[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564089":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":35,"centralContacts":40,"locations":50,"responsibleParty":76,"collaborators":78,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":26,"maxAge":104,"enrollmentInfo":105,"targetDuration":26,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":53,"whyStopped":26,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Liverpool School of Tropical Medicine","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Decentralized, monthly delivery of Post Discharge Malaria Chemoprevention (PDMC) drugs (Arm A)","EXPERIMENTAL","Delivery of initial course of PDMC at discharge from the admitting facility. Referral to caregiver's peripheral facility of choice for delivery of subsequent monthly courses",[13,14,15],"Other: SMS reminders; adherence support strategy a","Other: Community Health Promoters (CHP) home visits; adherence support strategy b","Other: No reminders; adherence support strategy c",{"label":17,"type":18,"description":19,"interventionNames":20},"Centralised delivery of Post Discharge Malaria Chemoprevention (PDMC) drugs at discharge (Arm B)","ACTIVE_COMPARATOR","Delivery of all three courses of Post Discharge Malaria Chemoprevention (PDMC) drugs at discharge from the admitting facility.",[13,14,15],[22,27,31],{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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)",[17,9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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)",[17,9],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"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)",[17,9],[36],{"name":37,"affiliation":38,"role":39},"Feiko ter Kuile, MD, PhD","LSTM","PRINCIPAL_INVESTIGATOR",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":26,"email":45},"Jenny Hill, MSc, PhD","CONTACT","+44 7732 161 353","jenny.hill@lstmed.ac.uk",{"name":47,"role":43,"phone":48,"phoneExt":26,"email":49},"Juliet Otieno, MD, PhD","+254 721432548","Juliet.Otieno@lstmed.ac.uk",[51],{"facility":52,"status":53,"city":54,"state":26,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Kemri, Cghr","RECRUITING","Kisumu","40 100","Kenya","KE",{"type":59,"coordinates":60},"Point",[61,62],34.76171,-0.10221,{"lat":62,"lon":61},[65,69,73,74],{"name":66,"role":43,"phone":67,"phoneExt":26,"email":68},"Juliet Otieno, PhD","+254721432548","juliet.otieno@lstmed.ac.uk",{"name":70,"role":43,"phone":71,"phoneExt":26,"email":72},"Simon Kariuki, PhD","+254725389246","skariuki1578@gmail.com",{"name":66,"role":39,"phone":26,"phoneExt":26,"email":26},{"name":70,"role":75,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"type":77,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[79,81,83,86,89,91,93],{"name":80,"class":6},"Kenya Medical Research Institute",{"name":82,"class":6},"Institut de Recherche Clinique du Benin",{"name":84,"class":85},"Epicentre, Paris, France.","UNKNOWN",{"name":87,"class":88},"Institute of Research for Development, France","OTHER_GOV",{"name":90,"class":85},"Training Research Unit of Excellence, Blantyre, Malawi",{"name":92,"class":6},"Makerere University",{"name":94,"class":6},"Centres for Disease Control and Prevention, Kenya.","100564089","phase-4-pdmc-implementation-trial-in-kenya-100564089",false,"NCT06624631","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","PDMC-SL","Inclusion Criteria:\n\nCLUSTERS\n\n* Health facilities with blood transfusion services offering in-patient care for children with severe anaemia and severe malaria.\n* \\>=40 children per year admitted with severe anaemia or severe malaria\n* Agreement to participate by facility management\n* Located in areas with moderate to high malaria transmission\n\nINDIVIDUAL PARTICIPANTS\n\n* Aged \\\u003C10 years of both sexes\n* Hospitalised with severe anaemia or severe malaria: Initially hospitalised with haemoglobin \\\u003C5.0 g\u002Fdl or PCV \\\u003C15%, 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\u002For the presence of microscopy or RDT confirmed Plasmodium infection\n\nExclusion Criteria:\n\nCLUSTERS\n\n\\- Health facilities without subservient lower-level health facilities\n\nINDIVIDUAL PARTICIPANTS\n\n* Recognised specific other causes of severe anaemia (i.e., trauma, haematological malignancy, known bleeding disorders, such as haemophilia)\n* Sickle cell anaemia\u002Fsickle cell disease\n* Body weight \\\u003C5 kg\n* HIV infection and cotrimoxazole prophylaxis are not exclusion criteria.","ALL","9 Years",{"count":106,"type":107},600,"ESTIMATED","INTERVENTIONAL",[110],"PHASE4","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.\n\nThe actual interventions to be evaluated have been co-designed with national stakeholders during an initial formative research stage.",[113,114],"Severe Malaria","Severe Anemia",[116,117,118,119,120,121,122,123,124,125,126,56,127,128,129],"Children","Antimalarial","Prevention","Chemoprevention","Caregivers","Patient discharge","Healthcare providers","Health economics","Qualitative research","Feasibility","Cost effectiveness","Artemisinins","School age","Pre-school","2025-11-18",{"date":132,"type":133},"2025-11-21","ACTUAL",{"date":135,"type":133},"2025-09-05",{"date":137,"type":107},"2026-09-30",{"name":5,"class":6},1]