Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2025-12-26 @ 5:03 PM
Study NCT ID:
NCT05846503
Status:
COMPLETED
Last Update Posted:
2025-12-10
First Post:
2023-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
iHEART-SA Intervention Study
Sponsor:
University of Witwatersrand, South Africa
Organization:
Study Overview
Official Title:
The Integrating HIV and hEART Health in South Africa Intervention Study
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iHEART-SA
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.
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: