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

May 2, 2018 updated by: Dr Martin Duracinsky, University Paris 7 - Denis Diderot
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

70000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France
        • Recruiting
        • OFII Bordeaux
        • Contact:
          • Frédérique Thonon
      • Cergy, France
        • Recruiting
        • OFII Cergy
        • Contact:
          • Sabrina Lakhdari
      • Clermont-Ferrand, France
        • Terminated
        • OFII Clermont-Ferrand
      • Grenoble, France
        • Recruiting
        • OFII Grenoble
        • Contact:
          • Frédérique Thonon
      • Lille, France
        • Recruiting
        • OFII Lille
        • Contact:
          • Sabrina Lakhdari
      • Lyon, France
        • Recruiting
        • OFII Lyon
        • Contact:
          • Frédérique Thonon
      • Marseille, France
        • Recruiting
        • OFII Marseille
        • Contact:
          • Frédérique Thonon
      • Melun, France
        • Recruiting
        • OFII Melun
        • Contact:
          • Frédérique Thonon
      • Metz, France
        • Recruiting
        • OFII Metz
        • Contact:
          • Sabrina Lakhdari
      • Montpellier, France
        • Recruiting
        • OFII Montpellier
        • Contact:
          • Frédérique Thonon
      • Montrouge, France
        • Recruiting
        • OFII Montrouge
        • Contact:
          • Frédérique Thonon
      • Nantes, France
        • Recruiting
        • OFII Nantes
        • Contact:
          • Frédérique Thonon
      • Nice, France
        • Recruiting
        • OFII Nice
        • Contact:
          • Frédérique Thonon
      • Orléans, France
        • Recruiting
        • OFII Orléans
        • Contact:
          • Frédérique Thonon
      • Reims, France
        • Recruiting
        • OFII Reims
        • Contact:
          • Frédérique Thonon
      • Rennes, France
        • Recruiting
        • OFII Rennes
        • Contact:
          • Frédérique Thonon
      • Rouen, France
        • Recruiting
        • OFII Rouen
        • Contact:
          • Sabrina Lakhdari
      • Toulouse, France
        • Recruiting
        • OFII Toulouse
        • Contact:
          • Frédérique Thonon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Migrants undergoing the routine immigration medical visit

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of the number of HIV, HBV or HCV positive patients identified in both arms of the screening strategy.
Time Frame: 2 years
2 years
Number of tuberculosis patients identified through the modified TB screen questionnaire
Time Frame: 2 years
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Paris 7 - Denis Diderot

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2017

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

October 26, 2016

First Submitted That Met QC Criteria

November 7, 2016

First Posted (Estimate)

November 9, 2016

Study Record Updates

Last Update Posted (Actual)

May 3, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROunit-STRADA2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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