Implementation of an Opt-Out Testing and Rapid Diagnostic Strategy for Syphilis and HIV in Pregnant Patients Presenting to the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Number of participants that tested for HIV
研究概览
简要总结
The purpose of this study is to evaluate infection detection and treatment initiation rates for syphilis and HIV before and after integration of the Chembio DPP® HIV-Syphilis rapid POC test into an ongoing Emergency Department (ED) testing program and to determine whether dual rapid testing improves early initiation of HIV therapy in pregnant patients with newly identified HIV infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnancy
- •Presentation to the ED or obstetrical triage during the index pregnancy.
- •No established prenatal care (≤1 visit) and/or no documented HIV or syphilis testing during the current pregnancy.
排除标准
- •Medically unstable or critically ill at the time of ED presentation.
- •Incarcerated at the time of ED presentation.
- •Decline participation in testing (opt-out) or refuse survey participation.
研究组 & 干预措施
Chembio HIV/Syphilis rapid POC test plus standard of care lab based HIV/Syphilis testing
干预措施: Chembio HIV/Syphilis rapid Point of Care (POC) test (Diagnostic Test)
Chembio HIV/Syphilis rapid POC test plus standard of care lab based HIV/Syphilis testing
干预措施: Laboratory-based HIV and syphilis testing (Diagnostic Test)
结局指标
主要结局
Number of participants that tested for HIV
时间窗: Baseline
Number of participants that tested for syphilis
时间窗: Baseline
Number of participants that tested positive for syphilis and who receive same-visit treatment initiation with Benzathine Penicillin G according to the Centers for Disease Control and Prevention (CDC) 2021 Guidelines.
时间窗: about 15 minutes after baseline
次要结局
- Number of participants that tested positive for HIV who start antiretroviral therapy (bictegravir/emtricitabine/tenofovir alafenamide)(about 15 minutes after baseline)
研究者
Irene Stafford
Associate Professor
The University of Texas Health Science Center, Houston