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

NCT ID: NCT02574208

Last Updated: 2016-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-01-31

Brief Summary

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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

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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®).

Conditions

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HIV

Keywords

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Adult outpatients Paris, France

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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"HIV testing by ELISA"

Patients enrolled in this arm will be tested by usual HIV Elisa

Group Type ACTIVE_COMPARATOR

HIV testing by ELISA

Intervention Type PROCEDURE

HIV testing randomized between ELISA or rapid test

"HIV testing by rapid test"

Patients enrolled in this arm will be tested by the new rapid HIV test

Group Type EXPERIMENTAL

HIV testing by rapid test

Intervention Type PROCEDURE

HIV testing randomized between ELISA or rapid test

Interventions

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HIV testing by ELISA

HIV testing randomized between ELISA or rapid test

Intervention Type PROCEDURE

HIV testing by rapid test

HIV testing randomized between ELISA or rapid test

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hopital Lariboisière

OTHER

Sponsor Role lead

Responsible Party

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Célia Lloret-Linares, MD PhD

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pierre O Sellier, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Hopital Lariboisiere

References

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Prost A, Griffiths CJ, Anderson J, Wight D, Hart GJ. Feasibility and acceptability of offering rapid HIV tests to patients registering with primary care in London (UK): a pilot study. Sex Transm Infect. 2009 Sep;85(5):326-9. doi: 10.1136/sti.2008.033233. Epub 2009 May 31.

Reference Type BACKGROUND
PMID: 19487214 (View on PubMed)

Other Identifiers

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DEPICAB

Identifier Type: -

Identifier Source: org_study_id