NCT05846503

iHEART-SA Intervention Study

The Integrating HIV and hEART Health in South Africa Intervention Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,378 (actual)
• Sponsor: University of Witwatersrand, South Africa · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Investigational interventions: Implementation facilitation of improved hypertension screening and management in the HIV care setting through the iHEART-SA intervention model comprising: 1. Information management system 2. Task shifting 3. Audit and feedback 4. Healthcare worker education and training 5. Patient education and support Study design: Cluster randomized stepped wedge effectiveness-implementation type 2 hybrid Study objectives: 1. 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 2. 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 Duration of participation: 27 months Study duration: 37 months Intervention audience: 1. Healthcare workers (nurses and doctors) 2. Adult patients living with HIV from the 9 primary healthcare clinics

Conditions

• Hypertension
• HIV

Interventions

Type	Name	Description
BEHAVIORAL	1. Quality and info management system	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.

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-05-31
• Completion: 2025-08-31
• First posted: 2023-05-06
• Last updated: 2025-12-10

Locations

1 site across 1 country: South Africa