[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531757":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":33,"locations":43,"responsibleParty":113,"collaborators":116,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":127,"sex":128,"minAge":12,"maxAge":12,"enrollmentInfo":129,"targetDuration":12,"studyType":132,"phases":133,"briefSummary":135,"conditions":136,"keywords":12,"overallStatus":46,"whyStopped":12,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},{"fullName":5,"class":6},"University of Washington","OTHER",[8,13,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care","NO_INTERVENTION","In all arms, participants will receive syndromic STI assessment from study nurses at the antenatal clinic per Kenyan national guidelines, which entails a clinician (i.e., nurse, physician, clinical officer) using an algorithm asking whether clients have symptoms of vaginal discharge, lower abdominal pain, or genital ulcers followed by a physical examination for signs that match the self-reported symptoms. Based on clinical presentation, treatment is prescribed. Study nurses will capture information on symptoms, treatment acceptance, and dispensation. All participants will be provided with a study phone number to call at any time free of charge for clarifying questions or concerns with STI medication use.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Universal Testing","EXPERIMENTAL","Participants randomized to universal STI testing will be offered Xpert® CT\u002FNG and TV testing regardless of symptoms, and they will receive a standard syndromic STI assessment.",[18],"Diagnostic Test: Xpert® CT\u002FNG and TV testing",{"label":20,"type":15,"description":21,"interventionNames":22},"Asymptomatic Only Testing","Participants randomized to the asymptomatic only testing will be offered Xpert® CT\u002FNG and TV testing if no signs or symptoms of CT, NG, or TV are identified during STI assessment.",[18],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":12},"DIAGNOSTIC_TEST","Xpert® CT\u002FNG and TV testing","Participants randomized to universal STI testing will be offered Xpert® CT\u002FNG and TV testing regardless of symptoms, and they will receive a standard syndromic STI assessment. Participants randomized to the asymptomatic only testing will be offered Xpert® CT\u002FNG and TV testing if no signs or symptoms of CT, NG, or TV are identified during STI assessment. Participants assigned to receive Xpert® testing will be counseled on CT\u002FNG\u002FTV testing, including the benefits of testing even in the absence of symptoms to detect asymptomatic infections (as informed by pilot evaluation). If a client accepts Xpert® testing, she will be instructed by the study nurse on how to self-collect a vaginal swab.",[20,14],[30],{"name":31,"affiliation":5,"role":32},"Jillian Pintye, RN, MPH, PHD","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":12,"email":38},"Lauren Gomez","CONTACT","206-685-5044","gomezL4@uw.edu",{"name":40,"role":36,"phone":41,"phoneExt":12,"email":42},"Felix Abuna","+254 721 230652","fabuna@uw.edu",[44,58,65,72,82,89,96,103],{"facility":45,"status":46,"city":47,"state":12,"zip":12,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Homa Bay Teaching and Referral Hospital","RECRUITING","Homa Bay","Kenya","KE",{"type":51,"coordinates":52},"Point",[53,54],34.45714,-0.52731,{"lat":54,"lon":53},[57],{"name":40,"role":36,"phone":41,"phoneExt":12,"email":42},{"facility":59,"status":46,"city":47,"state":12,"zip":12,"country":48,"countryCode":49,"cosmosGeoPoint":60,"geoPoint":62,"contacts":63},"Rachuonyo South Sub County Hospital",{"type":51,"coordinates":61},[53,54],{"lat":54,"lon":53},[64],{"name":40,"role":36,"phone":41,"phoneExt":12,"email":42},{"facility":66,"status":46,"city":47,"state":12,"zip":12,"country":48,"countryCode":49,"cosmosGeoPoint":67,"geoPoint":69,"contacts":70},"Rangwe Sub County Hospital",{"type":51,"coordinates":68},[53,54],{"lat":54,"lon":53},[71],{"name":40,"role":36,"phone":41,"phoneExt":12,"email":42},{"facility":73,"status":46,"city":74,"state":12,"zip":12,"country":48,"countryCode":49,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Chulaimbo County hospital","Kisumu",{"type":51,"coordinates":76},[77,78],34.76171,-0.10221,{"lat":78,"lon":77},[81],{"name":40,"role":36,"phone":41,"phoneExt":12,"email":42},{"facility":83,"status":46,"city":74,"state":12,"zip":12,"country":48,"countryCode":49,"cosmosGeoPoint":84,"geoPoint":86,"contacts":87},"Kisumu County Hospital",{"type":51,"coordinates":85},[77,78],{"lat":78,"lon":77},[88],{"name":40,"role":36,"phone":41,"phoneExt":12,"email":42},{"facility":90,"status":46,"city":74,"state":12,"zip":12,"country":48,"countryCode":49,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},"Lumumba Sub County hospital",{"type":51,"coordinates":92},[77,78],{"lat":78,"lon":77},[95],{"name":40,"role":36,"phone":41,"phoneExt":12,"email":42},{"facility":97,"status":46,"city":74,"state":12,"zip":12,"country":48,"countryCode":49,"cosmosGeoPoint":98,"geoPoint":100,"contacts":101},"Migosi Sub County Hospital",{"type":51,"coordinates":99},[77,78],{"lat":78,"lon":77},[102],{"name":40,"role":36,"phone":41,"phoneExt":12,"email":42},{"facility":104,"status":46,"city":105,"state":12,"zip":12,"country":48,"countryCode":49,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Yala sub County Hospital","Yala",{"type":51,"coordinates":107},[108,109],34.53602,0.09438,{"lat":109,"lon":108},[112],{"name":40,"role":36,"phone":41,"phoneExt":12,"email":42},{"type":32,"investigatorFullName":114,"investigatorTitle":115,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Jillian Pintye","Associate Professor, Department of Biobehavioral Nursing and Health Informatics",[117],{"name":118,"class":119},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100531757","improving-perinatal-outcomes-among-kenyan-pregnant-women-with-an-integrated-sti-testing-model-100531757",false,"NCT06203951","Improving Perinatal Outcomes Among Kenyan Pregnant Women With an Integrated STI Testing Model","PrIMI","Inclusion Criteria:\n\n* Self-identifying as a cisgender woman\n* Seeking antenatal services from the clinic\n* Planning to receive antenatal and postnatal care at the clinic\n* Willingness to receive syndromic STI screening and HIV\u002Fsyphilis testing per national guidelines\n* Able and willing to provide informed consent for participation\n\nExclusion Criteria:\n\n* Male gender\n* Not seeking antenatal services from the clinic\n* Not planning to receive antenatal and postnatal care at the clinic\n* Not willing to receive syndromic STI screening and HIV\u002Fsyphilis testing per national guidelines\n* Not able or willing to provide informed consent for participation",true,"FEMALE",{"count":130,"type":131},3132,"ESTIMATED","INTERVENTIONAL",[134],"NA","The investigators will conduct a 3-arm individual-level RCT in Kisumu and Siaya, Kenya to compare perinatal outcomes associated with 3 models of STI testing and management in antenatal care. The investigators will enroll 3132 pregnant women and randomize 1:1:1 to receive standard-of-care (syndromic management only without CT, NG, or TV testing) vs. CT, NG, and TV testing using Xpert® assays universally vs. only among women without STI symptoms. All women with STIs detected and\u002For symptoms per Ministry of Health algorithms will receive immediate treatment, EPT per national guidelines, and tests of cure. All participants will be enrolled during routine antenatal care and followed through 9-months postpartum. The investigators will quantify and compare a composite outcome of pregnancy loss\u002Fstillbirth, PTB, LBW, SGA, and neonatal death, between randomization arms, in addition to several secondary and exploratory outcomes.",[137,138],"Hiv","Sexually Transmitted Infections (Not HIV or Hepatitis)","2025-07-10",{"date":141,"type":142},"2025-07-16","ACTUAL",{"date":144,"type":142},"2025-01-27",{"date":146,"type":131},"2028-12-31",{"name":5,"class":6},8]