Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2026-01-05 @ 5:58 PM
Study NCT ID:
NCT04088656
Status:
COMPLETED
Last Update Posted:
2024-11-27
First Post:
2019-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Systems Analysis and Improvement Approach for the Hypertension Care Cascade
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chazim@uw.edu', 'phone': '4042451459', 'title': 'Carmen Hazim', 'organization': 'University of Washingtion'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, an average of 3 years.', 'description': 'Definition of adverse event / serious adverse event does not differ from that of clinicaltrials.gov. Adverse Events were only monitored/assessed in healthcare worker participants. No healthcare worker participants were at risk in the control arm as no intervention was applied and thus no healthcare workers were exposed or at risk. All-Cause Mortality, Serious Adverse Events, and Other Adverse Events were not monitored/assessed in patient participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Hypertension Systems Analysis and Improvement', 'description': 'Eight (8) health facilities will receive the Systems Analysis and Improvement Approach (SAIA-HTN) intervention to optimize hypertension screening and management for people living with HIV/AIDS.\n\nSystems Analysis and Improvement Approach for Hypertension Screening and Treatment Optimization: The Systems Analysis and Improvement Approach to Optimize the Hypertension Care Cascade for People Living with HIV (SAIA-HTN) is a five-step systems analysis and iterative improvement cycle intervention which will be implemented by study nurses and district managers in intervention facilities. Components of the intervention include joint care cascade analysis, patient flow mapping and continuous quality improvement, aimed to incrementally improve hypertension screening, diagnosis, treatment and care in the HIV+ population at intervention health facilities.', 'otherNumAtRisk': 305, 'deathsNumAtRisk': 305, 'otherNumAffected': 0, 'seriousNumAtRisk': 305, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Eight (8) health facilities will not receive the Systems Analysis and Improvement Approach (SAIA-HTN) intervention to optimize hypertension screening and management for people living with HIV/AIDS.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Controlled Hypertension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '1447', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '1430', 'groupId': 'OG004'}, {'value': '161', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm - Baseline Phase', 'description': 'Newly eligible HIV-infected patients attending intervention facilities during baseline phase'}, {'id': 'OG001', 'title': 'Intervention Arm - Intensive Implementation Phase', 'description': 'Newly eligible HIV-infected patients attending intervention facilities during intensive implementation phase'}, {'id': 'OG002', 'title': 'Intervention Arm - Sustainment Phase', 'description': 'Newly eligible HIV-infected patients attending intervention facilities during sustainment phase'}, {'id': 'OG003', 'title': 'Control Arm - Baseline Phase', 'description': 'Newly eligible HIV-infected patients attending control facilities during baseline phase'}, {'id': 'OG004', 'title': 'Control Arm - Intensive Implementation Phase', 'description': 'Newly eligible HIV-infected patients attending control facilities during intensive implementation phase'}, {'id': 'OG005', 'title': 'Control Arm - Sustainment Phase', 'description': 'Newly eligible HIV-infected patients attending control facilities during sustainment phase'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '82', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase.', 'description': 'The proportion of HIV-infected patients with controlled hypertension among those who were diagnosed with hypertension and picked up their medications after receiving a prescription', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of new and existing HIV-infected patients attending enrolled facilities who were diagnosed with hypertension and picked up their medications after receiving a prescription'}, {'type': 'SECONDARY', 'title': 'Blood Pressure Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12307', 'groupId': 'OG000'}, {'value': '20617', 'groupId': 'OG001'}, {'value': '2183', 'groupId': 'OG002'}, {'value': '10042', 'groupId': 'OG003'}, {'value': '17909', 'groupId': 'OG004'}, {'value': '2567', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm - Baseline Phase', 'description': 'Newly eligible HIV-infected patients