Post-discharge malaria prevention with dihydroartemisinin-piperaquine for children 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
This project will test different delivery methods and adherence supports for post-discharge dihydroartemisinin-piperaquine to prevent malaria in children under 10 who were hospitalised with severe malaria or severe anaemia in western Kenya.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | N/A to 9 Years |
| Sex | All |
| Sponsor | Liverpool School of Tropical Medicine Academic / other |
| Locations | 1 site (Kisumu) |
| Trial ID | NCT06624631 on ClinicalTrials.gov |
What this trial studies
This multi-centre implementation trial uses a cluster-randomised design at hospitals with blood transfusion services and a nested individually-randomised component to compare adherence supports. The cluster component compares two health-system delivery strategies while the nested three-arm randomisation compares SMS reminders, community health promoter home visits, and no reminders for adherence. Interventions and delivery approaches were co-designed with national stakeholders following formative research. The trial enrols clinically stable children under 10 years discharged after severe malaria or severe anaemia and follows them through a four-month course of post-discharge chemoprevention with dihydroartemisinin-piperaquine.
Who should consider this trial
Good fit: Ideal candidates are clinically stable children under 10 years old (weighing ≥5 kg) recently discharged after treatment for severe malaria or severe anaemia who reside in the participating catchment areas.
Not a fit: Children with known hypersensitivity to dihydroartemisinin-piperaquine, certain cardiac conditions, sickle cell disease, non-residents of the study area, or those needing prohibited medications or scheduled surgery are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the approaches could improve adherence to post-discharge chemoprevention and reduce recurrent malaria, hospital readmissions, and child morbidity and mortality.
How similar studies have performed: Earlier clinical trials of post-discharge malaria chemoprevention with dihydroartemisinin-piperaquine have shown reductions in recurrent malaria and readmissions, but fewer studies have tested real-world delivery and adherence strategies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: 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 * HIV infection and cotrimoxazole prophylaxis are not exclusion criteria.
Where this trial is running
Kisumu
- Kemri, Cghr — Kisumu, Kenya (Recruiting)
Study contacts
- Principal investigator: Feiko ter Kuile, MD, PhD — Lstm
- Study coordinator: Jenny Hill, MSc, PhD
- Email: jenny.hill@lstmed.ac.uk
- Phone: +44 7732 161 353
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.