[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"syphilis-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:syphilis-infection":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,46,69,97,121,159,192,218,245],{"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":31,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"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":20,"type":21},1000,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30],"HIV 1 Infection","HIV 2 Infection","Syphilis Infection","Hepatitis B Infection",[32],"TruPlex HIV\u002FHepB\u002FSyphilis Rapid Test","RECRUITING","2026-04-29",{"date":36,"type":37},"2026-05-04","ACTUAL",{"date":39,"type":37},"2025-12-18",{"date":41,"type":21},"2027-01-01",{"name":43,"class":44},"bioLytical Laboratories","INDUSTRY",3,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"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":54,"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.",[58,28,29,30],"HIV1 Infection",[32],"NOT_YET_RECRUITING",{"date":62,"type":37},"2026-05-06",{"date":64,"type":21},"2026-09-01",{"date":66,"type":21},"2027-06-01",{"name":43,"class":44},1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":68},"100633314","implementation-of-an-opt-out-testing-and-rapid-diagnostic-strategy-for-syphilis-and-hiv-in-pregnant-patients-presenting-to-the-emergency-department-100633314","NCT07525076","Implementation of an Opt-Out Testing and Rapid Diagnostic Strategy for Syphilis and HIV in Pregnant Patients Presenting to the Emergency Department","Inclusion Criteria:\n\n* Pregnancy\n* Presentation to the ED or obstetrical triage during the index pregnancy.\n* No established prenatal care (≤1 visit) and\u002For no documented HIV or syphilis testing during the current pregnancy.\n\nExclusion Criteria:\n\n* Medically unstable or critically ill at the time of ED presentation.\n* Incarcerated at the time of ED presentation.\n* Decline participation in testing (opt-out) or refuse survey participation.","FEMALE","14 Years","45 Years",{"count":79,"type":21},1400,[24],"The purpose of this study is to evaluate infection detection and treatment initiation rates for syphilis and HIV before and after integration of the Chembio DPP® HIV-Syphilis rapid POC test into an ongoing Emergency Department (ED) testing program and to determine whether dual rapid testing improves early initiation of HIV therapy in pregnant patients with newly identified HIV infection.",[83,29],"HIV Infections",[85,86],"Mother-to-child transmission (MTCT)","Sexually Transmitted Infections (STI)","2026-04-06",{"date":89,"type":37},"2026-04-13",{"date":91,"type":21},"2026-04-15",{"date":93,"type":21},"2028-05-31",{"name":95,"class":96},"The University of Texas Health Science Center, Houston","OTHER",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":16,"sex":75,"minAge":76,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":105,"phases":4,"briefSummary":106,"conditions":107,"keywords":108,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":68},"100620540","feasibility-and-acceptability-of-point-of-care-rapid-syphilis-testing-among-patients-seeking-family-planning-services-in-hawaii-100620540","NCT07358949","Feasibility and Acceptability of Point of Care Rapid Syphilis Testing Among Patients Seeking Family Planning Services in Hawai'i","Inclusion Criteria:\n\n* 14 years or older\n* Seeking contraception or abortion services\n* Sexually active (engages in any form of sexual activity with another person)\n* Denies history of syphilis infection\n* Can speak and read English\n* Displays capacity for informed consent\n\nExclusion Criteria:\n\n* Confirmed history (by patient report or medical records) of syphilis\n* Home address outside Hawai'i\n* Currently incarcerated\n\nNumber of Subjects:\n\nRecommendations for sample size in pilot studies range from 70 to 100 patients.28 Given this is a nonrandomized feasibility study with no comparator (i.e., to a control or to serological testing), we aim to enroll 50 to 75 participants to support analysis for correlation between variables while being able to achieve relatively small confidence intervals. This number takes into account the practical considerations of study personnel resources and in-person patient volume in our clinic. All patients eligible for the rapid syphilis testing will be approached for study participation.",{"count":104,"type":21},70,"OBSERVATIONAL","The purpose of the study is to see if rapid syphilis testing at the time of a family planning (contraception or abortion) visit is acceptable and practical for patients.\n\nThis study involves a fingerstick blood sample for syphilis testing during a family planning visit. Results will be ready in 10-15 minutes.\n\nPotential Benefits\n\n* Participants can find out whether they are syphilis positive or negative within the visit, as soon as 10-15 minutes of the finger stick. Typically, syphilis testing results take several days.\n* If positive, there is the option of starting treatment within the same day.\n\nPotential Risks\n\n* The study team will do everything possible to protect participants' privacy, including removing names and other identifiable information from study materials, however this is still a small chance there may be a breach of privacy during the study.\n* Physical risks of fingerstick are exceptionally rare when sterile technique is used. The study team will be using all best practices to reduce risk of infection or injury.\n* There is a risk of discomfort or pain with fingerstick collection. The risk of scarring is usually only associated with repeat draws, for example in patients with diabetes who have to do fingerstick draws multiple times per day.\n* There is a very small chance that the positive result is incorrect (also known as a \"false positive\"), meaning the participant does not actually have syphilis. To confirm the result, the investigators recommend that any positive rapid syphilis result be followed up with a blood test at the lab.\n\nCost for Participation\n\no There is no direct cost to participate in this study. After consent is signed, the participant received renumeration of $50 in form of gift card. If the participant tests positive for a syphilis infection, the participant or their health insurance will be responsible cover the costs of this medical treatment. If they do not have access to health insurance, the study team will connect the participant with agencies that have assisted patients with treatment at a reduced cost or free of cost.",[29],[109,110,111],"feasibility","rapid syphilis testing","family planning","2026-03-16",{"date":114,"type":37},"2026-03-19",{"date":116,"type":21},"2026-03-30",{"date":118,"type":21},"2027-12",{"name":120,"class":96},"Queen's Medical Center",{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":16,"sex":17,"minAge":128,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":105,"phases":4,"briefSummary":130,"conditions":131,"keywords":138,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":158},"100599849","this-study-evaluates-the-alpco-syphilis-t-and-syphilis-nt-clia-kits-for-detecting-syphilis-antibodies-in-serum-and-plasma-samples-from-at-risk-hiv-positive-pregnant-and-healthy-individuals-will-assess-assay-performance-versus-established-comparator-tests-100599849","NCT07089836","This Study Evaluates the ALPCO Syphilis-T and Syphilis-NT CLIA Kits for Detecting Syphilis Antibodies in Serum and Plasma. Samples From At-risk, HIV-positive, Pregnant, and Healthy Individuals Will Assess Assay Performance Versus Established Comparator Tests.","ALPCO Syphilis-T and Syphilis-NT CLIA Kits: Detection of Antibodies to Treponema Pallidum and Against Lipoidal Antigens in Human Serum and Plasma","Inclusion Criteria:\n\n* Male, Female, or Other(s)\n* Patients undergoing routine syphilis testing (asymptomatic at risk, suspected with symptoms, prior history of syphilis, high risk for syphilis) or previously diagnosed with syphilis through a test performed in an accredited laboratory.\n* Participants must be willing to provide the required blood samples for the clinical study, in addition to any samples requested by their physician.\n* Pregnant individuals and children (under 22): 1 clinical study tube of blood.\n* All other participants (excluding pregnant individuals and children): 2 clinical study tubes of blood.\n* Participants must be able and willing to sign the informed consent form (ICF).\n* Participants aged 13 to 17 will be asked to sign an assent form. Written parental or guardian consent will also be required prior to enrollment. The assent form will use age-appropriate language and be reviewed with the participant before any procedures.