Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT03956758
Status:
WITHDRAWN
Last Update Posted:
2019-11-19
First Post:
2019-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HIV Prevention During Chemsex
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Reclassification by Ethics Committee', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-18', 'studyFirstSubmitDate': '2019-05-16', 'studyFirstSubmitQcDate': '2019-05-16', 'lastUpdatePostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'report to HIV', 'timeFrame': '1 day', 'description': 'report to HIV contamination during Chemsex'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MSM', 'Chemical sex', 'HIV prevention', 'HIV pre-exposure prophylaxis'], 'conditions': ['Men Having Sex With Other Men']}, 'descriptionModule': {'briefSummary': 'In 2016, the number of discoveries of HIV seropositivity is estimated at about 6000 in France. Men who have sex with men (MSM) account for 44% of these infections (68% in the Occitanie region). For the past ten years, there have been new practices of sexual drug use among MSM referred to as Chemsex. These practices expose to sexual risks but also to those related to the consumption of drugs making this population more at risk to get infectious contaminations. In the "PREVAGAY study" conducted in Montpellier in 2015, about 30% of MSM included said they had consumed at least one psychoactive product before or during sex during the last 12 months. In addition, this percentage was significantly higher among HIV-positive men (51% versus 24% of HIV-negative men) and 1% (N = 9) had practiced Slam (Sexual Injection). The results of this study also showed that PreP (Prophylaxis Pre-exposure to HIV) was known by 52% of MSM included and 4% (N = 4) had already used it in the last 12 months. Several observations are needed: many ChemSex users do not use the PreP despite the fact that its effectiveness has been proven in many studies.\n\nThe social sciences have been studying the HIV epidemic since its emergence. In the era of HIV chronic disease, the sociologist Gabriel Girard wanted to question the pessimistic observation of epidemiological studies in his thesis work. Some contradictory logics explains this epidemiology of HIV which is maintained, particularly in Montpellier despite the arrival of the PreP.\n\nThe main objective of our study is to explore the reflexive logic structuring the report to HIV prevention by MSM practicing ChemSex in Montpellier, in the context of the appearance and dissemination of the PreP.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'MSM living in Montpellier with negative HIV status, having at least one sexual intercourse under drug use during the last 12 months', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men who have sex with men (MSM)\n* living in Montpellier\n* using chemsex drugs at least one during sexual intercourse\n\nExclusion Criteria:\n\n* under 18 years\n* seropositive HIV'}, 'identificationModule': {'nctId': 'NCT03956758', 'acronym': 'Chemsex', 'briefTitle': 'HIV Prevention During Chemsex', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'The Reflexive Logics Structuring the Report to HIV Prevention of MSM Practicing ChemSex in the Context of Circulation of the PreP', 'orgStudyIdInfo': {'id': 'RECHMPL19_0233'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Semi-directed interview', 'type': 'OTHER', 'description': 'Semi-directed interview on ChemSex practice'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Clemence GIRARD, Medical intern', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}