Early Detection of HCV in Injection Drug Users

Официальное название

Early Detection of Hepatitis C in Injection Drug Users

Обзор

The project is a national, prospective, multicenter, non-interventional pilot project of screening HCV in PWID in the Czech Republic. The main goal of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure of early detection of Hepatitis C and setting up and testing new methods and implementation into the system of social health care.

Подробное описание

The project is a national, prospective, multicenter, non-interventional pilot project of screening HCV in PWID in 18 clinical centers in the Czech Republic.

The main goal of the project is the elimination of further transmission of hepatitis C virus and to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure of early detection of Hepatitis C and setting up and testing new methods and implementation into the system of social health care.

The project will include testing the procedure on a sample of approx. 3,000 PWID which can help to identify weak points in the continuum of care. A methodology for the continuous care of the target group in the early diagnostic and therapeutic stages will be created. Proposal for a system change towards streamlining the screening process.

The project is supported by the European Social Fund (Operational Program Employment plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22\_005/0000281.

Вмешательства

• Диагностический тест Hepatitis C antibody (anti-HCV) test
  Testing for hepatitis C antibodies determines whether or not you have been exposed to HCV at some point in your life. This testing will be performed in all 3,000 persons who inject drugs enrolled in the project.
• Диагностический тест Hepatitis C RNA test and genotype test
  RNA is a type of genetic material from HCV that can be detected in the blood. This test will be used as a confirmation of the infection. This testing will be performed in all persons with positive antibody test who will come to clinical center.

Первичные конечные точки

• Incidence of the hepatitis C virus in screened cohort of persons who inject drugs [Срок оценки: Until 31. 12. 2025]

Вторичные конечные точки (2)

• Up to 3,000 persons who inject drugs (PWID) enrolled in the project [Срок оценки: Until 31. 12. 2025]
• Optimal methodological settings for early detection of the Hepatitis C virus based on hepatitis C antibody and hepatitis C RNA testing [Срок оценки: Until 31. 12. 2025]

Критерии участия

Критерии включения

• age 18+
• an active injecting drug user or have used injecting drugs at any time in the past

Критерии исключения

• not agreeing to participate in the project

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Чехия · 18 центров

• Brno University Hospital — Brno
• Clinic Podane ruce — Brno
• České Budějovice Hospital — České Budějovice
• Hospital Havířov — Havířov
• Hepatogastroenterology Hradec Kralove — Hradec Králové
• University Hospital Hradec Kralove — Hradec Králové
• Hospital Jihlava — Jihlava
• Regional Hospital Karlovy Vary — Karlovy Vary
• … и ещё 10 центров

Идентификаторы

NCT: NCT06431945 · UZIS 2023/1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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