Clinical trial NCT04405024: Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients
Official title: Pilot Study of the Feasibility of Routine Inpatient Hepatitis C Screening
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatitis C
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
Collaborators: name: Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux
First posted: 2020-05-28
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: potential patient versus
timeFrame: 7 days
Secondary outcomes:
measure: HCV positive
timeFrame: 7 days
measure: Follow-up
timeFrame: 2 months
measure: Polymerase chain reaction (PCR)
timeFrame: 7 days
measure: Viral risk factor
timeFrame: 7 days
measure: hepatic fibrosis
timeFrame: 7 days
measure: treatment initiation
timeFrame: 2 months
Other outcomes:
Locations:
city: Créteil
country: France
facility: CHI Créteil
city: Jossigny
country: France
facility: Grand Hôpital de l'Est Francilien - Site de Marne-la-Vallée
city: Meaux
country: France
facility: CH Meaux
city: Villeneuve-Saint-Georges
country: France
facility: CHIV
Study officials:
References: