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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02574208

Enrollment

260

Registered

2015-10-12

Start date

2015-10-31

Completion date

2016-01-31

Last updated

2016-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

Adult outpatients, Paris, France

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®).

Interventions

PROCEDUREHIV testing by rapid test

HIV testing randomized between ELISA or rapid test

PROCEDUREHIV testing by ELISA

HIV testing randomized between ELISA or rapid test

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026