Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-22 @ 6:12 AM
Study NCT ID:
NCT03044158
Status:
COMPLETED
Last Update Posted:
2025-02-18
First Post:
2017-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
GeneXpert Performance Evaluation for Linkage to Tuberculosis Care
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014397', 'term': 'Tuberculosis, Pulmonary'}, {'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Adithya.Cattamanchi@uci.edu', 'phone': '714-456-2959', 'title': 'Adithya Cattamanchi', 'organization': 'University of California Irvine'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Vital status was assessed up to 18 months following health center visit', 'description': 'For all-cause mortality, the denominator excludes those with unknown vital status and unknown HIV status. Vital status was ascertained through review of TB treatment registers, phone calls, and home visits.\n\nSerious and Other \\[Not Including Serious\\] Adverse Events were not monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Control Group', 'description': 'Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 3857, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 154, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intervention', 'description': 'Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback\n\nGeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy\n\nProcess re-design: Research and Uganda NTLP staff will engage health center staff in a discussion of how to re-organize clinical, laboratory and pharmacy services to enable same-day TB diagnosis and treatment.\n\nPerformance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 4556, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 145, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number Treated for Microbiologically-confirmed TB Within 14 Days After Presentation to the Health Center for TB Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5098', 'groupId': 'OG000'}, {'value': '5546', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback\n\nGeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy\n\nProcess re-design: Research and Uganda NTLP staff will engage health center staff in a discussion of how to re-organize clinical, laboratory and pharmacy services to enable same-day TB diagnosis and treatment.\n\nPerformance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff'}], 'classes': [{'categories': [{'measurements': [{'value': '220', 'groupId': 'OG000'}, {'value': '342', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Ratio (adjusted)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.56', 'ciLowerLimit': '1.21', 'ciUpperLimit': '2.01', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 14 days after presentation to the health center for tuberculosis evaluation', 'description': 'Effectiveness outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number Diagnosed With Microbiologically-confirmed TB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5098', 'groupId': 'OG000'}, {'value': '5546', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback\n\nGeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy\n\nProcess re-design: Research and Uganda NTLP staff will engage health center staff in a discussion of how to re-organize clinical, laboratory and pharmacy services to enable same-day TB diagnosis and treatment.\n\nPerformance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff'}], 'classes': [{'categories': [{'measurements': [{'value': '299', 'groupId': 'OG000'}, {'value': '389', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Ratio (adjusted)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.28', 'ciLowerLimit': '0.99', 'ciUpperLimit': '1.66', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 14 days after presentation to the health center for tuberculosis evaluation', 'description': 'Effectiveness outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Microbiologically-confirmed TB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback\n\nGeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy\n\nProcess re-design: Research and Uganda NTLP staff will engage health center staff in a discussion of how to re-organize clinical, laboratory and pharmacy services to enable same-day TB diagnosis and treatment.\n\nPerformance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio (adjusted)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.49', 'ciLowerLimit': '0.39', 'ciUpperLimit': '0.62', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 6 months of presentation to the health center for tuberculosis evaluation', 'description': 'Effectiveness outcome. Time-to-diagnosis if microbiologically-confirmed TB.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "All participants' data was analyzed to determine who had confirmed TB."