Strategic Screening for Infectious Diseases (Tuberculosis, HIV, HBV, HCV) Amongst Migrants in France

Last updated: May 2, 2018
Sponsor: University Paris 7 - Denis Diderot
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hiv

Liver Disorders

Hepatitis B

Treatment

N/A

Clinical Study ID

NCT02959684
PROunit-STRADA2016
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

To evaluate the efficacy of a new screening for infectious diseases: tuberculosis, HIV, HBV and HCV, based on risk factors questionnaires (TB screen for tuberculosis and TROD screen for HIV and hepatitis) amongst a population of legal migrants during their mandatory medical check-up. This study aims for a global improvement of screening and care for migrants.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Migrants undergoing the routine medical visit

  • Giving informed consent (oral consent)

Exclusion

Exclusion Criteria:

  • Asylum seekers

  • Persons not understanding the questionnaire

  • Persons aware of their HIV, HBV or HCV positive status

Study Design

Total Participants: 70000
Study Start date:
April 14, 2017
Estimated Completion Date:
July 31, 2019

Study Description

In France, the prevalence of infectious diseases such as tuberculosis, HIV/HBV/HCV is high amongst migrants originating from certain countries, hence the official guidelines recommending targeted testing. The rapid testing devices (TROD) give immediate results and reduce missed opportunities. However their use is not yet widespread and migrant populations remain insufficiently tested. Regarding the UNAIDS 90-90-90 goal, France is failing the screening part of the treatment cascade, while 90% of patients are treated and have undetectable viral load. Risk scores based on the best known risk factors for these infections (HIV/HBV/HCV) have previously been developed. They have helped build a pilot of a new unique questionnaire: TROD screen. An electronic survey, called TB screen, was designed to screen for tuberculosis amongst asylum seekers in Switzerland and validated. This survey enables to detect signs of active tuberculosis and may replace the use of pulmonary radiography, thus reducing exposure to X-rays.

It is a prospective multi-centric observational study validating screening tests for HIV/HBV/HCV in two phases:

  • Phase 1: a risk score will be validated, including a qualitative study analyzing its acceptability

  • Phase 2: its performance will be compared with that of a screening targeted based on the country of origin The phase 1 and phase 2 will include respectively 10.000 and 5000 participants.

For tuberculosis, the efficacy of the improved version of TB screen will be compared with a systematic radiography.

Participation to this study will be voluntary and independent from the delivery of a residence permit. Participants will be informed of it and will systematically receive information about prevention of those infectious diseases.

Connect with a study center

  • OFII Bordeaux

    Bordeaux,
    France

    Active - Recruiting

  • OFII Cergy

    Cergy,
    France

    Active - Recruiting

  • OFII Clermont-Ferrand

    Clermont-Ferrand,
    France

    Terminated

  • OFII Grenoble

    Grenoble,
    France

    Active - Recruiting

  • OFII Lille

    Lille,
    France

    Active - Recruiting

  • OFII Lyon

    Lyon,
    France

    Active - Recruiting

  • OFII Marseille

    Marseille,
    France

    Active - Recruiting

  • OFII Melun

    Melun,
    France

    Active - Recruiting

  • OFII Metz

    Metz,
    France

    Active - Recruiting

  • OFII Montpellier

    Montpellier,
    France

    Active - Recruiting

  • OFII Montrouge

    Montrouge,
    France

    Active - Recruiting

  • OFII Nantes

    Nantes,
    France

    Active - Recruiting

  • OFII Nice

    Nice,
    France

    Active - Recruiting

  • OFII Orléans

    Orléans,
    France

    Active - Recruiting

  • OFII Reims

    Reims,
    France

    Active - Recruiting

  • OFII Rennes

    Rennes,
    France

    Active - Recruiting

  • OFII Rouen

    Rouen,
    France

    Active - Recruiting

  • OFII Toulouse

    Toulouse,
    France

    Active - Recruiting

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