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HCV, HBV, HIV Testing During Consultation With Anesthesiologist

Pre-Surgery Assessing HCV, HBV, HIV Status and Revealing During Consultation With Anesthesiologist

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04286347
Acronym
SAHARA
Enrollment
363
Registered
2020-02-27
Start date
2021-08-05
Completion date
2021-10-27
Last updated
2021-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HBV, HCV, Hiv

Brief summary

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).

Detailed 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.

Interventions

PROCEDUREHCV, HBV, HIV tests

HCV, HBV, HIV testing during consultation with Anesthesiologist before a planned surgery

Sponsors

Gilead Sciences
CollaboratorINDUSTRY
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of HCV, HBV, HIV testingDay 0 : during initial consultation, up to 1 hourFeasibility (assessed by the number of tested patients divided by the number of patients who should have been tested according to the national guidelines (for each virus)) of HCV, HBV, HIV testing during consultation with Anesthesiologist before a planned surgery in Lariboisiere Hospital, Paris, France

Secondary

MeasureTime frameDescription
Acceptability of being treated (for each virus) for the patients who have been tested positive for HCV and/or HBV and/or HIV, by questionningduring Day 0, after the initial consultationAcceptability of being treated (for each virus) for the patients who have been tested positive for HCV and/or HBV and/or HIV during consultation, by direct questionning, with Anesthesiologist before a planned surgery in Lariboisiere Hospital, Paris, France.
Acceptability of HCV, HBV, HIV testingDay 0 : during initial consultation, up to 1 hourAcceptability (number of patients who accept to be tested divided by the number of patients who should have been tested according to the national guidelines (for each virus) of HCV, HBV, HIV testing during consultation with Anesthesiologist before a planned surgery in Lariboisiere Hospital, Paris, France

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026