iHEART-SA Intervention Study

University of Witwatersrand

Status: Completed

Conditions: Hypertension; HIV

Treatments: Behavioral: 1. Quality and info management system

Study type: Interventional

Funder types: Other

Identifiers

NCT05846503

iHEART-SA IS

Details and patient eligibility

About

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.

Full 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

Enrollment: 4,378 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Healthcare workers:

1. Adult >18 years men and women working in clinical roles at the selected clinics
2. Provide informed consent (only those participating in the qualitative components)

Patients:

1. Adults >18 years living with HIV and hypertension
2. Enrolled in the study clinic
3. Willing and able to provide informed consent

Exclusion criteria

Patients:

1. Unable or unwilling to provide informed consent
2. Planning to relocate or change service providers/clinics

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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4,378 participants in 2 patient groups

Intervention

Other group

Description:

Cluster of clinics receiving the five investigational interventions

Treatment:

Behavioral: 1. Quality and info management system

Control

No Intervention group

Description:

Standard of care