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Recruiting NCT06431945

Early Detection of HCV in Injection Drug Users

— Observational Hepatitis C Virus Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hepatitis C antibody (anti-HCV) test, Hepatitis C RNA test and genotype test.
Who it may be relevant to
Registry conditions: Hepatitis C Virus Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Early Detection of Hepatitis C in Injection Drug Users

Overview

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

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.

Interventions

  • 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.

Primary outcome measures

  • Incidence of the hepatitis C virus in screened cohort of persons who inject drugs [Time frame: Until 31. 12. 2025]
Secondary outcome measures (2)
  • Up to 3,000 persons who inject drugs (PWID) enrolled in the project [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Czechia · 18 centers
  • Brno University Hospital — Brno
  • Clinic Podane ruce — Brno
  • České Budějovice Hospital — České Budějovice
  • Hospital Havířov — Havířov
  • Hepatogastroenterology Hradec Kralove — Hradec Králové
  • University Hospital Hradec Kralove — Hradec Králové
  • Hospital Jihlava — Jihlava
  • Regional Hospital Karlovy Vary — Karlovy Vary
  • … and 10 more centers

Identifiers

NCT: NCT06431945 · UZIS 2023/1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