NCT02413632

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
495

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2015

Completed
25 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 10, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2017

Completed
Last Updated

July 16, 2018

Status Verified

August 1, 2017

Enrollment Period

2 years

First QC Date

March 7, 2015

Last Update Submit

July 13, 2018

Conditions

HIV

Keywords

HIV-positive MSM (men who have sex with men)asymptomatic sexually transmitted infectionsscreening

Outcome Measures

Primary Outcomes (1)

  • Sexually Transmitted Infections risk score in men HIV positive

    Construction of a STI risk score

    6 months

Secondary Outcomes (3)

  • cost-efficacy of a targeted screening versus universal screening

    12 months

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

    3 months

  • prevalence of asymptomatic STIs in a population of HIV-positive MSM

    6 months

Study Arms (2)

First period

OTHER

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

Second period

OTHER

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

Interventions

creation of a STIs score riskOTHER

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

Also known as: First period
First period
validation of a STIs score riskOTHER

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

Also known as: Second period
Second period

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Men who never had sex with men
  • Protected adults (adults under guardianship)
  • Have a STI symptom ( anal discharge, urethritis, proctitis, chancre, rush)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Hopital Foch

Suresnes, Hauts DE Seine, 92150, France

Location

CH Argenteuil

Argenteuil, 95107, France

Location

CHU Ambroise Paré

Boulogne-Billancourt, 92104, France

Location

CHU Louis Mourier

Colombes, 92700, France

Location

Hôpital Raymond Poincaré

Garches, 92380, France

Location

CH Marne La Vallée

Jossigny, 77600, France

Location

Hôpital Mignot-centre hospitalier de versailles

Le Chesnay, 78150, France

Location

CH Bicetre

Le Kremlin-Bicêtre, 94275, France

Location

Hôpital Franco-Britannique

Levallois-Perret, 92300, France

Location

CHU Necker

Paris, 750015, France

Location

Hôtel Dieu

Paris, 75004, France

Location

Hôpital de Saint-Antoine

Paris, 75012, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

CHU St Louis

Paris, 75475, France

Location

CHI Poissy/ Saint-Germain en Laye

Saint-Germain-en-Laye, 78100, France

Location

CHI Villeneuve Saint-Georges,

Villeneuve-Saint-Georges, 94190, France

Location

MeSH Terms

Conditions

Homosexuality

Condition Hierarchy (Ancestors)

SexualitySexual BehaviorBehavior

Study Officials

  • David ZUCMAN, MD

    Hôpital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2015

First Posted

April 10, 2015

Study Start

April 1, 2015

Primary Completion

April 14, 2017

Study Completion

April 14, 2017

Last Updated

July 16, 2018

Record last verified: 2017-08

Locations

FR(17)