Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2025-12-26 @ 5:03 PM
Study NCT ID:
NCT05846503
Status:
COMPLETED
Last Update Posted:
2025-12-10
First Post:
2023-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
iHEART-SA Intervention Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'There is no masking. This is an intervention study without drugs. Intervention comprises training and education, data and feedback, and task shifting.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized cluster stepped-wedge study design where clinics will be assigned to a time at which they initiate the intervention. There are nine clinics which have been classification (low, medium and high) according to their volume. One clinic from each classification has been randomized to a cluster such that there are three clusters each with a low, medium and high volume clinic.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4378}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2023-04-12', 'studyFirstSubmitQcDate': '2023-05-03', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healthcare worker', 'timeFrame': '24 months', 'description': 'Difference in percentage of patient visits with recorded BP measurement between intervention and control clinics'}, {'measure': 'Patient', 'timeFrame': '12 months', 'description': 'Difference in mean systolic BP between the intervention and control conditions'}], 'secondaryOutcomes': [{'measure': 'Healthcare worker implementation', 'timeFrame': '24 months', 'description': '% of healthcare workers who implement the iHEART-SA package as intended at month 12 and month 24'}, {'measure': 'Healthcare worker adoption', 'timeFrame': '24 months', 'description': 'Participation rate and representativeness of healthcare workers who adopt the BP screening and treatment model'}, {'measure': 'Healthcare worker maintenance - BP measurement', 'timeFrame': '12 months', 'description': '% of patients who had a BP measurement done at every clinic visit'}, {'measure': 'Healthcare worker satisfaction', 'timeFrame': '24 months', 'description': '% of healthcare workers who are satisfied with all components of the intervention'}, {'measure': 'Healthcare worker costing', 'timeFrame': '27 months', 'description': 'Costs of each intervention components will be recorded as healthcare worker time, material costs, and healthcare/monitoring equipment'}, {'measure': 'Patient adoption', 'timeFrame': '24 months', 'description': 'Participation rate and representativeness of eligible patients who consent to chart review'}, {'measure': 'Patient satisfaction', 'timeFrame': '24 months', 'description': '% of patients who are satisfied with all components of the intervention'}, {'measure': 'Healthcare worker maintenance - BP management', 'timeFrame': '12 months', 'description': '% of patients who had an elevate BP managed at every visit post intervention'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension', 'HIV']}, 'referencesModule': {'references': [{'pmid': '39402688', 'type': 'DERIVED', 'citation': 'Galaviz KI, Patel SA, Siedner MJ, Goss CW, Gumede SB, Johnson LC, Ordonez CE, Laxy M, Klipstein-Grobusch K, Heine M, Masterson M, Mody A, Venter WDF, Marconi VC, Ali MK, Lalla-Edward ST. Integrating hypertension detection and management in HIV care in South Africa: protocol for a stepped-wedged cluster randomized effectiveness-implementation hybrid trial. Implement Sci Commun. 2024 Oct 14;5(1):115. doi: 10.1186/s43058-024-00640-6.'}]}, 'descriptionModule': {'briefSummary': 'Using qualitative data during the formative phase the IHEART-SA research study filled deficiencies in knowledge regarding: 1) what barriers exist to integrating hypertension care within the HIV care setting in South Africa and, 2) how a hypertension care intervention can be adapted to effectively and sustainably function in this care setting. These data have been used to design a context-relevant intervention package for implementation in the next phase of effectiveness-implementation testing, answering the research question: How does an intervention aimed at enhancing hypertension diagnosis and management in people living with HIV improve the delivery of guideline-recommended care in primary healthcare clinics in Gauteng, South Africa, and hypertension control among patients?\n\nThe study will use an effectiveness-implementation study design. This design allows for the testing of strategies to promote integration of proven interventions in real-world practice (i.e., implementation strategies), while simultaneously assessing clinical effectiveness (i.e., patient level outcomes). For this the study will use a randomized cluster stepped-wedge study design where nine clinics (grouped in clusters of three) will be assigned to a time at which they initiate the intervention.', 'detailedDescription': 'Investigational interventions:\n\nImplementation facilitation of improved hypertension screening and management in the HIV care setting through the iHEART-SA intervention model comprising:\n\n1. Information management system\n2. Task shifting\n3. Audit and feedback\n4. Healthcare worker education and training\n5. Patient education and support\n\nStudy design:\n\nCluster randomized stepped wedge effectiveness-implementation type 2 hybrid\n\nStudy objectives:\n\n1. Assess the short- and long-term effects of an implementation strategy (i.e., healthcare worker intervention) on the adoption and implementation of hypertension screening and treatment among healthcare workers\n2. Assess the short- and long-term effects of a clinical intervention (i.e., patient-level intervention) on patient blood pressure control among patients living with HIV and hypertension\n\nDuration of participation: 27 months Study duration: 37 months\n\nIntervention audience:\n\n1. Healthcare workers (nurses and doctors)\n2. Adult patients living with HIV from the 9 primary healthcare clinics'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthcare workers:\n\n1. Adult \\>18 years men and women working in clinical roles at the selected clinics\n2. Provide informed consent (only those participating in the qualitative components)\n\nPatients:\n\n1. Adults \\>18 years living with HIV and hypertension\n2. Enrolled in the study clinic\n3. Willing and able to provide informed consent\n\nExclusion Criteria:\n\nPatients:\n\n1. Unable or unwilling to provide informed consent\n2. Planning to relocate or change service providers/clinics'}, 'identificationModule': {'nctId': 'NCT05846503', 'acronym': 'iHEART-SA', 'briefTitle': 'iHEART-SA Intervention Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Witwatersrand, South Africa'}, 'officialTitle': 'The Integrating HIV and hEART Health in South Africa Intervention Study', 'orgStudyIdInfo': {'id': 'iHEART-SA IS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention', 'description': 'Cluster of clinics receiving the five investigational interventions', 'interventionNames': ['Behavioral: 1. Quality and info management system']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard of care'}], 'interventions': [{'name': '1. Quality and info management system', 'type': 'BEHAVIORAL', 'otherNames': ['2. Case review meetings', '3. Patient health education and support', '4. Task shifting', '5. HCW education and training'], 'description': '1. The intervention package prioritizes information and quality management with a focus on HTN screening, diagnosis, and treatment. From the point-of-care, flow charts placed in the patient file will ensure that vitals are performed in accordance with national guidelines.\n2. The care coordinator will present data to clinic staff in multi-disciplinary meetings, providing an opportunity for programmatic feedback and discussion.\n3. Patients will be encouraged to complete the vital signs measurements at each clinic visit. They will be provided with their BP readings and given info about what their reading means. They will be issued with pocket sized color coded booklets providing info on the measurement and what to do to control their BP.\n4. Task shifting: A care coordinator will be the champion of the intervention package for the clinic.\n5. All staff will receive apt training on how to use the patient flow chart, info management system and how to respond to abnormal BP values.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2193', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Sunnyside Office Park', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}], 'overallOfficials': [{'name': 'Willem DF Venter, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ezintsha, University of the Witwatersrand'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Witwatersrand, South Africa', 'class': 'OTHER'}, 'collaborators': [{'name': 'Emory University', 'class': 'OTHER'}, {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, {'name': 'UMC Utrecht', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Executive Director', 'investigatorFullName': 'Professor Francois Venter', 'investigatorAffiliation': 'University of Witwatersrand, South Africa'}}}}