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
Sponsor study identifier
Secondary identifiers
NIH
observational
40
1 country
1
Study Start
November 5, 2020
Actual (reported)Primary Completion
June 30, 2023
Actual (reported)Study Completion
June 30, 2023
Actual (reported)The aim of this study is evaluate the acceptability/usage of a newly implemented model of delivery of care, namely a community-pharmacy program, to provide access to medications to treat hepatitis C (HCV), and prevent overdose and HIV, for persons who inject drugs (PWID) with HCV who are in need of treatment. Adults will be enrolled who test positive for HCV at community sites and who agree to linkage to the community-pharmacy program through the use of patient navigators. The primary outcome of the study will be the measure of the number/% of participants who are successfully linked to the community-pharmacy program and assess HCV treatment initiation, completion, and cure. In addition, other outcomes including receipt of other medications (e.g. Naloxone, pre-exposure prophylaxis (PrEP), and medications for opioid use disorders), and self-reported substance use and HIV risk behaviors will also be measured.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 5, 2020
Actual (reported)November 24, 2020
Actual (reported)January 7, 2021
Actual (reported)June 30, 2023
Actual (reported)June 30, 2023
Actual (reported)June 7, 2024
Actual (reported)Community Pharmacy Program Successful Linkage
The number/percent of participants who successfully link to the community pharmacy program and are seen for initial evaluation.
6 months
Initiation of HCV Treatment
6 months
Substance Use
6 months
HIV Drug Risk Behaviors
6 months
HIV Sex Risk Behaviors
6 months
Participants will be recruited at various community sites in Seattle where HCV screening occurs, including syringe exchange programs, addiction treatment programs (a methadone clinic and primary care-based buprenorphine program), homeless shelters, urban drop-in shelters and low-income housing sites.
University of Washington
Seattle, Washington, 98104, United States
Tsui JI, Gojic AJ, Pierce KA, Tung EL, Connolly NC, Radick AC, Hunt RR, Sandvold R, Taber K, Ninburg M, Kubiniec RH, Scott JD, Hansen RN, Stekler JD, Austin EJ, Williams EC, Glick SN. Pilot study of a community pharmacist led program to treat hepatitis C virus among people who inject drugs. Drug Alcohol Depend Rep. 2023 Dec 23;10:100213. doi: 10.1016/j.dadr.2023.100213. eCollection 2024 Mar.
Judith I Tsui, MD, MPH
University of Washington
40 participants (actual enrollment reported by the registry).
First Submitted
November 24, 2020
First Posted
January 7, 2021
Study Start
November 5, 2020
Actual (reported)Advanced Care Coordination and Enhanced Linkage and Retention Among Transitional Re-Entrants
Contact the study team to confirm eligibility.
Primary Completion
June 30, 2023
Actual (reported)Study Completion
June 30, 2023
Actual (reported)Last Updated
April 8, 2025
Results First Posted
June 7, 2024
Record last verified: 2025-03
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Source: ClinicalTrials.gov.
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