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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.
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:
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the number of HIV, HBV or HCV positive patients identified in both arms of the screening strategy. | 2 years | |
| Number of tuberculosis patients identified through the modified TB screen questionnaire | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of HIV/HBV/HCV patients linked to care after being identified through TROD screen. | 2 years | |
| Predictive value of the questionnaire TROD screen. | 2 years | |
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Inclusion Criteria:
Exclusion Criteria:
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Migrants undergoing the routine immigration medical visit
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin Duracinsky, MD, PhD | Contact | +33140275543 | duracinsky.m@gmail.com | |
| Frédérique Thonon, PhD | Contact | +33140275543 | studymanager.proqol@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OFII Bordeaux | Recruiting | Bordeaux | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20166185 | Background | 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. | |
| 20937177 |
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| Predictive value of the questionnaire TB screen. |
| 2 years |
| Cost-effectiveness of the TROD screen questionnaire compared with a non-targeted screening, calculated in terms of cost per QALY (quality-adjusted life years) gained through this program | 2 years |
| OFII Cergy | Recruiting | Cergy | France |
|
| OFII Clermont-Ferrand | Terminated | Clermont-Ferrand | France |
| OFII Grenoble | Recruiting | Grenoble | France |
|
| OFII Lille | Recruiting | Lille | France |
|
| OFII Lyon | Recruiting | Lyon | France |
|
| OFII Marseille | Recruiting | Marseille | France |
|
| OFII Melun | Recruiting | Melun | France |
|
| OFII Metz | Recruiting | Metz | France |
|
| OFII Montpellier | Recruiting | Montpellier | France |
|
| OFII Montrouge | Recruiting | Montrouge | France |
|
| OFII Nantes | Recruiting | Nantes | France |
|
| OFII Nice | Recruiting | Nice | France |
|
| OFII Orléans | Recruiting | Orléans | France |
|
| OFII Reims | Recruiting | Reims | France |
|
| OFII Rennes | Recruiting | Rennes | France |
|
| OFII Rouen | Recruiting | Rouen | France |
|
| OFII Toulouse | Recruiting | Toulouse | France |
|
| Background |
| 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. |
| 22025095 | Background | 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. |
| 23638133 | Background | 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. |
| 26668814 | Background | 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. |
| 22431561 | Background | 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. |
| 38839381 | Derived | 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. |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D006509 | Hepatitis B |
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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