmacy Services
Time Frame: 6 months
|
The number/percent who receive of other medications (naloxone, PrEP, and medications to treat OUD) via the community pharmacy program.
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6 months
|
Participant Satisfaction and Referral to the Community Pharmacy Program
Time Frame: 6 months
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Self-reported participant Likert scale surveys of satisfaction and willingness to refer an injecting partner to the community pharmacy for treatment; 1=strongly disagree, 2=disagree, 3=neutral, 4=agree, 5=strongly agree with the level of satisfaction/likelihood of referral to services.
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6 months
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Completion of HCV Treatment
Time Frame: 9 months
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The number/percent who complete treatment for HCV, defined as having received all planned medication doses.
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9 months
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Sustained Virologic Response (SVR12)
Time Frame: 12 months
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SVR12 will be defined as undetectable HCV viral load at least 12-weeks post treatment completion.
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12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Judith I Tsui, MD, MPH, University of Washington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00010476
- R34DA047660 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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