\n\nExclusion Criteria:\n\n* Patients currently being treated with antibiotics or completed a course of antibiotics within the past 30 days\n* Patients with pre-existing conditions that would make blood collection difficult or harmful\n* If the samples are not collected in strict accordance with the established sampling protocol, as determined by the study team.\n* Any medical, psychological, or social condition that, in the judgment of the investigator, could interfere with the participant's ability to comply with study requirements, or pose a risk to their safety, or compromise the integrity of the study.","13 Years",{"count":20,"type":21},"This study will evaluate the clinical performance of two investigational diagnostic kits developed by ALPCO: the Syphilis-T CLIA Kit and the Syphilis-NT CLIA Kit. These kits are designed to detect antibodies to Treponema pallidum and non-treponemal lipoidal antigens, respectively, in human serum and plasma using the automated KleeYa platform. The study will collect and analyze blood samples from individuals suspected of having syphilis, those at high risk, HIV-positive patients, pregnant individuals, and healthy controls. The aim is to determine the kits' Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) compared to established reference assays.",[132,133,29,134,135,136,137],"Treponema Pallidum","Treponema Pallidum Infection","Serum","Plasma","Blooddraw","Sexually Transmitted Infection (STI)",[139,140,141,142,143,144,145,146,147,148],"Non Treponema","Treponema","Syphilis","Sample Collection","Treponema pallidum","Non-treponemal test","Chemiluminescent immunoassay","HIV-positive","Pregnant women","Blood sample collection","2026-02-09",{"date":151,"type":37},"2026-02-11",{"date":153,"type":37},"2025-12-10",{"date":155,"type":21},"2026-07",{"name":157,"class":44},"American Laboratory Products Company",6,{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":16,"sex":167,"minAge":168,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":174,"conditions":175,"keywords":178,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":68},"100623497","phase-4-the-efficacy-of-doxycycline-post-exposure-prophylaxis-for-preventing-stis-among-msm-in-bangkok-thailand-100623497","NCT07397403","The Efficacy of Doxycycline Post Exposure Prophylaxis for Preventing STIs Among MSM in Bangkok, Thailand.","The Efficacy of Doxycycline Post Exposure Prophylaxis for Preventing Sexually Transmitted Diseases (Gonorrhea, Chlamydia, Syphilis) Among Men Who Have Sex With Men in Bangkok, Thailand.","ThaiDoxyPEP","Inclusion Criteria:\n\nBiological male, aged not over 60 years\n\nThai nationality\n\nAble to read, communicate, and understand the Thai language\n\nMen who have sex with men (MSM), aged 18 years or older and not over 60 years\n\nHaving at least one of the following risk factors:\n\nA history of condomless sex, or condom failure (breakage, leakage, or slippage), via any sexual route with at least two sexual partners within the past 3 months\n\nA diagnosis of gonorrhea, chlamydia, or syphilis within the past 6 months\n\nCurrent use of HIV pre-exposure prophylaxis (PrEP)\n\nWilling and able to participate in study procedures (e.g., able to return to the clinic for scheduled testing for gonorrhea, chlamydia, and syphilis; able to complete doxycycline use records; and able to receive follow-up phone calls from the research team)\n\nWilling and able to provide written informed consent to participate in the study\n\n\\-\n\nExclusion Criteria:\n\n* History of allergy to tetracycline-class antibiotics\n\nDiagnosed with syphilis and not yet treated, or currently receiving treatment with benzathine penicillin G or doxycycline\n\nReceipt of benzathine penicillin G within the past 12 weeks\n\nPrior receipt of a gonorrhea vaccine\n\nCurrent use of medications or products that may interact with doxycycline, including:\n\nVitamin A derivatives (e.g., isotretinoin, acitretin)\n\nAntiepileptic drugs (e.g., phenytoin, carbamazepine, phenobarbital)\n\nImmunosuppressive agents (e.g., methotrexate)\n\nMedications for heart failure or cardiac arrhythmias (e.g., digoxin)\n\nAnticoagulants (e.g., warfarin)\n\nUse of oral or injectable medications that affect blood cells, such as anticancer drugs, chemotherapy, systemic corticosteroids, or targeted therapies\n\nHistory of renal impairment (eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m²) or hepatic impairment (AST or ALT \\> 3 times the upper limit of normal)\n\nUncontrolled or unstable underlying diseases, such as hematologic disorders, cancer, autoimmune diseases, or neurological disorders\n\nSevere medical or psychiatric conditions that, in the investigator's judgment, may increase study-related risk or impair the participant's ability to provide informed consent\n\nAlcohol dependence (inability to control alcohol consumption, withdrawal symptoms upon reduction or cessation, or continued use despite harm) or illicit drug dependence (regular, uncontrolled use) within the past 12 months prior to enrollment, which may affect doxycycline use for STI prevention\n\nPrevious participation in this study with prior randomization","MALE","18 Days","60 Days",{"count":171,"type":21},400,[173],"PHASE4","The objective of this research is to evaluate the efficacy and safety of doxycycline in MSM for preventing sexually transmitted infections (gonorrhea, chlamydia, and syphilis) in Thailand\n\nParticipation in this study will last approximately 12 weeks and will include 2-3 clinic visits, along with 10-11 follow-up phone contacts over a period of 11 weeks.",[29,176,177],"Gonorrhea","Chlamydia",[179,180,141,181,177,182],"DoxyPEP","MSM","gonorrhea","Prevention","2026-02-02",{"date":149,"type":37},{"date":186,"type":37},"2025-10-06",{"date":188,"type":21},"2027-05-31",{"name":190,"class":191},"Bangrak STIs Center","OTHER_GOV",{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":201,"briefSummary":202,"conditions":203,"keywords":205,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":45},"100571146","multiplo-tphiv-self-test-100571146","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).",{"count":200,"type":21},900,[24],"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.",[204,29],"HIV Infection",[206,207,208],"self-test","device trial","screen test","2026-01-23",{"date":211,"type":37},"2026-01-27",{"date":213,"type":37},"2025-06-12",{"date":215,"type":21},"2026-12-10",{"name":217,"class":96},"Unity Health Toronto",{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":22,"phases":227,"briefSummary":229,"conditions":230,"keywords":232,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":68},"100546145","phase-3-limit-trial---lidocaine-with-intramuscular-injection-of-benzathine-penicillin-g-for-treponema-pallidum-treatment-100546145","NCT06391125","LIMIT Trial - Lidocaine With Intramuscular Injection of Benzathine Penicillin G for Treponema Pallidum Treatment","LIMIT","Inclusion Criteria:\n\n* Adults 18 years of age or above\n* Confirmed syphilis diagnosis (reactive RPR with confirmatory treponemal testing)\n* Receiving first injection in series if patient requires 3x weekly injections for syphilis treatment\n\nExclusion Criteria:\n\n* Penicillin allergy (anaphylaxis)\n* Lidocaine allergy (anaphylaxis)\n* Second or third injection in series if patient requires 3x weekly injections for syphilis treatment\n* Pregnancy",{"count":226,"type":21},48,[228],"PHASE3","There is evidence to suggest that lidocaine can help reduce the pain associated with intramuscular injections of benzathine penicillin G (BPG) or Bicillin, used to treat syphilis infections. A study published in the Journal of Family Practice in 2001 compared the pain experienced during bicillin injections with and without the use of lidocaine. The study found that patients who received lidocaine injections before receiving bicillin reported significantly less pain compared to those who received bicillin injections without lidocaine. Per the International Union against Sexually Transmitted Infections (IUSTI) European Guidelines for syphilis management, lidocaine has been used as a diluent for BPG since 1998. In the United States (US), BPG often comes prepackaged and lidocaine is unable to be used as a diluent with the same ease as it is in Europe. In light of this, the investigators propose a randomized controlled trial of benzathine penicillin G with and without lidocaine to quantify any site pain reduction with lidocaine in patients being treated for syphilis.\n\nThis study is a randomized, double blinded, placebo controlled trial. During this study, patients needing BPG treatment for syphilis will be screened for any penicillin allergies and consented to their participation. Each participant will receive 2 injections of BPG, 1.2 million units each (2x1.2 million units = 2.4 million units, the standard dose for syphilis treatment), as intramuscular injections, one in each gluteal muscle, with one of the injections randomly having 0.5ml of 1% lidocaine added while the other has 0.5 ml normal saline solution. The side of each injection will be randomized by the medical assistant (MA)\u002Fnurse filling the vials and the injecting MA will be blinded, as well as the study participant, as to which vial contains lidocaine and which contains normal saline. The participants will then be asked to rate their pain from 0-10 on each site of injection at 10 minutes post injection, then again at 24 hours after injection via email electronic survey (via RedCap). The differences in pain from the two injections will be compared and analyzed to see if lidocaine reduces pain associated with BPG injections compared to the control of normal saline added to BPG.",[29,231],"Benzathine Penicillin Adverse Reaction",[141,233,234,235],"Syphilis Treatment","Benzathine Penicillin G","Lidocaine","2025-03-24",{"date":238,"type":37},"2025-03-25",{"date":240,"type":37},"2024-07-01",{"date":242,"type":21},"2025-12",{"name":244,"class":96},"Washington University School of Medicine",{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":16,"sex":17,"minAge":252,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":22,"phases":254,"briefSummary":255,"conditions":256,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":68},"100560981","evaluation-of-the-diagnostic-sensitivity-and-specificity-of-the-determine-syphilis-advanced-test-100560981","NCT06584214","Evaluation of the Diagnostic Sensitivity and Specificity of the Determine™ Syphilis Advanced Test.","A Prospective, Multi-centre Study to Evaluate the Diagnostic Sensitivity and Specificity of the Determine™ Syphilis Advanced Test.","Inclusion Criteria:\n\n* 12 years of age or older.\n* The participant has confirmed previous \u002F current syphilis according to their medical history, or the participant has unknown or negative syphilis infection status.\n* The participant agrees to provide written informed consent.\n* The participant agrees to complete all aspects of the study.\n\nAdditional inclusion criteria for frozen samples:\n\n* The ethics committee-required written informed consent for study testing, or required documentation for sample use from a commercial vendor, is available.\n* Sufficient volume for testing is available and the sample quality is adequate (for example no significant sample hemolysis)\n* The sample must have been collected in EDTA vacutainers or serum tubes, processed to plasma and the plasma frozen within 36 hours of blood collection.\n\nExclusion Criteria:\n\n* Participant has already participated in this study on a previous occasion.\n* Participant is deemed vulnerable and \u002F or unfit for participation in the study by the Investigator.\n* Participant is unwilling or unable to provide informed consent.\n* Participant is currently enrolled in a study to evaluate an investigational new drug or vaccine.\n\nAdditional exclusion criteria for frozen samples\n\n* The sample has undergone more than one freeze thaw cycle\n* The sample has been kept at -20 °C (± 5 °C) longer than 12 months. If the sample has been kept longer than 12 months, the storage temperature must have been colder than -20 °C (± 5 °C).","12 Years",{"count":171,"type":21},[24],"This is a prospective, multi-centre study which will evaluate the diagnostic sensitivity and specificity of the Determine™ Syphilis Advanced test. The test is intended for professional use and the performance evaluation will be performed by professional healthcare and laboratory staff. The study will also have a retrospective study arm. The Determine™ Syphilis Advanced validation will be conducted in accordance with the World Health Organization\\'s TSS-6 guidance on Syphilis rapid diagnostic tests, ISO 20916 (In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice), the study protocol, Good Clinical Practice and the respective local medical device laws.",[29],"2024-09-02",{"date":259,"type":37},"2024-09-04",{"date":261,"type":21},"2024-09",{"date":263,"type":21},"2024-12",{"name":265,"class":44},"Abbott Rapid Dx"]