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RECRUITINGPhase 4INTERVENTIONAL

Post-discharge Malaria Chemoprevention Implementation Trial in Benin

Delivery Strategies for Malaria Chemoprevention in the Post-discharge Management of Children Hospitalised With Severe Anaemia or Severe Malaria: a Cluster Randomised Controlled Implementation Trial in Benin

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

About This Trial

The proposed research aims to conduct implementation trials in Benin, co-designed with national stakeholders, to evaluate different delivery strategies for optimizing health system delivery of post-discharge malaria chemoprevention (PDMC) drugs and adherence to PDMC. This chemoprevention strategy is effective in reducing hospital readmissions and deaths after discharge. However, there is no clear delivery platform for PDMC, and adherence to the 3-day dosing regimen, provided monthly three times after discharge, is a potential limitation. The current trial will provide evidence-based data on acceptability, feasibility, and cost-effectiveness to aid decision-makers. The evidence generated will be used to support the effective implementation and scale-up of PDMC in high malaria-endemic areas such as Benin.

Who May Be Eligible (Plain English)

Who May Qualify: - Aged below 10 years of both sexes - Hospitalised with severe anaemia or severe malaria: Initially hospitalised with haemoglobin below 5.0 g/dl or PCV below 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 the presence of microscopy or RDT confirmed Plasmodium infection Who Should NOT Join This Trial: - 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 below 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: * Aged below 10 years of both sexes * Hospitalised with severe anaemia or severe malaria: Initially hospitalised with haemoglobin below 5.0 g/dl or PCV below 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 the presence of microscopy or RDT confirmed Plasmodium infection Exclusion Criteria: * 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 below 5 kg * HIV infection and cotrimoxazole prophylaxis are not exclusion criteria

Treatments Being Tested

OTHER

Adherence support strategy A

Community health worker (CHW) support through monthly home visits to remind the caregiver to administrate the PDMC drugs

OTHER

Adherence support strategy B

SMS/phone reminders from the qualified community health officers (ASCQ) to the community health workers (CHW) to administrate the PDMC drugs

OTHER

Control

No reminders

Locations (2)

Goho Departmental Hospital Centre
Abomey, Benin
Centre Hospitalier Universitaire de la Mere et de l'Enfant Lagune (CHU-MEL)
Cotonou, Benin