Hepatitis C Pharmacy-based Strategy for Injectors

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04698629
Study type	Observational
Source	University of Washington
Contact
Status	Completed
Phase
Start date	November 5, 2020
Completion date	June 30, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Hepatitis C Pharmacy-based Strategy for Injectors — HepPSI

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms