Hepatitis C Pharmacy-based Strategy for Injectors

Completed

• Conditions: Hepatitis C

• Registration Number: NCT04698629
• Lead Sponsor: University of Washington

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.

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 Timeline

• Study Start: 2020-11-05
• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2021-01-04
• Study First Posted: 2021-01-07
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Results First Submitted: 2024-05-02
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-05
• Last Update Submitted: 2024-06-05
• Results First Posted: 2024-06-07
• Last Update Posted: 2024-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. >18 years old
2. Reports injecting drugs with 90 days of screening
3. Positive HCV test documented (screening antibody test or viral load test)
4. Not currently taking medications to treat HCV, and never previously treated with direct-acting antivirals (DAAs) for HCV
5. Willing to undergo evaluation for HCV through a community pharmacy program and work with Patient Navigators
6. Provides release of information (ROI) to access community pharmacy program records and/or other HCV treatment providers

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Exclusion Criteria

1. People who plan to leave the Seattle area within 6 months
2. Who do not wish to be treated for their HCV infection
3. Who are known to be pregnant
4. Who report impending incarceration that would disrupt clinical care
5. Who are not comfortable reading and speaking English
6. Who report being HIV-positive
7. Who report having end-stage renal disease or require dialysis treatments
8. 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")

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Community Pharmacy Program Successful Linkage	6 months	The number/percent of participants who successfully link to the community pharmacy program and are seen for initial evaluation.

Secondary Outcome Measures

Name	Time	Method
Initiation of HCV Treatment	6 months	The number/percent who initiate medications for HCV.

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States