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

NCT ID: NCT02959684

Last Updated: 2018-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-14

Study Completion Date

2019-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Hepatitis C Hepatitis B Tuberculosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Migrants undergoing the routine medical visit
* Giving informed consent (oral consent)

Exclusion Criteria

* Asylum seekers
* Persons not understanding the questionnaire
* Persons aware of their HIV, HBV or HCV positive status
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Paris 7 - Denis Diderot

OTHER

Sponsor Role lead

Responsible Party

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Dr Martin Duracinsky

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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OFII Bordeaux

Bordeaux, , France

Site Status RECRUITING

OFII Cergy

Cergy, , France

Site Status RECRUITING

OFII Clermont-Ferrand

Clermont-Ferrand, , France

Site Status TERMINATED

OFII Grenoble

Grenoble, , France

Site Status RECRUITING

OFII Lille

Lille, , France

Site Status RECRUITING

OFII Lyon

Lyon, , France

Site Status RECRUITING

OFII Marseille

Marseille, , France

Site Status RECRUITING

OFII Melun

Melun, , France

Site Status RECRUITING

OFII Metz

Metz, , France

Site Status RECRUITING

OFII Montpellier

Montpellier, , France

Site Status RECRUITING

OFII Montrouge

Montrouge, , France

Site Status RECRUITING

OFII Nantes

Nantes, , France

Site Status RECRUITING

OFII Nice

Nice, , France

Site Status RECRUITING

OFII Orléans

Orléans, , France

Site Status RECRUITING

OFII Reims

Reims, , France

Site Status RECRUITING

OFII Rennes

Rennes, , France

Site Status RECRUITING

OFII Rouen

Rouen, , France

Site Status RECRUITING

OFII Toulouse

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Martin Duracinsky, MD, PhD

Role: CONTACT

+33140275543

Frédérique Thonon, PhD

Role: CONTACT

+33140275543

Facility Contacts

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Frédérique Thonon

Role: primary

Sabrina Lakhdari

Role: primary

Frédérique Thonon

Role: primary

Sabrina Lakhdari

Role: primary

Frédérique Thonon

Role: primary

Frédérique Thonon

Role: primary

Frédérique Thonon

Role: primary

Sabrina Lakhdari

Role: primary

Frédérique Thonon

Role: primary

Frédérique Thonon

Role: primary

Frédérique Thonon

Role: primary

Frédérique Thonon

Role: primary

Frédérique Thonon

Role: primary

Frédérique Thonon

Role: primary

Frédérique Thonon

Role: primary

Sabrina Lakhdari

Role: primary

Frédérique Thonon

Role: primary

References

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Duracinsky M, Yaya I, Yombo-Kokule L, Bessonneau P, Thonon F, Rousset-Torrente O, Roudot-Thoraval F, Lert F, Zucman D, Chassany O. Development of a risk prediction score for screening for HBV, HCV and HIV among migrants in France: results from a multicentre observational study (STRADA study). BMJ Open. 2024 Jun 5;14(6):e075315. doi: 10.1136/bmjopen-2023-075315.

Reference Type DERIVED
PMID: 38839381 (View on PubMed)

Meffre C, Le Strat Y, Delarocque-Astagneau E, Dubois F, Antona D, Lemasson JM, Warszawski J, Steinmetz J, Coste D, Meyer JF, Leiser S, Giordanella JP, Gueguen R, Desenclos JC. Prevalence of hepatitis B and hepatitis C virus infections in France in 2004: social factors are important predictors after adjusting for known risk factors. J Med Virol. 2010 Apr;82(4):546-55. doi: 10.1002/jmv.21734.

Reference Type BACKGROUND
PMID: 20166185 (View on PubMed)

Schneeberger Geisler S, Helbling P, Zellweger JP, Altpeter ES. Screening for tuberculosis in asylum seekers: comparison of chest radiography with an interview-based system. Int J Tuberc Lung Dis. 2010 Nov;14(11):1388-94.

Reference Type BACKGROUND
PMID: 20937177 (View on PubMed)

d'Almeida KW, Kierzek G, de Truchis P, Le Vu S, Pateron D, Renaud B, Semaille C, Bousquet V, Simon F, Guillemot D, Lert F, Cremieux AC; Emergency Department HIV-Screening Group. Modest public health impact of nontargeted human immunodeficiency virus screening in 29 emergency departments. Arch Intern Med. 2012 Jan 9;172(1):12-20. doi: 10.1001/archinternmed.2011.535. Epub 2011 Oct 24.

Reference Type BACKGROUND
PMID: 22025095 (View on PubMed)

d'Almeida KW, Pateron D, Kierzek G, Renaud B, Semaille C, de Truchis P, Simon F, Leblanc J, Lert F, Le Vu S, Cremieux AC. Understanding providers' offering and patients' acceptance of HIV screening in emergency departments: a multilevel analysis. ANRS 95008, Paris, France. PLoS One. 2013 Apr 29;8(4):e62686. doi: 10.1371/journal.pone.0062686. Print 2013.

Reference Type BACKGROUND
PMID: 23638133 (View on PubMed)

Bottero J, Boyd A, Gozlan J, Carrat F, Nau J, Pauti MD, Rougier H, Girard PM, Lacombe K. Simultaneous Human Immunodeficiency Virus-Hepatitis B-Hepatitis C Point-of-Care Tests Improve Outcomes in Linkage-to-Care: Results of a Randomized Control Trial in Persons Without Healthcare Coverage. Open Forum Infect Dis. 2015 Oct 26;2(4):ofv162. doi: 10.1093/ofid/ofv162. eCollection 2015 Dec.

Reference Type BACKGROUND
PMID: 26668814 (View on PubMed)

Haukoos JS, Lyons MS, Lindsell CJ, Hopkins E, Bender B, Rothman RE, Hsieh YH, Maclaren LA, Thrun MW, Sasson C, Byyny RL. Derivation and validation of the Denver Human Immunodeficiency Virus (HIV) risk score for targeted HIV screening. Am J Epidemiol. 2012 Apr 15;175(8):838-46. doi: 10.1093/aje/kwr389. Epub 2012 Mar 19.

Reference Type BACKGROUND
PMID: 22431561 (View on PubMed)

Other Identifiers

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PROunit-STRADA2016

Identifier Type: -

Identifier Source: org_study_id

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