iHEART-SA Intervention Study (iHEART-SA)

The Integrating HIV and hEART Health in South Africa Intervention Study

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; HIV
• Intervention / Treatment: Behavioral: 1. Quality and info management system

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 Type: Interventional
• Enrollment (Anticipated): 2160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2193
      • Recruiting
      • Sunnyside Office Park
      • Contact: Samanta T Lalla-Edward, PhD; Phone Number: +27 826172490; Email: slallaedward@ezintsha.org
      • Contact: Willem DF Venter, MD, PhD; Phone Number: +27 833991066; Email: fventer@ezintsha.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard of care
Other: Intervention; Cluster of clinics receiving the five investigational interventions	Behavioral: 1. Quality and info management system; 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.; The care coordinator will present data to clinic staff in multi-disciplinary meetings, providing an opportunity for programmatic feedback and discussion.; 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.; Task shifting: A care coordinator will be the champion of the intervention package for the clinic.; 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.; Other Names: 2. Case review meetings; 3. Patient health education and support; 4. Task shifting; 5. HCW education and training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare worker	Difference in percentage of patient visits with recorded BP measurement between intervention and control clinics	24 months
Patient	Difference in mean systolic BP between the intervention and control conditions	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare worker implementation	% of healthcare workers who implement the iHEART-SA package as intended at month 12 and month 24	24 months
Healthcare worker adoption	Participation rate and representativeness of healthcare workers who adopt the BP screening and treatment model	24 months
Healthcare worker maintenance - BP measurement	% of patients who had a BP measurement done at every clinic visit	12 months
Healthcare worker satisfaction	% of healthcare workers who are satisfied with all components of the intervention	24 months
Healthcare worker costing	Costs of each intervention components will be recorded as healthcare worker time, material costs, and healthcare/monitoring equipment	27 months
Patient adoption	Participation rate and representativeness of eligible patients who consent to chart review	24 months
Patient satisfaction	% of patients who are satisfied with all components of the intervention	24 months
Healthcare worker maintenance - BP management	% of patients who had an elevate BP managed at every visit post intervention	12 months

Collaborators and Investigators

• Sponsor: University of Witwatersrand, South Africa
• Collaborators: Massachusetts General Hospital; Emory University; UMC Utrecht
• Investigators: Principal Investigator: Willem DF Venter, MD, PHD, Ezintsha, University of the Witwatersrand

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): May 31, 2025
• Study Completion (Anticipated): August 31, 2025

Study Registration Dates

• First Submitted: April 12, 2023
• First Submitted That Met QC Criteria: May 3, 2023
• First Posted (Estimate): May 5, 2023

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: iHEART-SA IS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No