The Integrating HIV and hEART Health in South Africa Intervention Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 4,378
- Locations
- 1
- Primary Endpoint
- Healthcare worker
Study Overview
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:
- Information management system
- Task shifting
- Audit and feedback
- Healthcare worker education and training
- Patient education and support
Study design:
Cluster randomized stepped wedge effectiveness-implementation type 2 hybrid
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Masking Description
There is no masking. This is an intervention study without drugs. Intervention comprises training and education, data and feedback, and task shifting.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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)
- •Adults >18 years living with HIV and hypertension
- •Enrolled in the study clinic
- •Willing and able to provide informed consent
Exclusion Criteria
- •Unable or unwilling to provide informed consent
- •Planning to relocate or change service providers/clinics
Arms & Interventions
Intervention
Cluster of clinics receiving the five investigational interventions
Intervention: 1. Quality and info management system (Behavioral)
Control
Standard of care
Outcomes
Primary Outcomes
Healthcare worker
Time Frame: 24 months
Difference in percentage of patient visits with recorded BP measurement between intervention and control clinics
Patient
Time Frame: 12 months
Difference in mean systolic BP between the intervention and control conditions
Secondary Outcomes
- Healthcare worker implementation(24 months)
- Healthcare worker adoption(24 months)
- Healthcare worker maintenance - BP measurement(12 months)
- Healthcare worker costing(27 months)
- Healthcare worker satisfaction(24 months)
- Patient adoption(24 months)
- Patient satisfaction(24 months)
- Healthcare worker maintenance - BP management(12 months)
Investigators
Professor Francois Venter
Executive Director
University of Witwatersrand, South Africa