Hepatitis C Pharmacy-based Strategy for Injectors

Hepatitis C Clinical Trial

— HepPSI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04698629
• Other study ID #: STUDY00010476
• Secondary ID: R34DA047660
• Status: Completed
• Start date: November 5, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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")

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Substance Use	Compare at baseline and 6-month follow-up the number of days of drug use within the past 30 days via self-report using the modified Addition Severity Index (ASI).	6 months
Other	HIV Drug Risk Behaviors	Compare at baseline and 6-month follow-up the number of injecting episodes using shared needle/syringe within the past 30 days via self-report using the modified Risk Behaviors Survey (RBS).	6 months
Other	HIV Sex Risk Behaviors	Compare at baseline and 6-month follow-up the number of episodes of unprotected vaginal or anal sex within the past 30 days via self-report using the modified Risk Behaviors Survey (RBS).	6 months
Other	Utilization of Other Community Pharmacy Services	The number/percent who receive of other medications (naloxone, PrEP, and medications to treat OUD) via the community pharmacy program.	6 months
Other	Participant Satisfaction and Referral to the Community Pharmacy Program	Self-reported participant Likert scale surveys of satisfaction and willingness to refer an injecting partner to the community pharmacy for treatment; 1=strongly disagree, 2=disagree, 3=neutral, 4=agree, 5=strongly agree with the level of satisfaction/likelihood of referral to services.	6 months
Other	Completion of HCV Treatment	The number/percent who complete treatment for HCV, defined as having received all planned medication doses.	9 months
Other	Sustained Virologic Response (SVR12)	SVR12 will be defined as undetectable HCV viral load at least 12-weeks post treatment completion.	12 months
Primary	Community Pharmacy Program Successful Linkage	The number/percent of participants who successfully link to the community pharmacy program and are seen for initial evaluation.	6 months
Secondary	Initiation of HCV Treatment	The number/percent who initiate medications for HCV.	6 months