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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
SMS reminders; adherence support strategy a
Other interventionMonthly SMS reminders sent to participants allocated to this adherence support intervention in both drug delivery arms (Centralized and decentralized arms)
Community Health Promoters (CHP) home visits; adherence support strategy b
Other interventionCommunity 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)
No reminders; adherence support strategy c
Other interventionNo monthly reminders sent for participants allocated to this control adherence support intervention group in both drug delivery arms (Centralized and Decentralized arms)
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Decentralized, monthly delivery of Post Discharge Malaria Chemoprevention (PDMC) drugs (Arm A)Experimental treatment 3 interventions
Group B: Centralised delivery of Post Discharge Malaria Chemoprevention (PDMC) drugs at discharge (Arm B)Active comparator 3 interventions
Trial outcomes
Primary outcomes
1
Proportion of eligible children who received 3 courses of PDMC
Proportion of eligible participants who received all 3 indicated PDMC courses from Ministry of Health staff
Time frame
2, 6 and 10 weeks post discharge2
Proportion of study children who adhered to 3 PDMC courses (9 doses)
Proportion of children with complete adherence to the full PDMC regimen (3 courses × 3 doses = 9 total doses)
Time frame
2, 6 and 10 weeks (days 1-3) post dischargeSecondary outcomes
1
Proportion of children who are readmitted with malaria
All-cause and malaria-specific sick-child clinic visits by the end of week 14 after discharge
Time frame
0-14 weeks post discharge2
Proportion of children who are readmitted with any cause
All-cause and cause-specific readmissions by the end of week 14 after discharge
Time frame
0-14 weeks post discharge3
Proportion of children who die within 14 weeks of discharge
All-cause mortality by the end of week 14 after discharge
Time frame
0-14 weeks post discharge4
Incidence of serious adverse events
Incidence of serious adverse events
Time frame
0-14 weeks post dischargeSponsors and contacts
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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