NCT02959684

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Typical duration for all trials

Geographic Reach
1 country

18 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

April 14, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

May 3, 2018

Status Verified

May 1, 2018

Enrollment Period

1.2 years

First QC Date

October 26, 2016

Last Update Submit

May 2, 2018

Conditions

HIVHepatitis CHepatitis BTuberculosis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Migrants undergoing the routine immigration medical visit

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

OFII Bordeaux

Bordeaux, France

RECRUITING

OFII Cergy

Cergy, France

RECRUITING

OFII Clermont-Ferrand

Clermont-Ferrand, France

TERMINATED

OFII Grenoble

Grenoble, France

RECRUITING

OFII Lille

Lille, France

RECRUITING

OFII Lyon

Lyon, France

RECRUITING

OFII Marseille

Marseille, France

RECRUITING

OFII Melun

Melun, France

RECRUITING

OFII Metz

Metz, France

RECRUITING

OFII Montpellier

Montpellier, France

RECRUITING

OFII Montrouge

Montrouge, France

RECRUITING

OFII Nantes

Nantes, France

RECRUITING

OFII Nice

Nice, France

RECRUITING

OFII Orléans

Orléans, France

RECRUITING

OFII Reims

Reims, France

RECRUITING

OFII Rennes

Rennes, France

RECRUITING

OFII Rouen

Rouen, France

RECRUITING

OFII Toulouse

Toulouse, France

RECRUITING

Related Publications (7)

  • 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.

    PMID: 20166185BACKGROUND

  • 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.

    PMID: 20937177BACKGROUND

  • 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.

    PMID: 22025095BACKGROUND

  • 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.

    PMID: 23638133BACKGROUND

  • 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.

    PMID: 26668814BACKGROUND

  • 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.

    PMID: 22431561BACKGROUND

  • 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.

    PMID: 38839381DERIVED

MeSH Terms

Conditions

Hepatitis CHepatitis BTuberculosis

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesHepadnaviridae InfectionsDNA Virus InfectionsMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Central Study Contacts

Martin Duracinsky, MD, PhD

CONTACT

+33140275543duracinsky.m@gmail.com

Frédérique Thonon, PhD

CONTACT

+33140275543studymanager.proqol@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

October 26, 2016

First Posted

November 9, 2016

Study Start

April 14, 2017

Primary Completion

July 1, 2018

Study Completion

July 1, 2019

Last Updated

May 3, 2018

Record last verified: 2018-05

Locations

FR(18)