## Protocol Section
### Identification Module
**NCT ID:** NCT06431945

**Acronym:** EDVIP

**Brief Title:** Early Detection of HCV in Injection Drug Users

**Official Title:** Early Detection of Hepatitis C in Injection Drug Users

#### Organization Study ID Info
**ID:** UZIS 2023/1
#### Organization
**Class:** OTHER_GOV
**Full Name:** Institute of Health Information and Statistics of the Czech Republic
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-05-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-12-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-23
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Institute for Clinical and Experimental Medicine

**Class:** OTHER

**Name:** Brno University Hospital

**Class:** OTHER

**Name:** České Budějovice Hospital

**Class:** OTHER

**Name:** University Hospital Hradec Kralove

**Class:** OTHER

**Name:** University Hospital Olomouc

**Class:** UNKNOWN

**Name:** Hepatogastroenterology Hradec Kralove

**Class:** UNKNOWN

**Name:** Regional Hospital Karlovy Vary

**Class:** UNKNOWN

**Name:** Clinic Podane ruce

**Class:** UNKNOWN

**Name:** Tomáš Baťa Regional Hospital in Zlín

**Class:** UNKNOWN

**Name:** Hospital Agel Prostějov

**Class:** UNKNOWN

**Name:** Hospital Jihlava

**Class:** UNKNOWN

**Name:** Hospital Havířov

**Class:** UNKNOWN

**Name:** Hospital Tábor

**Class:** UNKNOWN

**Name:** Remedis Prague

**Class:** UNKNOWN

**Name:** Hospital Opava

**Class:** OTHER

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

**Class:** OTHER

**Name:** Military University Hospital, Prague

**Class:** UNKNOWN

**Name:** Hospital Pardubice

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Institute of Health Information and Statistics of the Czech Republic

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Hepatitis C Virus Infection

**Keywords:**

- HCV

- PWID

- Point of care testing

- Hepatitis

- Czech Republic

- HCV genotype

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 3000

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 2 Months

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Diagnostic Test: Hepatitis C antibody (anti-HCV) test

- Diagnostic Test: Hepatitis C RNA test and genotype test

**Label:** People who inject drugs

### Interventions

#### Intervention 1

**Arm Group Labels:**

- People who inject drugs

**Description:** 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.

**Name:** Hepatitis C antibody (anti-HCV) test

**Type:** DIAGNOSTIC_TEST

#### Intervention 2

**Arm Group Labels:**

- People who inject drugs

**Description:** 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.

**Name:** Hepatitis C RNA test and genotype test

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Measure:** Incidence of the hepatitis C virus in screened cohort of persons who inject drugs

**Time Frame:** Until 31. 12. 2025

#### Secondary Outcomes

**Measure:** Up to 3,000 persons who inject drugs (PWID) enrolled in the project

**Time Frame:** 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

**Time Frame:** Until 31. 12. 2025

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** nikola.stourac@uzis.cz

**Name:** Nikola Stourac

**Phone:** +42073901254

**Role:** CONTACT

**Contact 2:**

**Email:** lucie.mandelova@uzis.cz

**Name:** Lucie Mandelova, PhD

**Phone:** +420 770190 828

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Brno

**Contacts:**

***Contact 1:***

- **Email:** husa.petr@fnbrno.cz

- **Name:** Petr Husa, Prof.

- **Role:** CONTACT

***Contact 2:***

- **Name:** Petr Husa, Prof.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Czechia

**Facility:** Brno University Hospital

**Status:** RECRUITING

**Location 2:**

**City:** Brno

**Contacts:**

***Contact 1:***

- **Email:** mravcik@podaneruce.cz

- **Name:** Viktor Mravčík, Assoc. Prof.

- **Role:** CONTACT

***Contact 2:***

- **Name:** Marek Bezděk, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Czechia

**Facility:** Clinic Podane ruce

**Status:** RECRUITING

**Location 3:**

**City:** Havířov

**Contacts:**

***Contact 1:***

- **Email:** ivo.mifek@nemhav.cz

- **Name:** Ivo Mifek, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Ivo Mifek, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Czechia

**Facility:** Hospital Havířov

**Status:** RECRUITING

**Location 4:**

**City:** Hradec Králové

**Contacts:**

***Contact 1:***

- **Email:** miroslava.volfova@hepato-gastro.com

- **Name:** Miroslava Volfova, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Miroslava Volfova, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Czechia

**Facility:** Hepatogastroenterology Hradec Kralove

**Status:** RECRUITING

**Location 5:**

**City:** Hradec Králové

**Contacts:**

***Contact 1:***

- **Email:** jaroslav.kapla@fnhk.cz

- **Name:** Jaroslav Kapla, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Jaroslav Kapla, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Czechia

**Facility:** University Hospital Hradec Kralove

**Status:** RECRUITING

**Location 6:**

**City:** Jihlava

**Contacts:**

***Contact 1:***

- **Email:** skarekj@nemji.cz

- **Name:** Josef Škárek, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Romana Kumštarová, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Czechia

**Facility:** Hospital Jihlava

**Status:** RECRUITING

**Location 7:**

**City:** Karlovy Vary

**Contacts:**

***Contact 1:***

- **Email:** katerina.zaleska@kkn.cz

- **Name:** Kateřina Záleská, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Kateřina Záleská, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Czechia

