SAHARA: HCV, HBV, HIV Testing During Consultation With Anesthesiologist

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04286347
• Collaborator: Gilead Sciences (Industry)
• Enrollment: 363
• Location: 1
• Arm: 1
• Actual Duration (Months): 2.7
• Patients Per Site Per Month: 133.1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
HCV; HBV; Hiv	Procedure: HCV, HBV, HIV tests	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 363 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Pre-Surgery Assessing HCV, HBV, HIV Status and Revealing During Consultation With Anesthesiologist
• Actual Study Start Date: Aug 5, 2021
• Actual Primary Completion Date: Oct 27, 2021
• Actual Study Completion Date: Oct 27, 2021

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

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

Outcome Measures

Primary Outcome Measures

1. Feasibility of HCV, HBV, HIV testing [Day 0 : during initial consultation, up to 1 hour]

   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

Secondary Outcome Measures

1. Acceptability of HCV, HBV, HIV testing [Day 0 : during initial consultation, up to 1 hour]

   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

2. 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 [during Day 0, after the initial consultation]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lariboisière	Paris		France	75475

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris
• Gilead Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT04286347
• Other Study ID Numbers: APHP191114; 2019-A03071-56
• First Posted: Feb 27, 2020
• Last Update Posted: Dec 2, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Dec 2, 2021