HIV TestingPOP-UPNCT03991767
Implementation and Evaluation of an Electronic Alert to Encourage Targeted Screening for HIV Infection at Foch Hospital According to Socio-demographic Criteria
A study testing "POP-UP" electronic alert and Serology HIV in people with HIV Testing, run by Hopital Foch at 1 site in France.
Trial summary
In 2013 in France, 29,000 people are reported to be unaware of their HIV status. HIV testing is a priority in France where one third of all diagnoses remain late despite 5 million annual tests. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Testing
- What is being tested?
- "POP-UP" electronic alert and Serology HIV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 297 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2018to 4 Oct 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient hospitalized at Foch Hospital over 18 years of age.
- Patient with AME or CMU and/or CMUc, or patient born in one of the following countries/regions: Sub-Saharan Africa, Haiti, South America, Asia, Eastern Europe, Guadeloupe, Martinique and Guyana
Who cannot join
- Patient whose vital prognosis at the time of admission does not allow him/her to indicate his/her non-opposition to an HIV test.
- Patient being followed for a known HIV infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation and Evaluation of an Electronic Alert to Encourage Targeted Screening for HIV Infection at Foch Hospital According to Socio-demographic Criteria: Pilot Study
In 2013 in France, 29,000 people are reported to be unaware of their HIV status. HIV testing is a priority in France where one third of all diagnoses remain late despite 5 million annual tests. It is recommended to offer at least one HIV test to the general population, over the life course, when seeking care and more frequently to populations at risk. Several international and national articles have shown that emergency screening is feasible and well accepted. But also that during systematic screening few infections were discovered, and the majority of newly diagnosed people belonged to the most exposed groups.
Our hypothesis is that an electronic alert would identify people who are unaware of their HIV status. This alert would be based on two data: social data (French health coverage) and the country of birth. This alert is only relevant in high-prevalence regions, as is the case in the Ile de France region.
- Conditions
- HIV Testing
- Being tested
- "POP-UP" electronic alert, Serology HIV
- Keywords
- medical practices, HIV, Electronic Alert
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"POP-UP" electronic alertOther
Implementation of the "POP-UP" electronic alert for all patients with eligibility criteria
Serology HIVDiagnostic test
Realization of HIV serology for included patients.
| Study group | Role | What they receive |
|---|---|---|
| period 1 | Experimental | Period 1: Retrospective period:
Collection of data from the 12 months preceding the start of the research of hospitalized patients:
* number of hospitalizations,
* number of HIV serologies performed,
* number of patients with socio-demographic criteria justifying HIV screening.
Start of research: Implementation of the "POP-UP" electronic alert
Period 2: Prospective period: 18 months POP-UP opens for patient who meet the eligibility criteria.
Six possibility to answer:
1. Patient accept to participate: patient is include and receive HIV serology during their hospitalization.
2. Not time to answer to the alert
3. Patient already has a serology less than 3 months old
4. Patient followed for a known HIV infection.
5. Patient who refused the test
6. Clinical condition of the patient not allowing his no opposition Only choice 1 include patient The response close the electronic alert, but it re-opens when the medical file is re-consulted (2/ and 6/) or new hospitalization. Receives: Other: "POP-UP" electronic alert; Diagnostic Test: Serology HIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of HIV testing practices : screening proposal rate, patient acceptance rate and serological achievement rate
Evaluation of the practice of hospital doctors at Foch Hospital following the implementation of "POP-UP" electronic alert to encourage targeted screening for HIV infection according to specific socio-demographic criteria :
- Screening proposal rate (= number of proposition compared to number of eligible patients).
- Patient acceptance rate (= number of eligible patients acceptances compared to number of screening proposals).
- Serological achievement rate (= number of serologies compared to number of eligible patients).
Measured: 18 months
Secondary outcomes (4)
Study of the obstacles
Study of the obstacles encountered by clinicians in proposing screening tests induced by electronic alerting by questionnaire of satisfaction.
Measured: 18 months
Prospective data vs retrospective data : number of screening serologies performed
Comparison of the number of screening serologies performed in eligible inpatients by the POP-UP" electronic alert versus the retrospective data of the 12 months preceding the implementation of the alert .
