NCT02574208

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable hiv

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 12, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

2 months

First QC Date

September 30, 2015

Last Update Submit

November 21, 2016

Conditions

HIV

Keywords

Adult outpatientsParis, France

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • feasibility of HIV testing

    one month after HIV testing proposal

Study Arms (2)

"HIV testing by ELISA"

ACTIVE COMPARATOR

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

Procedure: HIV testing by ELISA

"HIV testing by rapid test"

EXPERIMENTAL

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

Procedure: HIV testing by rapid test

Interventions

HIV testing by ELISAPROCEDURE

HIV testing randomized between ELISA or rapid test

"HIV testing by ELISA"
HIV testing by rapid testPROCEDURE

HIV testing randomized between ELISA or rapid test

"HIV testing by rapid test"

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients consulting their general practitioner in Paris, France

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. Epub 2009 May 31.

    PMID: 19487214BACKGROUND

Study Officials

  • Pierre O Sellier, M.D., Ph.D.

    Hopital Lariboisiere

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 12, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

November 22, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share