HCV, HBV, HIV Testing During Consultation With Anesthesiologist (SAHARA)

November 19, 2021 updated by: Assistance Publique - Hôpitaux de Paris

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
363

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75475
        • Lariboisière

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of HCV, HBV, HIV testing
Time Frame: 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
Day 0 : during initial consultation, up to 1 hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acceptability of HCV, HBV, HIV testing
Time Frame: 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
Day 0 : during initial consultation, up to 1 hour
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
Time Frame: 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.
during Day 0, after the initial consultation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 5, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 27, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 27, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP191114
  • 2019-A03071-56 (Other Identifier: RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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