- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04322981
Pharmacist-led Hepatitis C Management (PHARM-C)
19 april 2022 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Förväntat)
108
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Mia Biondi, PhD, NP-PHC
- Telefonnummer: 6476286471
- E-post: mia.biondi@mail.mcgill.ca
Studera Kontakt Backup
- Namn: Jordan Feld, MD, MPH
- Telefonnummer: 4163404584
- E-post: jordan.feld@uhn.ca
Studieorter
-
-
Ontario
-
Toronto, Ontario, Kanada, M4Y 1G7
- Rekrytering
- Specialty Rx Solutions
-
Kontakt:
- Jordan Feld, MD, MPH
- Telefonnummer: 4163404584
- E-post: jordan.feld@uhn.ca
-
Kontakt:
- Mia Biondi, NP-PHC, PhD
- Telefonnummer: 6476276461
- E-post: mbiondi@yorku.ca
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Intention to treat by Completion Rates
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Sustained Virologic Response by Intention-to-Treat
Tidsram: 24 months
|
Compare Sustained Virologic Response rates by Intention to treat in both sites.
|
24 months
|
Sustained Virologic Response by modified Intention-to-Treat
Tidsram: 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
Tidsram: 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
Tidsram: 18 months
|
Determine the seroprevalence of HCV among individuals tested in downtown Toronto.
|
18 months
|
Community Pharmacist Fibrosis Identification
Tidsram: 18 months
|
Comparison of pharmacist-assessed fibrosis stage vs fibrosis stage assessed by hepatologist (gold standard)
|
18 months
|
Community Pharmacist Decompensation Identification
Tidsram: 18 months
|
Comparison of pharmacist-assessed hepatic decompensation score vs hepatic decompensation assessed by hepatologist (gold standard)
|
18 months
|
Minimum Mean Time-to-Treatment
Tidsram: 18 months
|
Determine the minimum mean time-to-treatment initiation in both groups
|
18 months
|
Community Appointment Adherence
Tidsram: 24 months
|
Assess appointment adherence in both arms
|
24 months
|
Medication Adherence
Tidsram: 18 months
|
Assess self-reported medication adherence at both sites
|
18 months
|
Quality of Life and Substance Use
Tidsram: 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
Tidsram: 24 months
|
Evaluate the Maudsley Addiction Profile (MAP) before and after treatment (endpoint and SV12) at both sites.
|
24 months
|
Patient Understanding and Satisfaction
Tidsram: 24 months
|
Compare patient understanding and satisfaction with HCV treatment with the Hepatitis Patient Satisfaction Questionnaire (HPSQ)
|
24 months
|
Reinfection
Tidsram: 24 months
|
Assess rates of reinfection in patients who achieve Sustained Virologic Response, at 48 weeks.
|
24 months
|
Patient empowerment
Tidsram: 24 months
|
Compare measure of patient empowerment by treatment-arm using the Health Care Empowerment (HCE) survey
|
24 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
13 april 2022
Primärt slutförande (Förväntat)
1 juni 2023
Avslutad studie (Förväntat)
1 december 2023
Studieregistreringsdatum
Först inskickad
20 februari 2020
Först inskickad som uppfyllde QC-kriterierna
24 mars 2020
Första postat (Faktisk)
26 mars 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
27 april 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 april 2022
Senast verifierad
1 december 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20-5265
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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