[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648386":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":50,"centralContacts":57,"locations":37,"responsibleParty":62,"collaborators":37,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":37,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":37,"maxAge":37,"enrollmentInfo":72,"targetDuration":37,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":83,"whyStopped":37,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":37},{"fullName":5,"class":6},"St. Jude Children's Research Hospital","OTHER",[8,13,18,24,28],{"label":9,"type":6,"description":10,"interventionNames":11},"Patient participants","All infants between birth and 6.0 months of age who were screened through the UNIQUE study and tested positive for SCD (HbSS, HbSC, or other form of SCD) or had indeterminate results.",[12],"Other: Point-of-care testing (POCT) -Patient participants",{"label":14,"type":6,"description":15,"interventionNames":16},"Healthy control participants","Infants between birth and 6.0 months of age who screen negative for SCD (HbAA) through the UNIQUE study or tested positive for sickle cell trait (HbAS).",[17],"Other: Point-of-care testing (POCT) - Healthy control participants",{"label":19,"type":6,"description":20,"interventionNames":21},"Health facility staff participants","Healthcare staff ages ≥18 years working at secondary-level facilities involved in the UNIQUE study.",[22,23],"Other: Context Assessment for Community Health (COACH) survey","Other: Semi-structured interview",{"label":25,"type":6,"description":26,"interventionNames":27},"Supply chain expert participants","Administrative professionals with experience working in or around the national supply chain systems in Mozambique to support procurement, importation, customs clearance, storage, and in-country distribution of medical products.",[23],{"label":29,"type":6,"description":30,"interventionNames":31},"National public health system expert participants","Administrative professionals with experience working in the national public health system (e.g., Ministry of Health, MISAU) who oversee the delivery of health services to infants in-country, such as neonatal testing and vaccination programs.",[23],[33,38,42,46],{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Point-of-care testing (POCT) -Patient participants","Infants will be screened for Sickle Cell Disease using with point-of-care testing (POCT).",[9],null,{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":37},"Point-of-care testing (POCT) - Healthy control participants","Infants will be screened for Sickle Cell Disease using with point-of-care testing (POCT) and prospectively monitored for survival.",[14],{"type":6,"name":43,"description":44,"armGroupLabels":45,"otherNames":37},"Context Assessment for Community Health (COACH) survey","The COACH survey will collect quantitative data on eight contextual factors that impact a site's ability to implement evidence-based interventions.",[19],{"type":6,"name":47,"description":48,"armGroupLabels":49,"otherNames":37},"Semi-structured interview","Interview questions will revolve primarily around the current process for SCD screening and care referrals, factors impacting newborn care delivery and screening, and challenges to integrating SCD newborn screening and care referral into standard care delivery.",[19,29,25],[51,54],{"name":52,"affiliation":5,"role":53},"Jane Hankins, MD","PRINCIPAL_INVESTIGATOR",{"name":55,"affiliation":56,"role":53},"Ana O. Mocumbi, MD PhD FESC","Eduardo Mondlane University, National Institute of Health, Chronic Disease Determinants Program",[58],{"name":52,"role":59,"phone":60,"phoneExt":37,"email":61},"CONTACT","888-226-4343","referralinfo@stjude.org",{"type":63,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100648386","universal-newborn-screening-for-sickle-cell-disease-in-mozambique-100648386",false,"NCT07719972","Universal Newborn Screening For Sickle Cell Disease In Mozambique","Inclusion Criteria:\n\n* Children participants: All infants between birth and 6.0 months of age who are born or receive care at secondary-level facilities involved in the UNIQUE study.\n* Children participants will fall into one of two categories:\n\n  * Patient participants: All infants between birth and 6.0 months of age who were screened through the UNIQUE study and tested positive for SCD (HbSS, HbSC, or other form of SCD) or had indeterminate results.\n  * Healthy control participants: Infants between birth and 6.0 months of age who screen negative for SCD (HbAA) through the UNIQUE study or tested positive for sickle cell trait (HbAS).\n* Health facility staff participants: Healthcare staff ages ≥18 years working at secondary-level facilities involved in the UNIQUE study.\n* Supply chain expert participants: Administrative professionals with experience working in or around the national supply chain systems in Mozambique to support procurement, importation, customs clearance, storage, and in-country distribution of medical products.\n* National public health system expert participants: Administrative professionals with experience working in the national public health system (e.g., Ministry of Health, MISAU) who oversee the delivery of health services to infants in-country, such as neonatal testing and vaccination programs.\n\nExclusion Criteria:\n\n* Children participants:\n\n  * Stillbirths.\n  * Children who received an erythrocyte (blood) transfusion within 3 months of testing. Exogenous (transfused) HbA could artificially lower the sickle hemoglobin concentration, thus causing false-negative results.\n* Patient participants: none\n* Healthy control participants:\n\n  * Stillbirths.\n  * Children who received an erythrocyte (blood) transfusion within 3 months of testing. Exogenous (transfused) HbA could artificially lower the sickle hemoglobin concentration, thus causing false-negative results.\n* Health facility staff participants: none.\n* Supply chain expert participants: none.\n* National public health system expert participants: none.",true,"ALL",{"count":73,"type":74},6750,"ESTIMATED","INTERVENTIONAL",[77],"NA","The overarching goal of this study is to evaluate the feasibility of a new methodology that combines three multi-level implementation strategies to optimize the population-level uptake of essential evidence-based, standard of care treatments for infants with sickle cell disease (SCD) in low-resource settings. The study will be done in Mozambique.",[80],"Sickle Cell Disease",[82,9,14,19,25,29],"Mozambique","NOT_YET_RECRUITING","2026-07-17",{"date":86,"type":87},"2026-07-22","ACTUAL",{"date":89,"type":74},"2026-08",{"date":91,"type":74},"2031-08",{"name":5,"class":6}]