Last reviewed · How we verify
NCT04183413
Strengthening Primary Healthcare Delivery for Diabetes and Hypertension in Eswatini
NA trial testing DSD in Diabetes Mellitus in 3,500 participants. Completed in 31 December 2023.
5 December 2023
Quick facts
| Lead sponsor | University Hospital Heidelberg |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 3,500 |
| Start date | 1 November 2021 |
| Primary completion | 5 December 2023 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across Eswatini |
Drugs / interventions tested
- DSD
- CDP
Conditions studied
- Diabetes Mellitus — all drugs for Diabetes Mellitus →
- Hypertension — all drugs for Hypertension →
Sponsor
University Hospital Heidelberg
Who can join
40 and older, any sex, with Diabetes Mellitus or Hypertension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The WHO-PEN@Scale project is a three-arm cluster-randomized trial that is investigating the population-level effects of a healthcare reform in Eswatini, which aims to strengthen primary care for diabetes and hypertension. Prior to the reform, healthcare for diabetes and hypertension was mostly provided through physician-led teams in hospital outpatient departments. The healthcare reform aims to strengthen the provision of nurse-led care for diabetes and hypertension in primary healthcare facilities and community health worker-led care for these conditions in the facilities' catchment areas. The reform will broadly be guided by the World Health Organization's "Package of Essential Noncommunicable Disease Interventions for Primary Health Care in Low-Resource Settings" (WHO-PEN). The trial will take place at 84 clusters (a primary healthcare facility and its catchment area) across the country.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Strengthening primary care for diabetes and hypertension in Eswatini: study protocol for a nationwide cluster-randomized controlled trial.
Theilmann M, Ginindza N, Myeni J, Dlamini S, et al · · 2023 · cited 3× · PMID 36949485 · DOI 10.1186/s13063-023-07096-4 -
Human and financial resource needs for universal access to WHO-PEN interventions for diabetes and hypertension care in Eswatini: results from a time-and-motion and bottom-up costing study.
Harkare HV, Osetinsky B, Ginindza N, Cindzi BT, et al · · 2024 · cited 1× · PMID 38802811 · DOI 10.1186/s12960-024-00913-0 -
Implementation of WHO-PEN interventions in Eswatini: an assessment of health equity and out-of-pocket expenditure for diabetes and hypertension care.
Harkare HV, Ginindza N, Stehr L, Osetinsky B, et al · · 2026 · PMID 41888803 · DOI 10.1186/s12939-026-02829-8
Verify or expand the search:
- PubMed search for NCT04183413
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04183413 (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 Hospital Heidelberg
- Last refreshed: 31 October 2024
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/NCT04183413.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing