Lay User Evaluation of the Panbio™ HCV Self-Test

Официальное название

Lay User Evaluation of the Panbio™ HCV Self Test: a Prospective, Multi-centre Observed Untrained User Study.

Обзор

This is a prospective, multi-centre study designed to evaluate the usability of the Panbio™ HCV Self Test, when performed by untrained lay users in an observed study setting. The Panbio™ HCV Self Test detects antibodies to Hepatitis C Virus (HCV). The study validation will be conducted in accordance with the World Health Organisation's technical guidance on Hepatitis C rapid diagnostic tests for professional use and/or self-testing (TSS-16).

Подробное описание

Hepatitis C is a liver disease caused by the hepatitis C virus. The virus can cause both acute and chronic disease, ranging in severity from a mild illness lasting a few weeks to a serious, lifelong illness. Globally, Hepatitis C virus infects around 71 million people per year, resulting in 700,000 deaths. The WHO estimates that only 21% of individuals chronically infected with HCV are diagnosed, and the WHO HCV targets include increasing the diagnoses to 90% by 2030. WHO guidelines, published in 2021, strongly recommend offering self-testing for HCV as an additional approach to HCV testing services.

Вмешательства

• Диагностический тест Panbio™ HCV Self Test
  Rapid diagnostic test (self-test and professional) plus laboratory reference tests

Первичные конечные точки

• Lay user / professional user test result concordance [Срок оценки: 5 months]
• Lay user / laboratory test result concordance [Срок оценки: 5 months]

Вторичные конечные точки (3)

• Usability evaluation - lay user experience [Срок оценки: 5 months]
• Usability evaluation - Self-test observer records [Срок оценки: 5 months]
• Lay user / professional user results interpretation concordance [Срок оценки: 5 months]

Критерии участия

Критерии включения

• Participant is aged 14 or over
• Participant agrees to all aspects of the study and is able and willing to provide informed consent / assent with parental consent.

Критерии исключения

• Participant has already participated in this study on a previous occasion.
• Participant is aware of their HCV status
• Participant is deemed unfit for the study by the Investigator.
• Participant has a condition deemed unfit by the Investigator to safely perform or receive the test.
• Participant is a practising health-care professional or laboratory scientist / technician or has prior medical or laboratory training or experience
• Participant is currently enrolled in a study to evaluate an investigational drug or vaccine.
• Participant has a visual impairment that cannot be restored using glasses or contact lenses or is unable to read the Instructions for Use.
• Participant is unwilling or unable to provide informed consent.
• Participant has participated in the study "Lay user evaluation of the Panbio™ HCV Self Test: A prospective, multi-centre usability study to evaluate lay user labelling comprehension and test result interpretation".

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Простое слепое

Основная цель

Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06605573 · SDRD-I-030-P

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