- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04322981
Pharmacist-led Hepatitis C Management (PHARM-C)
19. april 2022 oppdatert av: University Health Network, Toronto
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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
108
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Mia Biondi, PhD, NP-PHC
- Telefonnummer: 6476286471
- E-post: mia.biondi@mail.mcgill.ca
Studer Kontakt Backup
- Navn: Jordan Feld, MD, MPH
- Telefonnummer: 4163404584
- E-post: jordan.feld@uhn.ca
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada, M4Y 1G7
- Rekruttering
- Specialty Rx Solutions
-
Ta kontakt med:
- Jordan Feld, MD, MPH
- Telefonnummer: 4163404584
- E-post: jordan.feld@uhn.ca
-
Ta kontakt med:
- Mia Biondi, NP-PHC, PhD
- Telefonnummer: 6476276461
- E-post: mbiondi@yorku.ca
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- HCV infection
- HCV RNA > 1,000 IU/mL
- Aged 18 to 80
- Willingness and capacity to provide informed consent
Exclusion Criteria:
- 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
- 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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Community Pharmacist-Led
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.
|
Rapid testing in a community pharmacy, with rapid linkage to care and treatment that is pharmacist-led
|
Aktiv komparator: Academic hepatology
Patients in Arm 2 will be evaluated and treated by hepatologists at the Toronto Centre for Liver Disease.
|
Rapid testing in a community pharmacy, with standard of care referral to academic hepatology
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Intention to treat by Completion Rates
Tidsramme: 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).
|
24 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Sustained Virologic Response by Intention-to-Treat
Tidsramme: 24 months
|
Compare Sustained Virologic Response rates by Intention to treat in both sites.
|
24 months
|
Sustained Virologic Response by modified Intention-to-Treat
Tidsramme: 24 months
|
Compare the rates of Sustained Virologic Response by modified Intention to treat (including all participants who take at least one dose of medication)
|
24 months
|
Sustained Virologic Response by Per Protocol analysis
Tidsramme: 24 months
|
Compare the rates of Sustained Virologic Response by per protocol analysis including all individuals who complete treatment in both groups.
|
24 months
|
Hepatitis C Community seroprevalence in downtown Toronto
Tidsramme: 18 months
|
Determine the seroprevalence of HCV among individuals tested in downtown Toronto.
|
18 months
|
Community Pharmacist Fibrosis Identification
Tidsramme: 18 months
|
Comparison of pharmacist-assessed fibrosis stage vs fibrosis stage assessed by hepatologist (gold standard)
|
18 months
|
Community Pharmacist Decompensation Identification
Tidsramme: 18 months
|
Comparison of pharmacist-assessed hepatic decompensation score vs hepatic decompensation assessed by hepatologist (gold standard)
|
18 months
|
Minimum Mean Time-to-Treatment
Tidsramme: 18 months
|
Determine the minimum mean time-to-treatment initiation in both groups
|
18 months
|
Community Appointment Adherence
Tidsramme: 24 months
|
Assess appointment adherence in both arms
|
24 months
|
Medication Adherence
Tidsramme: 18 months
|
Assess self-reported medication adherence at both sites
|
18 months
|
Quality of Life and Substance Use
Tidsramme: 24 months
|
Evaluate quality of life for patients with chronic liver disease (CLDQ-HCV) before and after treatment (endpoint and SV12) at both sites.
|
24 months
|
Substance Use
Tidsramme: 24 months
|
Evaluate the Maudsley Addiction Profile (MAP) before and after treatment (endpoint and SV12) at both sites.
|
24 months
|
Patient Understanding and Satisfaction
Tidsramme: 24 months
|
Compare patient understanding and satisfaction with HCV treatment with the Hepatitis Patient Satisfaction Questionnaire (HPSQ)
|
24 months
|
Reinfection
Tidsramme: 24 months
|
Assess rates of reinfection in patients who achieve Sustained Virologic Response, at 48 weeks.
|
24 months
|
Patient empowerment
Tidsramme: 24 months
|
Compare measure of patient empowerment by treatment-arm using the Health Care Empowerment (HCE) survey
|
24 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
13. april 2022
Primær fullføring (Forventet)
1. juni 2023
Studiet fullført (Forventet)
1. desember 2023
Datoer for studieregistrering
Først innsendt
20. februar 2020
Først innsendt som oppfylte QC-kriteriene
24. mars 2020
Først lagt ut (Faktiske)
26. mars 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. april 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. april 2022
Sist bekreftet
1. desember 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20-5265
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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