Clinical trial NCT02413632: Screening Strategy for Asymptomatic Sexually Transmitted Infections (STI) in a Cohort of HIV Outpatients Men Who Have Sex With Men (DRIVER)
Official title: Asymptomatic Sexually Transmitted Infections (STI) : Comparison of Two Screening Strategies 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV-positive MSM (men who have sex with men)
asymptomatic sexually transmitted infections
screening
Lead sponsor: Hopital Foch
Sponsor class: OTHER
Collaborators: name: Saint-Louis Hospital, Paris, France
name: Bicetre Hospital
name: Hotel Dieu Hospital
name: European Georges Pompidou Hospital
name: Hôpital Necker-Enfants Malades
name: Hôpital Franco-Britannique
name: Institut Mutualiste Montsouris
name: Hôpital Lagny Marne la Vallée
name: Hôpital Raymond Poincaré
name: Centre Hospitalier Argenteuil
name: Hôpital Louis Mourier
name: Hospital Ambroise Paré Paris
First posted: 2015-04-10
Enrollment: 495
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Men who never had sex with men
* Protected adults (adults under guardianship)
* Have a STI symptom ( anal discharge, urethritis, proctitis, chancre, rush)

Primary outcomes:
measure: Sexually Transmitted Infections risk score in men HIV positive
timeFrame: 6 months
Secondary outcomes:
measure: cost-efficacy of a targeted screening versus universal screening
timeFrame: 12 months
measure: patients' knowledge of STIs evaluated by a Sexually Transmitted Disease Knowledge Questionnaire (STD-KQ)
timeFrame: 3 months
measure: prevalence of asymptomatic STIs in a population of HIV-positive MSM
timeFrame: 6 months
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
state: Hauts DE Seine
city: Argenteuil
country: France
facility: CH Argenteuil
city: Boulogne-Billancourt
country: France
facility: CHU Ambroise Paré
city: Colombes
country: France
facility: CHU Louis Mourier
city: Garches
country: France
facility: Hôpital Raymond Poincaré
city: Jossigny
country: France
facility: CH Marne La Vallée
city: Le Chesnay
country: France
facility: Hôpital Mignot-centre hospitalier de versailles
city: Le Kremlin-Bicêtre
country: France
facility: CH Bicetre
city: Levallois-Perret
country: France
facility: Hôpital Franco-Britannique
city: Paris
country: France
facility: CHU Necker
city: Paris
country: France
facility: Hôtel Dieu
city: Paris
country: France
facility: Hôpital de Saint-Antoine
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: CHU St Louis
city: Saint-Germain en Laye
country: France
facility: CHI Poissy/ Saint-Germain en Laye
city: Villeneuve Saint-Georges
country: France
facility: CHI Villeneuve Saint-Georges,
Study officials:
affiliation: Hôpital Foch
name: David ZUCMAN, MD
role: PRINCIPAL_INVESTIGATOR
References: