N/A N=40

Hepatitis C Pharmacy-based Strategy for Injectors

Hepatitis C

Bottom Line

View on ClinicalTrials.gov: NCT04698629 ↗

Enrolled (actual)

Serious AEs

5.0%

Results posted

Jun 2024

Primary outcome: Primary: Community Pharmacy Program Successful Linkage — 38 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Washington
Primary completion: Jun 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Community Pharmacy Program Successful Linkage	38	—
SECONDARY Initiation of HCV Treatment	—	—

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.

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")

View full record on ClinicalTrials.gov →

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.