N/A
Completed N=40
Hepatitis C Pharmacy-based Strategy for Injectors
Source: ClinicalTrials.gov NCT04698629 ↗Enrolled (actual)
40
Serious AEs
5.0%
Results posted
Jun 2024
Primary outcomePrimary: Community Pharmacy Program Successful Linkage — 38 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Community Pharmacy Program Successful Linkage |
38 | — |
| SECONDARY Initiation of HCV Treatment |
— | — |
Eligibility Criteria
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")
Data sourced from ClinicalTrials.gov (NCT04698629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.