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临床试验/NCT07498153
NCT07498153已完成不适用

Spotting Syphilis: A Dual Point-of-Care Syphilis Screening Initiative in a Low-Resource Healthcare Setting

The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2025年9月30日最近更新:
适应症
干预措施

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

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

Experimental

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

发起方
The University of Texas Health Science Center, Houston
申办方类型
Other
责任方
Principal Investigator
主要研究者

Irene Stafford

Associate Professor

The University of Texas Health Science Center, Houston

研究点 (1)

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