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

November 21, 2016 updated by: Célia Lloret-Linares, MD PhD, Hopital Lariboisière

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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®).

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Not Applicable

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

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?"
immediately after HIV testing proposal

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
feasibility of HIV testing
Time Frame: one month after HIV testing proposal
Number of HIV test results recovered within a month upon enrollment
one month after HIV testing proposal

Collaborators and Investigators

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

Sponsor

Hopital Lariboisière

Investigators

  • Principal Investigator: Pierre O Sellier, M.D., Ph.D., Hôpital Lariboisière

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

September 30, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimate)

October 12, 2015

Study Record Updates

Last Update Posted (Estimate)

November 22, 2016

Last Update Submitted That Met QC Criteria

November 21, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DEPICAB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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