Health TrialsbyHealthPanel

Early Detection of HCV in Injection Drug Users

ConditionHepatitis C Virus Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitute of Health Information and Statistics of the Czech Republic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age 18+

an active injecting drug user or have used injecting drugs at any time in the past

Disqualifiers

not agreeing to participate in the project

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

3,000 Participants
are divided into 1 treatment group
Group A: People who inject drugs2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Health Information and Statistics of the Czech Republic

Lead sponsor

Institute for Clinical and Experimental Medicine

Collaborator

Brno University Hospital

Collaborator

České Budějovice Hospital

Collaborator

University Hospital Hradec Kralove

Collaborator

University Hospital Olomouc

Collaborator

Hepatogastroenterology Hradec Kralove

Collaborator

Regional Hospital Karlovy Vary

Collaborator

Clinic Podane ruce

Collaborator

Tomáš Baťa Regional Hospital in Zlín

Collaborator

Hospital Agel Prostějov

Collaborator

Hospital Jihlava

Collaborator

Hospital Havířov

Collaborator

Hospital Tábor

Collaborator

Remedis Prague

Collaborator

Hospital Opava

Collaborator

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

Collaborator

Military University Hospital, Prague

Collaborator

Hospital Pardubice

Collaborator

Source ClinicalTrials.gov
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