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OpenTrials
Completed

NCT Number: NCT02574208

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

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.

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Key information

Conditions

HIV

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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®).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HIV testing by ELISA

Procedure

HIV testing randomized between ELISA or rapid test

HIV testing by rapid test

Procedure

HIV testing randomized between ELISA or rapid test

Primary outcomes

  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 outcomes

  1. feasibility of HIV testing

    Time frame: one month after HIV testing proposal

    Number of HIV test results recovered within a month upon enrollment

Sponsors and collaborators

Lead sponsor

Hopital Lariboisière

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Oct 12, 2015
Registry last updated
Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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