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AzTrials

HIVSTRADANCT02959684

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

An observational study of HIV and Hepatitis C, run by University Paris 7 - Denis Diderot at 18 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV, Hepatitis C, Hepatitis B
How many people
70,000 participants
Where
18 sitesFrance
Study dates
14 Apr 2017to Jul 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Migrants undergoing the routine immigration medical visit

Who may be able to join

  • Migrants undergoing the routine medical visit
  • Giving informed consent (oral consent)

Who cannot join

  • Asylum seekers
  • Persons not understanding the questionnaire
  • Persons aware of their HIV, HBV or HCV positive status

Trial locations and contacts

18 sites in 1 country.

Martin Duracinsky, MD, PhD contact

+33140275543

duracinsky.m@gmail.com

Frédérique Thonon, PhD contact

+33140275543

studymanager.proqol@gmail.com

18 sites in 1 country

France18 sites, 17 recruiting

  • OFII Bordeaux

    Bordeaux

    Frédérique Thonon

    Recruiting

  • OFII Cergy

    Cergy

    Sabrina Lakhdari

    Recruiting

  • OFII Clermont-Ferrand

    Clermont-Ferrand

    Terminated

  • OFII Grenoble

    Grenoble

    Frédérique Thonon

    Recruiting

  • OFII Lille

    Lille

    Sabrina Lakhdari

    Recruiting

  • OFII Lyon

    Lyon

    Frédérique Thonon

    Recruiting

  • OFII Marseille

    Marseille

    Frédérique Thonon

    Recruiting

  • OFII Melun

    Melun

    Frédérique Thonon

    Recruiting

  • OFII Metz

    Metz

    Sabrina Lakhdari

    Recruiting

  • OFII Montpellier

    Montpellier

    Frédérique Thonon

    Recruiting

  • OFII Montrouge

    Montrouge

    Frédérique Thonon

    Recruiting

  • OFII Nantes

    Nantes

    Frédérique Thonon

    Recruiting

  • OFII Nice

    Nice

    Frédérique Thonon

    Recruiting

  • OFII Orléans

    Orléans

    Frédérique Thonon

    Recruiting

  • OFII Reims

    Reims

    Frédérique Thonon

    Recruiting

  • OFII Rennes

    Rennes

    Frédérique Thonon

    Recruiting

  • OFII Rouen

    Rouen

    Sabrina Lakhdari

    Recruiting

  • OFII Toulouse

    Toulouse

    Frédérique Thonon

    Recruiting

Other trials in France

About this study

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.

Read the 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.

Medical subject headings
Hepatitis C, Hepatitis B, Tuberculosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of the number of HIV, HBV or HCV positive patients identified in both arms of the screening strategy.

    Measured: 2 years

  2. Number of tuberculosis patients identified through the modified TB screen questionnaire

    Measured: 2 years

Secondary outcomes (4)

  1. Number of HIV/HBV/HCV patients linked to care after being identified through TROD screen.

    Measured: 2 years

  2. Predictive value of the questionnaire TROD screen.

    Measured: 2 years

  3. Predictive value of the questionnaire TB screen.

    Measured: 2 years

  4. 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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2016 (estimated)
  2. Study start14 Apr 2017
  3. Primary completionJul 2018 (estimated)
  4. Study completionJul 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
70,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02959684
Sponsor's protocol ID
PROunit-STRADA2016
Acronym
STRADA
Status last verified
May 2018
First submitted
26 Oct 2016
Last updated
3 May 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 20166185

  • 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.

    PubMed 20937177

  • 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.

    PubMed 22025095

  • 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.

    PubMed 23638133

  • 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.

    PubMed 26668814

  • 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.

    PubMed 22431561

  • 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.

    PubMed 38839381

Questions about this trial

What is this clinical trial studying?

An observational study of HIV and Hepatitis C, run by University Paris 7 - Denis Diderot at 18 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Martin Duracinsky, MD, PhD (+33140275543, duracinsky.m@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of the number of HIV, HBV or HCV positive patients identified in both arms of the screening strategy. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02959684, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.

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STRADA Clinical Trial NCT02959684 | AzTrials