Field Performance Evaluation of Dual Rapid HIV & Syphilis Tests in Zambia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,010
- 试验地点
- 1
- 主要终点
- performance of dual rapid HIV/syphilis tests
研究概览
简要总结
The purpose of this study is to provide evidence on the performance and operational characteristics of commercially available dual HIV/syphilis Rapid Diagnostic Tests (RDTs) in Zambia for their introduction into antenatal care and other settings.
详细描述
Early detection and timely intervention of pregnant women infected with HIV and/or syphilis is critical. To improve the number of women tested and treated, the Centre for Infectious Disease Research in Zambia (CIDRZ) and the Ministry of Community Development, Mother and Health (MCDMCH) this field study will assess the effectiveness of newly developed dual HIV and syphilis rapid diagnostic tests (RDTs) manufactured by Chembio and Standard Diagnostics in Lusaka District antenatal clinics.
The specific objectives of this field performance evaluation of the rapid diagnostics are to determine the antenatal clinic-based performance of dual HIV/syphilis RDTs compared to that of current reference standard assays, and to assess the operational characteristics and acceptability of these dual HIV/syphilis RDTs to patients and health care providers This cross-sectional study of 3,765 pregnant women will validate the performance of Chembio and Standard Diagnostics dual HIV and Syphilis RDTs.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women attending their first antenatal care visit at a study clinic
- •18 years of age or older
- •Willing and able to provide informed consent for study participation
排除标准
- •Prior participation in the study
结局指标
主要结局
performance of dual rapid HIV/syphilis tests
时间窗: day 1/enrollment
The performance of the rapid study tests will be assessed by determining the specificity and the sensitivity when compared to reference standard assays
次要结局
- acceptability of use of dual rapid HIV/syphilis tests(day 1/enrollment)