Hepatitis C Virus InfectionEDVIPNCT06431945
Early Detection of HCV in Injection Drug Users
An observational study of Hepatitis C Virus Infection, run by Institute of Health Information and Statistics of the Czech Republic at 18 sites in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Virus Infection
- What is being tested?
- Hepatitis C antibody (anti-HCV) test and Hepatitis C RNA test and genotype test
- How many people
- 2,776 participants
- Where
- 18 sitesCzechia
- Study dates
- 15 Dec 2023to 31 Dec 2025
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any people who inject drugs with age 18+ tested by cetres participating in the project.
Who may be able to join
- age 18+
- an active injecting drug user or have used injecting drugs at any time in the past
Who cannot join
- not agreeing to participate in the project
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Czechia18 sites
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
University Hospital Olomouc
Olomouc
Hospital Opava
Opava
Hospital Pardubice
Pardubice
Institute for Clinical and Experimental Medicine
Prague
Military University Hospital, Prague
Prague
Remedis Prague
Prague
Hospital Agel Prostějov
Prostějov
Hospital Tábor
Tábor
Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
Ústí nad Labem
Tomáš Baťa Regional Hospital in Zlín
Zlín
About this study
Official title: 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.
Read the 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.
- Conditions
- Hepatitis C Virus Infection
- Being tested
- Hepatitis C antibody (anti-HCV) test, Hepatitis C RNA test and genotype test
- Keywords
- HCV, PWID, Point of care testing, Hepatitis, Czech Republic, HCV genotype
- Medical subject headings
- Hepatitis C, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| People who inject drugs | Not described Receives: Diagnostic Test: Hepatitis C antibody (anti-HCV) test; Diagnostic Test: Hepatitis C RNA test and genotype test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of the hepatitis C virus in screened cohort of persons who inject drugs
Measured: Until 31. 12. 2025
Secondary outcomes (2)
Up to 3,000 persons who inject drugs (PWID) enrolled in the project
Measured: 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
Measured: Until 31. 12. 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start15 Dec 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,776 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Institute of Health Information and Statistics of the Czech Republic
- Sponsor type
- Other government
- Collaborators
- Institute for Clinical and Experimental Medicine, Brno University Hospital, České Budějovice Hospital, University Hospital Hradec Kralove, University Hospital Olomouc, Hepatogastroenterology Hradec Kralove, Regional Hospital Karlovy Vary, Clinic Podane ruce, Tomáš Baťa Regional Hospital in Zlín, Hospital Agel Prostějov, Hospital Jihlava, Hospital Havířov, Hospital Tábor, Remedis Prague, Hospital Opava, Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s., Military University Hospital, Prague, Hospital Pardubice
- Responsible party
- Sponsor
- Investigators
- Viktor Mravcik, assoc. prof., Study director, Charles University First Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431945
- Sponsor's protocol ID
- UZIS 2023/1
- Acronym
- EDVIP
- Status last verified
- Nov 2026
- First submitted
- 23 Apr 2024
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Hepatitis C in Injection Drug Users
- ClinicalTrials.gov ID
- NCT06431945
- Acronym / sponsor ID
- EDVIP / UZIS 2023/1
- Conditions
- Hepatitis C Virus Infection
- Keywords
- HCV, PWID, Point of care testing, Hepatitis, Czech Republic, HCV genotype
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,776 participants (actual)
- Lead sponsor
- Institute of Health Information and Statistics of the Czech RepublicOther government
- Collaborators
- Institute for Clinical and Experimental Medicine, Brno University Hospital, České Budějovice Hospital, University Hospital Hradec Kralove, University Hospital Olomouc, Hepatogastroenterology Hradec Kralove, Regional Hospital Karlovy Vary, Clinic Podane ruce, Tomáš Baťa Regional Hospital in Zlín, Hospital Agel Prostějov, Hospital Jihlava, Hospital Havířov, Hospital Tábor, Remedis Prague, Hospital Opava, Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s., Military University Hospital, Prague, Hospital Pardubice
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People who inject drugs | – | Diagnostic Test: Hepatitis C antibody (anti-HCV) test, Diagnostic Test: Hepatitis C RNA test and genotype test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any people who inject drugs with age 18+ tested by cetres participating in the project.
Key inclusion criteria (2 listed)
- age 18+
- an active injecting drug user or have used injecting drugs at any time in the past
Key exclusion criteria (1 listed)
- not agreeing to participate in the project
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatitis C antibody (anti-HCV) testTesting 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 | People who inject drugs |
| Hepatitis C RNA test and genotype testRNA 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. | Diagnostic test | People who inject drugs |
Primary outcome
Incidence of the hepatitis C virus in screened cohort of persons who inject drugs
Time frame: Until 31. 12. 2025
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viktor Mravcik, assoc. prof. study director
Charles University First Faculty of Medicine
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C Virus Infection, run by Institute of Health Information and Statistics of the Czech Republic at 18 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of the hepatitis C virus in screened cohort of persons who inject drugs (time frame: Until 31. 12. 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.