Screening Strategy for Asymptomatic Sexually Transmitted Infections (STI) in a Cohort of HIV Outpatients Men Who Have Sex With Men (DRIVER)
- Conditions
- HIV
- Registration Number
- NCT02413632
- Lead Sponsor
- Hopital Foch
- Brief Summary
Comparison of two screening strategies of asymptomatic sexually transmitted infections : routine screening versus screening as reported by the risks taken by the patient, in a cohort of HIV outpatients men who have sex with men. The aim of this study will be create and validate a simple tool for clinicians. A digital tool will be developed will allowed empowerment of HIV-positive men who have sex with men.
- Detailed Description
Main objectives are :
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 495
- HIV positive outpatients
- Men who have sex with men
- Speaking, literate french
- Having a french health insurance or an equivalent
- Asymptomatic for a STI the appointment day
- Men who never had sex with men
- Protected adults (adults under guardianship)
- Have a STI symptom ( anal discharge, urethritis, proctitis, chancre, rush)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Sexually Transmitted Infections risk score in men HIV positive 6 months Construction of a STI risk score
- Secondary Outcome Measures
Name Time Method prevalence of asymptomatic STIs in a population of HIV-positive MSM 6 months cost-efficacy of a targeted screening versus universal screening 12 months conduct a cost-efficiency analysis of both strategies
patients' knowledge of STIs evaluated by a Sexually Transmitted Disease Knowledge Questionnaire (STD-KQ) 3 months patients' knowledge of STIs will be evaluate
Trial Locations
- Locations (17)
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
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