Clinical trial NCT06431945: Early Detection of HCV in Injection Drug Users
Official title: Early Detection of Hepatitis C in Injection Drug Users
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis C Virus Infection
Keywords: HCV
PWID
Point of care testing
Hepatitis
Czech Republic
HCV genotype
Lead sponsor: Institute of Health Information and Statistics of the Czech Republic
Sponsor class: OTHER_GOV
Collaborators: name: Institute for Clinical and Experimental Medicine
name: Brno University Hospital
name: České Budějovice Hospital
name: University Hospital Hradec Kralove
name: University Hospital Olomouc
name: Hepatogastroenterology Hradec Kralove
name: Regional Hospital Karlovy Vary
name: Clinic Podane ruce
name: Tomáš Baťa Regional Hospital in Zlín
name: Hospital Agel Prostějov
name: Hospital Jihlava
name: Hospital Havířov
name: Hospital Tábor
name: Remedis Prague
name: Hospital Opava
name: Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
name: Military University Hospital, Prague
name: Hospital Pardubice
First posted: 2024-05-29
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any people who inject drugs with age 18+ tested by cetres participating in the project.

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.

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.

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

Primary outcomes:
measure: Incidence of the hepatitis C virus in screened cohort of persons who inject drugs
timeFrame: Until 31. 12. 2025
Secondary outcomes:
measure: Up to 3,000 persons who inject drugs (PWID) enrolled in the project
timeFrame: Until 31. 12. 2025
measure: Optimal methodological settings for early detection of the Hepatitis C virus based on hepatitis C antibody and hepatitis C RNA testing
timeFrame: Until 31. 12. 2025
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Brno University Hospital
city: Brno
country: Czechia
facility: Clinic Podane ruce
city: Havířov
country: Czechia
facility: Hospital Havířov
city: Hradec Králové
country: Czechia
facility: Hepatogastroenterology Hradec Kralove
city: Hradec Králové
country: Czechia
facility: University Hospital Hradec Kralove
city: Jihlava
country: Czechia
facility: Hospital Jihlava
city: Karlovy Vary
country: Czechia
facility: Regional Hospital Karlovy Vary
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
city: Opava
country: Czechia
facility: Hospital Opava
city: Pardubice
country: Czechia
facility: Hospital Pardubice
city: Prague
country: Czechia
facility: Institute for Clinical and Experimental Medicine
city: Praha
country: Czechia
facility: Military University Hospital, Prague
city: Praha
country: Czechia
facility: Remedis Prague
city: Prostějov
country: Czechia
facility: Hospital Agel Prostějov
city: Tábor
country: Czechia
facility: Hospital Tábor
city: Zlín
country: Czechia
facility: Tomáš Baťa Regional Hospital in Zlín
city: Ústí Nad Labem
country: Czechia
facility: Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
city: České Budějovice
country: Czechia
facility: České Budějovice Hospital
Study officials:
affiliation: Charles University First Faculty of Medicine
name: Viktor Mravcik, assoc. prof.
role: STUDY_DIRECTOR
References: