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

Study Overview
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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.

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

Conditions
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HIV, Hepatitis C, Hepatitis B, Tuberculosis

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |