[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"treponema-pallidum-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:treponema-pallidum-infection":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,56],{"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":4,"briefSummary":23,"conditions":24,"keywords":32,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"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",false,"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.",true,"ALL","13 Years",{"count":20,"type":21},1000,"ESTIMATED","OBSERVATIONAL","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.",[25,26,27,28,29,30,31],"Treponema Pallidum","Treponema Pallidum Infection","Syphilis Infection","Serum","Plasma","Blooddraw","Sexually Transmitted Infection (STI)",[33,34,35,36,37,38,39,40,41,42],"Non Treponema","Treponema","Syphilis","Sample Collection","Treponema pallidum","Non-treponemal test","Chemiluminescent immunoassay","HIV-positive","Pregnant women","Blood sample collection","RECRUITING","2026-02-09",{"date":46,"type":47},"2026-02-11","ACTUAL",{"date":49,"type":47},"2025-12-10",{"date":51,"type":21},"2026-07",{"name":53,"class":54},"American Laboratory Products Company","INDUSTRY",6,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":16,"sex":64,"minAge":4,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":76,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":90},"100615271","improving-maternal-and-child-health-through-point-of-care-sti-testing-100615271","NCT07290439","Improving Maternal and Child Health Through Point-of-care STI Testing","Improving Maternal and Child Health Through Point-of-care STI Testing (MATCH-POINT)","MATCH-POINT","Inclusion Criteria:\n\n* Pregnant and clinically indicated for STI testing (syphilis and\u002For Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) at a prenatal care (PNC ) or labor and delivery (L\\&D) triage visit at Grady Memorial Hospital (GMH). Indications for STI testing in pregnancy at GMH:\n\n  * Syphilis, CT, NG, and TV indicated at first PNC visit\n  * Syphilis serologic testing additionally indicated in 3rd trimester and at delivery\n  * CT\u002FNG\u002FTV additionally indicated in the 3rd trimester for those \\\u003C25 or with increased risk \\[1\\]\n  * Additional testing recommended based on clinical signs or symptoms (e.g., genital lesion or vaginal discharge, new exposure history)\n* English or Spanish-speaking\n* If \\\u003C16 years of age, has a parent or legal guardian present\n* Have STI risk factor:\n\n  * \\\u003C25 years of age\n  * Reports current substance use\n  * Reported or documented history of a positive STI\n  * More than one current sex partner\n  * A current sex partner who has concurrent partners\n  * A new sex partner (\\\u003C6 months )\n  * A current sex partner who has an STI\n  * Exchange of sex for money or drugs\n  * Incarceration\n  * No previous prenatal care during the current pregnancy\n* Able to follow study procedures and provide written informed consent or assent, as appropriate\n\nExclusion Criteria:\n\n* Indicated for syphilis test: negative RPR test during this pregnancy\n* Indicated for syphilis test: ever had a previous syphilis diagnosis (lifetime history)\n* Indicated for CT\u002FNG\u002FTV test: negative for all three of CT, NG, and TV within the previous 1 month\n* Indicated for CT\u002FNG\u002FTV test: positive for any of CT, NG, and\u002For TV and completed treatment \\\u003C3 weeks prior\n\nStakeholders:\n\n* GMH PNC or L\\&D providers, GMH leadership, Georgia Dept of Health leadership\n* \\>=18 years of age\n* Able to follow study procedures and provide verbal informed consent","FEMALE",{"count":66,"type":21},756,"INTERVENTIONAL",[69],"NA","The goal of this clinical trial is to learn if point-of-care tests (POCTs) for sexually transmitted infections (STIs) improve the timely treatment of syphilis, chlamydia, gonorrhea, and trichomonas in pregnant women. It will also learn about the feasibility, acceptability, and cost-effectiveness of implementing POCTs in a large safety-net hospital setting.\n\nThe main questions it aims to answer are:\n\n* Do POCTs reduce delays in STI treatment compared with standard laboratory-based testing?\n* What barriers, facilitators, and processes affect POCT implementation in prenatal and obstetric care?\n* What are the costs and cost-effectiveness of POCTs compared with standard testing?\n\nParticipants will:\n\n* Complete a baseline survey and receive either POCTs (fingerstick blood draw or vaginal swab) or standard laboratory STI testing.\n* If diagnosed with an STI, complete a follow-up survey approximately one month later.\n* Stakeholders (providers, hospital leadership, and public health officials) will complete interviews to inform implementation strategies.",[26,72,73,74,75],"Chlamydia Trachomatis Infection","Neisseria Gonorrheae Infection","Trichomonas Vaginalis Vaginitis","Sexually Transmitted Infection",[77,78],"Prenatal care","Point of care test","NOT_YET_RECRUITING","2025-12-16",{"date":82,"type":47},"2025-12-18",{"date":84,"type":21},"2026-05",{"date":86,"type":21},"2030-06",{"name":88,"class":89},"Emory University","OTHER",1]