Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-03-03 @ 4:10 PM
Study NCT ID:
NCT04269434
Status:
COMPLETED
Last Update Posted:
2024-10-16
First Post:
2020-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
GonoScreen: Efficacy of Screening STIs in MSM
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006069', 'term': 'Gonorrhea'}], 'ancestors': [{'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015231', 'term': 'Sexually Transmitted Diseases, Bacterial'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ckenyon@itg.be', 'phone': '+3232470786', 'title': 'Dr. Chris Kenyon', 'organization': 'Instituut van Tropische Geneeskunde Antwerpen'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'No adverse event data collected in this study.', 'description': 'Serious and other \\[non-serious\\] adverse events were not collected or assessed as part of the study', 'eventGroups': [{'id': 'EG000', 'title': 'Screening', 'description': 'In the screening arm, Ng/Ct results will be sent by the STI Laboratory to the study physicians and these participants will be treated and partner contact tracing will be done.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No Screening', 'description': 'In the no screening arm, the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.\n\nNo Screening: the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence Rate of Ng Plus Ct Detected at Any Site Whilst Individuals Are Screened vs. Not Screened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '344', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screening', 'description': 'In the screening arm, Ng/Ct results will be sent by the STI Laboratory to the study physicians and these participants will be treated and partner contact tracing will be done.'}, {'id': 'OG001', 'title': 'No Screening', 'description': 'In the no screening arm, the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.\n\nNo Screening: the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.155', 'groupId': 'OG000', 'lowerLimit': '0.128', 'upperLimit': '0.186'}, {'value': '0.205', 'groupId': 'OG001', 'lowerLimit': '0.171', 'upperLimit': '0.246'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'paramType': 'Incidence rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.318', 'ciLowerLimit': '1.068', 'ciUpperLimit': '1.627', 'groupDescription': 'Compared to screening group', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The "No Screening Arm" is considered non-inferior if the upper limit of the 95% Confidence Interval is less than 1.25'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'number of diagnoses of Ng plus Ct in 12 months in screening/non-screening arms divided by number of scheduled study visits with available results for the diagnosis of Ng/Ct. The denominator does not include unscheduled visits.', 'unitOfMeasure': 'Ng or CT cases per study visit', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol analysis'}, {'type': 'SECONDARY', 'title': 'Cumulative Antimicrobial Exposure (Ceftriaxone/Azithromycin/Doxycycline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '344', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screening', 'description': 'In the screening arm, Ng/Ct results will be sent by the STI Laboratory to the study physicians and these participants will be treated and partner contact tracing will be done.'}, {'id': 'OG001', 'title': 'No Screening', 'description': 'In the no screening arm, the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.\n\nNo Screening: the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.'}], 'classes': [{'title': 'Azithromycin', 'categories': [{'measurements': [{'value': '0.0059', 'groupId': 'OG000', 'lowerLimit': '0.0055', 'upperLimit': '0.0063'}, {'value': '0.0046', 'groupId': 'OG001', 'lowerLimit': '0.0043', 'upperLimit': '0.0050'}]}]}, {'title': 'Ceftriaxone', 'categories': [{'measurements': [{'value': '0.0008', 'groupId': 'OG000', 'lowerLimit': '0.0007', 'upperLimit': '0.0009'}, {'value': '0.0004', 'groupId': 'OG001', 'lowerLimit': '0.0004', 'upperLimit': '0.0006'}]}]}, {'title': 'Doxycycline', 'categories': [{'measurements': [{'value': '0.0081', 'groupId': 'OG000', 'lowerLimit': '0.0075', 'upperLimit': '0.0086'}, {'value': '0.0044', 'groupId': 'OG001', 'lowerLimit': '0.0041', 'upperLimit': '0.0048'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'paramType': 'Incidence rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.788', 'ciLowerLimit': '0.719', 'ciUpperLimit': '0.863', 'groupDescription': 'For Azithromycin. Compared to screening group', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'No prespecified margin'}, {'groupIds': ['OG001'], 'paramType': 'Incidence rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.561', 'ciLowerLimit': '0.426', 'ciUpperLimit': '0.739', 'groupDescription': 'For Ceftriaxone. Compared to screening group', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'No prespecified margin'}, {'groupIds': ['OG001'], 'paramType': 'Incidence rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '0.515', 'ciUpperLimit': '0.588', 'groupDescription': 'For Doxycycline. Compared to screening group', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'No prespecified margin'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Number of standard doses per 1000 person-years for azithromycin, ceftriaxone and doxycycline', 'unitOfMeasure': 'doses per 1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of Symptomatic Ng Plus Ct', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '344', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screening', 'description': 'In the screening arm, Ng/Ct results will be sent by the STI Laboratory to the study physicians and these participants will be treated and partner contact tracing will be done.'}, {'id': 'OG001', 'title': 'No Screening', 'description': 'In the no screening arm, the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.\n\nNo Screening: the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.034', 'groupId': 'OG000', 'lowerLimit': '0.023', 'upperLimit': '0.049'}, {'value': '0.046', 'groupId': 'OG001', 'lowerLimit': '0.032', 'upperLimit': '0.067'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'paramType': 'Incidence rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.373', 'ciLowerLimit': '0.963', 'ciUpperLimit': '1.956', 'groupDescription': 'Compared to screening group', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'No prespecified margin.'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Number of diagnoses of symptomatic Ng and Ct infections over 12 months divided by number of visits', 'unitOfMeasure': 'Symptomatic infections per study visit', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of Syphilis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '344', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screening', 'description': 'In the screening arm, Ng/Ct results will be sent by the STI Laboratory to the study physicians and these participants will be treated and partner contact tracing will be done.'}, {'id': 'OG001', 'title': 'No Screening', 'description': 'In the no screening arm, the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.\n\nNo Screening: the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.018', 'groupId': 'OG000', 'lowerLimit': '0.011', 'upperLimit': '0.029'}, {'value': '0.026', 'groupId': 'OG001', 'lowerLimit': '0.016', 'upperLimit': '0.042'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'paramType': 'Incidence rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.471', 'ciLowerLimit': '0.943', 'ciUpperLimit': '2.299', 'groupDescription': 'Compared to screening group', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'No prespecified margin.'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Number of diagnoses of syphilis over 12 months divided by number of visits', 'unitOfMeasure': 'Syphilis cases per study visit', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Screening', 'description': 'In the screening arm, Ng/Ct results will be sent by the STI Laboratory to the study physicians and these participants will be treated and partner contact tracing will be done.'}, {'id': 'FG001', 'title': 'No Screening', 'description': 'In the no screening arm, the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.\n\nNo Screening: the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'First Participant First Visit (FPFV)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '506'}, {'groupId': 'FG001', 'numSubjects': '508'}]}, {'type': 'COMPLETED', 'comment': 'Last Participant Last Visit (LPLV)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '439'}, {'groupId': 'FG001', 'numSubjects': '440'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '68'}]}]}], 'recruitmentDetails': 'Recruitment started on 21st September 2020 and was completed on 4th June 2021. Participants were recruited at 5 sites (Institute of Tropical Medicine Antwerp, University Hospital Ghent, University Hospital Erasme Brussels, University Hospital Saint-Pierre Brussels and University Hospital Liège.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'BG000'}, {'value': '508', 'groupId': 'BG001'}, {'value': '1014', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Screening', 'description': 'In the screening arm, Ng/Ct results will be sent by the STI Laboratory to the study physicians and these participants will be treated and partner contact tracing will be done.'}, {'id': 'BG001', 'title': 'No Screening', 'description': 'In the no screening arm, the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.\n\nNo Screening: the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'BG000'}, {'value': '508', 'groupId': 'BG001'}, {'value': '1014', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000', 'lowerLimit': '33', 'upperLimit': '47'}, {'value': '39', 'groupId': 'BG001', 'lowerLimit': '32.5', 'upperLimit': '48'}, {'value': '39', 'groupId': 'BG002', 'lowerLimit': '33', 'upperLimit': '47'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Sex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'BG000'}, {'value': '508', 'groupId': 'BG001'}, {'value': '1014', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Male', 'measurements': [{'value': '506', 'groupId': 'BG000'}, {'value': '505', 'groupId': 'BG001'}, {'value': '1011', 'groupId': 'BG002'}]}, {'title': 'Transwoman', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Number of sex partners (last 3 months)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'BG000'}, {'value': '508', 'groupId': 'BG001'}, {'value': '1014', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '8'}, {'value': '4', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '8'}, {'value': '4', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Number of sex partners', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Number of sex partners (mean)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'BG000'}, {'value': '508', 'groupId': 'BG001'}, {'value': '1014', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.28', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '7.26', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '150'}, {'value': '6.77', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '150'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Number of sex partners', 'dispersionType': 'FULL_RANGE'}, {'title': 'Number of unprotected sex partners in the last 3 months', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'BG000'}, {'value': '508', 'groupId': 'BG001'}, {'value': '1014', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Number of unprotected sex partners', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Number of unprotected sex partners (mean)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'BG000'}, {'value': '508', 'groupId': 'BG001'}, {'value': '1014', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.80', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '40'}, {'value': '4.28', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '4.04', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Number of unprotected sex partners', 'dispersionType': 'FULL_RANGE'}, {'title': 'STI symptoms', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'BG000'}, {'value': '508', 'groupId': 'BG001'}, {'value': '1014', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '504', 'groupId': 'BG000'}, {'value': '503', 'groupId': 'BG001'}, {'value': '1007', 'groupId': 'BG002'}]}, {'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Antibiotics in the last 6 months', 'classes': [{'title': 'Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'BG000'}, {'value': '508', 'groupId': 'BG001'}, {'value': '1014', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '365', 'groupId': 'BG002'}]}]}, {'title': 'Cephalosporins', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'BG000'}, {'value': '508', 'groupId': 'BG001'}, {'value': '1014', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}]}, {'title': 'Macroloides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'BG000'}, {'value': '508', 'groupId': 'BG001'}, {'value': '1014', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}]}, {'title': 'Penicillins', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'BG000'}, {'value': '508', 'groupId': 'BG001'}, {'value': '1014', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}]}, {'title': 'Quinolones', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'BG000'}, {'value': '508', 'groupId': 'BG001'}, {'value': '1014', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Tetracyclines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'BG000'}, {'value': '508', 'groupId': 'BG001'}, {'value': '1014', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'BG000'}, {'value': '508', 'groupId': 'BG001'}, {'value': '1014', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-28', 'size': 1094966, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-03-02T09:49', 'hasProtocol': True}, {'date': '2021-06-01', 'size': 368939, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-03-02T09:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The study statistician will be blinded until the statistical analysis plan (SAP) is approved'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1014}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-11', 'studyFirstSubmitDate': '2020-02-11', 'resultsFirstSubmitDate': '2023-04-03', 'studyFirstSubmitQcDate': '2020-02-12', 'lastUpdatePostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-11', 'studyFirstPostDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence Rate of Ng Plus Ct Detected at Any Site Whilst Individuals Are Screened vs. Not Screened', 'timeFrame': '12 months', 'description': 'number of diagnoses of Ng plus Ct in 12 months in screening/non-screening arms divided by number of scheduled study visits with available results for the diagnosis of Ng/Ct. The denominator does not include unscheduled visits.'}], 'secondaryOutcomes': [{'measure': 'Cumulative Antimicrobial Exposure (Ceftriaxone/Azithromycin/Doxycycline)', 'timeFrame': '12 months', 'description': 'Number of standard doses per 1000 person-years for azithromycin, ceftriaxone and doxycycline'}, {'measure': 'Incidence Rate of Symptomatic Ng Plus Ct', 'timeFrame': '12 months', 'description': 'Number of diagnoses of symptomatic Ng and Ct infections over 12 months divided by number of visits'}, {'measure': 'Incidence Rate of Syphilis', 'timeFrame': '12 months', 'description': 'Number of diagnoses of syphilis over 12 months divided by number of visits'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['screening'], 'conditions': ['Neisseria Gonorrhoeae Infection', 'Chlamydia Trachomatis Infection']}, 'referencesModule': {'references': [{'pmid': '38423024', 'type': 'DERIVED', 'citation': "Vanbaelen T, Tsoumanis A, Florence E, Van Dijck C, Huis In 't Veld D, Sauvage AS, Herssens N, De Baetselier I, Rotsaert A, Verhoeven V, Henrard S, Van Herrewege Y, Van den Bossche D, Goffard JC, Padalko E, Reyniers T, Vuylsteke B, Hayette MP, Libois A, Kenyon C. Effect of screening for Neisseria gonorrhoeae and Chlamydia trachomatis on incidence of these infections in men who have sex with men and transgender women taking HIV pre-exposure prophylaxis (the Gonoscreen study): results from a randomised, multicentre, controlled trial. Lancet HIV. 2024 Apr;11(4):e233-e244. doi: 10.1016/S2352-3018(23)00299-0. Epub 2024 Feb 26."}]}, 'descriptionModule': {'briefSummary': 'A Multicentre, controlled, randomized trial of 3 site (urethra, pharynx and rectum) sampling performed every 3 months (3x3) for Neisseria gonorrhoea (Ng)/Chlamydia trachomatis (Ct) screening (comparator) vs. no screening (intervention).', 'detailedDescription': 'This study is a multicentre, controlled, randomized trial of 3x3 Ng/Ct screening (comparator) vs. no screening (intervention). It will be performed in the PrEP cohorts situated at the Institute of Tropical Medicine (ITM), Hôpital Saint-Pierre (HSP), Liège University Hospital (CHU), University Hospital of Gent (UZG) and Erasmus Hospital (EH). All men in follow up at these five centres who report having had sex with another man in the previous year and are enrolled for PrEP follow up will be eligible to participate in the study. After signing informed consent participants will be randomized via a computer-generated schema to either 3x3 screening or no Ng/Ct screening. In both arms, participants will be followed up in an identical fashion including 3x3 screening. The only difference between the arms will be that in the screening arm, Ng/Ct results will be sent by the STI Laboratory to the study physicians and these participants will be treated and partner contact tracing will be done. The Sexually Transmitted Infection (STI) Laboratory will only process the samples/report the results from the non-screening arm at the end of the study. In both arms, all individuals with symptoms compatible with Ng or Ct will be tested and treated for these infections according to current best practice guidelines. At the end of the 12-month study period, participants whose most recent tests were positive for Ng or Ct will receive treatment for these.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able and willing to provide informed consent\n* Men (born as males) and transwomen aged 18 or more\n* Has had sex\\*\\* with another man in the last 12 months\n* Enrolled in Belgian PrEP program at ITM/HSP/EH/CHU/UZG with approval for TDF/FTC (Tenofovir disoproxil fumarate/Emtricitabine) reimbursement from a Belgian Medical Aid\n* Willing to comply with the study procedures and to attend the clinic for the 3-monthly visits\n\nExclusion Criteria:\n\n* Enrolment in another interventional trial\n* Tests HIV-positive at screening\n* Symptoms of proctitis or urethritis'}, 'identificationModule': {'nctId': 'NCT04269434', 'acronym': 'GonoScreen', 'briefTitle': 'GonoScreen: Efficacy of Screening STIs in MSM', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Tropical Medicine, Belgium'}, 'officialTitle': 'Does Screening for Gonorrhea and Chlamydia Affect the Incidence of These Infections in Men Who Have Sex With Men Taking HIV Pre Exposure Prophylaxis (PrEP): a Randomized, Multicentre Controlled Trial', 'orgStudyIdInfo': {'id': 'ITM202002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Screening', 'description': 'In the screening arm, Ng/Ct results will be sent by the STI Laboratory to the study physicians and these participants will be treated and partner contact tracing will be done.'}, {'type': 'OTHER', 'label': 'No screening', 'description': 'In the no screening arm, the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.', 'interventionNames': ['Other: No Screening']}], 'interventions': [{'name': 'No Screening', 'type': 'OTHER', 'description': 'the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.', 'armGroupLabels': ['No screening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2000', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Institute of Tropical Medicine', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Saint-Pierre', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hôpital Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '4000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'UZGent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Liège', 'country': 'Belgium', 'facility': 'CHU Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'overallOfficials': [{'name': 'Chris Kenyon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Tropical Medicine Antwerp'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Tropical Medicine, Belgium', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}