Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-31 @ 7:10 PM
Study NCT ID:
NCT06645106
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-06
First Post:
2024-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Offering Routine and Rapid Point of Care (POC) Syphilis Testing in Pregnant Patients Presenting to the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013587', 'term': 'Syphilis'}], 'ancestors': [{'id': 'D014211', 'term': 'Treponemal Infections'}, {'id': 'D013145', 'term': 'Spirochaetales Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015231', 'term': 'Sexually Transmitted Diseases, Bacterial'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013525', 'term': 'Surgical Instruments'}, {'id': 'D013588', 'term': 'Syphilis Serodiagnosis'}], 'ancestors': [{'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D012698', 'term': 'Serologic Tests'}, {'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2024-10-07', 'studyFirstSubmitQcDate': '2024-10-14', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients without prenatal care during the index pregnancy who received full treatment for all stages of syphilis', 'timeFrame': 'within 1 week of presentation until the time of delivery'}, {'measure': 'Percentage of patients with no documented syphilis test during the index pregnancy who received full treatment for all stages of syphilis', 'timeFrame': 'within 1 week of presentation until the time of delivery'}], 'secondaryOutcomes': [{'measure': 'The percentage of patients who adhere to recommended maternal and newborn longitudinal follow up', 'timeFrame': 'within 1 week of presentation until the time of delivery'}, {'measure': 'The percentage of patients who adhere to recommended maternal and newborn longitudinal follow up', 'timeFrame': 'at time of postpartum (upto 15 months after delivery)'}, {'measure': 'Percentage of participants that are married on completion of syphilis treatment', 'timeFrame': 'from presentation to delivery'}, {'measure': 'Percentage of participants that have health insurance on completion of syphilis treatment', 'timeFrame': 'from presentation to delivery'}, {'measure': 'Percentage of participants that have psychiatric problems on completion of syphilis treatment', 'timeFrame': 'from presentation to delivery'}, {'measure': 'Percentage of participants that show substance abuse including alcohol on completion of syphilis treatment', 'timeFrame': 'from presentation to delivery'}, {'measure': 'Percentage of participants that have unstable housing on completion of syphilis treatment', 'timeFrame': 'from presentation to delivery'}, {'measure': 'Percentage of participants that have transportation on completion of syphilis treatment', 'timeFrame': 'from presentation to delivery'}, {'measure': 'Percentage of participants that experience intimate partner violence on completion of syphilis treatment', 'timeFrame': 'from presentation to delivery'}, {'measure': 'number of prenatal care visits on completion of syphilis treatment', 'timeFrame': 'from presentation to delivery'}, {'measure': 'Percentage of participants that are married on completion of syphilis treatment', 'timeFrame': 'at time of postpartum (upto 15 months after delivery)'}, {'measure': 'Percentage of participants that have health insurance on completion of syphilis treatment', 'timeFrame': 'at time of postpartum (upto 15 months after delivery)'}, {'measure': 'Percentage of participants that have psychiatric problems on completion of syphilis treatment', 'timeFrame': 'at time of postpartum (upto 15 months after delivery)'}, {'measure': 'Percentage of participants that show substance abuse including alcohol on completion of syphilis treatment', 'timeFrame': 'at time of postpartum (upto 15 months after delivery)'}, {'measure': 'Percentage of participants that have unstable housing on completion of syphilis treatment', 'timeFrame': 'at time of postpartum (upto 15 months after delivery)'}, {'measure': 'Percentage of participants that have transportation on completion of syphilis treatment', 'timeFrame': 'at time of postpartum (upto 15 months after delivery)'}, {'measure': 'Percentage of participants that experience intimate partner violence on completion of syphilis treatment', 'timeFrame': 'at time of postpartum (upto 15 months after delivery)'}, {'measure': 'number of prenatal care visits on completion of syphilis treatment', 'timeFrame': 'at time of postpartum (upto 15 months after delivery)'}, {'measure': 'Number of birth parents that have reinfection', 'timeFrame': 'from presentation to delivery'}, {'measure': 'Number of birth parents that have reinfection', 'timeFrame': 'at time of postpartum (upto 15 months after delivery)'}, {'measure': 'Number of neonates that have congenital syphilis', 'timeFrame': 'from presentation to delivery'}, {'measure': 'Number of neonates that have congenital syphilis', 'timeFrame': 'at time of postpartum (upto 15 months after delivery)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['syphilis diagnostic testing', 'pregnancy'], 'conditions': ['Syphilis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to offer routine lab-based and rapid point of care (POC) syphilis diagnostic testing in the emergency department (ED) and obstetrical (OB) triage , thereby increasing screening and treatment initiation for pregnant patients without prenatal care or with no documented syphilis results during the index pregnancy in other to increase rates of full treatment to determine if the implementation of a robust linkage to care program for pregnant patients with positive rapid POC results will more likely result in complete treatment for all stages of syphilis and adherence to recommended maternal and newborn longitudinal follow up and to assess factors that contribute to treatment completion after implementation of the intervention will also be analyzed to tailor efforts targeting social and healthcare navigation factors that affect health equity; including poverty, insurance, health literacy and others.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant individuals that are seeking care at University of Texas, Memorial Herman and Lyndon B Johnson sites ED or obstetrical triage units.\n* No Prenatal care during index pregnancy\n* No documented syphilis result during the index pregnancy\n\nExclusion Criteria:\n\n* Pregnant individuals with documented care and syphilis results in the index pregnancy for specific trimester as mandated by Texas law'}, 'identificationModule': {'nctId': 'NCT06645106', 'briefTitle': 'Offering Routine and Rapid Point of Care (POC) Syphilis Testing in Pregnant Patients Presenting to the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Offering Routine and Rapid Point of Care (POC) Syphilis Testing in Pregnant Patients Presenting to the Emergency Department', 'orgStudyIdInfo': {'id': 'HSC-MS-24-0505'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rapid Point of Care (POC) Syphilis testing', 'interventionNames': ['Device: Rapid Point of Care (POC) Syphilis testing']}], 'interventions': [{'name': 'Rapid Point of Care (POC) Syphilis testing', 'type': 'DEVICE', 'description': 'Participants will undergo the point of care (POC) FDA cleared syphilis health check (SHC) POC test by a research staff using 50 microliters or 1-3 drops of whole blood via finger stick. The analyzer is handheld, and all testing equipment is temperature stable and does not need refrigeration. The SHC-Syphilis results will be available within 10 minutes of receipt given the published turnaround time to results of 15 minutes per package insert and will be recorded as a research note in the electronic medical record (EMR) while the provider assigned to the patient and the Houston Health Department will be notified of results and further treatment will be done if results are positive.', 'armGroupLabels': ['Rapid Point of Care (POC) Syphilis testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Irene Stafford, MD', 'role': 'CONTACT', 'email': 'Irene.Stafford@uth.tmc.edu', 'phone': '713-500-6412'}, {'name': 'Carrie Bakunas, MD', 'role': 'CONTACT', 'email': 'Carrie.A.Bakunas@uth.tmc.edu', 'phone': '(713) 500-7878'}], 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Irene Stafford, MD', 'role': 'CONTACT', 'email': 'Irene.Stafford@uth.tmc.edu', 'phone': '(713) 500-6412'}, {'name': 'Carrie Bakunas, MD', 'role': 'CONTACT', 'email': 'Carrie.A.Bakunas@uth.tmc.edu', 'phone': '(713) 500-7878'}], 'overallOfficials': [{'name': 'Irene Stafford, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Irene Stafford', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}