}, {'type': 'SECONDARY', 'title': 'Number Treated for TB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5098', 'groupId': 'OG000'}, {'value': '5546', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback\n\nGeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy\n\nProcess re-design: Research and Uganda NTLP staff will engage health center staff in a discussion of how to re-organize clinical, laboratory and pharmacy services to enable same-day TB diagnosis and treatment.\n\nPerformance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff'}], 'classes': [{'categories': [{'measurements': [{'value': '339', 'groupId': 'OG000'}, {'value': '485', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Ratio (adjusted)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.48', 'ciLowerLimit': '1.04', 'ciUpperLimit': '2.12', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 14 days of presentation to the health center for tuberculosis evaluation', 'description': 'Effectiveness outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time-to-treatment of Microbiologically-confirmed TB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback\n\nGeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy\n\nProcess re-design: Research and Uganda NTLP staff will engage health center staff in a discussion of how to re-organize clinical, laboratory and pharmacy services to enable same-day TB diagnosis and treatment.\n\nPerformance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio (adjusted)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.35', 'ciLowerLimit': '0.21', 'ciUpperLimit': '0.56', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Days from initial health center visit to initiation of treatment if diagnosed, up to 6 months.', 'description': 'Effectiveness outcome. Time-to-treatment if microbiologically-confirmed TB and treated.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "All participants' data was analyzed to determine who had confirmed TB and treatment initiated."}, {'type': 'SECONDARY', 'title': 'Number Who Died Within 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3695', 'groupId': 'OG000'}, {'value': '4421', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback\n\nGeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy\n\nProcess re-design: Research and Uganda NTLP staff will engage health center staff in a discussion of how to re-organize clinical, laboratory and pharmacy services to enable same-day TB diagnosis and treatment.\n\nPerformance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff'}], 'classes': [{'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.44', 'ciUpperLimit': '1.35', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 6 months of presentation to the health center for tuberculosis evaluation', 'description': 'Effectiveness outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes those with vital status follow-up at six months post-visit to health center'}, {'type': 'SECONDARY', 'title': 'Number of Patients Enrolled', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5098', 'groupId': 'OG000'}, {'value': '5546', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback\n\nGeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy\n\nProcess re-design: Research and Uganda NTLP staff will engage health center staff in a discussion of how to re-organize clinical, laboratory and pharmacy services to enable same-day TB diagnosis and treatment.\n\nPerformance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff'}], 'classes': [{'categories': [{'measurements': [{'value': '5098', 'groupId': 'OG000'}, {'value': '5546', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Presentation to the health center for tuberculosis evaluation during the 16-month study time frame', 'description': 'Effectiveness outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible were enrolled as there was a waiver of informed consent'}, {'type': 'SECONDARY', 'title': 'Number Tested for TB According to National Guidelines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5098', 'groupId': 'OG000'}, {'value': '5546', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback\n\nGeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy\n\nProcess re-design: Research and Uganda NTLP staff will engage health center staff in a discussion of how to re-organize clinical, laboratory and pharmacy services to enable same-day TB diagnosis and treatment.\n\nPerformance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff'}], 'classes': [{'categories': [{'measurements': [{'value': '2687', 'groupId': 'OG000'}, {'value': '5108', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 6 months of presentation to the health center for tuberculosis evaluation', 'description': 'Effectiveness outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number Suspected/Diagnosed With Rifampin-resistant TB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5201', 'groupId': 'OG000'}, {'value': '5637', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback\n\nGeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy\n\nProcess re-design: Research and Uganda NTLP staff will engage health center staff in a discussion of how to re-organize clinical, laboratory and pharmacy services to enable same-day TB diagnosis and treatment.\n\nPerformance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 6 months of presentation to the health center for tuberculosis evaluation', 'description': 'Effectiveness outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The data analyzed included all adult patients in the target population. Those with rifampin-resistant tuberculosis, extrapulmonary tuberculosis and/or missing age data were excluded from the trial population. Therefore, the number of participants analyzed for this measure differs from other parts of the record.'}, {'type': 'SECONDARY', 'title': 'Number Diagnosed and Treated for Microbiologically-confirmed TB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5098', 'groupId': 'OG000'}, {'value': '5546', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback\n\nGeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy\n\nProcess re-design: Research and Uganda NTLP staff will engage health center staff in a discussion of how to re-organize clinical, laboratory and pharmacy services to enable same-day TB diagnosis and treatment.\n\nPerformance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff'}], 'classes': [{'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'On the same-day of presentation to the health center for tuberculosis evaluation', 'description': 'Effectiveness outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number Diagnosed AND Treated for TB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5098', 'groupId': 'OG000'}, {'value': '5546', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback\n\nGeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy\n\nProcess re-design: Research and Uganda NTLP staff will engage health center staff in a discussion of how to re-organize clinical, laboratory and pharmacy services to enable same-day TB diagnosis and treatment.\n\nPerformance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff'}], 'classes': [{'categories': [{'measurements': [{'value': '199', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'On the same-day of presentation to the health center for tuberculosis evaluation', 'description': 'Effectiveness outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group', 'description': 'Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols'}, {'id': 'FG001', 'title': 'Intervention', 'description': 'Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback\n\nGeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy\n\nProcess re-design: Research and Uganda NTLP staff will engage health center staff in a discussion of how to re-organize clinical, laboratory and pharmacy services to enable same-day TB diagnosis and treatment.\n\nPerformance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '10', 'numSubjects': '5098'}, {'groupId': 'FG001', 'numUnits': '10', 'numSubjects': '5546'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '10', 'numSubjects': '5098'}, {'groupId': 'FG001', 'numUnits': '10', 'numSubjects': '5546'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Community Health Centers'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5098', 'groupId': 'BG000'}, {'value': '5546', 'groupId': 'BG001'}, {'value': '10644', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group', 'description': 'Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols'}, {'id': 'BG001', 'title': 'Intervention', 'description': 'Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback\n\nGeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy\n\nProcess re-design: Research and Uganda NTLP staff will engage health center staff in a discussion of how to re-organize clinical, laboratory and pharmacy services to enable same-day TB diagnosis and treatment.