Screening Strategy for Asymptomatic Sexually Transmitted Infections (STI) in a Cohort of HIV Outpatients Men Who Have Sex With Men (DRIVER)
NCT ID: NCT02413632
Last Updated: 2018-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
495 participants
INTERVENTIONAL
2015-04-30
2017-04-14
Brief Summary
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Detailed Description
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create and validate a risk score for STIs (DRIVER score) in a population of HIV-positive men who have sex with men (MSM).
determine the prevalence of asymptomatic STIs in a population of HIV-positive MSM
Secondary objectives are :
compare 2 screening strategies regarding STIs in HIV-positive MSM (systematic screening vs screening according to self-declared risk factors) conduct a cost-efficiency analysis of both strategies evaluate patients' knowledge of STIs develop a DRIVER digital tool that will be made available to patients on websites, mobile apps…
Position of the problem :
Over the past 15 years, a resurgence of symptomatic STIs has been observed at both at the global and at the local (French) level. This has been true for gonorrhea since 2008, for syphilis since 2000 and for lymphogranuloma venereum since 2003. The epidemiology of asymptomatic STIs has not been studied as thoroughly but asymptomatic carriage of Neisseria gonorrhoeae and Chlamydia trachomatis as well as latent syphilis account for at least half of cases declared in the past few years. The population of HIV-positive MSM is the demographic category with the highest rates of STIs. In addition, risky sexual attitudes are on the rise in the MSM population in general (in 2010, the French RESIST Network reported that condom use during anal penetrations between males had dropped from 49% in 2008 to 37% in 2010).
Screening practices are currently center- and healthcare-provider dependant. Study will allow a comparison of screening practices thanks to a score that will be built, validated and made available to clinicians and patients.
Type of study : Prospective, non randomized, multicentric and cross-sectional Timeline : Study duration : 18 months Beginning of study : March 2015
Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
SCREENING
NONE
Study Groups
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First period
creation of a STIs score risk
pharyngeal swab+urinary collection+blood specimens+rectal Chlamydia trachomatis l Neisseria gonorrhoeae (CT/GC) testing
creation of a STIs score risk
4 questionnaires 3 screening test ( syphilis, chlamydia, gonorrhea)
Second period
validation of a STIs score risk
pharyngeal swab+urinary collection+blood specimens+rectal Chlamydia trachomatis l Neisseria gonorrhoeae (CT/GC) testing
validation of a STIs score risk
DRIVER questionnaire (DRIVER STI score risk) 3 screening test ( syphilis, chlamydia, gonorrhea)
Interventions
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creation of a STIs score risk
4 questionnaires 3 screening test ( syphilis, chlamydia, gonorrhea)
validation of a STIs score risk
DRIVER questionnaire (DRIVER STI score risk) 3 screening test ( syphilis, chlamydia, gonorrhea)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Men who have sex with men
* Speaking, literate french
* Having a french health insurance or an equivalent
* Asymptomatic for a STI the appointment day
Exclusion Criteria
* Protected adults (adults under guardianship)
* Have a STI symptom ( anal discharge, urethritis, proctitis, chancre, rush)
18 Years
75 Years
MALE
No
Sponsors
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Saint-Louis Hospital, Paris, France
OTHER
Bicetre Hospital
OTHER
Hotel Dieu Hospital
OTHER
European Georges Pompidou Hospital
OTHER
Hôpital Necker-Enfants Malades
OTHER
Hôpital Franco-Britannique
UNKNOWN
Institut Mutualiste Montsouris
OTHER
Hôpital Lagny Marne la Vallée
UNKNOWN
Hôpital Raymond Poincaré
OTHER
Centre Hospitalier Argenteuil
OTHER
Hôpital Louis Mourier
OTHER
Hospital Ambroise Paré Paris
OTHER
Hopital Foch
OTHER
Responsible Party
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Principal Investigators
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David ZUCMAN, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Foch
Locations
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Hopital Foch
Suresnes, Hauts DE Seine, France
CH Argenteuil
Argenteuil, , France
CHU Ambroise Paré
Boulogne-Billancourt, , France
CHU Louis Mourier
Colombes, , France
Hôpital Raymond Poincaré
Garches, , France
CH Marne La Vallée
Jossigny, , France
Hôpital Mignot-centre hospitalier de versailles
Le Chesnay, , France
CH Bicetre
Le Kremlin-Bicêtre, , France
Hôpital Franco-Britannique
Levallois-Perret, , France
CHU Necker
Paris, , France
Hôtel Dieu
Paris, , France
Hôpital de Saint-Antoine
Paris, , France
Institut Mutualiste Montsouris
Paris, , France
Hôpital Européen Georges Pompidou
Paris, , France
CHU St Louis
Paris, , France
CHI Poissy/ Saint-Germain en Laye
Saint-Germain-en-Laye, , France
CHI Villeneuve Saint-Georges,
Villeneuve-Saint-Georges, , France
Countries
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Other Identifiers
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2014-A01358-39
Identifier Type: OTHER
Identifier Source: secondary_id
2014/50
Identifier Type: -
Identifier Source: org_study_id
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