[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571146":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":83,"collaborators":85,"id":88,"slug":20,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":20,"eligibilityCriteria":93,"healthyVolunteers":94,"sex":95,"minAge":96,"maxAge":20,"enrollmentInfo":97,"targetDuration":20,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":107,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Unity Health Toronto","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants with unknown HIV and syphilis status","EXPERIMENTAL","All participants will self-test fingerstick blood testing with the test device, along with venous blood testing at a central laboratory using licensed gold standard comparator methods.",[13],"Device: Multiplo TP\u002FHIV Antibody Test",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Multiplo TP\u002FHIV Antibody Test","The Multiplo TP\u002FHIV Antibody Test (MedMira Laboratories Inc., Halifax, NS), \\[\"Multiplo TP\u002FHIV Test\"\\] is a single use, rapid, vertical-flow in vitro qualitative immunoassay for the detection of antibodies to Human Immunodeficiency Virus (HIV) Type 1\u002FType 2 and Treponema pallidum (Syphilis) in human fingerstick blood. The Multiplo® TP\u002FHIV Test is intended as an aid in the diagnosis of HIV1\u002F2 and Syphilis infections in patients with signs and symptoms of HIV and syphilis. The test is intended for use by trained personnel in medical facilities, clinical laboratories, emergency care situations, and physicians' offices as an in vitro diagnostic device capable of providing results in less than five minutes. The Multiplo TP\u002FHIV Test has not yet sought approval for self-testing. All required pre and post-test counselling guidelines must be followed in each setting in which the Multiplo TP\u002FHIV Test is used. Results are read visually.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Megan Cedrone, BSc, MSc","CONTACT","647-786-8711","Megan.Cedrone@unityhealth.to",[28,52,67],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Cool Aid Community Health Centre","RECRUITING","Victoria","British Columbia","V8W 1M8","Canada","CA",{"type":37,"coordinates":38},"Point",[39,40],-123.35155,48.4359,{"lat":40,"lon":39},[43,47,49],{"name":44,"role":24,"phone":45,"phoneExt":20,"email":46},"Marion Selfridge","250-385-1466","mselfridge@coolaid.org",{"name":48,"role":24,"phone":20,"phoneExt":20,"email":46},"Katie Besko",{"name":50,"role":51,"phone":20,"phoneExt":20,"email":20},"Chris Fraser, MD","PRINCIPAL_INVESTIGATOR",{"facility":53,"status":30,"city":54,"state":55,"zip":56,"country":34,"countryCode":35,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Hassle Free Clinic","Toronto","Ontario","M5B 1G3",{"type":37,"coordinates":58},[59,60],-79.39864,43.70643,{"lat":60,"lon":59},[63],{"name":64,"role":24,"phone":65,"phoneExt":20,"email":66},"Francois MacDonald Research Coordinator","416-922-0566","francois@hasslefreeclinic.org",{"facility":68,"status":30,"city":54,"state":55,"zip":69,"country":34,"countryCode":35,"cosmosGeoPoint":70,"geoPoint":72,"contacts":73},"Women's Health in Women's Hands","M5B 1J3",{"type":37,"coordinates":71},[59,60],{"lat":60,"lon":59},[74,78,81],{"name":75,"role":24,"phone":76,"phoneExt":20,"email":77},"Wangari Tharao","416-263-4870","wangari@whiwh.com",{"name":79,"role":24,"phone":20,"phoneExt":20,"email":80},"Nonty Nkala","nonty@whiwh.com",{"name":82,"role":51,"phone":20,"phoneExt":20,"email":20},"Megan Saunders, MD, CCFP",{"type":84,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[86],{"name":87,"class":6},"University of Toronto","100571146",false,"NCT06716450","Multiplo Tp\u002FHIV Self-Test","A Study to Evaluate the Accuracy, Usability and Readability of the Multiplo® TP\u002FHIV Antibody Self-Test Performed by Observed Intended Users in Canada and the Impact of Peer-led HIV and Syphilis Care Among People Experiencing Homelessness in Toronto","Inclusion Criteria:\n\n* Are ≥18 years of age.\n* Can speak\u002Fread\u002Fwrite English or French.\n* Have presented for voluntary testing for HIV and\u002For syphilis infection in the clinic or community-based setting.\n* Are willing to participate in the study site's standard of care HIV and syphilis counselling and testing program and receive the study site's standard of care test results.\n* Are willing to be a participant in the study.\n* Can provide informed consent i.e. understand and sign or instruct the Observer to sign the informed consent form.\n* Can complete the required testing on the allocated testing day.\n* Are willing to provide the necessary fingerstick and venipuncture blood for use in the study protocol testing methods.\n* Are of unknown HIV and syphilis status (last HIV and syphilis negative test must be a minimum of 3 months prior).\n\nExclusion Criteria:\n\n* Do not meet the inclusion criteria.\n* Are known HIV and\u002For syphilis positive.\n* Have ever tested positive for syphilis or HIV at any time.\n* Have any experience in conducting rapid point-of-care tests on patients for HIV, syphilis or any other infectious disease.\n* Are familiar with the Multiplo® TP\u002FHIV Self-Test.\n* Are investigator site employees or immediate family members of sponsor or investigator sites.\n* Have participated in any prior, or concurrent trial of HIV and syphilis self-tests.\n* Are a practicing medical healthcare professional (doctor, nurse or HIV counsellor that performs HIV testing with Rapid Tests).\n* Any condition which, in the opinion of the Observer, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion of the assessment, consent form and questionnaire etc. or bias the outcome (e.g. being unable to see\u002Fread by forgetting to bring reading glasses, being intoxicated, acute sickness, visibly distressed).",true,"ALL","18 Years",{"count":98,"type":99},900,"ESTIMATED","INTERVENTIONAL",[102],"NA","To help reach the undiagnosed living with HIV and\u002For syphilis in Canada, self-tests for HIV and Syphilis may have substantial utility for increased identification of infected individuals through their relative ease of use and portability, as well as their ability to deliver rapid, actionable results while the care provider still has access to the patient. MedMira Laboratories Inc. (Halifax, Nova Scotia, Canada) has developed a point-of-care (POC) test to detect HIV and Syphilis antibodies in fingerstick blood samples that is under final review by Health Canada for use by trained Healthcare professionals. A self-test version of this test, with simplified instructions for use has been developed for investigational studies. The goal of the following study sponsored by REACH Nexus is to provide evidence that untrained lay persons \u002F intended users can perform the Multiplo Tp\u002FHIV Self-Test without any increased risk of obtaining erroneous results.",[105,106],"HIV Infection","Syphilis Infection",[108,109,110],"self-test","device trial","screen test","2026-01-23",{"date":113,"type":114},"2026-01-27","ACTUAL",{"date":116,"type":114},"2025-06-12",{"date":118,"type":99},"2026-12-10",{"name":5,"class":6},3]