POP-UP: Implementation and Evaluation of an Electronic Alert to Encourage Targeted Screening for HIV Infection at Foch Hospital According to Socio-demographic Criteria

Sponsor
Hopital Foch (Other)
Overall Status
Completed
CT.gov ID
NCT03991767
Collaborator
(none)
297
1
1
18
16.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: "POP-UP" electronic alert
  • Diagnostic Test: Serology HIV
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
297 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
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
Actual Study Start Date :
Apr 4, 2018
Actual Primary Completion Date :
Oct 4, 2019
Actual Study Completion Date :
Oct 4, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: period 1

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.

Other: "POP-UP" electronic alert
Implementation of the "POP-UP" electronic alert for all patients with eligibility criteria

Diagnostic Test: Serology HIV
Realization of HIV serology for included patients.

Outcome Measures

Primary Outcome Measures

  1. Evaluation of HIV testing practices : screening proposal rate, patient acceptance rate and serological achievement rate [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).

Secondary Outcome Measures

  1. Study of the obstacles [18 months]

    Study of the obstacles encountered by clinicians in proposing screening tests induced by electronic alerting by questionnaire of satisfaction.

  2. Prospective data vs retrospective data : number of screening serologies performed [18 months]

    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 .

  3. Newly HIV+ [18 months]

    Number of hospitalized patients newly diagnosed HIV

  4. Positivity rate [18 months]

    Number of newly diagnosed HIV vs the number of serologies performed

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hopital Foch Suresnes France 92150

Sponsors and Collaborators

  • Hopital Foch

Investigators

  • Study Director: David Zucman, MD, FOCH Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hopital Foch
ClinicalTrials.gov Identifier:
NCT03991767
Other Study ID Numbers:
  • 2016/51
First Posted:
Jun 19, 2019
Last Update Posted:
Jan 2, 2020
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hopital Foch
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 2, 2020