Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2026-01-04 @ 1:46 AM
Study NCT ID:
NCT02413632
Status:
COMPLETED
Last Update Posted:
2018-07-16
First Post:
2015-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening Strategy for Asymptomatic Sexually Transmitted Infections (STI) in a Cohort of HIV Outpatients Men Who Have Sex With Men (DRIVER)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006716', 'term': 'Homosexuality'}], 'ancestors': [{'id': 'D019529', 'term': 'Sexuality'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 495}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-13', 'studyFirstSubmitDate': '2015-03-07', 'studyFirstSubmitQcDate': '2015-04-09', 'lastUpdatePostDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sexually Transmitted Infections risk score in men HIV positive', 'timeFrame': '6 months', 'description': 'Construction of a STI risk score'}], 'secondaryOutcomes': [{'measure': 'cost-efficacy of a targeted screening versus universal screening', 'timeFrame': '12 months', 'description': 'conduct a cost-efficiency analysis of both strategies'}, {'measure': "patients' knowledge of STIs evaluated by a Sexually Transmitted Disease Knowledge Questionnaire (STD-KQ)", 'timeFrame': '3 months', 'description': "patients' knowledge of STIs will be evaluate"}, {'measure': 'prevalence of asymptomatic STIs in a population of HIV-positive MSM', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV-positive MSM (men who have sex with men)', 'asymptomatic sexually transmitted infections', 'screening'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "Main objectives are :\n\ncreate and validate a risk score for STIs (DRIVER score) in a population of HIV-positive men who have sex with men (MSM).\n\ndetermine the prevalence of asymptomatic STIs in a population of HIV-positive MSM\n\nSecondary objectives are :\n\ncompare 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…\n\nPosition of the problem :\n\nOver 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).\n\nScreening 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.\n\nType of study : Prospective, non randomized, multicentric and cross-sectional Timeline : Study duration : 18 months Beginning of study : March 2015"}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV positive outpatients\n* Men who have sex with men\n* Speaking, literate french\n* Having a french health insurance or an equivalent\n* Asymptomatic for a STI the appointment day\n\nExclusion Criteria:\n\n* Men who never had sex with men\n* Protected adults (adults under guardianship)\n* Have a STI symptom ( anal discharge, urethritis, proctitis, chancre, rush)'}, 'identificationModule': {'nctId': 'NCT02413632', 'acronym': 'DRIVER', 'briefTitle': 'Screening Strategy for Asymptomatic Sexually Transmitted Infections (STI) in a Cohort of HIV Outpatients Men Who Have Sex With Men (DRIVER)', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2014/50'}, 'secondaryIdInfos': [{'id': '2014-A01358-39', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'First period', 'description': 'creation of a STIs score risk\n\npharyngeal swab+urinary collection+blood specimens+rectal Chlamydia trachomatis l Neisseria gonorrhoeae (CT/GC) testing', 'interventionNames': ['Other: creation of a STIs score risk']}, {'type': 'OTHER', 'label': 'Second period', 'description': 'validation of a STIs score risk\n\npharyngeal swab+urinary collection+blood specimens+rectal Chlamydia trachomatis l Neisseria gonorrhoeae (CT/GC) testing', 'interventionNames': ['Other: validation of a STIs score risk']}], 'interventions': [{'name': 'creation of a STIs score risk', 'type': 'OTHER', 'otherNames': ['First period'], 'description': '4 questionnaires 3 screening test ( syphilis, chlamydia, gonorrhea)', 'armGroupLabels': ['First period']}, {'name': 'validation of a STIs score risk', 'type': 'OTHER', 'otherNames': ['Second period'], 'description': 'DRIVER questionnaire (DRIVER STI score risk) 3 screening test ( syphilis, chlamydia, gonorrhea)', 'armGroupLabels': ['Second period']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92150', 'city': 'Suresnes', 'state': 'Hauts DE Seine', 'country': 'France', 'facility': 'Hopital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'zip': '95107', 'city': 'Argenteuil', 'country': 'France', 'facility': 'CH Argenteuil', 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'zip': '92104', 'city': 'Boulogne-Billancourt', 'country': 'France', 'facility': 'CHU Ambroise Paré', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}, {'zip': '92700', 'city': 'Colombes', 'country': 'France', 'facility': 'CHU Louis Mourier', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}, {'zip': '92380', 'city': 'Garches', 'country': 'France', 'facility': 'Hôpital Raymond Poincaré', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}, {'zip': '77600', 'city': 'Jossigny', 'country': 'France', 'facility': 'CH Marne La Vallée', 'geoPoint': {'lat': 48.83765, 'lon': 2.75432}}, {'zip': '78150', 'city': 'Le Chesnay', 'country': 'France', 'facility': 'Hôpital Mignot-centre hospitalier de versailles', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}, {'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'CH Bicetre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '92300', 'city': 'Levallois-Perret', 'country': 'France', 'facility': 'Hôpital Franco-Britannique', 'geoPoint': {'lat': 48.89389, 'lon': 2.28864}}, {'zip': '750015', 'city': 'Paris', 'country': 'France', 'facility': 'CHU Necker', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75004', 'city': 'Paris', 'country': 'France', 'facility': 'Hôtel Dieu', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital de Saint-Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Mutualiste Montsouris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'CHU St Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '78100', 'city': 'Saint-Germain-en-Laye', 'country': 'France', 'facility': 'CHI Poissy/ Saint-Germain en Laye', 'geoPoint': {'lat': 48.89643, 'lon': 2.0904}}, {'zip': '94190', 'city': 'Villeneuve-Saint-Georges', 'country': 'France', 'facility': 'CHI Villeneuve Saint-Georges,', 'geoPoint': {'lat': 48.73219, 'lon': 2.44925}}], 'overallOfficials': [{'name': 'David ZUCMAN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Foch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'collaborators': [{'name': 'Saint-Louis Hospital, Paris, France', 'class': 'OTHER'}, {'name': 'Bicetre Hospital', 'class': 'OTHER'}, {'name': 'Hotel Dieu Hospital', 'class': 'OTHER'}, {'name': 'European Georges Pompidou Hospital', 'class': 'OTHER'}, {'name': 'Hôpital Necker-Enfants Malades', 'class': 'OTHER'}, {'name': 'Hôpital Franco-Britannique', 'class': 'UNKNOWN'}, {'name': 'Institut Mutualiste Montsouris', 'class': 'OTHER'}, {'name': 'Hôpital Lagny Marne la Vallée', 'class': 'UNKNOWN'}, {'name': 'Hôpital Raymond Poincaré', 'class': 'OTHER'}, {'name': 'Centre Hospitalier Argenteuil', 'class': 'OTHER'}, {'name': 'Hôpital Louis Mourier', 'class': 'OTHER'}, {'name': 'Hospital Ambroise Paré Paris', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}