\n\nPerformance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5098', 'groupId': 'BG000'}, {'value': '5546', 'groupId': 'BG001'}, {'value': '10644', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '50'}, {'value': '40', 'groupId': 'BG001', 'lowerLimit': '30', 'upperLimit': '52'}, {'value': '40', 'groupId': 'BG002', 'lowerLimit': '29', 'upperLimit': '51'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5098', 'groupId': 'BG000'}, {'value': '5546', 'groupId': 'BG001'}, {'value': '10644', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '3112', 'groupId': 'BG000'}, {'value': '3289', 'groupId': 'BG001'}, {'value': '6401', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1986', 'groupId': 'BG000'}, {'value': '2257', 'groupId': 'BG001'}, {'value': '4243', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5098', 'groupId': 'BG000'}, {'value': '5546', 'groupId': 'BG001'}, {'value': '10644', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5098', 'groupId': 'BG000'}, {'value': '5546', 'groupId': 'BG001'}, {'value': '10644', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5098', 'groupId': 'BG000'}, {'value': '5546', 'groupId': 'BG001'}, {'value': '10644', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5098', 'groupId': 'BG000'}, {'value': '5546', 'groupId': 'BG001'}, {'value': '10644', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Uganda', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5098', 'groupId': 'BG000'}, {'value': '5546', 'groupId': 'BG001'}, {'value': '10644', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5098', 'groupId': 'BG000'}, {'value': '5546', 'groupId': 'BG001'}, {'value': '10644', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HIV infection', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4290', 'groupId': 'BG000'}, {'value': '5273', 'groupId': 'BG001'}, {'value': '9563', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1905', 'groupId': 'BG000'}, {'value': '2285', 'groupId': 'BG001'}, {'value': '4190', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Excludes participants with unknown HIV status'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-12', 'size': 2322008, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-30T22:33', 'hasProtocol': True}, {'date': '2020-04-22', 'size': 176369, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-05-02T15:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10644}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-30', 'studyFirstSubmitDate': '2017-01-23', 'resultsFirstSubmitDate': '2024-05-02', 'studyFirstSubmitQcDate': '2017-02-02', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-30', 'studyFirstPostDateStruct': {'date': '2017-02-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number Treated for Microbiologically-confirmed TB Within 14 Days After Presentation to the Health Center for TB Evaluation', 'timeFrame': 'Within 14 days after presentation to the health center for tuberculosis evaluation', 'description': 'Effectiveness outcome.'}], 'secondaryOutcomes': [{'measure': 'Number Diagnosed With Microbiologically-confirmed TB', 'timeFrame': 'Within 14 days after presentation to the health center for tuberculosis evaluation', 'description': 'Effectiveness outcome.'}, {'measure': 'Time to Microbiologically-confirmed TB', 'timeFrame': 'Within 6 months of presentation to the health center for tuberculosis evaluation', 'description': 'Effectiveness outcome. Time-to-diagnosis if microbiologically-confirmed TB.'}, {'measure': 'Number Treated for TB', 'timeFrame': 'Within 14 days of presentation to the health center for tuberculosis evaluation', 'description': 'Effectiveness outcome.'}, {'measure': 'Time-to-treatment of Microbiologically-confirmed TB', 'timeFrame': 'Days from initial health center visit to initiation of treatment if diagnosed, up to 6 months.', 'description': 'Effectiveness outcome. Time-to-treatment if microbiologically-confirmed TB and treated.'}, {'measure': 'Number Who Died Within 6 Months', 'timeFrame': 'Within 6 months of presentation to the health center for tuberculosis evaluation', 'description': 'Effectiveness outcome.'}, {'measure': 'Number of Patients Enrolled', 'timeFrame': 'Presentation to the health center for tuberculosis evaluation during the 16-month study time frame', 'description': 'Effectiveness outcome.'}, {'measure': 'Number Tested for TB According to National Guidelines', 'timeFrame': 'Within 6 months of presentation to the health center for tuberculosis evaluation', 'description': 'Effectiveness outcome.'}, {'measure': 'Number Suspected/Diagnosed With Rifampin-resistant TB', 'timeFrame': 'Within 6 months of presentation to the health center for tuberculosis evaluation', 'description': 'Effectiveness outcome.'}, {'measure': 'Number Diagnosed and Treated for Microbiologically-confirmed TB', 'timeFrame': 'On the same-day of presentation to the health center for tuberculosis evaluation', 'description': 'Effectiveness outcome.'}, {'measure': 'Number Diagnosed AND Treated for TB', 'timeFrame': 'On the same-day of presentation to the health center for tuberculosis evaluation', 'description': 'Effectiveness outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tuberculosis', 'implementation science', 'point-of-care', 'diagnostics', 'GeneXpert', 'Uganda'], 'conditions': ['Tuberculosis, Pulmonary', 'Rifampicin Resistant Tuberculosis']}, 'referencesModule': {'references': [{'pmid': '24623906', 'type': 'BACKGROUND', 'citation': 'MacPherson P, Houben RM, Glynn JR, Corbett EL, Kranzer K. 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Healthcare professionals' intentions and behaviours: a systematic review of studies based on social cognitive theories. Implement Sci. 2008 Jul 16;3:36. doi: 10.1186/1748-5908-3-36."}, {'pmid': '1501333', 'type': 'BACKGROUND', 'citation': 'Davis DA, Thomson MA, Oxman AD, Haynes RB. Evidence for the effectiveness of CME. A review of 50 randomized controlled trials. JAMA. 1992 Sep 2;268(9):1111-7.'}, {'pmid': '25609495', 'type': 'BACKGROUND', 'citation': 'Cattamanchi A, Miller CR, Tapley A, Haguma P, Ochom E, Ackerman S, Davis JL, Katamba A, Handley MA. Health worker perspectives on barriers to delivery of routine tuberculosis diagnostic evaluation services in Uganda: a qualitative study to guide clinic-based interventions. BMC Health Serv Res. 2015 Jan 22;15:10. doi: 10.1186/s12913-014-0668-0.'}, {'pmid': '22696318', 'type': 'BACKGROUND', 'citation': "Ivers N, Jamtvedt G, Flottorp S, Young JM, Odgaard-Jensen J, French SD, O'Brien MA, Johansen M, Grimshaw J, Oxman AD. Audit and feedback: effects on professional practice and healthcare outcomes. Cochrane Database Syst Rev. 2012 Jun 13;2012(6):CD000259. doi: 10.1002/14651858.CD000259.pub3."}, {'pmid': '11101705', 'type': 'BACKGROUND', 'citation': 'Grogan S, Conner M, Norman P, Willits D, Porter I. Validation of a questionnaire measuring patient satisfaction with general practitioner services. Qual Health Care. 2000 Dec;9(4):210-5. doi: 10.1136/qhc.9.4.210.'}, {'pmid': '21775313', 'type': 'BACKGROUND', 'citation': 'Nabbuye-Sekandi J, Makumbi FE, Kasangaki A, Kizza IB, Tugumisirize J, Nshimye E, Mbabali S, Peters DH. Patient satisfaction with services in outpatient clinics at Mulago hospital, Uganda. Int J Qual Health Care. 2011 Oct;23(5):516-23. doi: 10.1093/intqhc/mzr040. Epub 2011 Jul 19.'}, {'pmid': '22853820', 'type': 'BACKGROUND', 'citation': 'Ivers NM, Halperin IJ, Barnsley J, Grimshaw JM, Shah BR, Tu K, Upshur R, Zwarenstein M. 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The impact of novel tests for tuberculosis depends on the diagnostic cascade. Eur Respir J. 2014 Nov;44(5):1366-9. doi: 10.1183/09031936.00111014. Epub 2014 Sep 3.'}, {'type': 'BACKGROUND', 'citation': 'Chandrasekaran V, Ramachandran R, Cunningham J, Balasubramaniun R, Thomas A, Sudha G, et al. Factors leading to tuberculosis diagnostic drop-out and delayed treatment initiation in Chennai, India. Int J Tuberc Lung Dis. 2005;9:172.'}, {'type': 'BACKGROUND', 'citation': 'Den Boon S, Semitala F, Cattamanchi A, Walter N, Worodria W, Joloba M, Huang L, Davis JL. Impact of patient drop-out on the effective sensitivity of smear microscopy strategies. Am J Respir Crit Care Med 2010;181:A2258.'}, {'type': 'BACKGROUND', 'citation': 'Miller C, Haguma P, Ochom E, Ross J, Davis JL, Cattamanchi A, Katamba A. Costs associated with tuberculosis evaluation in rural Uganda. 43rd Union World Conference on Lung Health; Kuala Lumpur, Malaysia 2012.'}, {'type': 'BACKGROUND', 'citation': 'WHO. Global strategy and targets for tuberculosis prevention, care and control after 2015. Geneva, Switzerland: World Health Organization, 2013 EB134/12.'}, {'type': 'BACKGROUND', 'citation': 'WHO. WHO monitoring of Xpert MTB/RIF roll-out. Available at: http://www.who.int/tb/areas-of-work/laboratory/mtb-rif-rollout/en/ [cited 2015 January 15].'}, {'type': 'BACKGROUND', 'citation': 'Churchyard GJ, on behalf of the Xtend study team. Xpert MTB/RIF vs microscopy as the first line TB test in South Africa: mortality, yield, initial loss to follow up and proportion treated. The Xtend Study. Conference on Retroviruses and Opportunistic Infections; Boston, USA: Available at: http://www.stoptb.org/wg/gli/assets/documents/M6/Churchyard%20-%20XTEND%20study.pdf; 2014.'}, {'type': 'BACKGROUND', 'citation': 'Cepheid. GeneXpert Omni: The True Point of Care Molecular Diagnostic System: Cepheid Inc; 2015. Available from: http://www.cepheid.com/us/genexpert-omni.'}, {'type': 'BACKGROUND', 'citation': 'Ajzen I. The theory of planned behavior. Organizational Behavior and Human Decision Processes. 1991;50:179-211.'}, {'type': 'BACKGROUND', 'citation': 'Green LW, Krueter M. Health Program Planning - An Educational and Ecological Approach. 4th ed. Philadelphia, USA: McGraw-Hill; 2005.'}, {'type': 'BACKGROUND', 'citation': 'Hayes RJ, Moulton LH. Cluster Randomized Trials. Boca Raton, Florida, USA: CRC Press; 2009.'}, {'pmid': '34936740', 'type': 'DERIVED', 'citation': 'Cattamanchi A, Reza TF, Nalugwa T, Adams K, Nantale M, Oyuku D, Nabwire S, Babirye D, Turyahabwe S, Tucker A, Sohn H, Ferguson O, Thompson R, Shete PB, Handley MA, Ackerman S, Joloba M, Moore DAJ, Davis JL, Dowdy DW, Fielding K, Katamba A. Multicomponent Strategy with Decentralized Molecular Testing for Tuberculosis. N Engl J Med. 2021 Dec 23;385(26):2441-2450. doi: 10.1056/NEJMoa2105470.'}, {'pmid': '32316993', 'type': 'DERIVED', 'citation': 'Reza TF, Nalugwa T, Farr K, Nantale M, Oyuku D, Nakaweesa A, Musinguzi J, Vangala M, Shete PB, Tucker A, Ferguson O, Fielding K, Sohn H, Dowdy D, Moore DAJ, Davis JL, Ackerman SL, Handley MA, Katamba A, Cattamanchi A. Study protocol: a cluster randomized trial to evaluate the effectiveness and implementation of onsite GeneXpert testing at community health centers in Uganda (XPEL-TB). Implement Sci. 2020 Apr 21;15(1):24. doi: 10.1186/s13012-020-00988-y.'}]}, 'descriptionModule': {'briefSummary': "The investigators' overall objective is to assess the effectiveness, implementation and costs of a streamlined TB diagnostic evaluation strategy based around rapid, onsite molecular testing. The intervention strategy was developed based on theory-informed assessment of barriers to TB diagnostic evaluation at community health centers in Uganda and a process of engagement with local stakeholders. It includes: 1) Point-of-care molecular testing using GeneXpert as a replacement for sputum smear microscopy; 2) Re-structuring of clinic-level procedures to facilitate same-day TB diagnosis and treatment; and 3) Quarterly feedback of TB evaluation metrics to health center staff. The investigators' central hypothesis is that the intervention strategy will have high uptake and increase the number of patients diagnosed with and treated for active pulmonary TB. To test this hypothesis, the investigators will conduct a pragmatic cluster-randomized trial at community health centers that provide TB microscopy services in Uganda in partnership with the National TB Program (NTP). The investigators utilize an effectiveness-implementation hybrid design in which, concurrent with the clinical trial, the investigators will conduct nested mixed methods, health economic and modeling studies to assess 1) whether the intervention strategy modifies targeted barriers to TB diagnostic evaluation; 2) fidelity of implementation of the intervention components (i.e, the degree to which intervention components were implemented as intended vs. adapted across sites); and 3) cost-effectiveness and public health impact.", 'detailedDescription': 'Aim 1: To compare patient outcomes at health centers randomized to intervention vs. standard-of-care TB diagnostic evaluation strategies. The investigators will randomize 20 community health centers to continue standard TB evaluation (routine microscopy plus referral of patients for Xpert testing per existing processes of care) or to implement the intervention strategy (1. Onsite molecular testing; 2. Re-structuring clinic-level procedures to facilitate same-day TB diagnosis and treatment; and 3. Performance feedback). The investigators will compare reach and effectiveness based on the numbers and proportions of patients (N=5500) who complete TB testing, are found to have TB, and have treatment initiated within one week of specimen provision.\n\nAim 2: To identify processes and contextual factors that influence the effectiveness and fidelity of the intervention TB diagnostic evaluation strategy. The investigators will use quantitative process metrics to assess the adoption and maintenance over time of the core components of the intervention strategy. The investigators will also collect quantitative and qualitative data to describe the fidelity of implementation of each component and faithfulness to the conceptual model.\n\nAim 3: To compare the costs and epidemiological impact of intervention vs. standard-of-care TB diagnostic evaluation strategies. The investigators will model the incremental costs and cost-effectiveness of intervention relative to standard-of-care TB diagnostic evaluation from the health system and patient perspective. The investigators will then construct an epidemic model of the population-level impact of the intervention strategy on TB incidence and mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Site-level: Use standard (multi-day) sputum smear microscopy as the primary method of TB diagnosis\n* Site-level: Participate in NTP-sponsored external quality assurance (EQA) for sputum smear microscopy\n* Site-level: Send samples to a district or regional hospital/health center for Xpert testing\n* Patient-level: Initiate evaluation for active TB at a study health center\n\nExclusion Criteria:\n\n* Site-level: Do not agree to be randomized to standard-of-care vs. intervention arms\n* Site-level: Perform sputum smear examination on \\<150 patients per year (based on 2015 data)\n* Site-level: Diagnose \\<15 smear-positive TB cases per year (based on 2015 data)\n* Patient-level: Have sputum collected for monitoring of response to anti-TB therapy\n* Patient-level: Have sputum collected as part of active, community-based case finding (e.g., contact tracing, community outreach campaign)\n* Patient-level: Referred to a study health center for TB treatment after a diagnosis is established elsewhere\n* Patient-level: Started on TB treatment for extra-pulmonary TB only'}, 'identificationModule': {'nctId': 'NCT03044158', 'acronym': 'XPEL-TB', 'briefTitle': 'GeneXpert Performance Evaluation for Linkage to Tuberculosis Care', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'GeneXpert Performance Evaluation for Linkage to Tuberculosis Care: The XPEL-TB Trial', 'orgStudyIdInfo': {'id': 'R01HL130192', 'link': 'https://reporter.nih.gov/quickSearch/R01HL130192', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'PACTR201610001763265', 'type': 'REGISTRY', 'domain': 'Pan African Clinical Trials Registry'}, {'id': 'R01HL130192', 'link': 'https://reporter.nih.gov/quickSearch/R01HL130192', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Onsite molecular testing for TB with GeneXpert I + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback', 'interventionNames': ['Device: GeneXpert I', 'Behavioral: Process re-design', 'Other: Performance Feedback']}], 'interventions': [{'name': 'GeneXpert I', 'type': 'DEVICE', 'otherNames': ['GeneXpert'], 'description': 'Onsite molecular testing with GeneXpert I as a replacement for microscopy', 'armGroupLabels': ['Intervention']}, {'name': 'Process re-design', 'type': 'BEHAVIORAL', 'description': 'Research and Uganda NTLP staff will engage health center staff in a discussion of how to re-organize clinical, laboratory and pharmacy services to enable same-day TB diagnosis and treatment.', 'armGroupLabels': ['Intervention']}, {'name': 'Performance Feedback', 'type': 'OTHER', 'description': 'Feedback of TB diagnostic evaluation quality indicators to health center staff', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buikwe', 'country': 'Uganda', 'facility': 'St Francis Njeru Health Center III', 'geoPoint': {'lat': 0.3375, 'lon': 33.01056}}, {'city': 'Busana', 'country': 'Uganda', 'facility': 'Busana Health Center III', 'geoPoint': {'lat': 0.76667, 'lon': 32.98333}}, {'city': 'Busesa', 'country': 'Uganda', 'facility': 'Busesa Health Center IV', 'geoPoint': {'lat': 0.62631, 'lon': 33.60027}}, {'city': 'Buwama', 'country': 'Uganda', 'facility': 'Buwama Health Center III', 'geoPoint': {'lat': 0.06247, 'lon': 32.10596}}, {'city': 'Iganga', 'country': 'Uganda', 'facility': 'Iganga TC', 'geoPoint': {'lat': 0.60917, 'lon': 33.46861}}, {'city': 'Kalungu', 'country': 'Uganda', 'facility': 'Bukulula Health Center IV', 'geoPoint': {'lat': 1.66872, 'lon': 32.84594}}, {'city': 'Kayunga', 'country': 'Uganda', 'facility': 'Nazigo Health Center III', 'geoPoint': {'lat': 0.7025, 'lon': 32.88861}}, {'city': 'Kiganda', 'country': 'Uganda', 'facility': 'Kiganda Health Center IV', 'geoPoint': {'lat': 1.06667, 'lon': 33.58333}}, {'city': 'Kira', 'country': 'Uganda', 'facility': 'Kira Health Center III', 'geoPoint': {'lat': 0.4, 'lon': 32.63333}}, {'city': 'Lugala', 'country': 'Uganda', 'facility': 'Lugasa Health Center III', 'geoPoint': {'lat': 0.68333, 'lon': 32.8}}, {'city': 'Luwero', 'country': 'Uganda', 'facility': 'Bishop Asili Health Center', 'geoPoint': {'lat': 0.84917, 'lon': 32.47306}}, {'city': 'Lwengo', 'country': 'Uganda', 'facility': 'Kinoni Health Center III', 'geoPoint': {'lat': -0.41611, 'lon': 31.40806}}, {'city': 'Mayuge', 'country': 'Uganda', 'facility': 'Kityerera Health Center IV', 'geoPoint': {'lat': 0.45972, 'lon': 33.48028}}, {'city': 'Mayuge', 'country': 'Uganda', 'facility': 'Malongo Health Center III', 'geoPoint': {'lat': 0.45972, 'lon': 33.48028}}, {'city': 'Mayuge', 'country': 'Uganda', 'facility': 'Mayuge Health Center III', 'geoPoint': {'lat': 0.45972, 'lon': 33.48028}}, {'city': 'Mayuge', 'country': 'Uganda', 'facility': 'Wabulungu Health Center III', 'geoPoint': {'lat': 0.45972, 'lon': 33.48028}}, {'city': 'Mityana', 'country': 'Uganda', 'facility': 'Malangala Health Center III', 'geoPoint': {'lat': 0.4175, 'lon': 32.02278}}, {'city': 'Nakasongola', 'country': 'Uganda', 'facility': 'Lwampanga Health Center III', 'geoPoint': {'lat': 1.30889, 'lon': 32.45639}}, {'city': 'Namungalwe', 'country': 'Uganda', 'facility': 'Namungalwe Health Center III', 'geoPoint': {'lat': 0.71521, 'lon': 33.5066}}, {'city': 'Nankandulo', 'country': 'Uganda', 'facility': 'Nankandulo Health Center IV', 'geoPoint': {'lat': 0.67953, 'lon': 33.07862}}], 'overallOfficials': [{'name': 'Adithya Cattamanchi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Makerere University', 'class': 'OTHER'}, {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, {'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}, {'name': 'Yale University', 'class': 'OTHER'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}