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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study of the Feasibility of Routine Inpatient Hepatitis C Screening

Conditions
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Hepatitis C

Intervention / Treatment
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* Diagnostic Test: Hepatitis C testing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hepatitis C testing<br>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<br>* Hepatitis C Screening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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