Early Detection of HCV in Injection Drug Users

Hepatitis C Virus Infection Clinical Trial

— EDVIP  

Official title:

Early Detection of Hepatitis C in Injection Drug Users

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06431945
• Other study ID #: UZIS 2023/1
• Status: Recruiting
• Start date: December 15, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Institute of Health Information and Statistics of the Czech Republic
• Contact: Nikola Stourac
• Phone: +42073901254
• Email: nikola.stourac[@]uzis.cz
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 Hepatitis C and setting up and testing new methods and implementation into the system of social health care.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus Infection

Intervention

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.
• 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.

Locations

Country	Name	City	State
Czechia	Brno University Hospital	Brno
Czechia	Clinic Podane ruce	Brno
Czechia	Ceské Budejovice Hospital	Ceské Budejovice
Czechia	Hospital Havírov	Havírov
Czechia	Hepatogastroenterology Hradec Kralove	Hradec Králové
Czechia	University Hospital Hradec Kralove	Hradec Králové
Czechia	Hospital Jihlava	Jihlava
Czechia	Regional Hospital Karlovy Vary	Karlovy Vary
Czechia	University Hospital Olomouc	Olomouc
Czechia	Hospital Opava	Opava
Czechia	Hospital Pardubice	Pardubice
Czechia	Institute for Clinical and Experimental Medicine	Prague
Czechia	Military University Hospital, Prague	Praha
Czechia	Remedis Prague	Praha
Czechia	Hospital Agel Prostejov	Prostejov
Czechia	Hospital Tábor	Tábor
Czechia	Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.	Ústí Nad Labem
Czechia	Tomáš Bata Regional Hospital in Zlín	Zlín

Sponsors (19)

Lead Sponsor

Collaborator

Institute of Health Information and Statistics of the Czech Republic

Brno University Hospital, Ceské Budejovice Hospital, Clinic Podane ruce, Hepatogastroenterology Hradec Kralove, Hospital Agel Prostejov, Hospital Havírov, Hospital Jihlava, Hospital Opava, Hospital Pardubice, Hospital Tábor, Institute for Clinical and Experimental Medicine, Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s., Military University Hospital, Prague, Regional Hospital Karlovy Vary, Remedis Prague, Tomáš Bata Regional Hospital in Zlín, University Hospital Hradec Kralove, University Hospital Olomouc

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of the hepatitis C virus in screened cohort of persons who inject drugs		Until 31. 12. 2025
Secondary	Up to 3,000 persons who inject drugs (PWID) enrolled in the project		Until 31. 12. 2025
Secondary	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