attending intervention facilities during baseline phase'}, {'id': 'OG001', 'title': 'Intervention Arm - Intensive Implementation Phase', 'description': 'Newly eligible HIV-infected patients attending intervention facilities during intensive implementation phase'}, {'id': 'OG002', 'title': 'Intervention Arm - Sustainment Phase', 'description': 'Newly eligible HIV-infected patients attending intervention facilities during sustainment phase'}, {'id': 'OG003', 'title': 'Control Arm - Baseline Phase', 'description': 'Newly eligible HIV-infected patients attending control facilities during baseline phase'}, {'id': 'OG004', 'title': 'Control Arm - Intensive Implementation Phase', 'description': 'Newly eligible HIV-infected patients attending control facilities during intensive implementation phase'}, {'id': 'OG005', 'title': 'Control Arm - Sustainment Phase', 'description': 'Newly eligible HIV-infected patients attending control facilities during sustainment phase'}], 'classes': [{'categories': [{'measurements': [{'value': '4275', 'groupId': 'OG000'}, {'value': '20359', 'groupId': 'OG001'}, {'value': '2182', 'groupId': 'OG002'}, {'value': '3351', 'groupId': 'OG003'}, {'value': '17882', 'groupId': 'OG004'}, {'value': '2556', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase.', 'description': 'The proportion of HIV-infected patients who were screened for hypertension', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of new and existing HIV-infected patients attending enrolled facilities'}, {'type': 'SECONDARY', 'title': 'Hypertension Diagnosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4275', 'groupId': 'OG000'}, {'value': '20359', 'groupId': 'OG001'}, {'value': '2182', 'groupId': 'OG002'}, {'value': '3351', 'groupId': 'OG003'}, {'value': '17882', 'groupId': 'OG004'}, {'value': '2556', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm - Baseline Phase', 'description': 'Newly eligible HIV-infected patients attending intervention facilities during baseline phase'}, {'id': 'OG001', 'title': 'Intervention Arm - Intensive Implementation Phase', 'description': 'Newly eligible HIV-infected patients attending intervention facilities during intensive implementation phase'}, {'id': 'OG002', 'title': 'Intervention Arm - Sustainment Phase', 'description': 'Newly eligible HIV-infected patients attending intervention facilities during sustainment phase'}, {'id': 'OG003', 'title': 'Control Arm - Baseline Phase', 'description': 'Newly eligible HIV-infected patients attending control facilities during baseline phase'}, {'id': 'OG004', 'title': 'Control Arm - Intensive Implementation Phase', 'description': 'Newly eligible HIV-infected patients attending control facilities during intensive implementation phase'}, {'id': 'OG005', 'title': 'Control Arm - Sustainment Phase', 'description': 'Newly eligible HIV-infected patients attending control facilities during sustainment phase'}], 'classes': [{'categories': [{'measurements': [{'value': '318', 'groupId': 'OG000'}, {'value': '2247', 'groupId': 'OG001'}, {'value': '244', 'groupId': 'OG002'}, {'value': '288', 'groupId': 'OG003'}, {'value': '2442', 'groupId': 'OG004'}, {'value': '404', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase.', 'description': 'The proportion of HIV-infected patients diagnosed with hypertension among those who were screened', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of new and existing HIV-infected patients attending enrolled facilities who were screened for hypertension'}, {'type': 'SECONDARY', 'title': 'Hypertension Treatment Prescription', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '2247', 'groupId': 'OG001'}, {'value': '244', 'groupId': 'OG002'}, {'value': '288', 'groupId': 'OG003'}, {'value': '2442', 'groupId': 'OG004'}, {'value': '404', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm - Baseline Phase', 'description': 'Newly eligible HIV-infected patients attending intervention facilities during baseline phase'}, {'id': 'OG001', 'title': 'Intervention Arm - Intensive Implementation Phase', 'description': 'Newly eligible HIV-infected patients attending intervention facilities during intensive implementation phase'}, {'id': 'OG002', 'title': 'Intervention Arm - Sustainment Phase', 'description': 'Newly eligible HIV-infected patients attending intervention facilities during sustainment phase'}, {'id': 'OG003', 'title': 'Control Arm - Baseline Phase', 'description': 'Newly eligible HIV-infected patients attending control facilities during baseline phase'}, {'id': 'OG004', 'title': 'Control Arm - Intensive Implementation Phase', 'description': 'Newly eligible HIV-infected patients attending control facilities during intensive implementation phase'}, {'id': 'OG005', 'title': 'Control Arm - Sustainment Phase', 'description': 'Newly eligible HIV-infected patients attending control facilities during sustainment phase'}], 'classes': [{'categories': [{'measurements': [{'value': '221', 'groupId': 'OG000'}, {'value': '1678', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}, {'value': '175', 'groupId': 'OG003'}, {'value': '1698', 'groupId': 'OG004'}, {'value': '256', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase.', 'description': 'The proportion of hypertension medication-eligible HIV patients receiving a prescription', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of new and existing HIV-infected patients attending enrolled facilities who were diagnosed with hypertension (i.e. medication-eligible)'}, {'type': 'SECONDARY', 'title': 'Hypertension Medication Pick up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '1678', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}, {'value': '175', 'groupId': 'OG003'}, {'value': '1698', 'groupId': 'OG004'}, {'value': '256', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm - Baseline Phase', 'description': 'Newly eligible HIV-infected patients attending intervention facilities during baseline phase'}, {'id': 'OG001', 'title': 'Intervention Arm - Intensive Implementation Phase', 'description': 'Newly eligible HIV-infected patients attending intervention facilities during intensive implementation phase'}, {'id': 'OG002', 'title': 'Intervention Arm - Sustainment Phase', 'description': 'Newly eligible HIV-infected patients attending intervention facilities during sustainment phase'}, {'id': 'OG003', 'title': 'Control Arm - Baseline Phase', 'description': 'Newly eligible HIV-infected patients attending control facilities during baseline phase'}, {'id': 'OG004', 'title': 'Control Arm - Intensive Implementation Phase', 'description': 'Newly eligible HIV-infected patients attending control facilities during intensive implementation phase'}, {'id': 'OG005', 'title': 'Control Arm - Sustainment Phase', 'description': 'Newly eligible HIV-infected patients attending control facilities during sustainment phase'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '1447', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '1430', 'groupId': 'OG004'}, {'value': '161', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase.', 'description': 'The proportion of HIV patients who are hypertension medication-eligible and pick up their medications after receiving a prescription', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of new and existing HIV-infected patients attending enrolled facilities who were diagnosed with hypertension (i.e. medication-eligible) and prescribed hypertension medication'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hypertension Systems Analysis and Improvement', 'description': 'Eight (8) health facilities will receive the Systems Analysis and Improvement Approach (SAIA-HTN) intervention to optimize hypertension screening and management for people living with HIV/AIDS.\n\nSystems Analysis and Improvement Approach for Hypertension Screening and Treatment Optimization: The Systems Analysis and Improvement Approach to Optimize the Hypertension Care Cascade for People Living with HIV (SAIA-HTN) is a five-step systems analysis and iterative improvement cycle intervention which will be implemented by study nurses and district managers in intervention facilities. Components of the intervention include joint care cascade analysis, patient flow mapping and continuous quality improvement, aimed to incrementally improve hypertension screening, diagnosis, treatment and care in the HIV+ population at intervention health facilities.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Eight (8) health facilities will not receive the Systems Analysis and Improvement Approach (SAIA-HTN) intervention to optimize hypertension screening and management for people living with HIV/AIDS.'