NCT04286347

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
363

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

August 5, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2021

Completed
Last Updated

December 2, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

January 17, 2020

Last Update Submit

November 19, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Acceptability of HCV, HBV, HIV testing

    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

    during Day 0, after the initial consultation

Study Arms (1)

HCV, HBV, HIV testing

EXPERIMENTAL

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

Interventions

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

HCV, HBV, HIV testing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lariboisière

Paris, 75475, France

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

HIV Testing

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Microbiological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2020

First Posted

February 27, 2020

Study Start

August 5, 2021

Primary Completion

October 27, 2021

Study Completion

October 27, 2021

Last Updated

December 2, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations