Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-31 @ 5:07 PM
Study NCT ID:
NCT06793605
Status:
RECRUITING
Last Update Posted:
2025-03-18
First Post:
2025-01-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community Burden of MG Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D006716', 'term': 'Homosexuality'}], 'ancestors': [{'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019529', 'term': 'Sexuality'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'urine specimen, rectal swab'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 920}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-14', 'studyFirstSubmitDate': '2025-01-21', 'studyFirstSubmitQcDate': '2025-01-21', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of MG infection', 'timeFrame': '1 year', 'description': 'detection of MG infections in self-collected samples divided by the total number of samples collected'}, {'measure': 'prevalence of MG resistance mutations', 'timeFrame': '1 year', 'description': 'detection of MG resistance mutations macrolide/fluoroquinolone in MG positive samples divided by the total number of MG positive samples'}], 'secondaryOutcomes': [{'measure': 'prevalence of CT infection', 'timeFrame': '1 year', 'description': 'detection of CT infections in self-collected samples divided by the total number of samples collected'}, {'measure': 'prevalence of NG infection', 'timeFrame': '1 year', 'description': 'detection of NG infections in self-collected samples divided by the total number of samples collected'}, {'measure': 'co-infection of STIs', 'timeFrame': '1 year', 'description': 'number of co-infection of HIV, CT, NG, and/or MG'}, {'measure': 'history of STI and HIV testing', 'timeFrame': 'ever', 'description': 'number of self-reported history of STI and/or HIV testing at survey'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mycoplasma genitalium', 'Chlamydia trachomatis', 'Neisseria gonorrhoeae', 'men who have sex with men'], 'conditions': ['Sexually Transmitted Infection (STI)', 'Mycoplasma Genitalium Infection']}, 'descriptionModule': {'briefSummary': 'Objective: To assess the burden and the transmission dynamics of Mycoplasma genitalium (MG) infection in men who have sex with men in Hong Kong.\n\nDesign and setting: involving a) a cross-sectional study (completion of an online self-administered survey, followed by self-sampling for testing in the laboratory, and performance of HIV self-test); b) a mathematical modelling study to simulate the transmission dynamics of MG infection and resistant MG infection and compare the impacts of test-and-treat strategies.\n\nParticipants: Around 920 men who have sex with men would be recruited', 'detailedDescription': 'Cross-sectional study: A total of 920 men who have sex with men aged 18 or above and normally living in Hong Kong would be recruited. Eligible participants would be asked to complete a self-administered online survey, submit self-collected urine specimen and rectal swabs for Chlamydia trachomatis, Neisseria gonorrhoeae, and Mycoplasma genitalium testing in the laboratory, and submit HIV self-test results.\n\nMathematical modelling study: A compartmental model would be constructed to simulate the transmission dynamics of MG infection and resistant MG infection, and analyse the impact of different test-and-treat strategies.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'men who have sex with men in Hong Kong', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men who have sex with men aged 18 or above, normally living in Hong Kong, and could communicate in written and spoken English or Chinese\n\nExclusion Criteria:\n\n* cannot provide consent'}, 'identificationModule': {'nctId': 'NCT06793605', 'briefTitle': 'Community Burden of MG Infection', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Community Burden of Mycoplasma Genitalium Infection and Its Implications for Test-and-treat Strategies', 'orgStudyIdInfo': {'id': 'MGMSM1'}}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Ngai Sze Wong, PhD', 'role': 'CONTACT', 'email': 'candy_wong@cuhk.edu.hk', 'phone': '22528862'}], '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'}}}}