[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615271":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":45,"responsibleParty":63,"collaborators":66,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":26,"maxAge":26,"enrollmentInfo":80,"targetDuration":26,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":93,"overallStatus":96,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Emory University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control arm","ACTIVE_COMPARATOR","Participants will undergo routine clinical care at Grady Memorial Hospital (GMH), consistent with CDC STI Treatment Guidelines.\n\n* Positive results will be communicated via phone and\u002For Patient Portal.\n* For trichomoniasis or chlamydia, treatment will involve sending a prescription to the patient's preferred pharmacy. For syphilis or gonorrhea, patients will be asked to return to the clinic for an antibiotic infection.",[13],"Diagnostic Test: Standard of care STI testing",{"label":15,"type":16,"description":17,"interventionNames":18},"Intervention arm","EXPERIMENTAL","If participants wait for POCT results:\n\n* Positive results will prompt same-day counseling and treatment.\n* Treatment will be directly observed for gonorrhea and syphilis, or provided as a same-day prescription for trichomonas.\n* Chlamydia treatment may be directly observed or prescribed, depending on the clinical setting, consistent with the standard of care.\n\nIf participants do not wait for POCT results:\n\n* Positive results will be communicated via phone and\u002For Patient Portal.\n* Treatment will proceed as in the standard-of-care control arm.",[19,13],"Diagnostic Test: Point-of-care STI tests",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIAGNOSTIC_TEST","Point-of-care STI tests","Point-of-care testing for syphilis and\u002For chlamydia, gonorrhea, and trichomonas, depending on clinical indication at the visit.\n\nTesting will be performed using the Syphilis Health Check (SHC) and\u002For the Visby Sexual Health Test.\n\n* Syphilis Health Check (SHC)\n\n  * Single-use, disposable, fully integrated rapid test.\n  * Provides results in approximately 10 minutes.\n  * Detects syphilis antibodies (IgM and IgG to treponemal antigens) from fingerstick, whole blood, serum, or plasma.\n* Visby Sexual Health Test (Visby Medical):\n\n  * Single-use, disposable, fully integrated rapid PCR-based assay.\n  * Provides results in \\\u003C30 minutes.\n  * Detects Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis from vaginal swabs.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Standard of care STI testing","Standard of care for STI testing\n\nTesting procedures:\n\n* Blood samples will be collected for syphilis screening using rapid plasma reagin (RPR) with reflex treponemal testing.\n* Vaginal swab samples will be collected for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) testing using nucleic acid amplification tests (NAATs).",[9,15],[32],"SOC",[34],{"name":35,"affiliation":5,"role":36},"Kristin Wall, PhD","PRINCIPAL_INVESTIGATOR",[38,42],{"name":35,"role":39,"phone":40,"phoneExt":26,"email":41},"CONTACT","(404)-616-0600","kmwall@emory.edu",{"name":43,"role":39,"phone":26,"phoneExt":26,"email":44},"Kimberly Workowski, MD","kworkow@emory.edu",[46],{"facility":47,"status":26,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Grady Memorial Hospital","Atlanta","Georgia","30303","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-84.38798,33.749,{"lat":57,"lon":56},[60,62],{"name":43,"role":39,"phone":61,"phoneExt":26,"email":44},"404-686-7893",{"name":43,"role":36,"phone":26,"phoneExt":26,"email":26},{"type":36,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Kristin Wall","Associate Professor",[67],{"name":68,"class":69},"National Institute on Minority Health and Health Disparities (NIMHD)","NIH","100615271","improving-maternal-and-child-health-through-point-of-care-sti-testing-100615271",false,"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",true,"FEMALE",{"count":81,"type":82},756,"ESTIMATED","INTERVENTIONAL",[85],"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.",[88,89,90,91,92],"Treponema Pallidum Infection","Chlamydia Trachomatis Infection","Neisseria Gonorrheae Infection","Trichomonas Vaginalis Vaginitis","Sexually Transmitted Infection",[94,95],"Prenatal care","Point of care test","NOT_YET_RECRUITING","2025-12-16",{"date":99,"type":100},"2025-12-18","ACTUAL",{"date":102,"type":82},"2026-05",{"date":104,"type":82},"2030-06",{"name":5,"class":6},1]