}], 'periods': [{'title': 'Baseline Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '8', 'numSubjects': '12307'}, {'groupId': 'FG001', 'numUnits': '8', 'numSubjects': '10042'}]}, {'type': 'Patients', 'achievements': [{'groupId': 'FG000', 'numUnits': '8', 'numSubjects': '12307'}, {'groupId': 'FG001', 'numUnits': '8', 'numSubjects': '10042'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '8', 'numSubjects': '12307'}, {'groupId': 'FG001', 'numUnits': '8', 'numSubjects': '10042'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Intensive Implementation Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Patients were counted in the phase in which they first came to the facility to receive HIV care. If they were captured in the previous period, they were not counted in this period or the subsequent period.', 'groupId': 'FG000', 'numUnits': '8', 'numSubjects': '20788'}, {'comment': 'Patients were counted in the phase in which they first came to the facility to receive HIV care. If they were captured in the previous period, they were not counted in this period or the subsequent period.', 'groupId': 'FG001', 'numUnits': '8', 'numSubjects': '17909'}]}, {'type': 'Healthcare Workers', 'achievements': [{'groupId': 'FG000', 'numUnits': '8', 'numSubjects': '171'}, {'comment': "In the control sites, the SAIA-HTN intervention was not delivered and thus there were no healthcare workers enrolled as they didn't receive the intervention.", 'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'Patients', 'comment': 'Patients were counted in the phase in which they first came to the facility to receive HIV care. If they were captured in the previous period, they were not counted in this period or the subsequent period.', 'achievements': [{'groupId': 'FG000', 'numUnits': '8', 'numSubjects': '20617'}, {'groupId': 'FG001', 'numUnits': '8', 'numSubjects': '17909'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '8', 'numSubjects': '20788'}, {'groupId': 'FG001', 'numUnits': '8', 'numSubjects': '17909'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Sustainment Implementation Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Patients were counted in the phase in which they first came to the facility to receive HIV care. If they were captured in the previous period, they were not counted in this period.', 'groupId': 'FG000', 'numUnits': '8', 'numSubjects': '2317'}, {'comment': 'Patients were counted in the phase in which they first came to the facility to receive HIV care. If they were captured in the previous period, they were not counted in this period.', 'groupId': 'FG001', 'numUnits': '8', 'numSubjects': '2567'}]}, {'type': 'Healthcare Workers', 'achievements': [{'groupId': 'FG000', 'numUnits': '8', 'numSubjects': '134'}, {'comment': "In the control sites, the SAIA-HTN intervention was not delivered and thus there were no healthcare workers enrolled as they didn't receive the intervention.", 'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'Patients', 'comment': 'Patients were counted in the phase in which they first came to the facility to receive HIV care. If they were captured in the previous period, they were not counted in this period.', 'achievements': [{'groupId': 'FG000', 'numUnits': '8', 'numSubjects': '2183'}, {'groupId': 'FG001', 'numUnits': '8', 'numSubjects': '2567'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '8', 'numSubjects': '2317'}, {'groupId': 'FG001', 'numUnits': '8', 'numSubjects': '2567'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'health facilities', 'recruitmentDetails': 'We randomly allocated health facilities (n=16) to the intervention (n=8) or control (n=8). We consented healthcare workers for qualitative interviews and surveys (n=305) throughout the study. There is no interaction with patients (patients are not consented nor enrolled), however we use the clinical outcomes of patients to determine the effect our implementation strategy (SAIA-HTN). Patient-level data comes from routine data sources and is de-identified. Data from 65,625 patients were captured.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35412', 'groupId': 'BG000'}, {'value': '30518', 'groupId': 'BG001'}, {'value': '65930', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Hypertension Systems Analysis and Improvement', 'description': 'Eight (8) health facilities will receive the Systems Analysis and Improvement Approach (SAIA-HTN) intervention to optimize hypertension screening and management for people living with HIV/AIDS.\n\nSystems Analysis and Improvement Approach for Hypertension Screening and Treatment Optimization: The Systems Analysis and Improvement Approach to Optimize the Hypertension Care Cascade for People Living with HIV (SAIA-HTN) is a five-step systems analysis and iterative improvement cycle intervention which will be implemented by study nurses and district managers in intervention facilities. Components of the intervention include joint care cascade analysis, patient flow mapping and continuous quality improvement, aimed to incrementally improve hypertension screening, diagnosis, treatment and care in the HIV+ population at intervention health facilities.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Eight (8) health facilities will not receive the Systems Analysis and Improvement Approach (SAIA-HTN) intervention to optimize hypertension screening and management for people living with HIV/AIDS.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': 'Healthcare Workers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '305', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '305', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '305', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34141', 'groupId': 'BG000'}, {'value': '30466', 'groupId': 'BG001'}, {'value': '64607', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '33465', 'groupId': 'BG000'}, {'value': '29871', 'groupId': 'BG001'}, {'value': '63336', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '676', 'groupId': 'BG000'}, {'value': '595', 'groupId': 'BG001'}, {'value': '1271', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'We consent healthcare workers for qualitative collection (n=305) throughout the study. There is no interaction with patients (patients are not consented nor enrolled), however we use the clinical outcomes of patients to determine the effect of SAIA-HTN. Patient-level data comes from routine data sources and is de-identified. Data from 65,625 patients were captured. Age is missing for 52 patients in control sites and 966 patients in intervention sites.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Healthcare Workers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '284', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}]}, {'title': 'Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35079', 'groupId': 'BG000'}, {'value': '30508', 'groupId': 'BG001'}, {'value': '65587', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '22718', 'groupId': 'BG000'}, {'value': '18821', 'groupId': 'BG001'}, {'value': '41539', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12361', 'groupId': 'BG000'}, {'value': '11687', 'groupId': 'BG001'}, {'value': '24048', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'We consent healthcare workers for qualitative collection (n=305) throughout the study. Sex is missing for 21 healthcare workers. There is no interaction with patients (patients are not consented nor enrolled), however we use the clinical outcomes of patients to determine the effect of SAIA-HTN. Patient-level data comes from routine data sources and is de-identified. Data from 65,625 patients were captured. Sex is missing for 10 patients in control sites and 28 patients in intervention sites.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Healthcare Workers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '305', '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': '305', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '305', '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'}]}]}, {'title': 'Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35107', 'groupId': 'BG000'}, {'value': '30518', 'groupId': 'BG001'}, {'value': '65625', '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': '35107', 'groupId': 'BG000'}, {'value': '30518', 'groupId': 'BG001'}, {'value': '65625', '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', 'populationDescription': 'We consent healthcare workers for qualitative collection (n=305) throughout the study. There is no interaction with patients (patients are not consented nor enrolled), however we use the clinical outcomes of patients to determine the effect of SAIA-HTN. Patient-level data comes from routine data sources and is de-identified. Data from 65,625 patients were captured.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mozambique', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35412', 'groupId': 'BG000'}, {'value': '30518', 'groupId': 'BG001'}, {'value': '65930', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '35412', 'groupId': 'BG000'}, {'value': '30518', 'groupId': 'BG001'}, {'value': '65930', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Healthcare workers and Patients'}], 'populationDescription': 'Enrolled and consented 305 healthcare workers in intervention sites and none in control sites. Data captured from 35107 patients in intervention sites and 30518 control sites.