Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients

Not Applicable

Recruiting

• Conditions: Hepatitis C
• Interventions: Diagnostic Test: Hepatitis C testing

• Registration Number: NCT04405024
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

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.

Study Timeline

• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-05-22
• Study First Posted: 2020-05-28
• Study Start: 2020-09-21
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-30
• Last Update Posted: 2023-10-31
• Primary Completion: 2024-06-21
• Study Completion: 2024-08-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hepatitis C testing	Hepatitis C testing	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.

Primary Outcome Measures

Name	Time	Method
potential patient versus	7 days	Number of HCV serologies collected compared to the number of patients meeting the inclusion criteria during the study period.

Secondary Outcome Measures

Name	Time	Method
HCV positive	7 days	Percentage positive for HCV
Follow-up	2 months	Percentage of patients referred for consultation if HCV positive
Polymerase chain reaction (PCR)	7 days	Percentage of HCV PCR positive patients
Viral risk factor	7 days	Percentage of patients with a viral risk factor
hepatic fibrosis	7 days	Percentage of patients with hepatic fibrosis
treatment initiation	2 months	Percentage of patients benefiting from treatment initiation

Trial Locations

Locations (4)

CHI Créteil; 🇫🇷 Créteil, France

Grand Hôpital de l'Est Francilien - Site de Marne-la-Vallée; 🇫🇷 Jossigny, France

CH Meaux; 🇫🇷 Meaux, France

CHIV; 🇫🇷 Villeneuve-Saint-Georges, France