Offering Routine and Rapid Point of Care (POC) Syphilis Testing in Pregnant Patients Presenting to the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 2
- 主要终点
- Percentage of patients without prenatal care during the index pregnancy who received full treatment for all stages of syphilis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant individuals that are seeking care at University of Texas, Memorial Herman and Lyndon B Johnson sites ED or obstetrical triage units.
- •No Prenatal care during index pregnancy
- •No documented syphilis result during the index pregnancy
排除标准
- •Pregnant individuals with documented care and syphilis results in the index pregnancy for specific trimester as mandated by Texas law
研究组 & 干预措施
Rapid Point of Care (POC) Syphilis testing
干预措施: Rapid Point of Care (POC) Syphilis testing (Device)
结局指标
主要结局
Percentage of patients without prenatal care during the index pregnancy who received full treatment for all stages of syphilis
时间窗: within 1 week of presentation until the time of delivery
Percentage of patients with no documented syphilis test during the index pregnancy who received full treatment for all stages of syphilis
时间窗: within 1 week of presentation until the time of delivery
次要结局
- Percentage of participants that have psychiatric problems on completion of syphilis treatment(from presentation to delivery)
- Percentage of participants that show substance abuse including alcohol on completion of syphilis treatment(from presentation to delivery)
- Percentage of participants that have unstable housing on completion of syphilis treatment(from presentation to delivery)
- Percentage of participants that have transportation on completion of syphilis treatment(from presentation to delivery)
- Percentage of participants that experience intimate partner violence on completion of syphilis treatment(from presentation to delivery)
- number of prenatal care visits on completion of syphilis treatment(from presentation to delivery)
- Number of birth parents that have reinfection(from presentation to delivery)
- Number of neonates that have congenital syphilis(from presentation to delivery)
- The percentage of patients who adhere to recommended maternal and newborn longitudinal follow up(within 1 week of presentation until the time of delivery)
- Percentage of participants that are married on completion of syphilis treatment(from presentation to delivery)
- Percentage of participants that have health insurance on completion of syphilis treatment(from presentation to delivery)
- The percentage of patients who adhere to recommended maternal and newborn longitudinal follow up(at time of postpartum (upto 15 months after delivery))
- Percentage of participants that are married on completion of syphilis treatment(at time of postpartum (upto 15 months after delivery))
- Percentage of participants that have health insurance on completion of syphilis treatment(at time of postpartum (upto 15 months after delivery))
- Percentage of participants that have psychiatric problems on completion of syphilis treatment(at time of postpartum (upto 15 months after delivery))
- Percentage of participants that show substance abuse including alcohol on completion of syphilis treatment(at time of postpartum (upto 15 months after delivery))
- Percentage of participants that have unstable housing on completion of syphilis treatment(at time of postpartum (upto 15 months after delivery))
- Percentage of participants that have transportation on completion of syphilis treatment(at time of postpartum (upto 15 months after delivery))
- Percentage of participants that experience intimate partner violence on completion of syphilis treatment(at time of postpartum (upto 15 months after delivery))
- number of prenatal care visits on completion of syphilis treatment(at time of postpartum (upto 15 months after delivery))
- Number of birth parents that have reinfection(at time of postpartum (upto 15 months after delivery))
- Number of neonates that have congenital syphilis(at time of postpartum (upto 15 months after delivery))
研究者
Irene Stafford
Assistant Professor
The University of Texas Health Science Center, Houston