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

Not Applicable

Completed

• Conditions: HIV
• Interventions: Procedure: HIV testing by ELISA; Procedure: HIV testing by rapid test

• Registration Number: NCT02574208
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-09-30
• Study Start: 2015-10
• Study First Submitted QC: 2015-10-09
• Study First Posted: 2015-10-12
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-21
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"HIV testing by ELISA"	HIV testing by ELISA	Patients enrolled in this arm will be tested by usual HIV Elisa
"HIV testing by rapid test"	HIV testing by rapid test	Patients enrolled in this arm will be tested by the new rapid HIV test

Primary Outcome Measures

Name	Time	Method
acceptability of HIV testing	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

Name	Time	Method
feasibility of HIV testing	one month after HIV testing proposal	Number of HIV test results recovered within a month upon enrollment