The National Australian HCV Point-of-Care Testing Program - HCV Antibody Testing Minimal Dataset

Официальное название

The National Australian HCV Point-of-Care Testing Program: An Observational Cohort Study to Evaluate the Use of Finger-stick Point-of-care Hepatitis C Testing to Enhance Diagnosis and Treatment of HCV Infection - HCV Antibody Testing Minimal Dataset

Обзор

The goal of this observational study is to learn if offering a point-of-care screening test for exposure to the Hepatitis C virus, before providing a diagnostic test for Hepatitis C infection can increase testing, diagnosis and treatment in Adults. Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of Hepatitis C viral infection. The main question it aims to answer is: What proportion of the participants that have been diagnosed with HCV infection have started treatment when their records are reviewed 12 weeks after diagnosis? Participants will have one in-person visit where they will provide informed consent and receive a finger-prick rapid result test for Hepatitis C infection. Participants with no previous Hepatitis C infection will have a screening test to see if they have an immune reaction to Hepatitis C. Participants who know they have been infected with Hepatitis C in the past, and all participants with a positive screening test result will then be given a Hepatitis C diagnostic test at this visit. No treatment is provided as a part of this study, participants who are diagnosed with Hepatitis C infection will be referred to testing locations standard of care for any additional clinical assessments and treatment initiation. A review of the participant's records will be made 12 weeks after their Hepatitis C result and their treatment data are gathered.

Вмешательства

• Устройство Diagnostic Test: Point-of-Care Testing
  Participants will be offered finger-stick point-of-care testing for HCV

Первичные конечные точки

• 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. [Срок оценки: 12 weeks from enrolment]

Вторичные конечные точки (9)

• To evaluate the proportion of people who accept point-of-care testing among those offered testing. [Срок оценки: Recruitment phase]
• To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested. [Срок оценки: Recruitment phase]
• To evaluate the HCV antibody prevalence among people tested. [Срок оценки: Recruitment phase]
• To evaluate the time to treatment uptake among people receiving point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment; [Срок оценки: 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. [Срок оценки: 52 weeks]
• To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment following point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment; [Срок оценки: 52 weeks]
• To evaluate the proportion of participants who achieve an SVR following point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment [Срок оценки: 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. [Срок оценки: 52 weeks]
• To evaluate the cost of point-of-care HCV antibody testing prior to reflex HCV RNA testing compared to direct point-of-care HCV RNA testing and standard of care. [Срок оценки: 52 weeks]

Критерии участия

Критерии включения

• Provide informed consent
• ≥ 18 years of age.

Критерии исключения

• Is unable or unwilling to provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Австралия · 12 центров

• ACT Justice Health — Canberra
• Justice Health and Forensic Mental Health Network — Sydney
• Queensland Injectors Health Network Ltd — Bowen Hills
• West Moreton Hospital and Health Service — Brisbane
• Lotus Glen Correctional Centre — Cairns
• Townsville Correctional Centre — Townsville
• Woodford Correctional Centre — Woodford
• South Australian Prison Health Service — Adelaide
• … и ещё 4 центра

Идентификаторы

NCT: NCT05713136 · VHCRP2203

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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