Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-01 @ 6:58 AM
Study NCT ID:
NCT05559658
Status:
RECRUITING
Last Update Posted:
2024-12-17
First Post:
2022-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comprehensive Assessment in a Longitudinal Study on Young Men Who Have Sex With Men Attracting to chemseX
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-12', 'studyFirstSubmitDate': '2022-09-26', 'studyFirstSubmitQcDate': '2022-09-26', 'lastUpdatePostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The study will be divided into two phases. The information on the procedures of the phase I single study visit is presented below.', 'timeFrame': '12 months', 'description': 'Qualitative data collection The qualitative study component will use semi-structured individual in-depth interviews (IDIs) in Thai conducted in-person at the team community health clinic facilities. All participants will be included in the qualitative data collection - 40 YMSM, all 10 family members or peers of chemsex users, and all 10 clinic staff.\n\nQuantitative data collection Demographic information of all participants, the proportion of all eligible participants who agree to participate in the study, and the relationship status between Group 2 and Group 1 participants will be collected.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ChemSex users'], 'conditions': ['ChemSex Users for YMSM', 'ChemSex Users']}, 'descriptionModule': {'briefSummary': 'The study is a two-phase observational study that assess multiple aspects of study and young men who have sex with men (YMSM).\n\nPhase I of the study will be a cross-sectional descriptive study using a mixed methods data collection (focusing on qualitative data collection) to acquire information necessary for developing a more extensive study on the same matter.\n\nPhase II of the study will be a prospective cohort study using a quantitative data collection.\n\nFindings from phase I will guide the development of phase II which consist of a larger number of YMSM, important baseline and follow-up questionnaires and comorbidities assessments, sexually transmitted infections testing, and integration to care.\n\nThis protocol exclusively addresses the phase I of the study.\n\nOnce the phase I findings are finalized, the principal investigator will submit the phase II to the IRB of the Faculty of Medicine, Chulalongkorn University.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Current chemsex users', 'eligibilityCriteria': 'Inclusion Criteria:\n\nGroup 1A: Current chemsex users\n\n1. Men who have sex with men\n2. Aged 16-35 years\n3. Able to communicate in Thai fluently\n4. Current chemsex users\n5. Provide informed consent\n\nInclusion Criteria:\n\nGroup 1B: Former chemsex users (discontinued ≥90 days)\n\n1. Men who have sex with men\n2. Aged 16-35 years\n3. Able to communicate in Thai fluently\n4. Former chemsex users (discontinued ≥90 days)\n5. Provide informed consent\n\nExclusion Criteria:\n\nNo exclusion criteria for all groups of participants'}, 'identificationModule': {'nctId': 'NCT05559658', 'acronym': 'CLYMAX', 'briefTitle': 'Comprehensive Assessment in a Longitudinal Study on Young Men Who Have Sex With Men Attracting to chemseX', 'organization': {'class': 'OTHER', 'fullName': 'Institute of HIV Research and Innovation Foundation, Thailand'}, 'officialTitle': 'A Cross-sectional Descriptive Study Using Mixed Method (Qualitative and Quantitative) Data Collection', 'orgStudyIdInfo': {'id': 'IHRI021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'A: Current chemsex users Men who have sex with men, Aged 16-35 years, Able to communicate in Thai fluently, Current chemsex users.\n\nB: Former chemsex users (discontinued ≥90 days) Men who have sex with men, Aged 16-35 years, Able to communicate in Thai fluently, Former chemsex users (discontinued ≥90 days).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Pathum Wan', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Nittaya Phanuphak, MD.,Ph.D.', 'role': 'CONTACT', 'email': 'nittaya.p@ihri.org', 'phone': '+66 2 1605371'}, {'name': 'Napasawan Chinlaertworasiri', 'role': 'CONTACT', 'email': 'napasawan@ihir.org', 'phone': '+66 2 1605371'}], 'facility': 'Institute of HIV Research and Innovation', 'geoPoint': {'lat': 13.73649, 'lon': 100.5239}}], 'centralContacts': [{'name': 'Nittaya Phanuphak, MD,PhD.', 'role': 'CONTACT', 'email': 'nittaya.p@ihri.org', 'phone': '6681 825 3544'}, {'name': 'Siriporn Nonenoy, RN.MPH.', 'role': 'CONTACT', 'email': 'siriporn.n@ihri.org', 'phone': '661 818 4143'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of HIV Research and Innovation Foundation, Thailand', 'class': 'OTHER'}, 'collaborators': [{'name': 'amfAR, The Foundation for AIDS Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}