Early Detection of HCV in Injection Drug Users
- Conditions
- Hepatitis C Virus Infection
- Interventions
- Diagnostic Test: Hepatitis C antibody (anti-HCV) testDiagnostic Test: Hepatitis C RNA test and genotype test
- Registration Number
- NCT06431945
- Lead Sponsor
- Institute of Health Information and Statistics of the Czech Republic
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3000
- age 18+
- an active injecting drug user or have used injecting drugs at any time in the past
- not agreeing to participate in the project
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description People who inject drugs Hepatitis C antibody (anti-HCV) test - People who inject drugs Hepatitis C RNA test and genotype test -
- Primary Outcome Measures
Name Time Method Incidence of the hepatitis C virus in screened cohort of persons who inject drugs Until 31. 12. 2025
- Secondary Outcome Measures
Name Time Method Up to 3,000 persons who inject drugs (PWID) enrolled in the project 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 Until 31. 12. 2025
Trial Locations
- Locations (18)
Brno University Hospital
🇨🇿Brno, Czechia
Clinic Podane ruce
🇨🇿Brno, Czechia
Hepatogastroenterology Hradec Kralove
🇨🇿Hradec Králové, Czechia
Hospital Havířov
🇨🇿Havířov, Czechia
University Hospital Hradec Kralove
🇨🇿Hradec Králové, Czechia
Hospital Jihlava
🇨🇿Jihlava, Czechia
Regional Hospital Karlovy Vary
🇨🇿Karlovy Vary, Czechia
Hospital Opava
🇨🇿Opava, Czechia
Hospital Pardubice
🇨🇿Pardubice, Czechia
University Hospital Olomouc
🇨🇿Olomouc, Czechia
Institute for Clinical and Experimental Medicine
🇨🇿Prague, Czechia
Remedis Prague
🇨🇿Praha, Czechia
Hospital Agel Prostějov
🇨🇿Prostějov, Czechia
Hospital Tábor
🇨🇿Tábor, Czechia
Tomáš Baťa Regional Hospital in Zlín
🇨🇿Zlín, Czechia
Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
🇨🇿Ústí Nad Labem, Czechia
České Budějovice Hospital
🇨🇿České Budějovice, Czechia
Military University Hospital, Prague
🇨🇿Praha, Czechia