Introduction Study of Dual HIV & Syphilis Rapid Diagnostic Tests in Antenatal Clinics in COLOMBIA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of participants in syphilis testing with SRDT compared to DRDT post intervention
研究概览
简要总结
Global and regional initiatives have been launched for the dual elimination of mother-to-child transmission (MTCT) of HIV and syphilis. As one of the important components in the initiatives, early detection and timely intervention of pregnant women infected with HIV and/or syphilis is critical. In order to improve the number of women tested and treated, innovative strategies are needed.
Serologic tests are the diagnostic tests of choice for HIV and syphilis. There are two types of serological tests (treponemal and non-treponemal tests) for diagnosis of syphilis. These generally require venous blood for screening of symptomatic and asymptomatic patients. In addition, these tests are technically demanding, and require laboratory equipment which is not widely available in most resource-limited settings.
Recently, Rapid diagnostic tests (RDTs) that can be used at point-of-care for simultaneously detecting antibodies to HIV and syphilis (dual HIV & syphilis treponemalRDTs) using serum/plasma, venous whole blood, or finger-stick whole blood have been developed and are now commercially available.
In low-resource settings, a combination of two or three rapid diagnostic tests (RDTs), in which one screening test with a second test to confirm initial positive results or two RDTs in parallel with a third test as a tiebreaker for discordant samples, can be used to diagnose HIV on finger-stick blood. To date, there are few data on the implications of using these RDTs in the antenatal clinic settings, although they have been evaluated in laboratory-based studies and shown encouraging sensitivities and specificities as compared with reference laboratory tests.
The objective of this research is to assess the uptake of syphilis testing after the introduction of dual HIV/syphilis rapid testing as compared to single rapid syphilis testing in antenatal clinics in Colombia.
The secondary objectives of the study are: To determine the uptake of treatment of syphilis after the intervention, To determine the uptake of HIV testing in ANC attendees after the intervention, To explore the acceptability of dual HIV/syphilis RDTs by ANC attendees and health workers, To assess the organizational and socio-cultural advantages and barriers to introduction with a aim of sustainable adoption of dual HIV/syphilis RDTs in antenatal services, To determine the workload and cost implications of introduction of dual HIV/syphilis RDTs in antenatal services
详细描述
Methods:
Desing: Cluster randomized trial including and quantitative component, a qualitative component (in-deep interviews)and a time and cost estimation component in the antenatal care setting.
Population: Primary health facilities (n=12) in Bogotá and Cali, Colombia. Eligibility criteria: Inclusion Criteria: Pregnant women attending first ANC visit at the study sites, or women not previously tested in this pregnancy,Women aged 14 years old or above, Any woman who has tested positive for HIV and/or syphilis in the past (will be permitted to enrol), Women providing a written informed consent.Exclusion Criteria: Women who have already been enrolled in this study, Women < 14 years of age, Women unable to provide informed consent.
Test to be evaluated: Each of the 12 institutions participating in the trial were assigned in a random way to rapid single test for HIV and Syphilis or dual rapid test HIV/syphilis. The brand of the rapid test selected for the study, passed throw a process of selection by the National Health Institute in Colombia, in order to choose the best test according to desirable performance and operational characteristics. The brand Standard Diagnostics the Bioline was donated to do the rapid test in the present study with pregnant women.
Analysis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women attending first ANC visit at the study sites, or women not previously tested in this pregnancy
- •Women aged 14 years old or above
- •Any woman who has tested positive for HIV and/or syphilis in the past (will be permitted to enrol)
- •Women providing a written informed consent
排除标准
- •Women who have already been enrolled in this study
- •Women < 14 years of age
- •Women unable to provide informed consent
结局指标
主要结局
Number of participants in syphilis testing with SRDT compared to DRDT post intervention
时间窗: 4 months
次要结局
- Differences in Number of participants with uptake of HIV testing between Arm A and Arm B.(4 months)
- Determine the workload and cost implications of the introduction of dual RDTs in antenatal services through a time/motion/cost exercise.(4 months)
- Number of participants with acceptability and feasibility of dual RDTand health care workers.(4 months)
- Number of participants with syphilis treatment between Arm A and Arm B(4 months)
- Number of participants with uptake of syphilis treatment between Arm A and Arm B(4 months)