[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647684":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":50,"studyPopulation":39,"armGroups":51,"interventions":62,"overallOfficials":68,"centralContacts":72,"locations":81,"responsibleParty":98,"collaborators":100,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":122,"sex":123,"minAge":39,"maxAge":39,"enrollmentInfo":124,"targetDuration":39,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":139,"whyStopped":39,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":39},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Proportion of eligible households that received spatial emanators","Proportion of eligible households in intervention CSI catchment areas that received Guardian spatial emanators during the distribution period.","1 month after distribution",{"measure":14,"description":15,"timeFrame":12},"Acceptability of the integrated delivery","Acceptability of integrated delivery of Guardian spatial emanators with azithromycin mass drug administration as perceived by households and community health workers, assessed by qualitative surveys.",{"measure":17,"description":18,"timeFrame":19},"Proportion of households with correct product placement","Proportion of households with correct placement of all installed Guardian spatial emanators, measured through longitudinal supervision visits","12 months after distribution",[21,25,28,31,35],{"measure":22,"description":23,"timeFrame":24},"Proportion of households reached with messaging regarding the intervention","Proportion of households in participating CSI catchment areas that were reached with program messaging about Guardian spatial emanators during the distribution period","During the distribution period (1 week)",{"measure":26,"description":27,"timeFrame":24},"Proportion of eligible children receiving azithromycin in integrated and non-integrated CSIs","Proportion of eligible children who received azithromycin mass drug administration in CSI catchment areas assigned to integrated Guardian delivery and in CSI catchment areas assigned to non-integrated delivery",{"measure":29,"description":30,"timeFrame":24},"Time required per household","Time required for delivery at the household level in integrated and non-integrated CSI catchment areas.",{"measure":32,"description":33,"timeFrame":34},"Cost per Guardian delivered","Average cost per Guardian spatial emanator delivered during implementation in CSI catchment areas assigned to the intervention","during study preparation and completion (1 year)",{"measure":36,"description":37,"timeFrame":38},"Incidence of malaria-related visits to the CSI by children under 5 years of age","Incidence of malaria-related clinic visits among children under 5 years of age in participating CSI catchment areas, assessed through CSI data collection and aggregation using District Health Information Software 2 (DHIS2)","12 month after distribution",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":43,"primaryPurpose":44,"observationalModel":39,"timePerspective":39,"maskingInfo":45},"RANDOMIZED","PARALLEL","Cluster-randomized, 1:1 assignment study in which Centre de Santé Intégré (CSI) are randomized to either integrated delivery of Guardian spatial emanators plus azithromycin mass drug administration or standard azithromycin mass drug administration without Guardian integration.","PREVENTION",{"masking":46,"maskingDescription":47,"whoMasked":48},"SINGLE","Participants, community health workers delivering the intervention, and team members supervising the program will not be masked. One biostatistician and one data analyst will remain unmasked to prepare the randomization sequence. Masked personnel include outcome assessors as well as the biostatistician and data analyst conducting the data analyses.",[49],"OUTCOMES_ASSESSOR","Niger is implementing azithromycin mass drug administration for child survival through door-to-door delivery by community health workers to children 1 to 59 months of age every 6 months. In areas with a high burden of seasonal malaria, integrating delivery of Guardian spatial emanators into this existing platform may provide an efficient way to add malaria prevention to an established community-based campaign. Guardian is a passive spatial emanator intended to reduce mosquito exposure indoors. Although spatial emanators have shown protective efficacy in previous studies, there is limited evidence on the feasibility, acceptability, and cost of integrating them into large-scale public health delivery systems in seasonal malaria settings.\n\nThis study is a randomized implementation study nested within AVENIR II. Selected Centre de Santé Intégré catchment areas participating in AVENIR II in high-malaria-transmission areas of Niger will be randomized to either integrated delivery of Guardian plus azithromycin mass drug administration or to standard azithromycin mass drug administration without Guardian integration. Within catchment areas assigned to integrated delivery, community health workers will conduct door-to-door visits to eligible households, provide malaria prevention messaging, determine the number of Guardian devices needed for the household, install the devices, and document delivery. Participating health centers in integrated areas will also receive Guardian devices.\n\nThe study will evaluate implementation outcomes including the proportion of households reached, the proportion of eligible households and health centers receiving Guardian, the proportion of eligible children receiving azithromycin in integrated and non-integrated areas, time required for delivery, fidelity to protocol, acceptability among households and community health workers, product placement over time, bioefficacy and active ingredient monitoring, and program costs. The study will also compare malaria-related clinic visits among children under 5 years of age in integrated and non-integrated catchment areas using routine health facility data. Data sources will include treatment records, fidelity observations, coverage evaluation surveys, repeated longitudinal monitoring surveys, cost records, and routine clinic data.",[52,58],{"label":53,"type":54,"description":55,"interventionNames":56},"Guardian Spatial Emanator","EXPERIMENTAL","Eligible households in CSI catchment areas assigned to the intervention will receive Guardian spatial emanators during integrated delivery with azithromycin mass drug administration.",[57],"Device: Spatial Emanator",{"label":59,"type":60,"description":61,"interventionNames":39},"No Guardian Spatial Emanator","NO_INTERVENTION","Eligible households in CSI catchment areas assigned to the comparison group will not receive Guardian spatial emanators and will continue to receive standard azithromycin mass drug administration procedures.",[63],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":39},"DEVICE","Spatial Emanator","Spatial emanators are a new intervention for malaria prevention, designed to passively release volatile active ingredients that repel or incapacitate mosquitoes before they bite.",[53],[69],{"name":70,"affiliation":5,"role":71},"Kieran S O'Brien, PhD","PRINCIPAL_INVESTIGATOR",[73,78],{"name":74,"role":75,"phone":76,"phoneExt":39,"email":77},"Andrea R Picariello, MPH","CONTACT","609-865-4532","andrea.picariello@ucsf.edu",{"name":79,"role":75,"phone":39,"phoneExt":39,"email":80},"Elodie J Lebas","elodie.lebas@ucsf.edu",[82],{"facility":83,"status":39,"city":84,"state":39,"zip":39,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"Program National de Santé Oculaire","Niamey","Niger","NE",{"type":88,"coordinates":89},"Point",[90,91],2.1098,13.51366,{"lat":91,"lon":90},[94],{"name":95,"role":75,"phone":96,"phoneExt":39,"email":97},"Almou Ibrahim, MD","+227 20 75 29 06","idralmou@yahoo.com",{"type":99,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[101,103,105,108,110,112],{"name":102,"class":6},"Centre de Recherche Médicale et Sanitaire",{"name":104,"class":6},"Bill and Melinda Gates Foundation",{"name":106,"class":107},"Le Programme National de Santé Oculaire","UNKNOWN",{"name":109,"class":107},"Centre de recherche et interventions en santé publique (CRISP)",{"name":111,"class":107},"Ministère de la Santé Publique du Niger",{"name":113,"class":114},"S.C. Johnson & Son, Inc.","INDUSTRY","100647684","integrating-the-guardian-spatial-emanator-within-avenir-ii-100647684",false,"NCT07712263","Integrating the Guardian Spatial Emanator Within AVENIR II","GUARD-AV","Inclusion Criteria:\n\n* Centre de Santé Intégré (CSI) catchment area participating in the AVENIR II azithromycin mass drug administration program\n* Located in a high malaria transmission setting in the study area\n* Randomly selected from the eligible pool for participation\n* Household located within a selected CSI catchment area\n* Verbal consent provided by the head of household for household-level study activities\n* Verbal consent provided by the CSI chief for CSI-level participation\n\nExclusion Criteria:\n\n* CSI catchment area not participating in the AVENIR II azithromycin mass drug administration program\n* Household not located within a selected CSI catchment area\n* Refusal of verbal consent by the head of household\n* Refusal of verbal consent by the CSI chief for CSI-level participation",true,"ALL",{"count":125,"type":126},150000,"ESTIMATED","INTERVENTIONAL",[129],"NA","This study will evaluate the implementation of integrating Guardian spatial emanators into the existing AVENIR II azithromycin mass drug administration program in Niger. The objective is to assess whether Guardian can be feasibly, acceptably, and effectively delivered through the same community-based platform already used for door-to-door azithromycin distribution to children 1 to 59 months of age.\n\nSelected health center catchment areas in high-malaria-transmission settings in Niger will be randomized to integrated delivery or non-integrated delivery. The study will measure implementation outcomes including reach, coverage, acceptability, fidelity to protocol, costs, and product placement over time, and will also assess malaria-related clinic visits among children under 5 years of age using routine health facility data",[132],"Malaria",[134,135,136,137,138],"transfluthrin","malaria","spatial emanator","implementation science","cluster randomized","NOT_YET_RECRUITING","2026-07-20",{"date":142,"type":143},"2026-07-22","ACTUAL",{"date":145,"type":126},"2026-12-01",{"date":147,"type":126},"2028-12-31",{"name":5,"class":6},1]