Hepatitis C Virus Infection
Conditions
Keywords
HCV, PWID, Point of care testing, Hepatitis, Czech Republic, HCV genotype
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.
Interventions
DIAGNOSTIC_TESTHepatitis 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.
DIAGNOSTIC_TESTHepatitis 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.
Sponsors
Institute for Clinical and Experimental Medicine
Brno University Hospital
České Budějovice Hospital
University Hospital Hradec Kralove
University Hospital Olomouc
Hepatogastroenterology Hradec Kralove
Regional Hospital Karlovy Vary
Clinic Podane ruce
Tomáš Baťa Regional Hospital in Zlín
Hospital Agel Prostějov
Hospital Jihlava
Hospital Havířov
Hospital Tábor
Remedis Prague
Hospital Opava
Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
Military University Hospital, Prague
Hospital Pardubice
Institute of Health Information and Statistics of the Czech Republic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 18+ * an active injecting drug user or have used injecting drugs at any time in the past
Exclusion criteria
* not agreeing to participate in the project
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of the hepatitis C virus in screened cohort of persons who inject drugs | Until 31. 12. 2025 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Czechia
Contacts
Primary ContactNikola Stourac
Backup ContactLucie Mandelova, PhD
Outcome results
None listed