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Completed

NCT Number: NCT02413632

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

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.

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Key information

Conditions

HIV Behavior Homosexuality Sexual Behavior Sexuality

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Foch, Suresnes, Hauts DE Seine, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

creation of a STIs score risk

Other

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

Other names: First period

validation of a STIs score risk

Other

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

Other names: Second period

Primary outcomes

  1. Sexually Transmitted Infections risk score in men HIV positive

    Time frame: 6 months

    Construction of a STI risk score

Secondary outcomes

  1. cost-efficacy of a targeted screening versus universal screening

    Time frame: 12 months

    conduct a cost-efficiency analysis of both strategies

  2. patients' knowledge of STIs evaluated by a Sexually Transmitted Disease Knowledge Questionnaire (STD-KQ)

    Time frame: 3 months

    patients' knowledge of STIs will be evaluate

  3. prevalence of asymptomatic STIs in a population of HIV-positive MSM

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Collaborators

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

Registry information

Official study 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

Acronym: DRIVER

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 10, 2015
Registry last updated
Jul 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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