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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03991767
Other study ID # 2016/51
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 4, 2018
Est. completion date October 4, 2019

Study information

Verified date December 2019
Source Hopital Foch
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 297
Est. completion date October 4, 2019
Est. primary completion date October 4, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France Hopital Foch Suresnes

Sponsors (1)

Lead Sponsor Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Study of the obstacles Study of the obstacles encountered by clinicians in proposing screening tests induced by electronic alerting by questionnaire of satisfaction. 18 months
Secondary 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 . 18 months
Secondary Newly HIV+ Number of hospitalized patients newly diagnosed HIV 18 months
Secondary Positivity rate Number of newly diagnosed HIV vs the number of serologies performed 18 months
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