NCT06431945

Early Detection of HCV in Injection Drug Users

Early Detection of Hepatitis C in Injection Drug Users

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Institute of Health Information and Statistics of the Czech Republic · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C Virus Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2023-12-15
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-05-29
• Last updated: 2025-06-29

Locations

18 sites across 1 country: Czechia