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Trial record 12 of 87764 for:    testing

Acceptability/Feasibility of HIV Testing by ELISA or Rapid Test to Adult Patients in Paris, France

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ClinicalTrials.gov Identifier: NCT02574208
Recruitment Status : Completed
First Posted : October 12, 2015
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
Célia Lloret-Linares, MD PhD, Hopital Lariboisière

Brief Summary:
CDC recommends universal HIV testing in all adults, at least once during life, to reduce the pool of infected patients unaware of their status. Routine universal HIV testing can use "classical" ELISA tests from serum, or rapid tests, ideally from finger-stick whole blood (FSB), which have shown close predictive values from classical tests. The investigators will compare the acceptability and feasibility of the two methods.

Condition or disease Intervention/treatment Phase
HIV Procedure: HIV testing by ELISA Procedure: HIV testing by rapid test Not Applicable

Detailed Description:
The multi-center prospective randomized study will compare the acceptability and feasibility of routine universal HIV testing to adult patients consulting their general practitioner in Paris, France, using either the " classical " ELISA tests from serum or rapid tests from FSB (Insti®).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Acceptability and Feasibility of HIV Testing by ELISA or Rapid Test to Adult Patients Consulting Their General Practitioner in Paris, France: A Multi-center Prospective Randomized Study
Study Start Date : October 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: "HIV testing by ELISA"
Patients enrolled in this arm will be tested by usual HIV Elisa
Procedure: HIV testing by ELISA
HIV testing randomized between ELISA or rapid test

Experimental: "HIV testing by rapid test"
Patients enrolled in this arm will be tested by the new rapid HIV test
Procedure: HIV testing by rapid test
HIV testing randomized between ELISA or rapid test




Primary Outcome Measures :
  1. acceptability of HIV testing [ Time Frame: immediately after HIV testing proposal ]
    answer by "yes" or "no" to the single following question: "do you agree to perform an HIV test?"


Secondary Outcome Measures :
  1. feasibility of HIV testing [ Time Frame: one month after HIV testing proposal ]
    Number of HIV test results recovered within a month upon enrollment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adult patients consulting their general practitioner in Paris, France

Exclusion Criteria:

  • patients previously known as HIV-positive,
  • patients who declare having been tested HIV-negative less than three months ago,
  • patients who can not give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02574208


Sponsors and Collaborators
Hopital Lariboisière
Investigators
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Principal Investigator: Pierre O Sellier, M.D., Ph.D. Hopital Lariboisiere

Publications:
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Responsible Party: Célia Lloret-Linares, MD PhD, MD PhD, Hopital Lariboisière
ClinicalTrials.gov Identifier: NCT02574208     History of Changes
Other Study ID Numbers: DEPICAB
First Posted: October 12, 2015    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Célia Lloret-Linares, MD PhD, Hopital Lariboisière:
Adult outpatients
Paris, France