HCV, HBV, HIV Testing During Consultation With Anesthesiologist (SAHARA)

Assistance Publique - Hôpitaux de Paris

Status: Terminated

Conditions: HCV; Hiv; HBV

Treatments: Procedure: HCV, HBV, HIV tests

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04286347

APHP191114

2019-A03071-56 (Other Identifier)

Details and patient eligibility

About

The aim of the study is to assess the feasibility of HCV, HBV, HIV testing (according to the national guidelines) during consultation with Anesthesiologist before a planned surgery in Lariboisiere Hospital, Paris, France. The feasibility will be the number of tested patients divided by the number of patients who should have been tested according to the national guidelines (for each virus).

Full description

The aim of the study is to assess the feasibility of HCV, HBV, HIV testing during consultation with Anesthesiologist before a planned surgery in Lariboisiere Hospital, Paris, France.

The national guidelines recommend at least one HIV testing during life and, more recently, one HCV testing during life to eradicate HCV infection. HBV testing is recommended in patients coming from high prevalence countries, IVDU, prisoners, patients with multiple sexual partners.

The feasibility will be the number of tested patients divided by the number of patients who should have been tested according to the national guidelines (for each virus).

HIV testing will use finger-stick whole blood (FSB) INSTI® HIV-1 & HIV-2 Rapid Antibody Test FSB (BioLytical TM Laboratories Inc., Richmond, B.C., Canada), with a sensitivity 99% [96.3-99.7] and a specificity 99.3%.

HCV testing will use finger-stick whole blood (FSB) Oraquick® HCV test, with a sensitivity and a specificity 99.1 and 100% respectively.

HBV testing will use finger-stick whole blood (FSB) Vikia® HBs Ag test, bioMérieux with a sensitivity and a specificity 96.5 and 99.9% respectively.

Enrollment: 363 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patient ≥ 18 years-old
• planned surgery in Lariboisiere Hospital, Paris, France
• able to give written informed consent for testing
• proposed to be tested for HIV and HCV if no previous testing found in the medical record
• proposed to be tested for HBV if the patient belong to a high-risk group: high prevalence area (Asia, sub-Saharan Africa, French Indies, East and South Europe, North-Africa, Middle-East, India, Pakistan, South-America), IVDU, prisoners, unprotected sexual intercourses.

Exclusion criteria

• patient < 18 years-old
• emergency surgery
• unable to give written informed consent for testing: psychiatric diseases, neurologic diseases, ...
• a previous testing for HIV and HCV found in the medical record and no obvious risk factor after previous testing
• the patient does not belong to a high-risk group for HBV

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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363 participants in 1 patient group

HCV, HBV, HIV testing

Experimental group

Description:

All patient ≥ 18 years-old with a next planned surgery in Lariboisiere Hospital, Paris, France, able to give written informed consent for testing will be proposed to be tested for HIV and HCV if no previous testing found in the medical record and will be proposed to be tested for HBV if the patient belong to a high-risk group: high prevalence area (Asia, sub-Saharan Africa, French Indies, East and South Europe, North-Africa, Middle-East, India, Pakistan, South-America), IVDU, prisoners, unprotected sexual intercourses.

Treatment:

Procedure: HCV, HBV, HIV tests