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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Maximum Age: 9
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Kenya
Kemri, Cghr
RECRUITING
Kisumu
Contact Information
Primary
Jenny Hill, MSc, PhD
jenny.hill@lstmed.ac.uk
+44 7732 161 353
Backup
Juliet Otieno, MD, PhD
Juliet.Otieno@lstmed.ac.uk
+254 721432548
Time Frame
Start Date: 2025-09-05
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 600
Treatments
Experimental: Arm A
Delivery of initial course of PDMC at discharge from the admitting facility. Referral to caregiver's peripheral facility of choice for delivery of subsequent monthly courses
Active_comparator: Arm B
Delivery of all three courses of PDMC at discharge from the admitting facility.
Related Therapeutic Areas
Sponsors
Collaborators: Makerere University, Centres for Disease Control and Prevention, Kenya., Institute of Research for Development, France, Kenya Medical Research Institute, Institut de Recherche Clinique du Benin (IRCB), Benin, Training Research Unit of Excellence, Blantyre, Malawi, Epicentre, Paris, France.
Leads: Liverpool School of Tropical Medicine

This content was sourced from clinicaltrials.gov