Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients (HOSPI-VHC)
Primary Purpose
Hepatitis C
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hepatitis C testing
Sponsored by

About this trial
This is an interventional diagnostic trial for Hepatitis C
Eligibility Criteria
Inclusion Criteria:
- Patient over 18 years of age
- Hospitalized during the study period
- Non-opposition for participation in the Protocol
Exclusion Criteria:
- Patients under 18 years of age
- Outpatient, long-stay, maternity and intensive care inpatients
- Patients refusing blood collection
- Patient may not understand the information sheet
- Patient under guardianship
Sites / Locations
- CHI CréteilRecruiting
- Grand Hôpital de l'Est Francilien - Site de Marne-la-ValléeRecruiting
- CH MeauxRecruiting
- CHIVRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Hepatitis C testing
Arm Description
If the patient is included in the study, HCV serology (2 x 5 ml tubes) will be taken at the time of admission as part of the routine entry assessment. These two tubes will be used for HCV screening. The patient is informed of the HCV serology result during hospitalization by an investigator.
Outcomes
Primary Outcome Measures
potential patient versus
Number of HCV serologies collected compared to the number of patients meeting the inclusion criteria during the study period.
Secondary Outcome Measures
HCV positive
Percentage positive for HCV
Follow-up
Percentage of patients referred for consultation if HCV positive
Polymerase chain reaction (PCR)
Percentage of HCV PCR positive patients
Viral risk factor
Percentage of patients with a viral risk factor
hepatic fibrosis
Percentage of patients with hepatic fibrosis
treatment initiation
Percentage of patients benefiting from treatment initiation
Full Information
NCT ID
NCT04405024
First Posted
May 22, 2020
Last Updated
June 7, 2023
Sponsor
Centre Hospitalier Intercommunal Creteil
Collaborators
Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux
1. Study Identification
Unique Protocol Identification Number
NCT04405024
Brief Title
Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients
Acronym
HOSPI-VHC
Official Title
Pilot Study of the Feasibility of Routine Inpatient Hepatitis C Screening
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
June 21, 2023 (Anticipated)
Study Completion Date
August 21, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Intercommunal Creteil
Collaborators
Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Ministry of Health has set the target of eradicating hepatitis C (HCV) in France by 2025.
The goal is to validate the feasibility and value of conducting routine HCV screening in hospitalized patients.
Detailed Description
The number of undetected HCV-infected persons has been extrapolated to 75,000 according to the results of a 2014 study. Screening efforts have been set up in groups of people said to be at high viral risk: drug users, prisoners, precarious persons or migrants from highly endemic countries. Nevertheless, the concept of universal screening has not yet been adopted by the guardians and the Ministry.
It is in this context that "hepatitis free hospital" projects have been carried out in several French cities such as Nice, Nancy and Marseille.
The aim of the HOSPI-VHC study is to evaluate the feasibility and efficiency of systematic HCV screening in all medical and surgical departments of 4 National Association of Hepato-Gastroenterologists of General Hospitals (ANGH) hospitals. This pilot project is part of a public health screening program. It will evaluate the interest and usefulness of implementing universal screening in hospitalized patients without taking into account the existence of viral risk factors. This study will also make it possible to evaluate the implementation of a dedicated care pathway: number of patients screened, number of patients referred for consultation and number of patients accepting the consultation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hepatitis C testing
Arm Type
Other
Arm Description
If the patient is included in the study, HCV serology (2 x 5 ml tubes) will be taken at the time of admission as part of the routine entry assessment.
These two tubes will be used for HCV screening. The patient is informed of the HCV serology result during hospitalization by an investigator.
Intervention Type
Diagnostic Test
Intervention Name(s)
Hepatitis C testing
Intervention Description
Hepatitis C Screening
Primary Outcome Measure Information:
Title
potential patient versus
Description
Number of HCV serologies collected compared to the number of patients meeting the inclusion criteria during the study period.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
HCV positive
Description
Percentage positive for HCV
Time Frame
7 days
Title
Follow-up
Description
Percentage of patients referred for consultation if HCV positive
Time Frame
2 months
Title
Polymerase chain reaction (PCR)
Description
Percentage of HCV PCR positive patients
Time Frame
7 days
Title
Viral risk factor
Description
Percentage of patients with a viral risk factor
Time Frame
7 days
Title
hepatic fibrosis
Description
Percentage of patients with hepatic fibrosis
Time Frame
7 days
Title
treatment initiation
Description
Percentage of patients benefiting from treatment initiation
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient over 18 years of age
Hospitalized during the study period
Non-opposition for participation in the Protocol
Exclusion Criteria:
Patients under 18 years of age
Outpatient, long-stay, maternity and intensive care inpatients
Patients refusing blood collection
Patient may not understand the information sheet
Patient under guardianship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle Rosa, PhD
Phone
01 45 17 50 00
Ext
+33
Email
isabelle.rosa@chicreteil.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Camille JUNG
Phone
01 45 17 50 00
Ext
+33
Email
camille.jung@chicreteil.fr
Facility Information:
Facility Name
CHI Créteil
City
Créteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Rosa
Email
isabelle.rosa@chicreteil.fr
Facility Name
Grand Hôpital de l'Est Francilien - Site de Marne-la-Vallée
City
Jossigny
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles MACAIGNE
Email
gmacaigne@ghef.fr
Facility Name
CH Meaux
City
Meaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hatem SALLOUM
Email
hatemsalloum@yahoo.fr
Facility Name
CHIV
City
Villeneuve-Saint-Georges
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Armand GARIOUD
Email
Armand.Garioud@chiv.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients
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