An interventional study of 1. Quality and info management system in Hypertension and HIV, sponsored by University of Witwatersrand, South Africa. Completed at 1 site in South Africa. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by University of Witwatersrand, South Africa · Not applicable, Interventional, and Other
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?
The 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.
Investigational interventions:
Implementation facilitation of improved hypertension screening and management in the HIV care setting through the iHEART-SA intervention model comprising:
Study design:
Cluster randomized stepped wedge effectiveness-implementation type 2 hybrid
Study objectives:
Duration of participation: 27 months Study duration: 37 months
Intervention audience:
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's enrollment of 4,378 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →University of Witwatersrand, South Africa is the lead sponsor of 47 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Healthcare workers:
Patients:
Exclusion Criteria:
Patients:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cluster of clinics receiving the five investigational interventions
Behavioral: 1. Quality and info management system
Standard of care
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. 2. The care coordinator will present data to clinic staff in multi-disciplinary meetings, providing an opportunity for programmatic feedback and discussion. 3. 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. 4. Task shifting: A care coordinator will be the champion of the intervention package for the clinic. 5. 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.
Also known as: 2. Case review meetings, 3. Patient health education and support, 4. Task shifting, 5. HCW education and training
Healthcare worker
Difference in percentage of patient visits with recorded BP measurement between intervention and control clinics
Time frame: 24 months
Patient
Difference in mean systolic BP between the intervention and control conditions
Time frame: 12 months
Healthcare worker implementation
% of healthcare workers who implement the iHEART-SA package as intended at month 12 and month 24
Time frame: 24 months
Healthcare worker adoption
Participation rate and representativeness of healthcare workers who adopt the BP screening and treatment model
Time frame: 24 months
Healthcare worker maintenance - BP measurement
% of patients who had a BP measurement done at every clinic visit
Time frame: 12 months
Healthcare worker satisfaction
% of healthcare workers who are satisfied with all components of the intervention
Time frame: 24 months
Healthcare worker costing
Costs of each intervention components will be recorded as healthcare worker time, material costs, and healthcare/monitoring equipment
Time frame: 27 months
Patient adoption
Participation rate and representativeness of eligible patients who consent to chart review
Time frame: 24 months
Patient satisfaction
% of patients who are satisfied with all components of the intervention
Time frame: 24 months
Healthcare worker maintenance - BP management
% of patients who had an elevate BP managed at every visit post intervention
Time frame: 12 months
Plan to share: No
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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University of Witwatersrand, South Africa