HIVNCT02574208
Acceptability/Feasibility of HIV Testing by ELISA or Rapid Test to Adult Patients in Paris, France
A study testing HIV testing by ELISA and HIV testing by rapid test in people with HIV, run by Hopital Lariboisière.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- HIV testing by ELISA and HIV testing by rapid test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult patients consulting their general practitioner in Paris, France
Who cannot join
- 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
About this study
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
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.
Read the 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®).
- Conditions
- HIV
- Being tested
- HIV testing by ELISA, HIV testing by rapid test
- Keywords
- Adult outpatients, Paris, France
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV testing by ELISAProcedure or surgery
HIV testing randomized between ELISA or rapid test
HIV testing by rapid testProcedure or surgery
HIV testing randomized between ELISA or rapid test
| Study group | Role | What they receive |
|---|---|---|
| "HIV testing by ELISA" | Active comparator | Patients enrolled in this arm will be tested by usual HIV Elisa Receives: 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 Receives: Procedure: HIV testing by rapid test |
What is being measured
The primary outcome is the main question the study is designed to answer.
acceptability of HIV testing
answer by "yes" or "no" to the single following question: "do you agree to perform an HIV test?"
Measured: immediately after HIV testing proposal
Secondary outcomes (1)
feasibility of HIV testing
Number of HIV test results recovered within a month upon enrollment
Measured: one month after HIV testing proposal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Lariboisière
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Célia Lloret-Linares, MD PhD, Hopital Lariboisière
- Investigators
- Pierre O Sellier, M.D., Ph.D., Principal investigator, Hopital Lariboisiere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574208
- Sponsor's protocol ID
- DEPICAB
- Status last verified
- Nov 2016
- First submitted
- 30 Sep 2015
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 19487214
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02574208
- Acronym / sponsor ID
- DEPICAB
- Conditions
- HIV
- Keywords
- Adult outpatients, Paris, France
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Hopital LariboisièreUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 12 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "HIV testing by ELISA" | Active comparator | Procedure: HIV testing by ELISAPatients enrolled in this arm will be tested by usual HIV Elisa |
| "HIV testing by rapid test" | Experimental | Procedure: HIV testing by rapid testPatients enrolled in this arm will be tested by the new rapid HIV test |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients consulting their general practitioner in Paris, France
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV testing by ELISAHIV testing randomized between ELISA or rapid test | Procedure or surgery | "HIV testing by ELISA" |
| HIV testing by rapid testHIV testing randomized between ELISA or rapid test | Procedure or surgery | "HIV testing by rapid test" |
Primary outcome
acceptability of HIV testing
Time frame: immediately after HIV testing proposal
answer by "yes" or "no" to the single following question: "do you agree to perform an HIV test?"
1 secondary outcome
feasibility of HIV testing
Time frame: one month after HIV testing proposal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Background: PubMed 19487214Prost 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre O Sellier, M.D., Ph.D. principal investigator
Hopital Lariboisiere
Questions about this trial
What is this clinical trial studying?
A study testing HIV testing by ELISA and HIV testing by rapid test in people with HIV, run by Hopital Lariboisière.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acceptability of HIV testing (time frame: immediately after HIV testing proposal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02574208, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2016.