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Completed

NCT Number: NCT05846503

iHEART-SA 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.

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Key information

Conditions

Hypertension Cardiovascular Diseases HIV Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnyside Office Park

Johannesburg, Gauteng, 2193, South Africa

About this study

Investigational interventions:

Implementation facilitation of improved hypertension screening and management in the HIV care setting through the iHEART-SA intervention model comprising:

  • Information management system
  • Task shifting
  • Audit and feedback
  • Healthcare worker education and training
  • Patient education and support

Study design:

Cluster randomized stepped wedge effectiveness-implementation type 2 hybrid

Study objectives:

  • 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
  • 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:

  • Healthcare workers (nurses and doctors)
  • Adult patients living with HIV from the 9 primary healthcare clinics

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Patients:

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

Treatment and study plan

1. Quality and info management system

Behavioral
  • 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

Primary outcomes

  1. Healthcare worker

    Time frame: 24 months

    Difference in percentage of patient visits with recorded BP measurement between intervention and control clinics

  2. Patient

    Time frame: 12 months

    Difference in mean systolic BP between the intervention and control conditions

Secondary outcomes

  1. Healthcare worker implementation

    Time frame: 24 months

    % of healthcare workers who implement the iHEART-SA package as intended at month 12 and month 24

  2. Healthcare worker adoption

    Time frame: 24 months

    Participation rate and representativeness of healthcare workers who adopt the BP screening and treatment model

  3. Healthcare worker maintenance - BP measurement

    Time frame: 12 months

    % of patients who had a BP measurement done at every clinic visit

  4. Healthcare worker satisfaction

    Time frame: 24 months

    % of healthcare workers who are satisfied with all components of the intervention

  5. Healthcare worker costing

    Time frame: 27 months

    Costs of each intervention components will be recorded as healthcare worker time, material costs, and healthcare/monitoring equipment

  6. Patient adoption

    Time frame: 24 months

    Participation rate and representativeness of eligible patients who consent to chart review

  7. Patient satisfaction

    Time frame: 24 months

    % of patients who are satisfied with all components of the intervention

  8. Healthcare worker maintenance - BP management

    Time frame: 12 months

    % of patients who had an elevate BP managed at every visit post intervention

Sponsors and collaborators

Lead sponsor

University of Witwatersrand, South Africa

Other

Collaborators

  • Emory University
  • Massachusetts General Hospital
  • UMC Utrecht

Registry information

Official study title

The Integrating HIV and hEART Health in South Africa Intervention Study

Acronym: iHEART-SA

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 6, 2023
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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