Clinical trial NCT04286347: HCV, HBV, HIV Testing During Consultation With Anesthesiologist
Official title: Pre-Surgery Assessing HCV, HBV, HIV Status and Revealing During Consultation With Anesthesiologist
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: HCV
HBV
Hiv
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2020-02-27
Enrollment: 363
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of HCV, HBV, HIV testing
timeFrame: Day 0 : during initial consultation, up to 1 hour
Secondary outcomes:
measure: Acceptability of HCV, HBV, HIV testing
timeFrame: Day 0 : during initial consultation, up to 1 hour
measure: 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
timeFrame: during Day 0, after the initial consultation
Other outcomes:
Locations:
city: Paris
country: France
facility: Lariboisière
Study officials:
References: