Hepatitis C Pharmacy-based Strategy for Injectors

NCT04698629 | Completed Results

• 2 other identifiers: STUDY00010476R34DA047660
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis C

Keywords

Hepatitis C; Community Pharmacy; Direct Acting Antivirals; Patient Navigator

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Initiation of HCV Treatment

  6 months

Other Outcomes (7)

• Substance Use

  6 months

• HIV Drug Risk Behaviors

  6 months

• HIV Sex Risk Behaviors

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• \>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

You may not qualify if:

• 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")

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• 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.

  PMID: 38261893 DERIVED

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr. Judith Tsui
• Organization: University of Washington

tsuij@uw.edu

206-744-1835

Study Officials

• Judith I Tsui, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: January 7, 2021
• Study Start: November 5, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: April 8, 2025
• Results First Posted: June 7, 2024

Record last verified: 2025-03

Locations

US (1)