Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2026-02-22 @ 6:47 PM
Study NCT ID:
NCT04624061
Status:
UNKNOWN
Last Update Posted:
2022-11-04
First Post:
2020-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Leveraging the HIV Platform for Hypertension Control in Uganda (INTEGRATED HIV/HTN) STUDY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-09-02', 'releaseDate': '2025-08-14'}], 'estimatedResultsFirstSubmitDate': '2025-08-14'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comparative effectiveness cluster-randomized trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-01', 'studyFirstSubmitDate': '2020-10-27', 'studyFirstSubmitQcDate': '2020-11-05', 'lastUpdatePostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of HIV patients screened for Hypertension(HTN) at Month 24', 'timeFrame': 'Month 24', 'description': 'Proportion of HIV patients Screened for HTN at 24 months months of follow up'}, {'measure': 'Proportion of HTN patients diagnosed and started on treatment', 'timeFrame': 'Month 24', 'description': 'Proportion of HTN patients diagnosed and started on treatment'}, {'measure': 'Proportion of HIV/HTN patients with HTN Control (systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg) at 12 months and 24 months.', 'timeFrame': '24 months', 'description': 'Proportion of HIV infected patients with with documented history of elevated blood pressure or prior HTN diagnosis on medication who are controlled (systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg) at 12 months and 24 months.'}, {'measure': 'Proportion of HIV/HTN patients with HIV/HTN Dual Control: (who are both "HTN controlled" and have undetectable HIV viral load (at 12 months and 24 months).', 'timeFrame': '24 months', 'description': 'Proportion of HIV/HTN patients with HIV/HTN Dual Control: (who are both "HTN controlled" and have undetectable HIV viral load (at 12 months and 24 months).'}], 'secondaryOutcomes': [{'measure': 'Lowered blood pressure', 'timeFrame': '24 months', 'description': 'Proportion of HTN patients with successfully lowered BP (by at least 10 mmHg systolic and/or diastolic) compared to the time at the first HTN diagnosis'}, {'measure': 'Routine Hypertension care', 'timeFrame': '12 and 24 months', 'description': 'Proportion of health facilities providing hypertension care as routine practice;'}, {'measure': 'Adoption of the integrated model', 'timeFrame': '12 and 24 months', 'description': 'Proportion of HC IIIs and IVs adopting the integrated HIV/HTN care model;'}, {'measure': 'Knowledge of HTN management and HTN complications among health workers', 'timeFrame': '12 and 24 months', 'description': 'Knowledge of HTN management and complications among health workers (measured through conducting surveys among health workers working in the HIV clinics using a standardised knowledge test)'}, {'measure': 'Patient satisfaction', 'timeFrame': '12 and 24 months', 'description': 'Patient satisfaction outcomes in a sub-sample of facilities (survey)'}, {'measure': 'Adoption of HMIS tools', 'timeFrame': '24 months', 'description': 'Adoption of the integrated HIV/HTN HMIS tools particularly NCD registers and NCD patient card approved by the MoH'}, {'measure': 'Service readiness for delivering hypertension care', 'timeFrame': '24 months', 'description': 'Proportion of health facilities (HFs) that demonstrate service readiness for delivering adequate hypertension care for patients with and without HIV-infection'}, {'measure': 'Adherence to national guidelines', 'timeFrame': '24 months', 'description': 'Proportion of hypertensive patients (HIV-positive and -negative) registered at HFs that are being managed according to national guidelines.'}, {'measure': 'Cost effectiveness of the integrated HIV/HTN care model', 'timeFrame': '24 months', 'description': 'Incremental costs of the intervention (will be measured using micro-costing through interviews with coordinators, site visits and time-and-motion studies with clinic'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '36600388', 'type': 'DERIVED', 'citation': 'Atukunda M, Kabami J, Mutungi G, Twinamatsiko B, Nangendo J, Shade SB, Charlebois E, Grosskurth H, Kamya M, Okello E. Rationale and design of leveraging the HIV platform for hypertension control in Africa: protocol of a cluster-randomised controlled trial in Uganda. BMJ Open. 2022 Dec 8;12(12):e063227. doi: 10.1136/bmjopen-2022-063227.'}]}, 'descriptionModule': {'briefSummary': 'The INTEGRATED HIV/HTN is a hybrid type-1 effectiveness/implementation cluster randomised trial evaluating the introduction of a multi-component integrated HIV/HTN care model intervention, randomised to 13 districts in the intervention arm compared to 13 districts in the control. Selected health facilities within the 13 intervention districts will receive the intervention while those in the 13 control districts will continue implementing the standard of care as per the Ministry of Health (MoH) guidelines. All the participating facilities will receive blood pressure (BP) machines, and Non- communicable diseases (NCDs) registers as a standard of care.', 'detailedDescription': 'The investigators propose to evaluate a multi-component integrated HIV/HTN care intervention through a cluster randomised controlled trial. A cluster has been defined at the level of the district which is the randomisation unit. A total of 26 districts will be randomised. Selected health facilities within the 13 intervention districts will receive the multi-component intervention of combined HIV and (hypertension) HTN care which includes; 1) Training and capacity building on the INTEGRATED HIV/HTN model and NCD care; 2) the Integrated HIV/HTN care delivery model by promoting HTN screening and care in HIV clinics; 3) Health management information system (HMIS) enhancements through mentorship and coaching on the use of NCD registers and NCD patient cards and HTN data capture in the EMR system; and 4) Short messaging system (SMS) and/or WhatsApp for data coordination and communication among providers, DHOs and the study team (who acts as mentors). The 13 control districts will continue implementing the current standard of care as per MoH guidelines.