Hepatitis C Virus InfectionPhase 4PHARM-CNCT04322981
Pharmacist-led Hepatitis C Management
A Phase 4 study testing Pharmacist-Led care in people with Hepatitis C Virus Infection, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Hepatitis C virus (HCV) continues to disproportionately affect vulnerable and marginalized persons in Canada. During the interferon treatment era, certain circumstances precluded individuals from receiving treatment, most notably mental health concerns or active substance use. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatitis C Virus Infection
- What is being tested?
- Pharmacist-Led care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteCanada
- Study dates
- 13 Apr 2022to 1 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HCV infection
- HCV RNA > 1,000 IU/mL
- Aged 18 to 80
- Willingness and capacity to provide informed consent
Who cannot join
- Presence of or history of decompensated cirrhosis. This will be defined as evidence of clinical decompensation (history of either ascites, variceal hemorrhage, or hepatic encephalopathy/confusion), and Child-Pugh-Turcotte and Model for Endstage Liver Disease (MELD) score will also be used to assess this using laboratory investigations and clinical findings.
- Platelets < 75,000/mm3, total albumin <35 g/L, total bilirubin (total and direct) >34.2 μmol/L, International Normalized Ratio (INR) >1.5
- History of current or past hepatocellular carcinoma
- Hepatitis B virus (HBV) co-infection as indicated by positive testing for hepatitis B surface antigen (HBsAg +ve)or untreated HIV co-infection
- Prior HCV antiviral therapy with direct-acting antivirals with or without peginterferon/ribavirin
- Chronic liver disease other than mild non-alcoholic or alcoholic fatty liver disease from a cause other than HCV
Show all 10Show fewer
- Significant co-morbid illness that precludes inclusion in the opinion of the investigator
- Life expectancy of less than 1 year. If clarity is required, the provider who delivered the diagnosis will be contacted.
- Pregnancy/breast-feeding/inability to use contraception
- Use of concomitant contraindicated drugs
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Specialty Rx Solutions
Toronto, Ontario, M4Y 1G7
Mia Biondi, NP-PHC, PhD, 6476276461, mbiondi@yorku.ca
Jordan Feld, MD, MPH, 4163404584, jordan.feld@uhn.ca
About this study
Official title: Pharmacist-led Hepatitis C Diagnosis and Rapid Management - in Community
Hepatitis C virus (HCV) continues to disproportionately affect vulnerable and marginalized persons in Canada. During the interferon treatment era, certain circumstances precluded individuals from receiving treatment, most notably mental health concerns or active substance use. In addition to the tolerability and efficacy of all-oral direct acting antivirals (DAAs), novel diagnostic strategies have also increased engagement in the care cascade. Point-of care and/or dried blood spot antibody as well as RNA testing allow for diagnosis without the need for phlebotomy, a major barrier for those with a history of past or current injection drug use. Despite these advances in diagnostic streamlining and increased cure rates, engagement post-diagnosis continues to be a major gap. Although the exact mechanism of HCV acquisition may not be clear - people who inject drugs, persons who are street-involved or low-income, or persons who are difficult-to-reach for other reasons, often experience both structural and geographic challenges to obtaining care. Community pharmacists may be the first point of contact for higher risk populations and may avoid testing and/or treatment for fear of judgement or poor treatment in hospital/specialist settings. While studies have demonstrated the feasibility of treating people receiving opioid against therapy (OAT), it remains unclear whether Canadian pharmacists can safely and effectively screen, and/or confirm HCV, work-up patients for HCV treatment, and prescribe with minimal oversight. If this model proves successful, it may have global utility especially in areas of the world where pharmacists are the initial point of contact for healthcare issues. The aim of this study is to determine whether being tested and linked care and treatment will be more effective in a community pharmacy than a referral to a tertiary care hospital for management of HCV among people on stable OAT, or other populations who experience barriers to care but use community pharmacy services.
