An observational study in HIV, Hepatitis C and Hepatitis B, sponsored by University Paris 7 - Denis Diderot. Status unknown at 18 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-03.
Sponsored by University Paris 7 - Denis Diderot · Observational
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.
Migrants undergoing the routine immigration medical visit
Exclusion Criteria:
Comparison of the number of HIV, HBV or HCV positive patients identified in both arms of the screening strategy.
Time frame: 2 years
Number of tuberculosis patients identified through the modified TB screen questionnaire
Time frame: 2 years
Number of HIV/HBV/HCV patients linked to care after being identified through TROD screen.
Time frame: 2 years
Predictive value of the questionnaire TROD screen.
Time frame: 2 years
Predictive value of the questionnaire TB screen.
Time frame: 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
Time frame: 2 years
Plan to share: Undecided
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University Paris 7 - Denis Diderot