\n\nThe investigators will test the hypothesis that a multi-component intervention of combined HIV and HTN care, based on the PRECEDE framework, to continuously identify barriers and facilitators leads to better health outcomes including dual control of HIV/HTN among adults in HIV care in the intervention compared to control facilities.\n\nSpecific Objectives are as follows;\n\n1. To determine the effectiveness of an integrated HIV/HTN care model on HTN and dual HIV/HTN control among adult patients in HIV clinics.\n2. To assess the barriers and facilitators of the integrated HIV/HTN care model for HIV patients at different levels.\n3. To determine the cost, cost-effectiveness and incremental gain costs of the integrated HIV/Hypertension care model approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 18 years and above with HIV for one category\n* Adults 18 years and above with HIV and hypertension for the second category\n* Willing to consent\n\nExclusion Criteria:\n\n* Patients who are very sick\n* Patients not willing to continue seeking care from the study health facility'}, 'identificationModule': {'nctId': 'NCT04624061', 'briefTitle': 'Leveraging the HIV Platform for Hypertension Control in Uganda (INTEGRATED HIV/HTN) STUDY', 'organization': {'class': 'OTHER', 'fullName': 'Infectious Diseases Research Collaboration, Uganda'}, 'officialTitle': 'Leveraging the HIV Platform for Hypertension Control in Uganda', 'orgStudyIdInfo': {'id': '2020-156'}, 'secondaryIdInfos': [{'id': '22196', 'type': 'OTHER', 'domain': 'London School of Hygiene and Tropical Medicine'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'The integrated HIV/HTN care model with the following components;\n\n1. Training and capacity building on the INTEGRATED HIV/HTN model and NCD care\n2. Integrated HIV/HTN care delivery model by promoting HTN screening and care in HIV clinics.\n3. HMIS enhancements through mentorship and coaching on the use of NCD registers and NCD patient cards and HTN data capture in the (Electronic Medical Record) EMR system.\n4. SMS and/or WhatsApp for data coordination and communication among providers, District Health officers (DHOs) and study team (Mentors) to strengthen feedback.', 'interventionNames': ['Behavioral: Integrated HIV/HTN care model']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard of care maintained. These are procedures conducted during the routine HIV and Hypertension care visits at the health facilities include;a) Provision of BP machines b)Provision of NCD register and NCD patient card and ; c) Following MOH treatment guidelines'}], 'interventions': [{'name': 'Integrated HIV/HTN care model', 'type': 'BEHAVIORAL', 'description': 'The intervention is a multi-component intervention of combined HIV and HTN care, based on the PRECEDE framework, to continuously identify barriers and facilitators leads to better health outcomes including dual control of HIV/HTN among adults in HIV care in the intervention compared to control facilities', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kampala', 'state': 'Central Region', 'country': 'Uganda', 'facility': 'Infectious Diseases Research Collaboration', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}], 'overallOfficials': [{'name': 'Jane Kabami, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Infectious Diseases Research Collaboration, Uganda'}, {'name': 'Moses R Kamya, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Infectious Diseases Research Collaboration, Uganda'}, {'name': 'Heiner Grosskurth, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London School of Hygiene and Tropical Medicine'}]}, 'ipdSharingStatementModule': {'timeFrame': 'During the study and at least 5 years after the end of the study', 'ipdSharing': 'YES', 'description': 'IDRC will use its proprietary Data Management system to manage and store the data throughout the life of the project. Data is transferred to the system from remote sites via an encrypted link using secure File Transfer Protocol. The system includes a data repository specific to this study which is accessible only to designated study personnel. Study staff will access the repository via a password protected website and the data will be transferred over an encrypted connection via secure Hypertext Transfer Protocol.\n\nAfter the study, clean study datasets will be made shareable in a public certified repository that supports open access. Prior to release, all datasets will be reviewed to ensure they are properly de identified. Any workflows will be exactly described and documented such that it will allow any external groups to precisely reproduce results from the raw data. IDRC will also keep the raw data on the IDRC servers for at least 5 years after the end of the study.', 'accessCriteria': 'All final, clean study datasets will be made shareable in a public certified repository that supports open access.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Infectious Diseases Research Collaboration, Uganda', 'class': 'OTHER'}, 'collaborators': [{'name': 'Makerere University', 'class': 'OTHER'}, {'name': 'Uganda Heart Institute', 'class': 'OTHER'}, {'name': 'Ministry of Health, Uganda', 'class': 'OTHER_GOV'}, {'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-08-14', 'type': 'RELEASE'}, {'date': '2025-09-02', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Infectious Diseases Research Collaboration, Uganda'}}}}