Early Detection of HCV in Injection Drug Users

NCT ID: NCT06431945

Last Updated: 2025-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-15

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Hepatitis C Virus Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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People who inject drugs

Hepatitis C antibody (anti-HCV) test

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute for Clinical and Experimental Medicine

OTHER_GOV

Sponsor Role collaborator

Brno University Hospital

OTHER

Sponsor Role collaborator

České Budějovice Hospital

OTHER

Sponsor Role collaborator

University Hospital Hradec Kralove

OTHER

Sponsor Role collaborator

University Hospital Olomouc

OTHER

Sponsor Role collaborator

Hepatogastroenterology Hradec Kralove

UNKNOWN

Sponsor Role collaborator

Regional Hospital Karlovy Vary

UNKNOWN

Sponsor Role collaborator

Clinic Podane ruce

UNKNOWN

Sponsor Role collaborator

Tomáš Baťa Regional Hospital in Zlín

UNKNOWN

Sponsor Role collaborator

Hospital Agel Prostějov

UNKNOWN

Sponsor Role collaborator

Hospital Jihlava

UNKNOWN

Sponsor Role collaborator

Hospital Havířov

UNKNOWN

Sponsor Role collaborator

Hospital Tábor

UNKNOWN

Sponsor Role collaborator

Remedis Prague

UNKNOWN

Sponsor Role collaborator

Hospital Opava

UNKNOWN

Sponsor Role collaborator

Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

OTHER

Sponsor Role collaborator

Military University Hospital, Prague

OTHER

Sponsor Role collaborator

Hospital Pardubice

UNKNOWN

Sponsor Role collaborator

Institute of Health Information and Statistics of the Czech Republic

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Viktor Mravcik, assoc. prof.

Role: STUDY_DIRECTOR

Charles University First Faculty of Medicine

Locations

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Brno University Hospital

Brno, , Czechia

Site Status RECRUITING

Clinic Podane ruce

Brno, , Czechia

Site Status RECRUITING

České Budějovice Hospital

České Budějovice, , Czechia

Site Status RECRUITING

Hospital Havířov

Havířov, , Czechia

Site Status RECRUITING

Hepatogastroenterology Hradec Kralove

Hradec Králové, , Czechia

Site Status RECRUITING

University Hospital Hradec Kralove

Hradec Králové, , Czechia

Site Status RECRUITING

Hospital Jihlava

Jihlava, , Czechia

Site Status RECRUITING

Regional Hospital Karlovy Vary

Karlovy Vary, , Czechia

Site Status RECRUITING

University Hospital Olomouc

Olomouc, , Czechia

Site Status RECRUITING

Hospital Opava

Opava, , Czechia

Site Status RECRUITING

Hospital Pardubice

Pardubice, , Czechia

Site Status RECRUITING

Institute for Clinical and Experimental Medicine

Prague, , Czechia

Site Status RECRUITING

Military University Hospital, Prague

Prague, , Czechia

Site Status RECRUITING

Remedis Prague

Prague, , Czechia

Site Status RECRUITING

Hospital Agel Prostějov

Prostějov, , Czechia

Site Status RECRUITING

Hospital Tábor

Tábor, , Czechia

Site Status RECRUITING

Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

Ústí nad Labem, , Czechia

Site Status RECRUITING

Tomáš Baťa Regional Hospital in Zlín

Zlín, , Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Nikola Stourac

Role: CONTACT

+42073901254

Lucie Mandelova, PhD

Role: CONTACT

+420 770190 828

Facility Contacts

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Petr Husa, Prof.

Role: primary

Viktor Mravčík, Assoc. Prof.

Role: primary

Aleš Chrdle, MD

Role: primary

Ivo Mifek, MD

Role: primary

Miroslava Volfova, MD

Role: primary

Jaroslav Kapla, MD

Role: primary

Josef Škárek, MD

Role: primary

Kateřina Záleská, MD

Role: primary

Květoslava Aiglová, MD

Role: primary

Petr Kümpel, MD

Role: primary

Šárka Kropáčková, MD

Role: primary

Soňa Fraňková, MD

Role: primary

Petr Urbánek, Prof.

Role: primary

Vratislav Řehák, MD

Role: primary

Zdeněk Prokeš, MD

Role: primary

Jana Sysová, MD

Role: primary

Pavel Dlouhý, MD

Role: primary

Ivan Macek, MD

Role: primary

Other Identifiers

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UZIS 2023/1

Identifier Type: -

Identifier Source: org_study_id

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