**Facility:** Regional Hospital Karlovy Vary

**Status:** RECRUITING

**Location 8:**

**City:** Olomouc

**Contacts:**

***Contact 1:***

- **Email:** kvetoslava.aiglova@fnol.cz

- **Name:** Květoslava Aiglová, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Květoslava Aiglová, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Czechia

**Facility:** University Hospital Olomouc

**Status:** RECRUITING

**Location 9:**

**City:** Opava

**Contacts:**

***Contact 1:***

- **Email:** petr.kumpel@snopava.cz

- **Name:** Petr Kümpel, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Petr Kümpel, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Czechia

**Facility:** Hospital Opava

**Status:** RECRUITING

**Location 10:**

**City:** Pardubice

**Contacts:**

***Contact 1:***

- **Email:** sarka.kropackova@nempk.cz

- **Name:** Šárka Kropáčková, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Šárka Kropáčková, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Czechia

**Facility:** Hospital Pardubice

**Status:** RECRUITING

**Location 11:**

**City:** Prague

**Contacts:**

***Contact 1:***

- **Email:** sona.frankova@ikem.cz

- **Name:** Soňa Fraňková, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Soňa Fraňková, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Czechia

**Facility:** Institute for Clinical and Experimental Medicine

**Status:** RECRUITING

**Location 12:**

**City:** Praha

**Contacts:**

***Contact 1:***

- **Email:** petr.urbanek@uvn.cz

- **Name:** Petr Urbánek, Prof.

- **Role:** CONTACT

***Contact 2:***

- **Name:** Petr Urbánek, Prof.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Czechia

**Facility:** Military University Hospital, Prague

**Status:** RECRUITING

**Location 13:**

**City:** Praha

**Contacts:**

***Contact 1:***

- **Email:** rehak@vratislav.cz

- **Name:** Vratislav Řehák, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Vratislav Řehák, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Czechia

**Facility:** Remedis Prague

**Status:** RECRUITING

**Location 14:**

**City:** Prostějov

**Contacts:**

***Contact 1:***

- **Email:** zdenek.prokes@npv.agel.cz

- **Name:** Zdeněk Prokeš, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Zdeněk Prokeš, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Czechia

**Facility:** Hospital Agel Prostějov

**Status:** RECRUITING

**Location 15:**

**City:** Tábor

**Contacts:**

***Contact 1:***

- **Email:** jana.sysova@nemta.cz

- **Name:** Jana Sysová, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Jana Sysová, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Czechia

**Facility:** Hospital Tábor

**Status:** RECRUITING

**Location 16:**

**City:** Zlín

**Contacts:**

***Contact 1:***

- **Email:** macek.ivan@seznam.cz

- **Name:** Ivan Macek, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Ivan Macek, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Czechia

**Facility:** Tomáš Baťa Regional Hospital in Zlín

**Status:** RECRUITING

**Location 17:**

**City:** Ústí Nad Labem

**Contacts:**

***Contact 1:***

- **Email:** Pavel.Dlouhy@KZCR.EU

- **Name:** Pavel Dlouhý, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Pavel Dlouhý, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Czechia

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

**Status:** RECRUITING

**Location 18:**

**City:** České Budějovice

**Contacts:**

***Contact 1:***

- **Email:** chrdle.ales@nemcb.cz

- **Name:** Aleš Chrdle, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Aleš Chrdle, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Czechia

**Facility:** České Budějovice Hospital

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Charles University First Faculty of Medicine

**Name:** Viktor Mravcik, assoc. prof.

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000006525

- Term: Hepatitis, Viral, Human

- ID: D000014777

- Term: Virus Diseases

- ID: D000007239

- Term: Infections

- ID: D000004769

- Term: Enterovirus Infections

- ID: D000010850

- Term: Picornaviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000018178

- Term: Flaviviridae Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC25

- Name: Substance Related Disorders

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9592

- Name: Hepatitis A

- Relevance: HIGH

- As Found: Hepatitis

- ID: M9611

- Name: Hepatitis C

- Relevance: HIGH

- As Found: Hepatitis C

- ID: M9591

- Name: Hepatitis

- Relevance: HIGH

- As Found: Hepatitis

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M1557

- Name: Drug Misuse

- Relevance: LOW

- As Found: Unknown

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9610

- Name: Hepatitis, Viral, Human

- Relevance: LOW

- As Found: Unknown

- ID: M7930

- Name: Enterovirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M13745

- Name: Picornaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M2593

- Name: Blood-Borne Infections

- Relevance: LOW

- As Found: Unknown

- ID: M20324

- Name: Flaviviridae Infections

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006506

- Term: Hepatitis A

- ID: D000006526

- Term: Hepatitis C

- ID: D000006505

- Term: Hepatitis

### Intervention Browse Module - Ancestors

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: HIGH

- As Found: Given

- ID: M20971

- Name: Hepatitis C Antibodies

- Relevance: HIGH

- As Found: Tether

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000906

- Term: Antibodies

- ID: D000018937

- Term: Hepatitis C Antibodies

### Misc Info Module

- Version Holder: 2024-05-31
