Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2025-12-24 @ 7:33 PM
NCT ID:
NCT05846503
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
Study:
NCT05846503
Study Brief:
Protocol Section:
NCT05846503