NCT06431945

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Typical duration for all trials

Geographic Reach
1 country

18 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 29, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

2 years

First QC Date

April 23, 2024

Last Update Submit

June 25, 2025

Conditions

Hepatitis C Virus Infection

Keywords

HCVPWIDPoint of care testingHepatitisCzech RepublicHCV genotype

Outcome Measures

Primary Outcomes (1)

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

    Until 31. 12. 2025

Secondary Outcomes (2)

  • 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

Study Arms (1)

People who inject drugs

Diagnostic Test: Hepatitis C antibody (anti-HCV) testDiagnostic Test: Hepatitis C RNA test and genotype test

Interventions

Hepatitis C antibody (anti-HCV) testDIAGNOSTIC_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.

People who inject drugs
Hepatitis C RNA test and genotype testDIAGNOSTIC_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.

People who inject drugs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • age 18+
  • an active injecting drug user or have used injecting drugs at any time in the past

You may not qualify if:

  • not agreeing to participate in the project

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Brno University Hospital

Brno, Czechia

RECRUITING

Clinic Podane ruce

Brno, Czechia

RECRUITING

České Budějovice Hospital

České Budějovice, Czechia

RECRUITING

Hospital Havířov

Havířov, Czechia

RECRUITING

Hepatogastroenterology Hradec Kralove

Hradec Králové, Czechia

RECRUITING

University Hospital Hradec Kralove

Hradec Králové, Czechia

RECRUITING

Hospital Jihlava

Jihlava, Czechia

RECRUITING

Regional Hospital Karlovy Vary

Karlovy Vary, Czechia

RECRUITING

University Hospital Olomouc

Olomouc, Czechia

RECRUITING

Hospital Opava

Opava, Czechia

RECRUITING

Hospital Pardubice

Pardubice, Czechia

RECRUITING

Institute for Clinical and Experimental Medicine

Prague, Czechia

RECRUITING

Military University Hospital, Prague

Prague, Czechia

RECRUITING

Remedis Prague

Prague, Czechia

RECRUITING

Hospital Agel Prostějov

Prostějov, Czechia

RECRUITING

Hospital Tábor

Tábor, Czechia

RECRUITING

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

Ústí nad Labem, Czechia

RECRUITING

Tomáš Baťa Regional Hospital in Zlín

Zlín, Czechia

RECRUITING

MeSH Terms

Conditions

Hepatitis CHepatitis

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsLiver DiseasesDigestive System Diseases

Study Officials

  • Viktor Mravcik, assoc. prof.

    Charles University First Faculty of Medicine

    STUDY DIRECTOR

Central Study Contacts

Nikola Stourac

CONTACT

+42073901254nikola.stourac@uzis.cz

Lucie Mandelova, PhD

CONTACT

+420 770190 828lucie.mandelova@uzis.cz

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2024

First Posted

May 29, 2024

Study Start

December 15, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

CZ(18)