- Conditions
- Hepatitis C Virus Infection
- Being tested
- Pharmacist-Led care, Standard of Care (Hepatology)
- Keywords
- Point-of-care testing, Rapid access to treatment, Pharmacist-led, Service co-localization
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-Led careBehavioural
Rapid testing in a community pharmacy, with rapid linkage to care and treatment that is pharmacist-led
Standard of Care (Hepatology)Behavioural
Rapid testing in a community pharmacy, with standard of care referral to academic hepatology
| Study group | Role | What they receive |
|---|---|---|
| Community Pharmacist-Led | Experimental | Patients in Arm 1 will receive care and treatment at their home pharmacy and be evaluated and treated by a community pharmacist under medical directives and with study oversight. Receives: Behavioral: Pharmacist-Led care |
| Academic hepatology | Active comparator | Patients in Arm 2 will be evaluated and treated by hepatologists at the Toronto Centre for Liver Disease. Receives: Behavioral: Standard of Care (Hepatology) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intention to treat by Completion Rates
Intention to treat direct acting antiviral (DAA) completion rates in non-cirrhotic or compensated cirrhotic patients treated with DAAs in pharmacist-led programs in community pharmacies, compared to treatment completion rates with referral and treatment in tertiary care hepatology (Toronto Centre for Liver Disease).
Measured: 24 months
Secondary outcomes (14)
Sustained Virologic Response by Intention-to-Treat
Compare Sustained Virologic Response rates by Intention to treat in both sites.
Measured: 24 months
Sustained Virologic Response by modified Intention-to-Treat
Compare the rates of Sustained Virologic Response by modified Intention to treat (including all participants who take at least one dose of medication)
Measured: 24 months
Sustained Virologic Response by Per Protocol analysis
Compare the rates of Sustained Virologic Response by per protocol analysis including all individuals who complete treatment in both groups.
Measured: 24 months
Hepatitis C Community seroprevalence in downtown Toronto
Determine the seroprevalence of HCV among individuals tested in downtown Toronto.
Measured: 18 months
Community Pharmacist Fibrosis Identification
Comparison of pharmacist-assessed fibrosis stage vs fibrosis stage assessed by hepatologist (gold standard)
Measured: 18 months
Community Pharmacist Decompensation Identification
Comparison of pharmacist-assessed hepatic decompensation score vs hepatic decompensation assessed by hepatologist (gold standard)
Measured: 18 months
Minimum Mean Time-to-Treatment
Determine the minimum mean time-to-treatment initiation in both groups
Measured: 18 months
Community Appointment Adherence
Assess appointment adherence in both arms
Measured: 24 months
Medication Adherence
Assess self-reported medication adherence at both sites
Measured: 18 months
Quality of Life and Substance Use
Evaluate quality of life for patients with chronic liver disease (CLDQ-HCV) before and after treatment (endpoint and SV12) at both sites.
Measured: 24 months
Substance Use
Evaluate the Maudsley Addiction Profile (MAP) before and after treatment (endpoint and SV12) at both sites.
Measured: 24 months
Patient Understanding and Satisfaction
Compare patient understanding and satisfaction with HCV treatment with the Hepatitis Patient Satisfaction Questionnaire (HPSQ)
Measured: 24 months
Reinfection
Assess rates of reinfection in patients who achieve Sustained Virologic Response, at 48 weeks.
Measured: 24 months
Patient empowerment
Compare measure of patient empowerment by treatment-arm using the Health Care Empowerment (HCE) survey
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start13 Apr 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C Virus InfectionStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Screening, evaluation and treatment at an outpatient pharmacy compared to referral to hepatology clinics
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322981
- Sponsor's protocol ID
- 20-5265
- Acronym
- PHARM-C
- Status last verified
- Dec 2021
- First submitted
- 20 Feb 2020
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist-led Hepatitis C Diagnosis and Rapid Management - in Community
- ClinicalTrials.gov ID
- NCT04322981
- Acronym / sponsor ID
- PHARM-C / 20-5265
- Conditions
- Hepatitis C Virus Infection
- Keywords
