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

December 30, 2019 updated by: Hopital Foch

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

297

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Suresnes, France, 92150
        • Hopital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:

  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.
Implementation of the "POP-UP" electronic alert for all patients with eligibility criteria
Realization of HIV serology for included patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study of the obstacles
Time Frame: 18 months
Study of the obstacles encountered by clinicians in proposing screening tests induced by electronic alerting by questionnaire of satisfaction.
18 months
Prospective data vs retrospective data : number of screening serologies performed
Time Frame: 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 .
18 months
Newly HIV+
Time Frame: 18 months
Number of hospitalized patients newly diagnosed HIV
18 months
Positivity rate
Time Frame: 18 months
Number of newly diagnosed HIV vs the number of serologies performed
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: David Zucman, MD, Foch Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2018

Primary Completion (Actual)

October 4, 2019

Study Completion (Actual)

October 4, 2019

Study Registration Dates

First Submitted

June 11, 2019

First Submitted That Met QC Criteria

June 18, 2019

First Posted (Actual)

June 19, 2019

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 30, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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