Back to resultsImplementation and Evaluation of an Electronic Alert to Encourage Targeted Screening for HIV Infection at Foch Hospital According to Socio-demographic Criteria (POP-UP)
Primary Purpose
HIV Testing
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
"POP-UP" electronic alert
Serology HIV
Sponsored by
About this trial
This is an interventional screening trial for HIV Testing focused on measuring medical practices, HIV, Electronic Alert
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Hopital Foch
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
period 1
Arm Description
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: Patient accept to participate: patient is include and receive HIV serology during their hospitalization. Not time to answer to the alert Patient already has a serology less than 3 months old Patient followed for a known HIV infection. Patient who refused the test 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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Study of the obstacles
Study of the obstacles encountered by clinicians in proposing screening tests induced by electronic alerting by questionnaire of satisfaction.
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 .
Newly HIV+
Number of hospitalized patients newly diagnosed HIV
Positivity rate
Number of newly diagnosed HIV vs the number of serologies performed
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03991767
Brief Title
Implementation and Evaluation of an Electronic Alert to Encourage Targeted Screening for HIV Infection at Foch Hospital According to Socio-demographic Criteria
Acronym
POP-UP
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 4, 2018 (Actual)
Primary Completion Date
October 4, 2019 (Actual)
Study Completion Date
October 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Testing
Keywords
medical practices, HIV, Electronic Alert
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
297 (Actual)
8. Arms, Groups, and Interventions
Arm Title
period 1
Arm Type
Experimental
Arm Description
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:
Patient accept to participate: patient is include and receive HIV serology during their hospitalization.
Not time to answer to the alert
Patient already has a serology less than 3 months old
Patient followed for a known HIV infection.
Patient who refused the test
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.
Intervention Type
Other
Intervention Name(s)
"POP-UP" electronic alert
Intervention Description
Implementation of the "POP-UP" electronic alert for all patients with eligibility criteria
Intervention Type
Diagnostic Test
Intervention Name(s)
Serology HIV
Intervention Description
Realization of HIV serology for included patients.
Primary Outcome Measure Information:
Title
Evaluation of HIV testing practices : screening proposal rate, patient acceptance rate and serological achievement rate
Description
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).
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Study of the obstacles
Description
Study of the obstacles encountered by clinicians in proposing screening tests induced by electronic alerting by questionnaire of satisfaction.
Time Frame
18 months
Title
Prospective data vs retrospective data : number of screening serologies performed
Description
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 .
Time Frame
18 months
Title
Newly HIV+
Description
Number of hospitalized patients newly diagnosed HIV
Time Frame
18 months
Title
Positivity rate
Description
Number of newly diagnosed HIV vs the number of serologies performed
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Zucman, MD
Organizational Affiliation
FOCH Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Implementation and Evaluation of an Electronic Alert to Encourage Targeted Screening for HIV Infection at Foch Hospital According to Socio-demographic Criteria
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