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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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HIV

Intervention / Treatment
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* Other: creation of a STIs score risk
* Other: validation of a STIs score risk


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: First period<br>creation of a STIs score risk pharyngeal swab+urinary collection+blood specimens+rectal Chlamydia trachomatis l Neisseria gonorrhoeae (CT/GC) testing | Other: creation of a STIs score risk<br>* 4 questionnaires 3 screening test ( syphilis, chlamydia, gonorrhea)<br>* Other names: First period;|
| Other: Second period<br>validation of a STIs score risk pharyngeal swab+urinary collection+blood specimens+rectal Chlamydia trachomatis l Neisseria gonorrhoeae (CT/GC) testing | Other: validation of a STIs score risk<br>* DRIVER questionnaire (DRIVER STI score risk) 3 screening test ( syphilis, chlamydia, gonorrhea)<br>* Other names: Second period;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexually Transmitted Infections risk score in men HIV positive | Construction of a STI risk score | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost-efficacy of a targeted screening versus universal screening | conduct a cost-efficiency analysis of both strategies | 12 months | 
| patients' knowledge of STIs evaluated by a Sexually Transmitted Disease Knowledge Questionnaire (STD-KQ) | patients' knowledge of STIs will be evaluate | 3 months | 
| prevalence of asymptomatic STIs in a population of HIV-positive MSM |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-positive MSM (men who have sex with men), asymptomatic sexually transmitted infections, screening