iHEART-SA Intervention Study — iHEART-SA  

Hypertension Clinical Trial

Official title: The Integrating HIV and hEART Health in South Africa Intervention Study

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• HIV
• Hypertension

• NCT number: NCT05846503
• Study type: Interventional
• Source: University of Witwatersrand, South Africa
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Completion date: August 31, 2025