Measured: 18 months
Newly HIV+
Number of hospitalized patients newly diagnosed HIV
Measured: 18 months
Positivity rate
Number of newly diagnosed HIV vs the number of serologies performed
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start4 Apr 2018
- Primary completion4 Oct 2019
- Study completion4 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV TestingStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Zucman, MD, Study director, FOCH Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991767
- Sponsor's protocol ID
- 2016/51
- Acronym
- POP-UP
- Status last verified
- Dec 2019
- First submitted
- 11 Jun 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of an Electronic Alert to Encourage Targeted Screening for HIV Infection at Foch Hospital According to Socio-demographic Criteria: Pilot Study
- ClinicalTrials.gov ID
- NCT03991767
- Acronym / sponsor ID
- POP-UP / 2016/51
- Conditions
- HIV Testing
- Keywords
- medical practices, HIV, Electronic Alert
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 4 Oct 2019 (actual)
- Study completion
- 4 Oct 2019 (actual)
- First posted
- 19 Jun 2019 (actual)
- 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.
In 2013 in France, 29,000 people are reported to be unaware of their HIV status. HIV testing is a priority in France where one third of all diagnoses remain late despite 5 million annual tests. It is recommended to offer at least one HIV test to the general population, over the life course, when seeking care and more frequently to populations at risk. Several international and national articles have shown that emergency screening is feasible and well accepted. But also that during systematic screening few infections were discovered, and the majority of newly diagnosed people belonged to the most exposed groups.
Our hypothesis is that an electronic alert would identify people who are unaware of their HIV status. This alert would be based on two data: social data (French health coverage) and the country of birth. This alert is only relevant in high-prevalence regions, as is the case in the Ile de France region.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| period 1 | Experimental | Other: "POP-UP" electronic alert, Diagnostic Test: Serology HIVPeriod 1: Retrospective period: Collection of data from the 12 months preceding the start of the research of hospitalized patients: * number of hospitalizations, * number of HIV serologies performed, * number of patients with socio-demographic criteria justifying HIV screening. Start of research: Implementation of the "POP-UP" electronic alert Period 2: Prospective period: 18 months POP-UP opens for patient who meet the eligibility criteria. Six possibility to answer: 1. Patient accept to participate: patient is include and receive HIV serology during their hospitalization. 2. Not time to answer to the alert 3. Patient already has a serology less than 3 months old 4. Patient followed for a known HIV infection. 5. Patient who refused the test 6. Clinical condition of the patient not allowing his no opposition Only choice 1 include patient The response close the electronic alert, but it re-opens when the medical file is re-consulted (2/ and 6/) or new hospitalization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient hospitalized at Foch Hospital over 18 years of age.
- Patient with AME or CMU and/or CMUc, or patient born in one of the following countries/regions: Sub-Saharan Africa, Haiti, South America, Asia, Eastern Europe, Guadeloupe, Martinique and Guyana
Key exclusion criteria (2 listed)
- Patient whose vital prognosis at the time of admission does not allow him/her to indicate his/her non-opposition to an HIV test.
- Patient being followed for a known HIV infection.
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 |
|---|---|---|
| "POP-UP" electronic alertImplementation of the "POP-UP" electronic alert for all patients with eligibility criteria | Other | period 1 |
| Serology HIVRealization of HIV serology for included patients. | Diagnostic test | period 1 |
Primary outcome
Evaluation of HIV testing practices : screening proposal rate, patient acceptance rate and serological achievement rate
Time frame: 18 months
Evaluation of the practice of hospital doctors at Foch Hospital following the implementation of "POP-UP" electronic alert to encourage targeted screening for HIV infection according to specific socio-demographic criteria : * Screening proposal rate (= number of proposition compared to number of eligible patients). * Patient acceptance rate (= number of eligible patients acceptances compared to number of screening proposals). * Serological achievement rate (= number of serologies compared to number of eligible patients).
4 secondary outcomes
Study of the obstacles
Time frame: 18 months
Prospective data vs retrospective data : number of screening serologies performed
Time frame: 18 months
Newly HIV+
Time frame: 18 months
Positivity rate
Time frame: 18 months
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 2 Jan 2020.
- 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.
David Zucman, MD study director
FOCH Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "POP-UP" electronic alert and Serology HIV in people with HIV Testing, run by Hopital Foch at 1 site in France.
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 2 inclusion and 2 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 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Evaluation of HIV testing practices : screening proposal rate, patient acceptance rate and serological achievement rate (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2020.