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HypertensioniHEART-SANCT05846503

iHEART-SA Intervention Study

A study testing 1. Quality and info management system in people with Hypertension and HIV, run by University of Witwatersrand, South Africa at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hypertension, HIV
What is being tested?
1. Quality and info management system
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,378 participants
Where
1 siteSouth Africa
Study dates
1 Jun 2023to 31 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Africa1 site

  • Sunnyside Office Park

    Johannesburg, Gauteng, 2193

Other trials in South Africa

About this study

Official title: 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.

Read the 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
Conditions
Hypertension, HIV
Being tested
1. Quality and info management system
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1. Quality and info management systemBehavioural

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

    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.
Study groups in NCT05846503
Study groupRoleWhat they receive
InterventionOtherCluster of clinics receiving the five investigational interventions
Receives: Behavioral: 1. Quality and info management system
ControlNo interventionStandard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Healthcare worker

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

    Measured: 24 months

  2. Patient

    Difference in mean systolic BP between the intervention and control conditions

    Measured: 12 months

Secondary outcomes (8)

  1. Healthcare worker implementation

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

    Measured: 24 months

  2. Healthcare worker adoption

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

    Measured: 24 months

  3. Healthcare worker maintenance - BP measurement

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

    Measured: 12 months

  4. Healthcare worker satisfaction

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

    Measured: 24 months

  5. Healthcare worker costing

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

    Measured: 27 months

  6. Patient adoption

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

    Measured: 24 months

  7. Patient satisfaction

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

    Measured: 24 months

  8. Healthcare worker maintenance - BP management

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study start1 Jun 2023
  3. Primary completion31 May 2025
  4. Study completion31 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
None (open label)
Enrolment
4,378 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05846503
Sponsor's protocol ID
iHEART-SA IS
Acronym
iHEART-SA
Status last verified
Dec 2025
First submitted
12 Apr 2023
Last updated
10 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gala P, Mugala A, Hickey MD, Ordonez CE, Gimbel S, Galaviz KI, Lalla-Edward ST, Kiggundu JB, Henry DA, Mogaetsho GE, Aifah A, Katahoire A, Semitala F, Hirschhorn LR. Models for Integrated HIV-Hypertension Care: Comparative Analysis of Six Integration Approaches from Implementation Research Projects Across Africa. Res Sq [Preprint]. 2026 Jun 17:rs.3.rs-9464167. doi: 10.21203/rs.3.rs-9464167/v1.

    PubMed 42370263

  • 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.

    PubMed 39402688

Questions about this trial

What is this clinical trial studying?

A study testing 1. Quality and info management system in people with Hypertension and HIV, run by University of Witwatersrand, South Africa at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Healthcare worker (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05846503, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.

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iHEART-SA Intervention Study (NCT05846503) | AzTrials