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RECRUITINGPhase 4INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

OTHER

SMS reminders; adherence support strategy a

Monthly SMS reminders sent to participants allocated to this adherence support intervention in both drug delivery arms (Centralized and decentralized arms)

OTHER

Community Health Promoters (CHP) home visits; adherence support strategy b

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)

OTHER

No reminders; adherence support strategy c

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)

Kemri, Cghr
Kisumu, Kenya