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

HIV Clinical Trial

— STRADA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02959684
• Other study ID #: PROunit-STRADA2016
• Status: Recruiting
• Start date: April 14, 2017
• Est. completion date: July 2019

Study information

• Verified date: May 2018
• Source: University Paris 7 - Denis Diderot
• Contact: Martin Duracinsky, MD, PhD
• Phone: +33140275543
• Email: duracinsky.m[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. This study aims for a global improvement of screening and care for migrants.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70000
• Est. completion date: July 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis C
• HIV
• Infection
• Tuberculosis

Locations

Country	Name	City	State
France	OFII Bordeaux	Bordeaux
France	OFII Cergy	Cergy
France	OFII Clermont-Ferrand	Clermont-Ferrand
France	OFII Grenoble	Grenoble
France	OFII Lille	Lille
France	OFII Lyon	Lyon
France	OFII Marseille	Marseille
France	OFII Melun	Melun
France	OFII Metz	Metz
France	OFII Montpellier	Montpellier
France	OFII Montrouge	Montrouge
France	OFII Nantes	Nantes
France	OFII Nice	Nice
France	OFII Orléans	Orléans
France	OFII Reims	Reims
France	OFII Rennes	Rennes
France	OFII Rouen	Rouen
France	OFII Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Paris 7 - Denis Diderot

Country where clinical trial is conducted

France, 

References & Publications (6)

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. — View Citation

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, Crémieux 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. — View Citation

d'Almeida KW, Pateron D, Kierzek G, Renaud B, Semaille C, de Truchis P, Simon F, Leblanc J, Lert F, Le Vu S, Crémieux 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the number of HIV, HBV or HCV positive patients identified in both arms of the screening strategy.		2 years
Primary	Number of tuberculosis patients identified through the modified TB screen questionnaire		2 years
Secondary	Number of HIV/HBV/HCV patients linked to care after being identified through TROD screen.		2 years
Secondary	Predictive value of the questionnaire TROD screen.		2 years
Secondary	Predictive value of the questionnaire TB screen.		2 years
Secondary	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

External Links

•   Guidelines for HBV rapid testing
•   Guidelines for HCV testing
•   Guidelines for HIV testing