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

Hopital Foch

Status: Completed

Conditions: HIV

Treatments: Other: validation of a STIs score risk; Other: creation of a STIs score risk

Study type: Interventional

Funder types: Other

Identifiers

NCT02413632

2014/50

2014-A01358-39 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 495 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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495 participants in 2 patient groups

First period

Other group

Description:

creation of a STIs score risk pharyngeal swab+urinary collection+blood specimens+rectal Chlamydia trachomatis l Neisseria gonorrhoeae (CT/GC) testing

Treatment:

Other: creation of a STIs score risk

Second period

Other group

Description:

validation of a STIs score risk pharyngeal swab+urinary collection+blood specimens+rectal Chlamydia trachomatis l Neisseria gonorrhoeae (CT/GC) testing

Treatment:

Other: validation of a STIs score risk