[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594590":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":31,"centralContacts":22,"locations":35,"responsibleParty":47,"collaborators":49,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":22,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":61,"minAge":22,"maxAge":22,"enrollmentInfo":62,"targetDuration":22,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":75,"whyStopped":22,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"University of North Carolina, Chapel Hill","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"A single dose of Dihydroartemisinin Piperaquine","EXPERIMENTAL","A single administration of Dihydroartemisinin Piperaquine as a focal mass drug administration Focal Mass Drug Administration.",[13],"Drug: Dihydroartemisinin Piperaquine",{"label":15,"type":10,"description":16,"interventionNames":17},"Monthly dose of Dihydroartemisinin Piperaquine","Monthly doses of Dihydroartemisinin Piperaquine for household members",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Control","NO_INTERVENTION","Participants in this arm will receive current standard of care.",null,[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Dihydroartemisinin Piperaquine","A single or monthly dose of Dihydroartemisinin Piperaquine based on weight will be taken orally.",[9,15],[30],"Focal Mass Drug Administration",[32],{"name":33,"affiliation":5,"role":34},"Ross Boyce, MD","PRINCIPAL_INVESTIGATOR",[36],{"facility":37,"status":22,"city":38,"state":22,"zip":22,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":22},"Bugoye Level III Health Center","Kasese","Uganda","UG",{"type":42,"coordinates":43},"Point",[44,45],30.08333,0.18333,{"lat":45,"lon":44},{"type":48,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[50],{"name":51,"class":52},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH","100594590","early-phase-1-focal-mass-drug-administration-for-the-prevention-of-malaria-in-pregnancy-100594590",false,"NCT07021430","Focal Mass Drug Administration for the Prevention of Malaria in Pregnancy","Focal Mass Drug Administration for the Prevention of Malaria in Pregnancy: a Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Primary residence (i.e., where a person lives for ≥ 6 months per year) in Kasese District with no plans to change residency in subsequent 6 months\n* Able and willing to comply with all study procedures and be available for the duration of the study\n* Able and willing to consent to study procedures as documented on informed consent form. For children (age \\\u003C18 years), parent or guardian must provide consent. Children age ≥8 to 17 years will also be asked to provide written assent.\n\nEach pregnant women will also need to meet additional eligibility criteria:\n\n18 years old or older Presenting to Bugoye Level III Health Center for antenatal care and plan to deliver at Bugoye Level III Health Center (i.e., not planned cesarean section) Gestational age ≤22 weeks Human Immunodeficiency Virus negative\n\nExclusion Criteria:\n\n* An individual who meets any of the following criteria will be excluded from participation:\n* Temporary or part-time residence in Kasese District (i.e., where a person lives for \\\u003C 6 months per year)\n* Known plans to move within the next 6 months\n* Unable or unwilling to provide consent\n* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study\n\nIn addition, individuals with any of the following will still be eligible to participate (e.g,, complete surveys, provide blood samples) but will not be eligible to receive Dihydroartemisinin Piperaquine if randomized to one of the intervention arms:\n\n* Known arrythmia, QT prolongation, or seizure disorder will not be eligible to receive Dihydroartemisinin Piperaquine\n* Use of potentially contraindicated medications outlined in Section 5.6\n* Weight \\\u003C5 kg\n* Known allergic reaction to Dihydroartemisinin Piperaquine or other Artemisinin Combination Therapies",true,"ALL",{"count":63,"type":64},300,"ESTIMATED","INTERVENTIONAL",[67],"EARLY_PHASE1","The purpose of this study is to demonstrate the feasibility, acceptability, and preliminary effectiveness of a focal mass drug administration program for household members of pregnant women to protect against malaria in pregnancy.",[70],"Malaria Prevention",[72,73,74],"Malaria","Focal mass drug administration","Dihydroartemisinin-piperaquine","NOT_YET_RECRUITING","2026-02-13",{"date":78,"type":79},"2026-02-17","ACTUAL",{"date":81,"type":64},"2026-04",{"date":83,"type":64},"2028-04",{"name":5,"class":6},1]