iHEART-SA Intervention Study
- Conditions
- HIVHypertension
- Interventions
- Behavioral: 1. Quality and info management system
- Registration Number
- NCT05846503
- Lead Sponsor
- University of Witwatersrand, South Africa
- Brief 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 4378
Healthcare workers:
- Adult >18 years men and women working in clinical roles at the selected clinics
- Provide informed consent (only those participating in the qualitative components)
Patients:
- Adults >18 years living with HIV and hypertension
- Enrolled in the study clinic
- Willing and able to provide informed consent
Patients:
- Unable or unwilling to provide informed consent
- Planning to relocate or change service providers/clinics
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Intervention 1. Quality and info management system Cluster of clinics receiving the five investigational interventions
- Primary Outcome Measures
Name Time Method Healthcare worker 24 months Difference in percentage of patient visits with recorded BP measurement between intervention and control clinics
Patient 12 months Difference in mean systolic BP between the intervention and control conditions
- Secondary Outcome Measures
Name Time Method Healthcare worker implementation 24 months % of healthcare workers who implement the iHEART-SA package as intended at month 12 and month 24
Healthcare worker adoption 24 months Participation rate and representativeness of healthcare workers who adopt the BP screening and treatment model
Healthcare worker maintenance - BP measurement 12 months % of patients who had a BP measurement done at every clinic visit
Healthcare worker costing 27 months Costs of each intervention components will be recorded as healthcare worker time, material costs, and healthcare/monitoring equipment
Healthcare worker satisfaction 24 months % of healthcare workers who are satisfied with all components of the intervention
Patient adoption 24 months Participation rate and representativeness of eligible patients who consent to chart review
Patient satisfaction 24 months % of patients who are satisfied with all components of the intervention
Healthcare worker maintenance - BP management 12 months % of patients who had an elevate BP managed at every visit post intervention
Trial Locations
- Locations (1)
Sunnyside Office Park
πΏπ¦Johannesburg, Gauteng, South Africa