Early Detection of HCV in Injection Drug Users (EDVIP)

June 25, 2025 updated by: Institute of Health Information and Statistics of the Czech Republic

Early Detection of Hepatitis C 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
      • Brno, Czechia
        • Recruiting
        • Brno University Hospital
        • Contact:
        • Principal Investigator:
          • Petr Husa, Prof.
      • Brno, Czechia
        • Recruiting
        • Clinic Podane ruce
        • Contact:
        • Principal Investigator:
          • Marek Bezděk, MD
      • Havířov, Czechia
        • Recruiting
        • Hospital Havířov
        • Contact:
        • Principal Investigator:
          • Ivo Mifek, MD
      • Hradec Králové, Czechia
        • Recruiting
        • University hospital Hradec Králové
        • Contact:
        • Principal Investigator:
          • Jaroslav Kapla, MD
      • Hradec Králové, Czechia
      • Jihlava, Czechia
        • Recruiting
        • Hospital Jihlava
        • Contact:
        • Principal Investigator:
          • Romana Kumštarová, MD
      • Karlovy Vary, Czechia
        • Recruiting
        • Regional Hospital Karlovy Vary
        • Contact:
        • Principal Investigator:
          • Kateřina Záleská, MD
      • Olomouc, Czechia
        • Recruiting
        • University Hospital Olomouc
        • Contact:
        • Principal Investigator:
          • Květoslava Aiglová, MD
      • Opava, Czechia
        • Recruiting
        • Hospital Opava
        • Contact:
        • Principal Investigator:
          • Petr Kümpel, MD
      • Pardubice, Czechia
        • Recruiting
        • Hospital Pardubice
        • Contact:
        • Principal Investigator:
          • Šárka Kropáčková, MD
      • Prague, Czechia
        • Recruiting
        • Institute for Clinical and Experimental Medicine
        • Contact:
        • Principal Investigator:
          • Soňa Fraňková, MD
      • Praha, Czechia
        • Recruiting
        • Military University Hospital, Prague
        • Contact:
        • Principal Investigator:
          • Petr Urbánek, Prof.
      • Praha, Czechia
        • Recruiting
        • Remedis Prague
        • Contact:
        • Principal Investigator:
          • Vratislav Řehák, MD
      • Prostějov, Czechia
        • Recruiting
        • Hospital Agel Prostějov
        • Contact:
        • Principal Investigator:
          • Zdeněk Prokeš, MD
      • Tábor, Czechia
        • Recruiting
        • Hospital Tábor
        • Contact:
        • Principal Investigator:
          • Jana Sysová, MD
      • Zlín, Czechia
        • Recruiting
        • Tomas Bata Regional Hospital in Zlin
        • Contact:
        • Principal Investigator:
          • Ivan Macek, MD
      • Ústí Nad Labem, Czechia
        • Recruiting
        • Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
        • Contact:
        • Principal Investigator:
          • Pavel Dlouhý, MD
      • České Budějovice, Czechia
        • Recruiting
        • Ceske Budejovice Hospital
        • Contact:
        • Principal Investigator:
          • Aleš Chrdle, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Any people who inject drugs with age 18+ tested by cetres participating in the project.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
People who inject drugs
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of the hepatitis C virus in screened cohort of persons who inject drugs
Time Frame: Until 31. 12. 2025
Until 31. 12. 2025

Secondary Outcome Measures

Outcome Measure
Time Frame
Up to 3,000 persons who inject drugs (PWID) enrolled in the project
Time Frame: Until 31. 12. 2025
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
Time Frame: Until 31. 12. 2025
Until 31. 12. 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Health Information and Statistics of the Czech Republic

Collaborators

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

Investigators

  • Study Director: Viktor Mravcik, assoc. prof., Charles University First Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 23, 2024

First Submitted That Met QC Criteria

May 21, 2024

First Posted (Actual)

May 29, 2024

Study Record Updates

Last Update Posted (Actual)

June 29, 2025

Last Update Submitted That Met QC Criteria

June 25, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UZIS 2023/1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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