Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT05031832
Status:
COMPLETED
Last Update Posted:
2025-01-23
First Post:
2021-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chemsex Engagement and HIV Biomedical Prevention in MSM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000084783', 'term': 'Recreational Drug Use'}, {'id': 'D006716', 'term': 'Homosexuality'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019529', 'term': 'Sexuality'}, {'id': 'D012725', 'term': 'Sexual Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082922', 'term': 'HIV Testing'}], 'ancestors': [{'id': 'D008828', 'term': 'Microbiological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 733}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-21', 'studyFirstSubmitDate': '2021-08-30', 'studyFirstSubmitQcDate': '2021-08-30', 'lastUpdatePostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pre-exposure prophylaxis coverage', 'timeFrame': '6 months', 'description': 'proportion of HIV-negative MSM taking pre-exposure prophylaxis; based on self-reported data in questionnaire'}, {'measure': 'Good antiretroviral therapy adherence', 'timeFrame': '2 years', 'description': 'proportion of HIV-positive MSM with good antiretroviral therapy adherence; based on self-reported data (CD4 count, viral load level, history of stoppoing ART / missing doses) in questionnaire'}, {'measure': 'Drug use pattern', 'timeFrame': '6 months', 'description': 'types of drugs taken for chemsex engagement (taking before or during sex); based on self-reported data in questionnaire'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chemsex engagement', 'Pre-exposure prophylaxis', 'Antiretroviral therapy', 'men who have sex with men'], 'conditions': ['Recreational Drug Use']}, 'descriptionModule': {'briefSummary': 'HIV biomedical prevention through treatment-as-prevention (TasP) and pre-exposure prophylaxis (PrEP) is highly efficacious for reducing HIV transmission risk. The benefits could be undermined by the rising HIV transmission risks in men who have sex with men (MSM) who engaged in chemsex. This project aims to assess the impacts of chemsex on the growth of the HIV epidemic by exploring the complex relationships between chemsex engagement and usage of HIV biomedical prevention in MSM in Hong Kong. Participants would be recruited from the community and clinics in 2 cross-sectional studies (500 HIV-negative and 500 HIV-positive MSM), for HIV self-testing and completing an electronic questionnaire. The association of chemsex would be examined between PrEP-naïve and PrEP experienced HIV-negative MSM, and between good and poor adherence to antiretroviral therapy (ART) among HIV-positive subjects in case-control analyses using logistic regression and multilevel models. The main outcomes include coverage of biomedical prevention in MSM, and their drug use patterns.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'sexually active adult men who have sex with men living in Hong Kong, and able to complete the questionnaire', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18 or above\n* male\n* have had sex with men since 2019\n* could be communicated in English or Chinese\n\nExclusion Criteria:\n\n* failed to provide consent'}, 'identificationModule': {'nctId': 'NCT05031832', 'briefTitle': 'Chemsex Engagement and HIV Biomedical Prevention in MSM', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'The Interrelationship Between Chemsex Engagement and HIV Biomedical Prevention in MSM', 'orgStudyIdInfo': {'id': 'MSS344R'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV-negative', 'interventionNames': ['Diagnostic Test: HIV test']}, {'label': 'HIV-positive'}], 'interventions': [{'name': 'HIV test', 'type': 'DIAGNOSTIC_TEST', 'description': 'HIV test would be offered to self-reported HIV-negative / unknown HIV status MSM to confirm their HIV status', 'armGroupLabels': ['HIV-negative']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Hong Kong', 'state': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ngai Sze WONG', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}