- Point-of-care testing, Rapid access to treatment, Pharmacist-led, Service co-localization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hepatitis C virus (HCV) continues to disproportionately affect vulnerable and marginalized persons in Canada. During the interferon treatment era, certain circumstances precluded individuals from receiving treatment, most notably mental health concerns or active substance use. In addition to the tolerability and efficacy of all-oral direct acting antivirals (DAAs), novel diagnostic strategies have also increased engagement in the care cascade. Point-of care and/or dried blood spot antibody as well as RNA testing allow for diagnosis without the need for phlebotomy, a major barrier for those with a history of past or current injection drug use. Despite these advances in diagnostic streamlining and increased cure rates, engagement post-diagnosis continues to be a major gap. Although the exact mechanism of HCV acquisition may not be clear - people who inject drugs, persons who are street-involved or low-income, or persons who are difficult-to-reach for other reasons, often experience both structural and geographic challenges to obtaining care. Community pharmacists may be the first point of contact for higher risk populations and may avoid testing and/or treatment for fear of judgement or poor treatment in hospital/specialist settings. While studies have demonstrated the feasibility of treating people receiving opioid against therapy (OAT), it remains unclear whether Canadian pharmacists can safely and effectively screen, and/or confirm HCV, work-up patients for HCV treatment, and prescribe with minimal oversight. If this model proves successful, it may have global utility especially in areas of the world where pharmacists are the initial point of contact for healthcare issues. The aim of this study is to determine whether being tested and linked care and treatment will be more effective in a community pharmacy than a referral to a tertiary care hospital for management of HCV among people on stable OAT, or other populations who experience barriers to care but use community pharmacy services.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Screening, evaluation and treatment at an outpatient pharmacy compared to referral to hepatology clinics
| Arm | Type | Receives |
|---|---|---|
| Community Pharmacist-Led | Experimental | Behavioral: Pharmacist-Led carePatients in Arm 1 will receive care and treatment at their home pharmacy and be evaluated and treated by a community pharmacist under medical directives and with study oversight. |
| Academic hepatology | Active comparator | Behavioral: Standard of Care (Hepatology)Patients in Arm 2 will be evaluated and treated by hepatologists at the Toronto Centre for Liver Disease. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HCV infection
- HCV RNA > 1,000 IU/mL
- Aged 18 to 80
- Willingness and capacity to provide informed consent
Key exclusion criteria (10 listed)
- Presence of or history of decompensated cirrhosis. This will be defined as evidence of clinical decompensation (history of either ascites, variceal hemorrhage, or hepatic encephalopathy/confusion), and Child-Pugh-Turcotte and Model for Endstage Liver Disease (MELD) score will also be used to assess this using laboratory investigations and clinical findings.
- Platelets < 75,000/mm3, total albumin <35 g/L, total bilirubin (total and direct) >34.2 μmol/L, International Normalized Ratio (INR) >1.5
- History of current or past hepatocellular carcinoma
- Hepatitis B virus (HBV) co-infection as indicated by positive testing for hepatitis B surface antigen (HBsAg +ve)or untreated HIV co-infection
- Prior HCV antiviral therapy with direct-acting antivirals with or without peginterferon/ribavirin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist-Led careRapid testing in a community pharmacy, with rapid linkage to care and treatment that is pharmacist-led | Behavioural | Community Pharmacist-Led |
| Standard of Care (Hepatology)Rapid testing in a community pharmacy, with standard of care referral to academic hepatology | Behavioural | Academic hepatology |
Primary outcome
Intention to treat by Completion Rates
Time frame: 24 months
Intention to treat direct acting antiviral (DAA) completion rates in non-cirrhotic or compensated cirrhotic patients treated with DAAs in pharmacist-led programs in community pharmacies, compared to treatment completion rates with referral and treatment in tertiary care hepatology (Toronto Centre for Liver Disease).
14 secondary outcomes
Sustained Virologic Response by Intention-to-Treat
Time frame: 24 months
Sustained Virologic Response by modified Intention-to-Treat
Time frame: 24 months
Sustained Virologic Response by Per Protocol analysis
Time frame: 24 months
Hepatitis C Community seroprevalence in downtown Toronto
Time frame: 18 months
Community Pharmacist Fibrosis Identification
Time frame: 18 months
Community Pharmacist Decompensation Identification
Time frame: 18 months
Minimum Mean Time-to-Treatment
Time frame: 18 months
Community Appointment Adherence
Time frame: 24 months
Medication Adherence
Time frame: 18 months
Quality of Life and Substance Use
Time frame: 24 months
Substance Use
Time frame: 24 months
Patient Understanding and Satisfaction
Time frame: 24 months
Reinfection
Time frame: 24 months
Patient empowerment
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pharmacist-Led care in people with Hepatitis C Virus Infection, run by University Health Network, Toronto at 1 site in Canada.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 27 Apr 2022. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mia Biondi, PhD, NP-PHC (6476286471, mia.biondi@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intention to treat by Completion Rates (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2022.