NCT03991767

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
297

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 4, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 19, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2019

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

1.5 years

First QC Date

June 11, 2019

Last Update Submit

December 30, 2019

Conditions

Keywords

medical practicesHIVElectronic Alert

Outcome Measures

Primary Outcomes (1)

  • 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).

    18 months

Secondary Outcomes (4)

  • Study of the obstacles

    18 months

  • Prospective data vs retrospective data : number of screening serologies performed

    18 months

  • Newly HIV+

    18 months

  • Positivity rate

    18 months

Study Arms (1)

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.

Other: "POP-UP" electronic alertDiagnostic Test: Serology HIV

Interventions

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

period 1
Serology HIVDIAGNOSTIC_TEST

Realization of HIV serology for included patients.

period 1

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

MeSH Terms

Interventions

AIDS Serodiagnosis

Intervention Hierarchy (Ancestors)

Serologic TestsImmunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHIV TestingMicrobiological TechniquesInvestigative TechniquesImmunologic Techniques

Study Officials

  • David Zucman, MD

    FOCH Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2019

First Posted

June 19, 2019

Study Start

April 4, 2018

Primary Completion

October 4, 2019

Study Completion

October 4, 2019

Last Updated

January 2, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations