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

HIV Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02413632
• Other study ID #: 2014/50
• Secondary ID: 2014-A01358-39
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: April 14, 2017

Study information

• Verified date: August 2017
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 495
• Est. completion date: April 14, 2017
• Est. primary completion date: April 14, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• HIV
• Infection
• Sexually Transmitted Diseases

Intervention

Other:
• 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)

Locations

Country	Name	City	State
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	CHU St Louis	Paris
France	Hôpital de Saint-Antoine	Paris
France	Hôpital Européen Georges Pompidou	Paris
France	Hôtel Dieu	Paris
France	Institut Mutualiste Montsouris	Paris
France	CHI Poissy/ Saint-Germain en Laye	Saint-Germain en Laye
France	Hopital Foch	Suresnes	Hauts DE Seine
France	CHI Villeneuve Saint-Georges,	Villeneuve Saint-Georges

Sponsors (13)

Lead Sponsor	Collaborator
Hopital Foch	Bicetre Hospital, Centre Hospitalier Argenteuil, European Georges Pompidou Hospital, Hôpital Franco-Britannique, Hôpital Lagny Marne la Vallée, Hôpital Louis Mourier, Hôpital Necker-Enfants Malades, Hôpital Raymond Poincaré, Hospital Ambroise Paré Paris, Hotel Dieu Hospital, Institut Mutualiste Montsouris, Saint-Louis Hospital, Paris, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexually Transmitted Infections risk score in men HIV positive	Construction of a STI risk score	6 months
Secondary	cost-efficacy of a targeted screening versus universal screening	conduct a cost-efficiency analysis of both strategies	12 months
Secondary	patients' knowledge of STIs evaluated by a Sexually Transmitted Disease Knowledge Questionnaire (STD-KQ)	patients' knowledge of STIs will be evaluate	3 months
Secondary	prevalence of asymptomatic STIs in a population of HIV-positive MSM		6 months