PDMC Implementation Trial in Kenya
Delivery Strategies for Malaria Chemoprevention in the Post-discharge Management of Children Hospitalised With Severe Anaemia or Severe Malaria: Cluster and Individually Randomised Controlled Implementation Trial and Economic Evaluation in Kenya
Liverpool School of Tropical Medicine
600 participants
Sep 5, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this implementation trial is to evaluate at least two alternative delivery strategies and adherence support for malaria chemoprevention with dihydroartemisinin-piperaquine in the post-discharge management of children hospitalised with severe anaemia or severe malaria to optimise adherence in Kenya. The actual interventions to be evaluated have been co-designed with national stakeholders during an initial formative research stage.
Eligibility
Inclusion Criteria8
- CLUSTERS
- Health facilities with blood transfusion services offering in-patient care for children with severe anaemia and severe malaria.
- >=40 children per year admitted with severe anaemia or severe malaria
- Agreement to participate by facility management
- Located in areas with moderate to high malaria transmission
- INDIVIDUAL PARTICIPANTS
- Aged <10 years of both sexes
- Hospitalised with severe anaemia or severe malaria: Initially hospitalised with haemoglobin <5.0 g/dl or PCV <15%, or requirement for blood transfusion for other clinical reasons on or during admission to the hospital, or severe malaria, defined as a requirement for parenteral artesunate in the opinion of the treating clinician and/or the presence of microscopy or RDT confirmed Plasmodium infection
Exclusion Criteria6
- CLUSTERS
- \- Health facilities without subservient lower-level health facilities
- INDIVIDUAL PARTICIPANTS
- Recognised specific other causes of severe anaemia (i.e., trauma, haematological malignancy, known bleeding disorders, such as haemophilia)
- Sickle cell anaemia/sickle cell disease
- Body weight <5 kg
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Monthly SMS reminders sent to participants allocated to this adherence support intervention in both drug delivery arms (Centralized and decentralized arms)
Community Health Promoters' (CHPs) monthly reminder home visits conducted for participants allocated to this adherence support intervention in both drug delivery arms (Centralized and Decentralized arms)
No monthly reminders sent for participants allocated to this control adherence support intervention group in both drug delivery arms (Centralized and Decentralized arms)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06624631