Hepatitis C Pharmacy-based Strategy for Injectors (HepPSI)

• ClinicalTrials.gov Identifier: NCT04698629
• Recruitment Status: Recruiting
• First Posted: January 7, 2021
• Last Update Posted: February 10, 2021
• Sponsor: University of Washington
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Judith I. Tsui, University of Washington

Study Description

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.

Condition or disease
Hepatitis C

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 40 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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
• Actual Study Start Date: November 5, 2020
• Estimated Primary Completion Date: April 30, 2022
• Estimated Study Completion Date: June 30, 2022

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Community Pharmacy Program Successful Linkage [ Time Frame: 6 months ]
   The number/percent of participants who successfully link to the community pharmacy program and are seen for initial evaluation.

Secondary Outcome Measures :

1. Initiation of HCV Treatment [ Time Frame: 6 months ]
   The number/percent who initiate medications for HCV.

Other Outcome Measures:

1. Substance Use [ Time Frame: 6 months ]
   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).
2. HIV Drug Risk Behaviors [ Time Frame: 6 months ]
   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).
3. HIV Sex Risk Behaviors [ Time Frame: 6 months ]
   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).
4. Utilization of Other Community Pharmacy Services [ Time Frame: 6 months ]
   The number/percent who receive of other medications (naloxone, PrEP, and medications to treat OUD) via the community pharmacy program.
5. Participant Satisfaction and Referral to the Community Pharmacy Program [ Time Frame: 6 months ]
   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. Completion of HCV Treatment [ Time Frame: 9 months ]
   The number/percent who complete treatment for HCV, defined as having received all planned medication doses.
7. Sustained Virologic Response (SVR12) [ Time Frame: 12 months ]
   SVR12 will be defined as undetectable HCV viral load at least 12-weeks post treatment completion.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited at various community sites in Seattle where HCV screening occurs, including syringe exchange programs, addiction treatment programs (a methadone clinic and primary care-based buprenorphine program), homeless shelters, urban drop-in shelters and low-income housing sites.

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")

Contacts and Locations

Contacts

Contact: Alexander J Gojic, MS; 206-744-1801; agojic@uw.edu

Locations

United States, Washington

University of Washington; Recruiting

Seattle, Washington, United States, 98104

Contact: Judith I Tsui, MD, MPH 206-744-1835 tsuij@uw.edu

Sponsors and Collaborators

University of Washington

National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Judith I Tsui, MD, MPH; University of Washington

More Information

• Responsible Party: Judith I. Tsui, Associate Professor, School of Medicine, University of Washington
• ClinicalTrials.gov Identifier: NCT04698629
• Other Study ID Numbers: STUDY00010476; R34DA047660 ( U.S. NIH Grant/Contract )
• First Posted: January 7, 2021
• Last Update Posted: February 10, 2021
• Last Verified: February 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Judith I. Tsui, University of Washington:

Hepatitis C; Community Pharmacy; Direct Acting Antivirals; Patient Navigator

Additional relevant MeSH terms:

Hepatitis A; Hepatitis C; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Blood-Borne Infections; Communicable Diseases; Flaviviridae Infections