NCT05846503Completed
iHEART-SA Intervention Study
The Integrating HIV and hEART Health in South Africa Intervention Study
Source: ClinicalTrials.gov · Last updated 10 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 4378 (actual)
- First submitted
- 12 Apr 2023
- Start date
- 1 Jun 2023
- Primary completion date
- 31 May 2025
- Lead sponsor
- University of Witwatersrand, South Africa
- Diseases
- HIV, High blood pressure
- NCT number
- NCT05846503
What you commit to
- Study type: Interventional
- Participants enrolled: 4378
- From 1 Jun 2023 to the primary completion date, 31 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patients:
- Unable or unwilling to provide informed consent
- Planning to relocate or change service providers/clinics
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunnyside Office Park Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.