Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-29 @ 12:49 AM
Study NCT ID:
NCT05789134
Status:
RECRUITING
Last Update Posted:
2025-01-23
First Post:
2023-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mycoplasma Genitalium Infection and Associated Antimicrobial Resistance Among HIV-infected Male in Hong Kong
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, pharyngeal swab'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-21', 'studyFirstSubmitDate': '2023-03-16', 'studyFirstSubmitQcDate': '2023-03-16', 'lastUpdatePostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', '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\n* detection of MG resistance mutations macrolide/fluoroquinolone in MG positive samples divided by the total number of samples collected'}], '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': 'prevalence of syphilis', 'timeFrame': '1 year', 'description': 'total number of reported syphilis diagnosis divided by total number of participants tested for syphilis in the clinic'}, {'measure': 'prevalence of HCV infection', 'timeFrame': '1 year', 'description': 'total number of reported HCV diagnosis divided by total number of participants tested for HCV in the clinic'}, {'measure': 'prevalence of overall STI', 'timeFrame': '1 year', 'description': 'total number of reported STI diagnosis divided by total number of participants tested for STI in the clinic'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chlamydia trachomatis', 'Mycoplasma Genitalium Infection', 'Neisseria gonorrhoeae', 'men who have sex with men', 'heterosexual men', 'people living with HIV'], 'conditions': ['STI', 'Mycoplasma Genitalium Infection']}, 'descriptionModule': {'briefSummary': 'Worldwide, Mycoplasma genitalium (MG) is increasingly reported as an emerging cause of sexually transmitted infections. Internationally, the prevalence of MG is higher in male with urethritis and community groups especially among people living with HIV (PLHIV). While MG is treatable, antimicrobial resistance is a rising concern. This cross-sectional study aims to determine the prevalence of MG infection and the antimicrobial resistance pattern in HIV-infected male in Hong Kong.\n\nA total of 750 HIV-infected male attending HIV specialist clinic in Hong Kong would be recruited. The main outcome measures include prevalence of MG and resistance mutations to macrolide/fluoroquinolone in HIV-infected male; prevalence of MG/STI co-infections, as defined by concurrent detection of MG and one or more other bacterial STI.', 'detailedDescription': 'A total of 750 HIV-infected male attending HIV specialist clinic in Hong Kong would be recruited. An online questionnaire would be self-administered. The participants would self-collect urine sample, rectal and pharyngeal swabs for MG, Chlamydia trachomatis (CT) and Neisseria Gonorrhoeae (NG) screening by nucleic acid amplification tests, and MG genotypic resistance mutations detection. Clinical data would be transcribed from medical records of recruited subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV-infected male who are attending the HIV specialist clinic in Hong Kong', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18 or older, male, HIV-infected, and are attendees of the HIV specialist clinic, and can communicate in written and spoken English or Chinese\n\nExclusion Criteria:\n\n* not able to provide consent'}, 'identificationModule': {'nctId': 'NCT05789134', 'briefTitle': 'Mycoplasma Genitalium Infection and Associated Antimicrobial Resistance Among HIV-infected Male in Hong Kong', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Mycoplasma Genitalium Infection and Associated Antimicrobial Resistance Among HIV-infected Male in Hong Kong', 'orgStudyIdInfo': {'id': '22210282'}}, 'armsInterventionsModule': {'interventions': [{'name': 'self-sampling kits for STI testing in the laboratory', 'type': 'OTHER', 'description': 'Participants will receive the self-sampling kits and their submitted samples would be sent to laboratory for testing'}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Hong Kong', 'state': 'Hong Kong, China', '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'}}}}