iHEART-SA Intervention Study

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.

Conditions

• Hypertension
• HIV

Interventions

BEHAVIORAL

1. Quality and info management system

1. The intervention package prioritizes information and quality management with a focus on HTN screening, diagnosis, and treatment. From the point-of-care, flow charts placed in the patient file will ensure that vitals are performed in accordance with national guidelines. 2. The care coordinator will present data to clinic staff in multi-disciplinary meetings, providing an opportunity for programmatic feedback and discussion. 3. Patients will be encouraged to complete the vital signs measurements at each clinic visit. They will be provided with their BP readings and given info about what their reading means. They will be issued with pocket sized color coded booklets providing info on the measurement and what to do to control their BP. 4. Task shifting: A care coordinator will be the champion of the intervention package for the clinic. 5. All staff will receive apt training on how to use the patient flow chart, info management system and how to respond to abnormal BP values.

Sponsors & Collaborators

• Emory University

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• University of Witwatersrand, South Africa

  lead OTHER

Principal Investigators

• Willem DF Venter, MD, PHD · Ezintsha, University of the Witwatersrand

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-06-01

Primary Completion

2025-05-31

Completion

2025-08-31

Countries

• South Africa

Study Locations