[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636255":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":30,"responsibleParty":76,"collaborators":78,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":20,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":90,"minAge":91,"maxAge":20,"enrollmentInfo":92,"targetDuration":20,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":104,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"bioLytical Laboratories","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TruPlex HIV\u002FHepB\u002FSyphilis Rapid Test Performance","EXPERIMENTAL","Capillary blood, EDTA whole blood, EDTA plasma, and SST serum samples collected by trained operators in point-of-care settings will be tested on the TruPlex HIV\u002FHepB\u002FSyphilis Rapid Test.",[13],"Device: TruPlex HIV\u002FHepB\u002FSyphilis Rapid Test",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","TruPlex HIV\u002FHepB\u002FSyphilis Rapid Test","A rapid in vitro diagnostic device designed to determine HIV, Syphilis and Hep B infection status",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Ana Subramanian","CONTACT","16042046784","asubramanian@biolytical.com",{"name":28,"role":24,"phone":25,"phoneExt":20,"email":29},"Patrick Diaz","pdiaz@biolytical.com",[31,49,62],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Epicentre Health Research (Johannesburg)","RECRUITING","Johannesburg","Gauteng","2193","South Africa","ZA",{"type":40,"coordinates":41},"Point",[42,43],28.04363,-26.20227,{"lat":43,"lon":42},[46],{"name":47,"role":24,"phone":20,"phoneExt":20,"email":48},"Cherie Cawood","cheriec@epicentre.org.za",{"facility":50,"status":33,"city":51,"state":52,"zip":53,"country":37,"countryCode":38,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Epicentre Health Research","Durban","KwaZulu-Natal","3650",{"type":40,"coordinates":55},[56,57],31.0292,-29.8579,{"lat":57,"lon":56},[60],{"name":47,"role":24,"phone":61,"phoneExt":20,"email":48},"+27 31 880 2150",{"facility":63,"status":33,"city":64,"state":65,"zip":66,"country":37,"countryCode":38,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Epicentre Health Research (Cape Town)","Cape Town","Western Cape","7925",{"type":40,"coordinates":68},[69,70],18.42322,-33.92584,{"lat":70,"lon":69},[73],{"name":74,"role":24,"phone":75,"phoneExt":20,"email":48},"Cherie Cawoood","+27 21 201 1658",{"type":77,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[79],{"name":80,"class":81},"Epicentre","OTHER","100636255","a-study-to-evaluate-performance-usability-and-contrived-result-interpretation-of-truplex-hivhepbsyphilis-rapid-test-100636255",false,"NCT07563309","A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV\u002FHepB\u002FSyphilis Rapid Test","A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of TruPlex HIV\u002FHepB\u002FSyphilis Rapid Test by Trained Personnel at Near-Patient and Point-of-Care Settings","Inclusion Criteria:\n\n* 18 years of age or older\n* Subject is able to provide and willing to sign and date the Informed Consent Form\n* Subject is able to complete the required testing on the allocated testing day.\n* Subject able to speak\u002Fread\u002Fwrite English or a translator is available\n* Subject is getting tested for HIV, and\u002For Syphilis, and\u002For Hepatitis B for one or more of the following reasons:\n\n  * At risk for any one of the target diseases\n  * Having signs or symptoms indicative of the target diseases\n  * Routine testing\n  * Note: Subjects who are pregnant and re-infected are eligible to participate\n* Unknown HIV or known HIV positive status with less than 12 months of Anti-Retroviral Treatment (ART).\n* Subject is willing to provide the fingerstick blood sample(s) and whole blood samples collected through venous blood draw (approximately 16 ml) required for the study.\n* Subject willing to participate in the study site's standard of care counselling and testing program and receive the study site's standard of care test results\n\nExclusion Criteria:\n\n* Subject has a bleeding disorder\n* Subject is currently undergoing Syphilis treatment\n* Subject has received any experimental HIV vaccine\n* Subject received HBV vaccine within the last 7 days\n* Known HIV positive subjects and currently on ART for 12 months or longer\n* Any condition which, in the opinion of the Investigator, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion of study assessment, consent form and questionnaire etc. or bias the study outcome.",true,"ALL","18 Years",{"count":93,"type":94},1000,"ESTIMATED","INTERVENTIONAL",[97],"NA","The objectives of this study are as follows:\n\nTo evaluate the clinical performance of the TruPlex test using capillary blood, EDTA whole blood, EDTA plasma, and SST serum samples collected by trained operators in point-of-care settings\n\nTo evaluate the usability of the TruPlex test through:\n\nStructured usability assessments, via a questionnaire, completed by trained operators in point-of-care settings.\n\nTo assess user interpretation accuracy through a contrived result interpretation questionnaire, where intended users evaluate a set of pre-defined test results (e.g., strong\u002Fweak positives, negatives, invalids).\n\nTo monitor test system reliability, including invalid rates.",[100,101,102,103],"HIV 1 Infection","HIV 2 Infection","Syphilis Infection","Hepatitis B Infection",[17],"2026-04-29",{"date":107,"type":108},"2026-05-04","ACTUAL",{"date":110,"type":108},"2025-12-18",{"date":112,"type":94},"2027-01-01",{"name":5,"class":6},3]