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

Hepatitis C Clinical Trial

— HOSPI-VHC  

Official title:

Pilot Study of the Feasibility of Routine Inpatient Hepatitis C Screening

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
• 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
• 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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

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