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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) (DRIVER)

Primary Purpose

HIV

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
creation of a STIs score risk
validation of a STIs score risk
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for HIV focused on measuring HIV-positive MSM (men who have sex with men), asymptomatic sexually transmitted infections, screening

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Hopital Foch
  • CH Argenteuil
  • CHU Ambroise Paré
  • CHU Louis Mourier
  • Hôpital Raymond Poincaré
  • CH Marne La Vallée
  • Hôpital Mignot-centre hospitalier de versailles
  • CH Bicetre
  • Hôpital Franco-Britannique
  • CHU Necker
  • Hôtel Dieu
  • Hôpital de Saint-Antoine
  • Institut Mutualiste Montsouris
  • Hôpital Européen Georges Pompidou
  • CHU St Louis
  • CHI Poissy/ Saint-Germain en Laye
  • CHI Villeneuve Saint-Georges,

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

First period

Second period

Arm Description

creation of a STIs score risk pharyngeal swab+urinary collection+blood specimens+rectal Chlamydia trachomatis l Neisseria gonorrhoeae (CT/GC) testing

validation of a STIs score risk pharyngeal swab+urinary collection+blood specimens+rectal Chlamydia trachomatis l Neisseria gonorrhoeae (CT/GC) testing

Outcomes

Primary Outcome Measures

Sexually Transmitted Infections risk score in men HIV positive
Construction of a STI risk score

Secondary Outcome Measures

cost-efficacy of a targeted screening versus universal screening
conduct a cost-efficiency analysis of both strategies
patients' knowledge of STIs evaluated by a Sexually Transmitted Disease Knowledge Questionnaire (STD-KQ)
patients' knowledge of STIs will be evaluate
prevalence of asymptomatic STIs in a population of HIV-positive MSM

Full Information

First Posted
March 7, 2015
Last Updated
July 13, 2018
Sponsor
Hopital Foch
Collaborators
Saint-Louis Hospital, Paris, France, Bicetre Hospital, Hotel Dieu Hospital, European Georges Pompidou Hospital, Hôpital Necker-Enfants Malades, Hôpital Franco-Britannique, Institut Mutualiste Montsouris, Hôpital Lagny Marne la Vallée, Hôpital Raymond Poincaré, Centre Hospitalier Argenteuil, Hôpital Louis Mourier, Hospital Ambroise Paré Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02413632
Brief Title
Screening Strategy for Asymptomatic Sexually Transmitted Infections (STI) in a Cohort of HIV Outpatients Men Who Have Sex With Men (DRIVER)
Acronym
DRIVER
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 14, 2017 (Actual)
Study Completion Date
April 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
Collaborators
Saint-Louis Hospital, Paris, France, Bicetre Hospital, Hotel Dieu Hospital, European Georges Pompidou Hospital, Hôpital Necker-Enfants Malades, Hôpital Franco-Britannique, Institut Mutualiste Montsouris, Hôpital Lagny Marne la Vallée, Hôpital Raymond Poincaré, Centre Hospitalier Argenteuil, Hôpital Louis Mourier, Hospital Ambroise Paré Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV
Keywords
HIV-positive MSM (men who have sex with men), asymptomatic sexually transmitted infections, screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
495 (Actual)

8. Arms, Groups, and Interventions

Arm Title
First period
Arm Type
Other
Arm Description
creation of a STIs score risk pharyngeal swab+urinary collection+blood specimens+rectal Chlamydia trachomatis l Neisseria gonorrhoeae (CT/GC) testing
Arm Title
Second period
Arm Type
Other
Arm Description
validation of a STIs score risk pharyngeal swab+urinary collection+blood specimens+rectal Chlamydia trachomatis l Neisseria gonorrhoeae (CT/GC) testing
Intervention Type
Other
Intervention Name(s)
creation of a STIs score risk
Other Intervention Name(s)
First period
Intervention Description
4 questionnaires 3 screening test ( syphilis, chlamydia, gonorrhea)
Intervention Type
Other
Intervention Name(s)
validation of a STIs score risk
Other Intervention Name(s)
Second period
Intervention Description
DRIVER questionnaire (DRIVER STI score risk) 3 screening test ( syphilis, chlamydia, gonorrhea)
Primary Outcome Measure Information:
Title
Sexually Transmitted Infections risk score in men HIV positive
Description
Construction of a STI risk score
Time Frame
6 months
Secondary Outcome Measure Information:
Title
cost-efficacy of a targeted screening versus universal screening
Description
conduct a cost-efficiency analysis of both strategies
Time Frame
12 months
Title
patients' knowledge of STIs evaluated by a Sexually Transmitted Disease Knowledge Questionnaire (STD-KQ)
Description
patients' knowledge of STIs will be evaluate
Time Frame
3 months
Title
prevalence of asymptomatic STIs in a population of HIV-positive MSM
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David ZUCMAN, MD
Organizational Affiliation
Hôpital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Foch
City
Suresnes
State/Province
Hauts DE Seine
ZIP/Postal Code
92150
Country
France
Facility Name
CH Argenteuil
City
Argenteuil
ZIP/Postal Code
95107
Country
France
Facility Name
CHU Ambroise Paré
City
Boulogne-Billancourt
ZIP/Postal Code
92104
Country
France
Facility Name
CHU Louis Mourier
City
Colombes
ZIP/Postal Code
92700
Country
France
Facility Name
Hôpital Raymond Poincaré
City
Garches
ZIP/Postal Code
92380
Country
France
Facility Name
CH Marne La Vallée
City
Jossigny
ZIP/Postal Code
77600
Country
France
Facility Name
Hôpital Mignot-centre hospitalier de versailles
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
Facility Name
CH Bicetre
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94275
Country
France
Facility Name
Hôpital Franco-Britannique
City
Levallois-Perret
ZIP/Postal Code
92300
Country
France
Facility Name
CHU Necker
City
Paris
ZIP/Postal Code
750015
Country
France
Facility Name
Hôtel Dieu
City
Paris
ZIP/Postal Code
75004
Country
France
Facility Name
Hôpital de Saint-Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
CHU St Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
CHI Poissy/ Saint-Germain en Laye
City
Saint-Germain en Laye
ZIP/Postal Code
78100
Country
France
Facility Name
CHI Villeneuve Saint-Georges,
City
Villeneuve Saint-Georges
ZIP/Postal Code
94190
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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