iHEART-SA Intervention Study

NCT05846503 | Completed DMC

• 1 other identifier: iHEART-SA IS
• Study Type: interventional
• Target: 4,378
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; HIV

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Healthcare worker implementation

  24 months

• Healthcare worker adoption

  24 months

• Healthcare worker maintenance - BP measurement

  12 months

• Healthcare worker satisfaction

  24 months

• Healthcare worker costing

  27 months

Study Arms (2)

Intervention

OTHER

Cluster of clinics receiving the five investigational interventions

Behavioral: 1. Quality and info management system

Control

NO INTERVENTION

Standard of care

Interventions

1. Quality and info management system BEHAVIORAL

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.

Also known as: 2. Case review meetings, 3. Patient health education and support, 4. Task shifting, 5. HCW education and training

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthcare workers:
• Adult \>18 years men and women working in clinical roles at the selected clinics
• Provide informed consent (only those participating in the qualitative components)
• Patients:
• Adults \>18 years living with HIV and hypertension
• Enrolled in the study clinic
• Willing and able to provide informed consent

You may not qualify if:

• Patients:
• Unable or unwilling to provide informed consent
• Planning to relocate or change service providers/clinics

Sponsors & Collaborators

• Emory University: collaborator
• Massachusetts General Hospital: collaborator
• UMC Utrecht: collaborator
• University of Witwatersrand, South Africa: lead

Study Sites (1)

Sunnyside Office Park

Johannesburg, Gauteng, 2193, South Africa

Location

Related Publications (1)

• Galaviz KI, Patel SA, Siedner MJ, Goss CW, Gumede SB, Johnson LC, Ordonez CE, Laxy M, Klipstein-Grobusch K, Heine M, Masterson M, Mody A, Venter WDF, Marconi VC, Ali MK, Lalla-Edward ST. Integrating hypertension detection and management in HIV care in South Africa: protocol for a stepped-wedged cluster randomized effectiveness-implementation hybrid trial. Implement Sci Commun. 2024 Oct 14;5(1):115. doi: 10.1186/s43058-024-00640-6.

  PMID: 39402688 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Willem DF Venter, MD, PHD

  Ezintsha, University of the Witwatersrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There is no masking. This is an intervention study without drugs. Intervention comprises training and education, data and feedback, and task shifting.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director

Model Details: Randomized cluster stepped-wedge study design where clinics will be assigned to a time at which they initiate the intervention. There are nine clinics which have been classification (low, medium and high) according to their volume. One clinic from each classification has been randomized to a cluster such that there are three clusters each with a low, medium and high volume clinic.

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 6, 2023
• Study Start: June 1, 2023
• Primary Completion: May 31, 2025
• Study Completion: August 31, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)