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

• Conditions: HIV; Hepatitis B; Hepatitis C; Tuberculosis

• Registration Number: NCT02959684
• Lead Sponsor: University Paris 7 - Denis Diderot

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-10-26
• Study First Submitted QC: 2016-11-07
• Study First Posted: 2016-11-09
• Study Start: 2017-04-14
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-03
• Primary Completion: 2018-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Predictive value of the questionnaire TROD screen.	2 years
Predictive value of the questionnaire TB screen.	2 years
Number of HIV/HBV/HCV patients linked to care after being identified through TROD screen.	2 years

Trial Locations

Locations (18)

OFII Bordeaux; 🇫🇷 Bordeaux, France

OFII Cergy; 🇫🇷 Cergy, France

OFII Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

OFII Lille; 🇫🇷 Lille, France

OFII Montpellier; 🇫🇷 Montpellier, France

OFII Nantes; 🇫🇷 Nantes, France

OFII Montrouge; 🇫🇷 Montrouge, France

OFII Reims; 🇫🇷 Reims, France

OFII Marseille; 🇫🇷 Marseille, France

OFII Melun; 🇫🇷 Melun, France

OFII Orléans; 🇫🇷 Orléans, France

OFII Grenoble; 🇫🇷 Grenoble, France

OFII Lyon; 🇫🇷 Lyon, France

OFII Metz; 🇫🇷 Metz, France

OFII Nice; 🇫🇷 Nice, France

OFII Rennes; 🇫🇷 Rennes, France

OFII Rouen; 🇫🇷 Rouen, France

OFII Toulouse; 🇫🇷 Toulouse, France