[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Helmy Sajali, MD, MPH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100657444","chipcat-and-hfmd-prep-for-hfmd-prevention-in-childcare-centres-in-kota-kinabalu-100657444",false,"NCT07839442","CHIPCAT and HFMD-PREP for HFMD Prevention in Childcare Centres in Kota Kinabalu","Development and Evaluation of CHIPCAT and HFMD-PREP for HFMD Prevention in Childcare Centres in Kota Kinabalu: A Stepped-Wedge Cluster Randomised Trial","Inclusion Criteria:\n\nInclusion Criteria (centre level):\n\n* Registered\u002Flicensed childcare or ECEC centre\n* Operational for 2 years or more\n* 10 or more children enrolled\n* Located within Kota Kinabalu district\n\nExclusion Criteria (centre level):\n\n* Planned closure or relocation during the study period\n* Concurrent participation in another infection-prevention intervention\n* Home-based centre with fewer than 10 children enrolled\n\nInclusion Criteria (individual level - staff and parents\u002Fguardians):\n\n* Employed as childcare staff at, or parent\u002Fguardian of a child enrolled at, a participating centre\n* Willing and able to provide informed consent\n\nExclusion Criteria (individual level):\n\n* Unable to provide informed consent\n* Children are not individually enrolled at any stage; no child is approached, examined, interviewed, or identified as part of this study.\n\nExclusion Criteria:\n\n\\-",true,"ALL","18 Years",{"count":20,"type":21},780,"ESTIMATED","INTERVENTIONAL",[24],"NA","Hand, foot and mouth disease (HFMD) is endemic in Malaysia and disproportionately affects children in childcare settings, where institutional infection prevention and control (IPC) capacity is frequently inadequate. This study develops and evaluates two linked tools: CHIPCAT (Childcare Infection Prevention Capacity Assessment Tool), which generates the Infection Prevention Capacity Index (IPCI) as an institutional capacity score, and HFMD-PREP (HFMD Prevention and Response Enhancement Programme), a structured capacity-building intervention mapped to CHIPCAT domains. Following instrument development and validation, the intervention is evaluated using a stepped-wedge cluster randomised trial (SW-CRT) across 12 licensed childcare centres in Kota Kinabalu, Sabah, Malaysia. All centres receive HFMD-PREP by the end of the study; only the timing of crossover differs by randomised sequence. The primary outcome is the change in IPCI. Secondary outcomes are staff and parent knowledge, attitude and practice (KAP) scores. HFMD incidence is analysed as an exploratory secondary disease outcome. This study is also registered with the Malaysian National Medical Research Register (NMRR ID RSCH ID-26-05258-LQ3), with parallel ethics submission to the Ministry of Health Malaysia Medical Research Ethics Committee (MOH MREC).",[27,28],"Hand, Foot and Mouth Disease","Infection Control",[30,31,32,33],"HFMD","childcare centres","stepped-wedge cluster randomised trial","Malaysia","NOT_YET_RECRUITING","2026-10-09",{"date":37,"type":38},"2026-10-13","ACTUAL",{"date":40,"type":21},"2026-10",{"date":42,"type":21},"2028-06",{"name":44,"class":45},"Helmy Sajali, MD, MPH","OTHER",""]