Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients (HOSPI-VHC)

October 30, 2023 updated by: Centre Hospitalier Intercommunal Creteil

Pilot Study of the Feasibility of Routine Inpatient Hepatitis C Screening

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

2500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Diagnostic test: Hepatitis C testing
Hepatitis C Screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
potential patient versus
Time Frame: 7 days
Number of HCV serologies collected compared to the number of patients meeting the inclusion criteria during the study period.
7 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal Creteil

Collaborators

Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2020

Primary Completion (Estimated)

June 21, 2024

Study Completion (Estimated)

August 21, 2024

Study Registration Dates

First Submitted

May 22, 2020

First Submitted That Met QC Criteria

May 22, 2020

First Posted (Actual)

May 28, 2020

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOSPI-VHC
  • 2019-A03309-48 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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