[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neisseria-gonorrheae-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neisseria-gonorrheae-infection":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100633724","performance-acceptability-and-usability-of-a-novel-rapid-lateral-flow-test-for-detecting-neisseria-gonorrhoeae-in-pregnant-and-symptomatic-women-attending-clinics-in-south-africa-100633724",false,"NCT07530406","Performance, Acceptability, and Usability of a Novel Rapid Lateral Flow Test for Detecting Neisseria Gonorrhoeae in Pregnant and Symptomatic Women Attending Clinics in South Africa.","Evaluation of Performance, Acceptability, and Usability of a Novel Lateral Flow Assay for Point-of-Care Detection of Neisseria Gonorrhoeae Infection Among Pregnant and Symptomatic Women in South Africa","GO-SA","Inclusion Criteria:\n\nANC population\n\n* Women age ≥18 years\n* Pregnant women\n* Attending a study site for antenatal care\n* Willingness to participate and signed informed consent form (ICF)\n\nExclusion Criteria:\n\n* Self-reported use of antimicrobial therapy within 21 days preceding enrolment\n* Use of vaginal douche or vaginal product in the previous 24 hours\n* Unable to provide specimens for testing\n* A medical condition, serious illness, or other condition that could interfer with study procedures or jeopardise participant safety Symptomatic population Inclusion -\n* Non pregnant women age ≥18 years\n* Diagnosis of VDS. Diagnosis of VDS will be based on self-reported presence ofsymptoms consistent with VDS, such as increased or abnormal vaginal discharge\n* Willingness to participate and sign ICF Exclusion -\n* Self-reported use of antimicrobial therapy within 21 days preceding enrolment\n* Use of vaginal douche or vaginal product in the previous 24 hours\n* Unable to provide specimens for testing\n* A medical condition, serious illness, or other condition that could interfere with study procedures or jeopardise participant safety",true,"FEMALE","18 Years",{"count":21,"type":22},1239,"ESTIMATED","OBSERVATIONAL","Previous studies of the Neisseria gonorrhoeae (NG) lateral flow assay (LFA) have shown promising results. In East London, South Africa, the LFA demonstrated a sensitivity of 80% in asymptomatic women. However, a study in Zimbabwe reported a lower sensitivity of 65% among pregnant women attending antenatal care (ANC). This discrepancy raises important questions about the test's performance in pregnant women in the East London ANC population. Physiological changes during pregnancy may influence test accuracy, highlighting the need for further investigation in this specific population and setting.\n\nThis study aims to evaluate the performance, acceptability, and usability of the NG LFA among pregnant and symptomatic women attending clinics in East London. Participants will provide clinical samples that are tested using both the NG LFA and standard laboratory methods to assess diagnostic accuracy, including sensitivity and specificity. The study will specifically determine whether pregnancy affects the test's performance and whether the LFA is reliable for routine use in ANC clinics. Confirming its accuracy could enable wider implementation, improving case detection, treatment rates, and reducing the burden of gonorrhea in the community.\n\nIn addition to evaluating performance, the study will investigate the feasibility of self-collected samples. Self-collection offers privacy, convenience, and may increase participation in testing, particularly for women who prefer this method. It may also reduce the workload for healthcare providers, especially in resource-limited settings. The study will compare the accuracy of self-collected samples with clinician-collected samples to determine whether self-collection is a viable option in ANC and symptomatic populations.\n\nThe findings will provide crucial evidence to guide implementation of the NG LFA in primary care and ANC clinics, supporting timely diagnosis and treatment. If successful, this approach could strengthen gonorrhea screening programs, enhance patient-centered care, and contribute to better sexual and reproductive health outcomes for women in South Africa.",[26],"Neisseria Gonorrheae Infection",[15],"RECRUITING","2026-04-08",{"date":31,"type":32},"2026-04-15","ACTUAL",{"date":34,"type":32},"2025-09-11",{"date":36,"type":22},"2026-06-30",{"name":38,"class":39},"Foundation for Professional Development (Pty) Ltd","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":48,"minAge":4,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":51,"conditions":52,"keywords":53,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100578764","master-protocol-for-evaluating-multiple-infection-diagnostics-for-ciprofloxacin-resistant-neisseria-gonorrhoeae-100578764","NCT06815536","Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae","MASTERMINDRING","Inclusion Criteria:\n\n* Be N. gonorrhoeae-positive on an FDA-cleared molecular assay\n* Have sufficient N. gonorrhoeae-positive specimen volume for testing using the corresponding investigational reflex test and genetic sequencing\n* Undergo proper handling and storage conditions\n\nExclusion Criteria:\n\n* The N. gonorrhoeae-positive specimen media is not compatible with the investigational reflex test(s) at the laboratory site\n* The N. gonorrhoeae-positive specimen is not clearly labeled by the laboratory to link to basic epidemiologic data (age, sex) and source","ALL",{"count":50,"type":22},3291,"The goal of this study is to learn if a few investigational tests can correctly find the gene mutation (mutant allele gyrA 91F) that predicts ciprofloxacin resistance in clinical specimens that harbor Neisseria gonorrhoeae. The main question the study aims to answer:\n\nCan the investigational reflex test find the correct gene mutation (Neisseria gonorrhoeae gyrA 91F or gyrA 91S) as compared to the sequenced result?\n\nSpecimens that are collected for routine clinical care and harbor Neisseria gonorrhoeae will be evaluated in this study.",[26],[54,55,56],"mutant allele gyrA 91F","wildtype allele gyrA 91S","ciprofloxacin-resistant Neisseria gonorrhoeae","2026-03-04",{"date":59,"type":32},"2026-03-05",{"date":61,"type":32},"2025-04-16",{"date":63,"type":22},"2026-07",{"name":65,"class":39},"Duke University",8,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":86,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":40},"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",{"count":76,"type":22},756,"INTERVENTIONAL",[79],"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.",[82,83,26,84,85],"Treponema Pallidum Infection","Chlamydia Trachomatis Infection","Trichomonas Vaginalis Vaginitis","Sexually Transmitted Infection",[87,88],"Prenatal care","Point of care test","NOT_YET_RECRUITING","2025-12-16",{"date":92,"type":32},"2025-12-18",{"date":94,"type":22},"2026-05",{"date":96,"type":22},"2030-06",{"name":98,"class":39},"Emory University"]