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-10-23', 'size': 315522, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-23T15:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 305}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-20', 'studyFirstSubmitDate': '2019-07-01', 'resultsFirstSubmitDate': '2024-09-06', 'studyFirstSubmitQcDate': '2019-09-11', 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-20', 'studyFirstPostDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Controlled Hypertension', 'timeFrame': 'Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase.', 'description': 'The proportion of HIV-infected patients with controlled hypertension among those who were diagnosed with hypertension and picked up their medications after receiving a prescription'}], 'secondaryOutcomes': [{'measure': 'Blood Pressure Screening', 'timeFrame': 'Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase.', 'description': 'The proportion of HIV-infected patients who were screened for hypertension'}, {'measure': 'Hypertension Diagnosis', 'timeFrame': 'Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase.', 'description': 'The proportion of HIV-infected patients diagnosed with hypertension among those who were screened'}, {'measure': 'Hypertension Treatment Prescription', 'timeFrame': 'Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase.', 'description': 'The proportion of hypertension medication-eligible HIV patients receiving a prescription'}, {'measure': 'Hypertension Medication Pick up', 'timeFrame': 'Per Phase: up 3 months for Baseline Phase, up to 2 years for Intensive Implementation Phase, up to 1 year for Sustainment Phase.', 'description': 'The proportion of HIV patients who are hypertension medication-eligible and pick up their medications after receiving a prescription'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV/AIDS', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '32143657', 'type': 'DERIVED', 'citation': 'Gimbel S, Mocumbi AO, Asbjornsdottir K, Coutinho J, Andela L, Cebola B, Craine H, Crocker J, Hicks L, Holte S, Hossieke R, Itai E, Levin C, Manaca N, Murgorgo F, Nhumba M, Pfeiffer J, Ramiro I, Ronen K, Sotoodehnia N, Uetela O, Wagner A, Weiner BJ, Sherr K. Systems analysis and improvement approach to optimize the hypertension diagnosis and care cascade for PLHIV individuals (SAIA-HTN): a hybrid type III cluster randomized trial. Implement Sci. 2020 Mar 6;15(1):15. doi: 10.1186/s13012-020-0973-4.'}]}, 'descriptionModule': {'briefSummary': 'As undiagnosed and untreated hypertension is one of the largest drivers of cardiovascular disease in sub-Saharan Africa approaches are needed to optimize the hypertension care cascade. The HIV treatment platform in low and middle income countries provides a robust, scalable foundation to address other chronic care priorities, such as hypertension. This proposal will evaluate an evidence-based intervention designed to improve chronic care services (the Systems Analysis and Improvement Approach (SAIA)) for hypertension detection and management in people living with HIV, and will build evidence on how to achieve rapid, sustainable and scalable improvements in services that can dramatically improve population health in resource-limited countries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (A1) Frontline Health Workers / Health Facility Managers currently working in outpatient, emergency or related (pharmacy, laboratory) services at one of the study clinics in Manica and Sofala provinces, Mozambique; (A2) District Health Supervisors currently employed in a study district in Manica and Sofala provinces, Mozambique regularly engaged in service provision or management of HIV-infected and/or hypertensive populations; and (A3) Clinical Experts currently working in Mozambique in the clinical delivery of HIV and/or hypertension care and treatment or (B1) People Living with HIV \\>14 years old (B2) access HIV care and treatment services via outpatient/emergency services in study clinics. \\>14 years is being used as the current Ministry of Health forms only use the age bounds of \\<15y, \\>14y and there is significant concern by the Mozambican Ministry of Health to minimize additional data collection when not absolutely necessary.\n\nExclusion Criteria:\n\n* (A1) not currently working as a Frontline Health Worker/Health Facility Manager at a participating study facility or (A2) not currently working as a District Health Supervisor in a participating district or (A3) not currently working in Mozambique in the clinical delivery of HIV and/or hypertension care and treatment or (B1) HIV-negative or of unknown status or (B2) \\<15 years old or age not recorded, (B3) or pregnant or postpartum.'