HCV, HBV, HIV Testing During Consultation With Anesthesiologist
NCT ID: NCT04286347
Last Updated: 2021-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
363 participants
INTERVENTIONAL
2021-08-05
2021-10-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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HCV, HBV, HIV testing
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.
HCV, HBV, HIV tests
HCV, HBV, HIV testing during consultation with Anesthesiologist before a planned surgery
Interventions
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HCV, HBV, HIV tests
HCV, HBV, HIV testing during consultation with Anesthesiologist before a planned surgery
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Locations
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Lariboisière
Paris, , France
Countries
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Other Identifiers
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2019-A03071-56
Identifier Type: OTHER
Identifier Source: secondary_id
APHP191114
Identifier Type: -
Identifier Source: org_study_id