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

Study Overview
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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®).

Official Title
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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

Conditions
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HIV

Intervention / Treatment
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* Procedure: HIV testing by ELISA
* Procedure: HIV testing by rapid test


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HIV testing by ELISA<br>Patients enrolled in this arm will be tested by usual HIV Elisa | Procedure: HIV testing by ELISA<br>* HIV testing randomized between ELISA or rapid test<br>|
| Experimental: HIV testing by rapid test<br>Patients enrolled in this arm will be tested by the new rapid HIV test | Procedure: HIV testing by rapid test<br>* HIV testing randomized between ELISA or rapid test<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adult outpatients, Paris, France