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NCT05846503: iHEART-SA
iHEART-SA Intervention Study
NA trial testing 1. Quality and info management system in Hypertension in 4,378 participants. Completed in 31 August 2025.
31 May 2025
Quick facts
| Lead sponsor | University of Witwatersrand, South Africa |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 4,378 |
| Start date | 1 June 2023 |
| Primary completion | 31 May 2025 |
| Estimated completion | 31 August 2025 |
| Sites | 1 location across South Africa |
Drugs / interventions tested
- 1. Quality and info management system
Conditions studied
- Hypertension — all drugs for Hypertension →
- HIV — all drugs for HIV →
Sponsor
University of Witwatersrand, South Africa
Who can join
18 and older, any sex, with Hypertension or HIV. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Integrating hypertension detection and management in HIV care in South Africa: protocol for a stepped-wedged cluster randomized effectiveness-implementation hybrid trial.
Galaviz KI, Patel SA, Siedner MJ, Goss CW, et al · · 2024 · cited 8× · PMID 39402688 · DOI 10.1186/s43058-024-00640-6 -
Dissemination and implementation research coordination and training to improve cardiovascular health in people living with HIV in sub-Saharan Africa: the research coordinating center of the HLB-SIMPLe Alliance.
Tetteh EK, Effah W, de las Fuentes L, Steger-May K, et al · · 2024 · cited 4× · PMID 38845055 · DOI 10.1186/s43058-024-00599-4 -
Acceptability of patient education for hypertension self-management among healthcare providers and beneficiaries in South Africa, 2024: A qualitative study.
Simelane X, Kagura J, Nyatela A, Lalla-Edward ST. · · 2025 · PMID 40599029 · DOI 10.4102/phcfm.v17i1.4801
Verify or expand the search:
- PubMed search for NCT05846503
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hypertension
Currently open trials in the same condition.
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Other University of Witwatersrand, South Africa trials
Trials by the same sponsor.
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- NCT06485154 — Post-Injectable Cabotegravir Antiretroviral Salvage Strategy Options Trial · Phase 4 · active not recruiting
- NCT06138600 — Acceptability and Feasibility of Injectable Cabotegravir Pre-exposure Prophylaxis (PrEP) Versus Oral PrEP in Routine Car · Phase 3 · active not recruiting
- NCT05459532 — A Randomised, Multi-centre, Double-blind, Phase 3 Study to Observe the Effectiveness, Safety and Tolerability of Molnupi · Phase 2, PHASE3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05846503 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Witwatersrand, South Africa
- Last refreshed: 10 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05846503.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing