PDMC Implementation Trial in Kenya
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeUp to 9
SponsorLiverpool School of Tropical Medicine
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- SMS reminders; adherence support strategy a
- Community Health Promoters (CHP) home visits; adherence support strategy b
- No reminders; adherence support strategy c
Treatment groups
600 Participants
are divided into 2 treatment groupsSponsors and collaborators
Liverpool School of Tropical Medicine
Lead sponsor
Kenya Medical Research Institute
Collaborator
Institut de Recherche Clinique du Benin
Collaborator
Epicentre, Paris, France.
Collaborator
Institute of Research for Development, France
Collaborator
Training Research Unit of Excellence, Blantyre, Malawi
Collaborator
Makerere University
Collaborator
Centres for Disease Control and Prevention, Kenya.
Collaborator
Source ClinicalTrials.gov