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Pharmacist-led Hepatitis C Management (PHARM-C)

19 de abril de 2022 actualizado por: 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.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

108

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Jordan Feld, MD, MPH
  • Número de teléfono: 4163404584
  • Correo electrónico: jordan.feld@uhn.ca

Ubicaciones de estudio

    • Ontario
      • Toronto, Ontario, Canadá, M4Y 1G7
        • Reclutamiento
        • Specialty Rx Solutions
        • Contacto:
          • Jordan Feld, MD, MPH
          • Número de teléfono: 4163404584
          • Correo electrónico: jordan.feld@uhn.ca
        • Contacto:
          • Mia Biondi, NP-PHC, PhD
          • Número de teléfono: 6476276461
          • Correo electrónico: mbiondi@yorku.ca

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. HCV infection
  2. HCV RNA > 1,000 IU/mL
  3. Aged 18 to 80
  4. Willingness and capacity to provide informed consent

Exclusion Criteria:

  1. 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.
  2. Platelets < 75,000/mm3, total albumin <35 g/L, total bilirubin (total and direct) >34.2 μmol/L, International Normalized Ratio (INR) >1.5
  3. History of current or past hepatocellular carcinoma
  4. Hepatitis B virus (HBV) co-infection as indicated by positive testing for hepatitis B surface antigen (HBsAg +ve)or untreated HIV co-infection
  5. Prior HCV antiviral therapy with direct-acting antivirals with or without peginterferon/ribavirin
  6. Chronic liver disease other than mild non-alcoholic or alcoholic fatty liver disease from a cause other than HCV
  7. Significant co-morbid illness that precludes inclusion in the opinion of the investigator
  8. Life expectancy of less than 1 year. If clarity is required, the provider who delivered the diagnosis will be contacted.
  9. Pregnancy/breast-feeding/inability to use contraception
  10. Use of concomitant contraindicated drugs

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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
Comparador activo: 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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Intention to treat by Completion Rates
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Sustained Virologic Response by Intention-to-Treat
Periodo de tiempo: 24 months
Compare Sustained Virologic Response rates by Intention to treat in both sites.
24 months
Sustained Virologic Response by modified Intention-to-Treat
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 18 months
Determine the seroprevalence of HCV among individuals tested in downtown Toronto.
18 months
Community Pharmacist Fibrosis Identification
Periodo de tiempo: 18 months
Comparison of pharmacist-assessed fibrosis stage vs fibrosis stage assessed by hepatologist (gold standard)
18 months
Community Pharmacist Decompensation Identification
Periodo de tiempo: 18 months
Comparison of pharmacist-assessed hepatic decompensation score vs hepatic decompensation assessed by hepatologist (gold standard)
18 months
Minimum Mean Time-to-Treatment
Periodo de tiempo: 18 months
Determine the minimum mean time-to-treatment initiation in both groups
18 months
Community Appointment Adherence
Periodo de tiempo: 24 months
Assess appointment adherence in both arms
24 months
Medication Adherence
Periodo de tiempo: 18 months
Assess self-reported medication adherence at both sites
18 months
Quality of Life and Substance Use
Periodo de tiempo: 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
Periodo de tiempo: 24 months
Evaluate the Maudsley Addiction Profile (MAP) before and after treatment (endpoint and SV12) at both sites.
24 months
Patient Understanding and Satisfaction
Periodo de tiempo: 24 months
Compare patient understanding and satisfaction with HCV treatment with the Hepatitis Patient Satisfaction Questionnaire (HPSQ)
24 months
Reinfection
Periodo de tiempo: 24 months
Assess rates of reinfection in patients who achieve Sustained Virologic Response, at 48 weeks.
24 months
Patient empowerment
Periodo de tiempo: 24 months
Compare measure of patient empowerment by treatment-arm using the Health Care Empowerment (HCE) survey
24 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

13 de abril de 2022

Finalización primaria (Anticipado)

1 de junio de 2023

Finalización del estudio (Anticipado)

1 de diciembre de 2023

Fechas de registro del estudio

Enviado por primera vez

20 de febrero de 2020

Primero enviado que cumplió con los criterios de control de calidad

24 de marzo de 2020

Publicado por primera vez (Actual)

26 de marzo de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de abril de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

19 de abril de 2022

Última verificación

1 de diciembre de 2021

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Infección por el virus de la hepatitis C

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