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

July 13, 2018 updated by: Hopital Foch

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

495

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Argenteuil, France, 95107
        • CH Argenteuil
      • Boulogne-Billancourt, France, 92104
        • CHU Ambroise Pare
      • Colombes, France, 92700
        • CHU Louis Mourier
      • Garches, France, 92380
        • Hôpital Raymond Poincaré
      • Jossigny, France, 77600
        • CH Marne La Vallée
      • Le Chesnay, France, 78150
        • Hôpital Mignot-centre hospitalier de versailles
      • Le Kremlin-Bicêtre, France, 94275
        • Ch Bicetre
      • Levallois-Perret, France, 92300
        • Hopital Franco-Britannique
      • Paris, France, 75015
        • Hopital Europeen Georges Pompidou
      • Paris, France, 75014
        • Institut Mutualiste Montsouris
      • Paris, France, 75004
        • Hotel Dieu
      • Paris, France, 750015
        • CHU Necker
      • Paris, France, 75012
        • Hôpital de Saint-Antoine
      • Paris, France, 75475
        • CHU St Louis
      • Saint-Germain en Laye, France, 78100
        • CHI Poissy/ Saint-Germain en Laye
      • Villeneuve Saint-Georges, France, 94190
        • CHI Villeneuve Saint-Georges,
    • Hauts DE Seine
      • Suresnes, Hauts DE Seine, France, 92150
        • Hopital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: First period

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
4 questionnaires 3 screening test ( syphilis, chlamydia, gonorrhea)
Other Names:
  • First period
Other: Second period

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
DRIVER questionnaire (DRIVER STI score risk) 3 screening test ( syphilis, chlamydia, gonorrhea)
Other Names:
  • Second period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexually Transmitted Infections risk score in men HIV positive
Time Frame: 6 months
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
Time Frame: 12 months
conduct a cost-efficiency analysis of both strategies
12 months
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 months
prevalence of asymptomatic STIs in a population of HIV-positive MSM
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Collaborators

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

Investigators

  • Principal Investigator: David ZUCMAN, MD, Hopital Foch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

April 14, 2017

Study Completion (Actual)

April 14, 2017

Study Registration Dates

First Submitted

March 7, 2015

First Submitted That Met QC Criteria

April 9, 2015

First Posted (Estimate)

April 10, 2015

Study Record Updates

Last Update Posted (Actual)

July 16, 2018

Last Update Submitted That Met QC Criteria

July 13, 2018

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/50
  • 2014-A01358-39 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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