Screening Strategy for Asymptomatic Sexually Transmitted Infections (STI) in a Cohort of HIV Outpatients Men Who Have Sex With Men (DRIVER)

Not Applicable

Completed

• Conditions: HIV
• Interventions: Other: creation of a STIs score risk; Other: validation of a STIs score risk

• 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

Study Timeline

• Study First Submitted: 2015-03-07
• Study Start: 2015-04
• Study First Submitted QC: 2015-04-09
• Study First Posted: 2015-04-10
• Primary Completion: 2017-04-14
• Study Completion: 2017-04-14
• Status Verified: 2017-08
• Last Update Submitted: 2018-07-13
• Last Update Posted: 2018-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 495

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
First period	creation of a STIs score risk	creation of a STIs score risk pharyngeal swab+urinary collection+blood specimens+rectal Chlamydia trachomatis l Neisseria gonorrhoeae (CT/GC) testing
Second period	validation of a STIs score risk	validation of a STIs score risk pharyngeal swab+urinary collection+blood specimens+rectal Chlamydia trachomatis l Neisseria gonorrhoeae (CT/GC) testing

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

CH Bicetre; 🇫🇷 Le Kremlin-Bicêtre, France

Hôpital Mignot-centre hospitalier de versailles; 🇫🇷 Le Chesnay, France

Hôpital Franco-Britannique; 🇫🇷 Levallois-Perret, France

CHU Necker; 🇫🇷 Paris, France

Hôpital de Saint-Antoine; 🇫🇷 Paris, France

Institut Mutualiste Montsouris; 🇫🇷 Paris, France

Hôtel Dieu; 🇫🇷 Paris, France

CHI Poissy/ Saint-Germain en Laye; 🇫🇷 Saint-Germain en Laye, France

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France

CHU St Louis; 🇫🇷 Paris, France

CHI Villeneuve Saint-Georges,; 🇫🇷 Villeneuve Saint-Georges, France