[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562623":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":16,"centralContacts":27,"locations":7,"responsibleParty":37,"collaborators":39,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":7,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":56,"maxAge":7,"enrollmentInfo":57,"targetDuration":7,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":72,"whyStopped":7,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":7},{"fullName":5,"class":6},"Abbott Rapid Dx","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"DIAGNOSTIC_TEST","Panbio™ HCV Self Test","Rapid diagnostic test (self-test and professional) plus laboratory reference tests",[14,15],"Fingerstick HIV testing (optional)","Laboratory reference testing for HCV (immunoassays and PCR, CE marked)",[17,21,24],{"name":18,"affiliation":19,"role":20},"Huma Qureshi, MD","Clinic 553","PRINCIPAL_INVESTIGATOR",{"name":22,"affiliation":23,"role":20},"Saeed Hamid, Pr","Aga Khan University",{"name":25,"affiliation":26,"role":20},"Mohammed Majam, BSc, MBA","Ezintsha",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":7,"email":32},"Jocelyn Farge, MSc, MBA","CONTACT","+33666483563","jocelyn.farge@abbott.com",{"name":34,"role":30,"phone":35,"phoneExt":7,"email":36},"Camilla S Forssten, PhD","+447792902244","camilla.forssten@abbott.com",{"type":38,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[40,42,45],{"name":23,"class":41},"OTHER",{"name":43,"class":44},"Clinic 553 Karachi","UNKNOWN",{"name":46,"class":44},"Ezintsha Clinical Research Center","100562623","lay-user-evaluation-of-the-panbio-hcv-self-test-100562623",false,"NCT06605573","Lay User Evaluation of the Panbio™ HCV Self-Test","Lay User Evaluation of the Panbio™ HCV Self Test: a Prospective, Multi-centre Observed Untrained User Study.","Inclusion Criteria:\n\n* Participant is aged 14 or over\n* Participant agrees to all aspects of the study and is able and willing to provide informed consent \u002F assent with parental consent.\n\nExclusion Criteria:\n\n* Participant has already participated in this study on a previous occasion.\n* Participant is aware of their HCV status\n* Participant is deemed unfit for the study by the Investigator.\n* Participant has a condition deemed unfit by the Investigator to safely perform or receive the test.\n* Participant is a practising health-care professional or laboratory scientist \u002F technician or has prior medical or laboratory training or experience\n* Participant is currently enrolled in a study to evaluate an investigational drug or vaccine.\n* Participant has a visual impairment that cannot be restored using glasses or contact lenses or is unable to read the Instructions for Use.\n* Participant is unwilling or unable to provide informed consent.\n* Participant has participated in the study \"Lay user evaluation of the Panbio™ HCV Self Test: A prospective, multi-centre usability study to evaluate lay user labelling comprehension and test result interpretation\".",true,"ALL","14 Years",{"count":58,"type":59},1185,"ESTIMATED","INTERVENTIONAL",[62],"NA","This is a prospective, multi-centre study designed to evaluate the usability of the Panbio™ HCV Self Test, when performed by untrained lay users in an observed study setting. The Panbio™ HCV Self Test detects antibodies to Hepatitis C Virus (HCV). The study validation will be conducted in accordance with the World Health Organisation's technical guidance on Hepatitis C rapid diagnostic tests for professional use and\u002For self-testing (TSS-16).",[65],"HEPATITIS C (HCV)",[67,68,69,70,71],"diagnostics","rapid test","untrained user","hepatitis C","lateral flow test","NOT_YET_RECRUITING","2024-09-18",{"date":75,"type":76},"2024-09-20","ACTUAL",{"date":78,"type":59},"2024-10",{"date":80,"type":59},"2025-03",{"name":5,"class":6}]