Spotting Syphilis: A Dual Point-of-Care Syphilis Screening Initiative in a Low-Resource Healthcare Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Number of Participants That Completed Screening
研究概览
简要总结
The purpose of this study is to determine if a strategy utilizing the Chembio HIV/syphilis rapid point-of-care (POC) test for diagnosis of HIV and syphilis in pregnant women attending prenatal clinics in Guatemala will increase screening and detection rates thereby resulting in higher rates of treatment during pregnancy and ultimately reducing congenital syphilis and HIV Mother-to-child transmission (MTCT) and to provide knowledge and technical expertise on the use of Point-of-care ultrasound for all pregnant patients testing positive for syphilis during the intervention to evaluate the fetus for evidence of congenital syphilis.
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 65 Years(Child, Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women at any gestational age
- •Nonpregnant women may also be included if unsure of pregnancy status and attend clinic for pregnancy care and confirmed to be not pregnant by routine testing such as urine pregnancy tests and/or the absence of an intrauterine pregnancy by ultrasound
排除标准
- •Participants not at clinical sites in Puerto Barrios, Guatemala between 09/27/2025 and 10/03/2025
研究组 & 干预措施
Chembio HIV/Syphilis rapid POC test
干预措施: Chembio HIV/Syphilis rapid POC test (Device)
结局指标
主要结局
Number of Participants That Completed Screening
时间窗: end of study (15 minutes after baseline)
Number of Participants That Tested Positive for Syphilis
时间窗: end of study (15 minutes after baseline)
Number of Participants That Tested Positive for HIV
时间窗: end of study (15 minutes after baseline)
Number of Participants That Tested Positive for Syphilis and HIV
时间窗: end of study (15 minutes after baseline)
Number of Participants That Received Treatment
时间窗: end of study (15 minutes after baseline)
次要结局
未报告次要终点
研究者
Irene Stafford
Associate Professor
The University of Texas Health Science Center, Houston
