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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A01358-39 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Saint-Louis Hospital, Paris, France | OTHER |
| Bicetre Hospital | OTHER |
| Hotel Dieu Hospital | OTHER |
| European Georges Pompidou Hospital |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First period | Other | creation of a STIs score risk pharyngeal swab+urinary collection+blood specimens+rectal Chlamydia trachomatis l Neisseria gonorrhoeae (CT/GC) testing |
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| Second period | Other | validation of a STIs score risk pharyngeal swab+urinary collection+blood specimens+rectal Chlamydia trachomatis l Neisseria gonorrhoeae (CT/GC) testing |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| creation of a STIs score risk | Other | 4 questionnaires 3 screening test ( syphilis, chlamydia, gonorrhea) |
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| Measure | Description | Time Frame |
|---|---|---|
| Sexually Transmitted Infections risk score in men HIV positive | Construction of a STI risk score | 6 months |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David ZUCMAN, MD | Hôpital Foch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Foch | Suresnes | Hauts DE Seine | 92150 | France | ||
| CH Argenteuil |
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| OTHER |
| Hôpital Necker-Enfants Malades | OTHER |
| Hôpital Franco-Britannique | UNKNOWN |
| Institut Mutualiste Montsouris | OTHER |
| Hôpital Lagny Marne la Vallée | UNKNOWN |
| Hôpital Raymond Poincaré | OTHER |
| Centre Hospitalier Argenteuil | OTHER |
| Hôpital Louis Mourier | OTHER |
| Hospital Ambroise Paré Paris | OTHER |
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| validation of a STIs score risk | Other | DRIVER questionnaire (DRIVER STI score risk) 3 screening test ( syphilis, chlamydia, gonorrhea) |
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patients' knowledge of STIs will be evaluate
| 3 months |
| prevalence of asymptomatic STIs in a population of HIV-positive MSM | 6 months |
| Argenteuil |
| 95107 |
| France |
| CHU Ambroise Paré | Boulogne-Billancourt | 92104 | France |
| CHU Louis Mourier | Colombes | 92700 | France |
| Hôpital Raymond Poincaré | Garches | 92380 | France |
| CH Marne La Vallée | Jossigny | 77600 | France |
| Hôpital Mignot-centre hospitalier de versailles | Le Chesnay | 78150 | France |
| CH Bicetre | Le Kremlin-Bicêtre | 94275 | France |
| Hôpital Franco-Britannique | Levallois-Perret | 92300 | France |
| CHU Necker | Paris | 750015 | France |
| Hôtel Dieu | Paris | 75004 | France |
| Hôpital de Saint-Antoine | Paris | 75012 | France |
| Institut Mutualiste Montsouris | Paris | 75014 | France |
| Hôpital Européen Georges Pompidou | Paris | 75015 | France |
| CHU St Louis | Paris | 75475 | France |
| CHI Poissy/ Saint-Germain en Laye | Saint-Germain-en-Laye | 78100 | France |
| CHI Villeneuve Saint-Georges, | Villeneuve-Saint-Georges | 94190 | France |
| ID | Term |
|---|---|
| D006716 | Homosexuality |
| ID | Term |
|---|---|
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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