Early Detection of HCV in Injection Drug Users

Recruiting

• Conditions: Hepatitis C Virus Infection

• 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.

Study Timeline

• Study Start: 2023-12-15
• Study First Submitted: 2024-04-23
• Study First Submitted QC: 2024-05-21
• Study First Posted: 2024-05-29
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-25
• Last Update Posted: 2025-06-29
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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

Hospital Havířov; 🇨🇿 Havířov, Czechia

Hepatogastroenterology Hradec Kralove; 🇨🇿 Hradec Králové, Czechia

University Hospital Hradec Kralove; 🇨🇿 Hradec Králové, Czechia

Hospital Jihlava; 🇨🇿 Jihlava, Czechia

Regional Hospital Karlovy Vary; 🇨🇿 Karlovy Vary, Czechia

University Hospital Olomouc; 🇨🇿 Olomouc, Czechia

Hospital Opava; 🇨🇿 Opava, Czechia

Hospital Pardubice; 🇨🇿 Pardubice, Czechia

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