[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"bioLytical Laboratories\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":94},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,71],{"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":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100636762","a-study-to-evaluate-the-performance-usability-and-contrived-result-interpretation-of-istatis-gonorrhea-antigen-test-100636762",false,"NCT07569900","A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of iStatis Gonorrhea Antigen Test","A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of iStatis Gonorrhea Antigen Test by Trained Personnel at Near-Patient or Point-of-Care Settings","Inclusion Criteria\n\n* Age \\> 16 years\n* Subject (or legally authorized representative) is willing to provide written informed consent before any study procedures\n* Female gender\n* Subject is able and willing to provide vaginal swab specimen for study procedures (3-4 swabs)\n* Subject can complete the required testing on the allocated testing day\n* Subject can speak, read, and write English\n* Subject's demographic information, risk factors, and symptoms are available and can be recorded on case report forms\n* Subject agrees to comply with study procedures and sample collection for both the investigational device and the reference method\n* Subject is willing to participate in the study site's standard-of-care Gonorrhea counselling and testing program and receive standard-of-care test results, as required and applicable\n* Subject is indicated for sexually transmitted infection testing for one or more of the following reasons:\n\n  * At risk of Gonorrhea, such as recent unprotected intercourse, multiple or new partners within \\\u003C 60 days, known exposure to an infected partner, or prior STI history\n  * Having signs and\u002For symptoms suggestive of Gonorrhea (e.g., urethral, vaginal, rectal, or pharyngeal discharge; dysuria; pelvic or lower-abdominal pain; sore throat; or rectal discomfort)\n  * Undergoing routine or opportunistic STI screening, including family-planning, antenatal, or sexual-health clinic visits\n  * Undergoing re-testing (test-of-cure) \\> 7 days after completion of Gonorrhea treatment and clinically stable\n  * Undergoing co-testing for other STIs where Gonorrhea testing is part of a broader diagnostic panel\n\nExclusion Criteria\n\n* Subject 15 years of age or younger\n* Male gender\n* Female currently menstruating\n* Subject is unable or unwilling to provide informed consent\n* Subject is medically unstable or has psychiatric condition(s) that pose a risk or prevent study compliance\n* Subject is unable to provide paired samples for reference testing\n* Subject requires urgent antimicrobial treatment before specimen collection\n* Subject received systemic or topical antibiotics active against Gonorrhea within the previous 7 days\n* Subject used topical intravaginal or rectal antiseptics within 48 hours prior to study sampling\n* Previously enrolled for the same infection episode\n* Anatomical or clinical contraindication to study sampling (e.g., severe cervical pathology)\n* Recent urogenital procedure (e.g., cystoscopy, lavage) \\\u003C 72 hours before study sampling\n* Subject belongs to a protected group excluded by local ethics (e.g., incarcerated persons), unless explicitly approved by the EC\u002FIRB\n* Any condition that, in the opinion of trained personnel or study staff, would make the participant unsuitable or unsafe for enrolment, interfere with completion of assessments, consent, or questionnaires, or bias study outcomes\n* Subject is participating in another interventional clinical study within 30 days that could interfere with study results",true,"FEMALE","16 Years",{"count":20,"type":21},650,"ESTIMATED","INTERVENTIONAL",[24],"NA","The objective of this study is to evaluate the performance, usability, and contrived result interpretation of iStatis Gonorrhea Antigen Test (iStatis Gonorrhea Test) in the intended near-patient or point-of-care setting by trained personnel.",[27],"Gonorrhea Infection",[29,30,31],"Gonorrhea test","Point-of-care test","iStatis test","RECRUITING","2026-06-30",{"date":35,"type":36},"2026-07-02","ACTUAL",{"date":38,"type":36},"2025-11-26",{"date":40,"type":21},"2027-01-01",{"name":42,"class":43},"bioLytical Laboratories","INDUSTRY",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":16,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":70,"locationsCount":5},"100636255","a-study-to-evaluate-performance-usability-and-contrived-result-interpretation-of-truplex-hivhepbsyphilis-rapid-test-100636255","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.","ALL","18 Years",{"count":54,"type":21},1000,[24],"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.",[58,59,60,61],"HIV 1 Infection","HIV 2 Infection","Syphilis Infection","Hepatitis B Infection",[63],"TruPlex HIV\u002FHepB\u002FSyphilis Rapid Test","2026-04-29",{"date":66,"type":36},"2026-05-04",{"date":68,"type":36},"2025-12-18",{"date":40,"type":21},{"name":42,"class":43},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":16,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"100636763","a-study-to-evaluate-the-performance-and-usability-of-truplex-hivhepbsyphilis-rapid-test-100636763","NCT07569913","A Study to Evaluate the Performance, and Usability of TruPlex HIV\u002FHepB\u002FSyphilis Rapid Test","A Study to Evaluate the Performance, and Usability 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 is 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.",{"count":79,"type":21},500,[24],"To evaluate the clinical performance of each analyte (HIV, HBsAg, and Syphilis) on the TruPlex HIV\u002FHepB\u002FSyphilis Rapid Test (TruPlex Test) using capillary blood (fingerstick), EDTA whole blood, EDTA-plasma, and SST-serum samples collected by trained operators at point-of-care settings. Additionally, to evaluate the usability of the TruPlex test through: structured usability assessments, via a questionnaire, completed by trained operators in point-of-care settings.",[83,59,60,61],"HIV1 Infection",[63],"NOT_YET_RECRUITING",{"date":87,"type":36},"2026-05-06",{"date":89,"type":21},"2026-09-01",{"date":91,"type":21},"2027-06-01",{"name":42,"class":43},1,""]