protocolSection identificationModule nctId: NCT06337253, orgStudyIdInfo id: MOZ202401, briefTitle: Seasonal Malaria Chemoprevention Rapid Assessment Study Mozambique, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2024-05-26, completionDateStruct date: 2024-11-26, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Malaria Consortium, class: OTHER, descriptionModule briefSummary: Seasonal malaria chemoprevention (SMC) is a highly effective community-based intervention to prevent malaria infections caused by Plasmodium falciparum in areas where the burden of malaria is high and malaria transmission is seasonal. SMC is commonly seen as a success story in the Sahel region, however, there are regions in east and southern Africa where malaria transmission is seasonal, and the burden is high. However, the same decision-making frameworks that was used in the Sahel are unlikely to be applicable to east and southern Africa due to higher pre-existing resistance to the drugs used, seasonality heterogeneity, contextual difference, and unknown cost-effectiveness, amongst others. This study aims to estimate the chemoprevention efficacy, potential upscale impact, acceptability, and feasibility of SMC with sulfadoxine-pyrimenthamine + amodiaquine (SP+AQ) medicines in Niassa Province in Mozambique.The study is divided into two separate components with different objectives which outputs feed into each other: a non-randomized controlled trial to estimate the chemoprevention efficacy of SP+AQ; and a qualitative study that will evaluate the feasibility and acceptability of the intervention.These will be the first studies analysing the chemoprevention efficacy, feasibility, acceptability, and potential scale-up impact of SMC in Niassa Province, Mozambique The outcomes of these studies aim to guide future policy changes at local, national, and international levels and potentially allow for a historically successful program to expand in a sustained and cost-effective way beyond the Sahel region., conditionsModule conditions: Malaria,Falciparum, conditions: Chemoprevention, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The intervention in this study is the administration of one cycle of SPAQ medicines. SPAQ medicines procured by Malaria Consortium are from one of the 3 manufacturers with WHO prequalification, with whom Malaria Consortium has framework agreements: Tridem Pharma, S Kant Healthcare Ltd, or MacLeods Pharmaceuticals Ltd.Each monthly SMC cycle consists of one dispersible tablet of SP and three daily dispersible tablets of AQ. There are two doses of SPAQ: a lower dose for children aged three to \<12 months, and a higher dose for children aged 12 to 59 months. For children aged 12 to 59 months, the dosage comprises a single dose of a full tablet of SP 500/25mg and three daily doses of a full tablet of AQ 153mg. Those aged three to \<12 months are administered half the dose given to those aged 12 to 59 months, given as full dispersible tablets., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Sulfadoxine/pyrimethamine plus amodiaquine, outcomesModule primaryOutcomes measure: Chemoprevention failure, secondaryOutcomes measure: Uncomplicated malaria within 28 days, eligibilityModule sex: ALL, minimumAge: 3 Months, maximumAge: 59 Months, stdAges: CHILD, contactsLocationsModule, hasResults: False