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Programa Nacional Australiano de Pruebas de VHC en el Punto de Atención - Conjunto de datos mínimo

23 de septiembre de 2026 actualizado por: Kirby Institute

El Programa Nacional Australiano de Pruebas de VHC en el Punto de Atención: Un Estudio de Cohorte Observacional para Evaluar el Uso de Pruebas de Hepatitis C en el Punto de Atención con Punción Dactilar para Mejorar el Diagnóstico y el Tratamiento de la Infección por VHC - Conjunto de Datos Mínimo

The National Australian HCV Point-of-Care Testing Program will establish an observational cohort to evaluate whether scale-up of finger-stick point-of-care HCV testing increases diagnosis and treatment for HCV infection. Participants will be recruited from settings providing services to people with a risk factor for the acquisition of HCV infection (including drug treatment clinics, needle and syringe programs, homelessness settings, mental health services, prisons, and mobile outreach). All participants who undergo HCV point-of-care testing at the study site will be included in the data collection. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will be linked to standard of care.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

The advent of simple direct-acting antiviral hepatitis C (HCV) therapies with cure rates >95% is one of the greatest medical advances in decades, having led to a reversal in liver-related mortality. In Australia, treatment uptake has declined between 2016 (32,000 treated) and 2019/20 (2019: 11,500; 2020: 8,500).1 Progress towards HCV elimination has been impeded by COVID-19, affecting the delivery of national and state-based HCV strategies. Improving HCV treatment uptake to reduce disease burden is a key aim of global, national and state-based HCV strategies.2-4

Scale-up of HCV testing and treatment will be required to achieve elimination by 2030. Current diagnostic pathways require multiple visits to a practitioner reducing the proportion who receive a diagnosis. In Australia, 81% of people have had HCV antibody testing (indicates exposure), but only 47% have been HCV RNA tested (indicates active infection and the need for HCV treatment).5 Mathematical modelling suggests that HCV RNA testing needs to increase by at least 50% annually to achieve elimination in Australia by 2030.6

The Kirby Institute is an international leader in research evaluating the Xpert HCV assay (Grebely Lancet Gastro Hep 2017), having built a large network of Xpert platforms for HCV testing in needle and syringe programs, prisons, drug treatment clinics, tertiary hospitals, and Aboriginal Community Controlled Health Service. In Kirby-led research, point-of-care HCV testing interventions in needle and syringe programs and prisons have resulted in high HCV treatment uptake (70-90%). The Kirby Institute and Flinders University also have a strong track record of implementing point-of-care testing for STIs and COVID-19, providing an ideal foundation to scale-up Xpert HCV testing in Australia.

The Kirby Institute and Flinders University will establish the Australian National HCV Point-of-care Testing Program for the scale-up of point-of-care HCV RNA testing in services with high prevalence of HCV infection, including community health centres, drug treatment clinics, needle and syringe programs, and prisons. This program will include the development of standard operating procedures, logistics/deployment, initial set-up, an operator training program, and quality assurance and competency assessment program.

An observational cohort study will be established to evaluate HCV treatment uptake following scale-up of point-of-care HCV testing among people with a risk factor for acquisition of HCV infection or people attending a service caring for people with risk factors for the acquisition of HCV infection.

Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of HCV infection. All participants who undergo point-of-care HCV testing at the study site will be included in the data collection. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will be linked to standard of care for any other clinical assessments and treatment initiation.

Tipo de estudio

De observación

Inscripción (Estimado)

80000

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

Ubicaciones de estudio

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia
        • Activo, no reclutando
        • Justice Health and Forensic Mental Health Network
    • Queensland
      • Aldershot, Queensland, Australia, 4650
      • Brisbane, Queensland, Australia, 4000
        • Reclutamiento
        • QuIHN
        • Contacto:
      • Cairns, Queensland, Australia
        • Reclutamiento
        • Lotus Glen Correctional Centre
        • Contacto:
          • Darren Russell
        • Investigador principal:
          • Darren Russell
      • Coorparoo, Queensland, Australia, 4151
        • Terminado
        • Hepatitis Queensland
      • Ipswich, Queensland, Australia
        • Reclutamiento
        • West Moreton Hospital and Health Service
        • Contacto:
          • Blake Ponting
        • Investigador principal:
          • Blake Ponting
      • Rathdowney, Queensland, Australia, 4287
      • Townsville, Queensland, Australia
        • Reclutamiento
        • Townsville Correctional Centre
        • Contacto:
          • John Morey
        • Investigador principal:
          • John Morey
      • Woodford, Queensland, Australia
        • Reclutamiento
        • Woodford Correctional Centre
        • Contacto:
          • Rajendra Prakash
        • Investigador principal:
          • Rajendra Prakash
    • South Australia
      • Hackney, South Australia, Australia, 5069
        • Reclutamiento
        • Hepatitis SA
        • Contacto:
      • Marden, South Australia, Australia, 5070
        • Aún no reclutando
        • South Australian Prison Health Service
        • Contacto:
          • Tom Turnbull
        • Investigador principal:
          • Tom Turnbull
      • Mount Gambier, South Australia, Australia, 5290
        • Reclutamiento
        • Mount Gambier Priosn
        • Contacto:
          • William Galloway
        • Investigador principal:
          • William Galloway
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • Activo, no reclutando
        • St Vincent's Correctional Health Services
      • Melbourne, Victoria, Australia, 3000
        • Reclutamiento
        • Medically Supervised Injecting Room
        • Contacto:
          • Nathan Stam
        • Investigador principal:
          • Nathan Stam
      • Ravenhall, Victoria, Australia, 3023
        • Reclutamiento
        • Dame Phyllis Frost Centre
        • Contacto:
      • Ravenhall, Victoria, Australia, 3023
        • Reclutamiento
        • Geo Healthcare - The Geo Group Australia Pty Ltd
        • Contacto:
          • David Grace
        • Investigador principal:
          • David Grace

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 y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of HCV infection, including drug treatment clinics, needle and syringe programs, prisons, mobile outreach services, community health services, mental health services, homelessness services, and other appropriate settings nationally. It is anticipated approximately 40,000 participants will be screened for HCV infection using point-of-care HCV testing.

Descripción

Inclusion Criteria:

  • ≥ 18 years of age.
  • Received point-of-care HCV testing.

Exclusion Criteria:

  • Nil

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

  • Modelos observacionales: COHORT
  • Perspectivas temporales: PROSPECTIVE

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
People at risk of HCV acquisition

Clinic staff will offer HCV point-of-care testing to participants as they access services. Testing will be performed using point-of-care HCV RNA testing.
Prueba de diagnóstico: Point-of-Care Testing

Participants will be offered finger-stick point-of-care testing for HCV

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The proportion of HCV infected participants who initiate HCV treatment at 12 weeks
Periodo de tiempo: 12 Weeks from enrolment

To evaluate the proportion of HCV infected (HCV RNA quantifiable) participants who initiate HCV treatment at 12 weeks following finger-stick point-of-care HCV RNA testing.
12 Weeks from enrolment

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The proportion of participants who accept point-of-care testing
Periodo de tiempo: 2 years from recruitment commencement

To evaluate the proportion of people who accept point-of-care testing among those offered testing.
2 years from recruitment commencement
The prevalence of HCV infection amongst study participants tested
Periodo de tiempo: 2 years from recruitment commencement

To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested.
2 years from recruitment commencement
To evaluate the time to HCV treatment uptake among HCV RNA positive participants
Periodo de tiempo: 52 weeks

To evaluate the length of time participants take to initiate HCV treatment after diagnosis
52 weeks
To evaluate proportion of HCV RNA positive participants who initiate HCV treatment
Periodo de tiempo: 52 weeks

To evaluate the proportion of HCV RNA positive participants who initiate HCV treatment at 12 months (52 weeks) following finger-stick point-of-care HCV RNA testing.
52 weeks
To evaluate the proportion of participants who complete HCV (DAA) treatment
Periodo de tiempo: 52 weeks

To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment.
52 weeks
To evaluate the proportion of participants who achieve an SVR
Periodo de tiempo: 12 weeks

To evaluate the proportion of participants who achieve an SVR (defined as HCV RNA below the lower limit of quantitation at post treatment week 12).
12 weeks
To evaluate the proportion of participants who are HCV RNA negative at 12 months
Periodo de tiempo: 52 weeks

To evaluate the proportion of participants who are HCV RNA negative at 12 months (52 weeks) following finger-stick point-of-care HCV RNA testing.
52 weeks

Colaboradores e Investigadores

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

Patrocinador

Kirby Institute

Colaboradores

Flinders University

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)

23 de enero de 2023

Finalización primaria (Estimado)

1 de diciembre de 2029

Finalización del estudio (Estimado)

1 de diciembre de 2029

Fechas de registro del estudio

Enviado por primera vez

12 de diciembre de 2021

Primero enviado que cumplió con los criterios de control de calidad

9 de febrero de 2022

Publicado por primera vez (Actual)

21 de febrero de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de septiembre de 2026

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

23 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • VHCRP2104

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

Request to share IPD will be considered by the protocol steering committee on individual basis

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. .

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