HCV, HBV, HIV Testing During Consultation With Anesthesiologist

Hiv Clinical Trial

— SAHARA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04286347
• Other study ID #: APHP191114
• Secondary ID: 2019-A03071-56
• Status: Terminated
• Phase: N/A
• Start date: August 5, 2021
• Est. completion date: October 27, 2021

Study information

• Verified date: November 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 363
• Est. completion date: October 27, 2021
• Est. primary completion date: October 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HBV
• HCV
• Hiv

Intervention

Procedure:
• HCV, HBV, HIV tests
HCV, HBV, HIV testing during consultation with Anesthesiologist before a planned surgery

Locations

Country	Name	City	State
France	Lariboisière	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Gilead Sciences

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of HCV, HBV, HIV testing	Feasibility (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	Day 0 : during initial consultation, up to 1 hour
Secondary	Acceptability of HCV, HBV, HIV testing	Acceptability (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	Day 0 : during initial consultation, up to 1 hour
Secondary	Acceptability of being treated (for each virus) for the patients who have been tested positive for HCV and/or HBV and/or HIV, by questionning	Acceptability 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.	during Day 0, after the initial consultation