}, 'identificationModule': {'nctId': 'NCT04088656', 'acronym': 'SAIA-HTN', 'briefTitle': 'Systems Analysis and Improvement Approach for the Hypertension Care Cascade', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Systems Analysis and Improvement Approach to Optimize the Hypertension Diagnosis and Care Cascade for HIV-infected Individuals', 'orgStudyIdInfo': {'id': 'STUDY00006694'}, 'secondaryIdInfos': [{'id': 'R01HL142412', 'link': 'https://reporter.nih.gov/quickSearch/R01HL142412', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypertension Systems Analysis and Improvement', 'description': 'Eight (8) health facilities will receive the Systems Analysis and Improvement Approach (SAIA-HTN) intervention to optimize hypertension screening and management for people living with HIV/AIDS.', 'interventionNames': ['Other: Systems Analysis and Improvement Approach for Hypertension Screening and Treatment Optimization']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Eight (8) health facilities will not receive the Systems Analysis and Improvement Approach (SAIA-HTN) intervention to optimize hypertension screening and management for people living with HIV/AIDS.'}], 'interventions': [{'name': 'Systems Analysis and Improvement Approach for Hypertension Screening and Treatment Optimization', 'type': 'OTHER', 'description': 'The Systems Analysis and Improvement Approach to Optimize the Hypertension Care Cascade for People Living with HIV (SAIA-HTN) is a five-step systems analysis and iterative improvement cycle intervention which will be implemented by study nurses and district managers in intervention facilities. Components of the intervention include joint care cascade analysis, patient flow mapping and continuous quality improvement, aimed to incrementally improve hypertension screening, diagnosis, treatment and care in the HIV+ population at intervention health facilities.', 'armGroupLabels': ['Hypertension Systems Analysis and Improvement']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Catandica', 'state': 'Manica Province', 'country': 'Mozambique', 'facility': 'Hospital Distrital de Catandica', 'geoPoint': {'lat': -18.0575, 'lon': 33.17361}}, {'city': 'Chimoio', 'state': 'Manica Province', 'country': 'Mozambique', 'facility': 'Centro de Saude 1 de Maio', 'geoPoint': {'lat': -19.11639, 'lon': 33.48333}}, {'city': 'Chimoio', 'state': 'Manica Province', 'country': 'Mozambique', 'facility': 'Centro de Saude 7 de Abril', 'geoPoint': {'lat': -19.11639, 'lon': 33.48333}}, {'city': 'Chimoio', 'state': 'Manica Province', 'country': 'Mozambique', 'facility': 'Centro de Saude Eduardo Mondlane', 'geoPoint': {'lat': -19.11639, 'lon': 33.48333}}, {'city': 'Chimoio', 'state': 'Manica Province', 'country': 'Mozambique', 'facility': 'Centro de Saude Nhamaonha', 'geoPoint': {'lat': -19.11639, 'lon': 33.48333}}, {'city': 'Sussundenga', 'state': 'Manica Province', 'country': 'Mozambique', 'facility': 'Centro de Saude de Sussundenga', 'geoPoint': {'lat': -19.40389, 'lon': 33.29028}}, {'city': 'Vanduzi', 'state': 'Manica Province', 'country': 'Mozambique', 'facility': 'Centro de Saude Vanduzi', 'geoPoint': {'lat': -18.95111, 'lon': 33.26861}}, {'city': 'Beira', 'state': 'Sofala', 'country': 'Mozambique', 'facility': 'Centro de Saude de Macurungo', 'geoPoint': {'lat': -19.84361, 'lon': 34.83889}}, {'city': 'Beira', 'state': 'Sofala', 'country': 'Mozambique', 'facility': 'Centro de Saude de Manga Mascarenhas', 'geoPoint': {'lat': -19.84361, 'lon': 34.83889}}, {'city': 'Beira', 'state': 'Sofala', 'country': 'Mozambique', 'facility': 'Centro de Saude de Manga Nhanconjo', 'geoPoint': {'lat': -19.84361, 'lon': 34.83889}}, {'city': 'Beira', 'state': 'Sofala', 'country': 'Mozambique', 'facility': 'Centro de Saude de Ponte Gea', 'geoPoint': {'lat': -19.84361, 'lon': 34.83889}}, {'city': 'Búzi', 'state': 'Sofala', 'country': 'Mozambique', 'facility': 'Hospital Rural de Buzi', 'geoPoint': {'lat': -19.86439, 'lon': 34.46735}}, {'city': 'Dondo', 'state': 'Sofala', 'country': 'Mozambique', 'facility': 'Centro de Saude de Dondo', 'geoPoint': {'lat': -19.60944, 'lon': 34.74306}}, {'city': 'Dondo', 'state': 'Sofala', 'country': 'Mozambique', 'facility': 'Centro de Saude de Mafambisse', 'geoPoint': {'lat': -19.60944, 'lon': 34.74306}}, {'city': 'Nhamatanda', 'state': 'Sofala', 'country': 'Mozambique', 'facility': 'Hospital Rural de Nhamatanda', 'geoPoint': {'lat': -19.26917, 'lon': 34.21278}}, {'city': 'Manica', 'country': 'Mozambique', 'facility': 'Hospital Distrital de Manica', 'geoPoint': {'lat': -18.93444, 'lon': 32.87556}}], 'overallOfficials': [{'name': 'Sarah O Gimbel-Sherr, RN, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, School of Nursing: Family and Child Nursing', 'investigatorFullName': 'Sarah Odell Gimbel-Sherr', 'investigatorAffiliation': 'University of Washington'}}}}