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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04405024
Other study ID # HOSPI-VHC
Secondary ID 2019-A03309-48
Status Recruiting
Phase N/A
First received
Last updated
Start date September 21, 2020
Est. completion date August 21, 2024

Study information

Verified date October 2023
Source Centre Hospitalier Intercommunal Creteil
Contact Isabelle Rosa, PhD
Phone 01 45 17 50 00
Email isabelle.rosa@chicreteil.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2500
Est. completion date August 21, 2024
Est. primary completion date June 21, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Hepatitis C testing
Hepatitis C Screening

Locations

Country Name City State
France 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

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Intercommunal Creteil Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary potential patient versus Number of HCV serologies collected compared to the number of patients meeting the inclusion criteria during the study period. 7 days
Secondary HCV positive Percentage positive for HCV 7 days
Secondary Follow-up Percentage of patients referred for consultation if HCV positive 2 months
Secondary Polymerase chain reaction (PCR) Percentage of HCV PCR positive patients 7 days
Secondary Viral risk factor Percentage of patients with a viral risk factor 7 days
Secondary hepatic fibrosis Percentage of patients with hepatic fibrosis 7 days
Secondary treatment initiation Percentage of patients benefiting from treatment initiation 2 months
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