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

HIV Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02574208
• Other study ID #: DEPICAB
• Status: Completed
• Phase: N/A
• First received: September 30, 2015
• Last updated: November 21, 2016
• Start date: October 2015
• Est. completion date: January 2016

Study information

• Verified date: November 2016
• Source: Hopital Lariboisière
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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®).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• HIV

Intervention

Procedure:
• HIV testing by ELISA
HIV testing randomized between ELISA or rapid test
• HIV testing by rapid test
HIV testing randomized between ELISA or rapid test

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Lariboisière

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	feasibility of HIV testing	Number of HIV test results recovered within a month upon enrollment	one month after HIV testing proposal	No