Hepatitis CHepPSINCT04698629

Hepatitis C Pharmacy-based Strategy for Injectors

An observational study of Hepatitis C, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 5 Nov 2020to 30 Jun 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

>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

Who cannot join

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")

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Washington
Seattle, Washington, 98104

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Hepatitis C
Keywords: Hepatitis C, Community Pharmacy, Direct Acting Antivirals, Patient Navigator
Medical subject headings: Hepatitis C

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

Initiation of HCV Treatment
The number/percent who initiate medications for HCV.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Nov 202030 Jun 2023

First posted7 Jan 2021
Study start5 Nov 2020
Primary completion30 Jun 2023
Study completion30 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatitis CStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04698629
Sponsor's protocol ID: STUDY00010476
Other IDs: R34DA047660
Acronym: HepPSI
Status last verified: Mar 2025
First submitted: 24 Nov 2020
Last updated: 8 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Tsui JI, Gojic AJ, Pierce KA, Tung EL, Connolly NC, Radick AC, Hunt RR, Sandvold R, Taber K, Ninburg M, Kubiniec RH, Scott JD, Hansen RN, Stekler JD, Austin EJ, Williams EC, Glick SN. Pilot study of a community pharmacist led program to treat hepatitis C virus among people who inject drugs. Drug Alcohol Depend Rep. 2023 Dec 23;10:100213. doi: 10.1016/j.dadr.2023.100213. eCollection 2024 Mar.
PubMed 38261893

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Not yet recruitingPhase 4
Combating Related Epidemics in HCV
HIV - Human Immunodeficiency Virus, Hepatitis B Virus (HBV)

All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04698629
Acronym / sponsor ID: HepPSI / STUDY00010476
Conditions: Hepatitis C
Keywords: Hepatitis C, Community Pharmacy, Direct Acting Antivirals, Patient Navigator
Study type: Observational
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 5 Nov 2020 (actual)
Primary completion: 30 Jun 2023 (actual)
Study completion: 30 Jun 2023 (actual)
First posted: 7 Jan 2021 (actual)
Results: Posted 7 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (6 listed)

>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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

1 secondary outcome

Initiation of HCV Treatment
Time frame: 6 months

Results and safety

Results posted to the registry on 7 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Observational Group	40	39

Primary outcome: Community Pharmacy Program Successful Linkage

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Observational Group n = 40
Value	38

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Observational Group	2 of 40 (5%)	0 of 40 (0%)	1 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38261893Tsui JI, Gojic AJ, Pierce KA, Tung EL, Connolly NC, Radick AC, Hunt RR, Sandvold R, Taber K, Ninburg M, Kubiniec RH, Scott JD, Hansen RN, Stekler JD, Austin EJ, Williams EC, Glick SN. Pilot study of a community pharmacist led program to treat hepatitis C virus among people who inject drugs. Drug Alcohol Depend Rep. 2023 Dec 23;10:100213. doi: 10.1016/j.dadr.2023.100213. eCollection 2024 Mar.

Related trials for Hepatitis C

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Not yet recruitingPhase 4
Combating Related Epidemics in HCV
HIV - Human Immunodeficiency Virus, Hepatitis B Virus (HBV)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Judith I Tsui, MD, MPH principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Community Pharmacy Program Successful Linkage (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04698629, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.