Hepatitis C Pharmacy-based Strategy for Injectors

Pilot Study of a Community-Pharmacy Model to Expand Access to Medications to Treat and Prevent Hepatitis C, Opioid Use Disorders, Overdose and HIV Among Persons Who Inject Drugs

Sponsors

Lead Sponsor: University of Washington

Collaborator: National Institute on Drug Abuse (NIDA)

Source 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.

Overall Status Recruiting
Start Date November 5, 2020
Completion Date June 30, 2022
Primary Completion Date April 30, 2022
Study Type Observational
Primary Outcome
Measure Time Frame
Community Pharmacy Program Successful Linkage 6 months
Secondary Outcome
Measure Time Frame
Initiation of HCV Treatment 6 months
Enrollment 40
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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 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")

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Judith I Tsui, MD, MPH Principal Investigator University of Washington
Overall Contact

Last Name: Alexander J Gojic, MS

Phone: 206-744-1801

Email: [email protected]

Location
Facility: Status: Contact: University of Washington Judith I Tsui, MD, MPH 206-744-1835 [email protected]
Location Countries

United States

Verification Date

November 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Washington

Investigator Full Name: Judith I. Tsui

Investigator Title: Associate Professor, School of Medicine

Keywords
Has Expanded Access No
Condition Browse
Acronym HepPSI
Study Design Info

Observational Model: Case-Only

Time Perspective: Prospective

Source: ClinicalTrials.gov