NCT03088995

Brief Summary

The purpose of the OPDEP pilot study is to assess the feasibility of implementing a pre-operative HIV / HCV / HBV screening proposal for all persons over 18 years of age and refer for surgical intervention under general anesthesia in the Department of Stomatology of the Pitié-salpêtrière hospital. Patients undergoing treatment in Stomatology have particular areas at risk for the infections we are looking for: young patients, precarious situation, drug use, migrants ... The aim is to evaluate the conditions for a generalization of screening in the framework of the preoperative assessment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 8, 2017

Status Verified

March 1, 2017

Enrollment Period

5 months

First QC Date

March 20, 2017

Last Update Submit

December 7, 2017

Conditions

HIV InfectionsHepatitis BHepatitis C

Outcome Measures

Primary Outcomes (3)

  • Measure of HIV infection to assess the conditions for a generalization of screening in the Framework of the preoperative assessment

    Measure of HIV infection assessed by serology using ARCHITECT Ag/Ac VIH Combo kit

    12 months

  • Measure of viral hepatitis B infection to assess the conditions for a generalization of screening in the Framework of the preoperative assessment

    Measure of viral hepatitis B infection assessed by serology using ARCHITECT AgHBs qualitative II kit

    12 months

  • Measure of viral hepatitis C infection to assess the conditions for a generalization of screening in the Framework of the preoperative assessment

    Measure of viral hepatitis C infection assessed by serology using ARCHITECT Anti-HCV kit

    12 months

Interventions

Pilot studyDIAGNOSTIC_TEST

Pilot study of HIV and viral hepatitis B and C screening in surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pre-operative screening for HIV and viral hepatitis B and C: Pilot study in stomatology, Pitie salpetriere hospital. This study is part of a study to evaluate routine care. Screening for HIV and viral hepatitis B and C is a common clinical practice, and the populations on which it is practiced are both populations with risk behaviors and the general population. The evaluation of the strategy for scaling up HIV testing in healthcare facilities is broadly based, including a report by the National AIDS Council and the HAS and WHO recommendations that call for enlargement Of the existing screening offer.

You may qualify if:

  • men and women
  • \> 18 years
  • address for surgical intervention under general anesthesia in the Department of Stomatology of Pitié-Salpêtrière.
  • have given their oral consent during the consultation of anesthesia.

You may not qualify if:

  • refusal of screening
  • any patient already known to be HIV-positive / HBV / HCV.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yasmine Dudoit

Paris, 75013, France

Location

MeSH Terms

Conditions

HIV InfectionsHepatitis BHepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepadnaviridae InfectionsDNA Virus InfectionsHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesFlaviviridae Infections

Study Officials

  • Valérie Pourcher-martinez, MD, PhD

    Pitié-Salpêtrière Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2017

First Posted

March 24, 2017

Study Start

April 1, 2017

Primary Completion

September 1, 2017

Study Completion

December 1, 2017

Last Updated

December 8, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)