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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02413632
Acronym
DRIVER
Enrollment
495
Registered
2015-04-10
Start date
2015-04-30
Completion date
2017-04-14
Last updated
2018-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

HIV-positive MSM (men who have sex with men), asymptomatic sexually transmitted infections, screening

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

Interventions

OTHERcreation of a STIs score risk

4 questionnaires 3 screening test ( syphilis, chlamydia, gonorrhea)

OTHERvalidation of a STIs score risk

DRIVER questionnaire (DRIVER STI score risk) 3 screening test ( syphilis, chlamydia, gonorrhea)

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Sexually Transmitted Infections risk score in men HIV positive6 monthsConstruction of a STI risk score

Secondary

MeasureTime frameDescription
patients' knowledge of STIs evaluated by a Sexually Transmitted Disease Knowledge Questionnaire (STD-KQ)3 monthspatients' knowledge of STIs will be evaluate
cost-efficacy of a targeted screening versus universal screening12 monthsconduct a cost-efficiency analysis of both strategies
prevalence of asymptomatic STIs in a population of HIV-positive MSM6 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026