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Trial record 85 of 362 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

Pilot Study of HIV and Hepatitis B and C Screening in Surgery (OPDEP)

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified March 2017 by Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
Sponsor:
Information provided by (Responsible Party):
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
ClinicalTrials.gov Identifier:
NCT03088995
First received: March 20, 2017
Last updated: March 23, 2017
Last verified: March 2017
  Purpose

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.


Condition Intervention
HIV Infections Hepatitis B Hepatitis C Diagnostic Test: Pilot study

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pre-operative Screening for HIV and Viral Hepatitis B and C: Pilot Study in Stomatology

Resource links provided by NLM:


Further study details as provided by Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida:

Primary Outcome Measures:
  • Measure of HIV infection to assess the conditions for a generalization of screening in the Framework of the preoperative assessment [ Time Frame: 12 months ]
    Measure of HIV infection assessed by serology using ARCHITECT Ag/Ac VIH Combo kit

  • Measure of viral hepatitis B infection to assess the conditions for a generalization of screening in the Framework of the preoperative assessment [ Time Frame: 12 months ]
    Measure of viral hepatitis B infection assessed by serology using ARCHITECT AgHBs qualitative II kit

  • Measure of viral hepatitis C infection to assess the conditions for a generalization of screening in the Framework of the preoperative assessment [ Time Frame: 12 months ]
    Measure of viral hepatitis C infection assessed by serology using ARCHITECT Anti-HCV kit


Estimated Enrollment: 1000
Anticipated Study Start Date: April 1, 2017
Estimated Study Completion Date: December 1, 2017
Estimated Primary Completion Date: September 1, 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Diagnostic Test: Pilot study
    Pilot study of HIV and viral hepatitis B and C screening in surgery
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • refusal of screening
  • any patient already known to be HIV-positive / HBV / HCV.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03088995

Contacts
Contact: Yasmine Dudoit 330142164181 yasmine.dudoit@aphp.fr

Sponsors and Collaborators
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
Investigators
Principal Investigator: Valérie Pourcher-martinez, MD, PhD Pitié-Salpêtrière Hospital
  More Information

Responsible Party: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
ClinicalTrials.gov Identifier: NCT03088995     History of Changes
Other Study ID Numbers: CREPATS 006
Study First Received: March 20, 2017
Last Updated: March 23, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis B
Hepatitis, Viral, Human
HIV Infections
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on June 28, 2017