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NCT Number: NCT06431945

Early Detection of HCV in Injection Drug Users

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brno University Hospital, Brno, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hepatitis C antibody (anti-HCV) test

Diagnostic 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.

Hepatitis C RNA test and genotype test

Diagnostic 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.

Primary outcomes

  1. Incidence of the hepatitis C virus in screened cohort of persons who inject drugs

    Time frame: Until 31. 12. 2025

Secondary outcomes

  1. Up to 3,000 persons who inject drugs (PWID) enrolled in the project

    Time frame: Until 31. 12. 2025

  2. Optimal methodological settings for early detection of the Hepatitis C virus based on hepatitis C antibody and hepatitis C RNA testing

    Time frame: Until 31. 12. 2025

Study contacts

Contact information is provided by the study sponsor or research team.

Lucie Mandelova, PhD

CONTACT

[email protected]

+420 770190 828

Nikola Stourac

CONTACT

[email protected]

+42073901254

Sponsors and collaborators

Lead sponsor

Institute of Health Information and Statistics of the Czech Republic

Other Gov

Collaborators

  • Brno University Hospital
  • Clinic Podane ruce
  • Hepatogastroenterology Hradec Kralove
  • Hospital Agel Prostějov
  • Hospital Havířov
  • Hospital Jihlava
  • Hospital Opava
  • Hospital Pardubice
  • Hospital Tábor
  • Institute for Clinical and Experimental Medicine
  • Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
  • Military University Hospital, Prague
  • Regional Hospital Karlovy Vary
  • Remedis Prague
  • Tomáš Baťa Regional Hospital in Zlín
  • University Hospital Hradec Kralove
  • University Hospital Olomouc
  • České Budějovice Hospital

Registry information

Official study title

Early Detection of Hepatitis C in Injection Drug Users

Acronym: EDVIP

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 29, 2024
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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