Syphilis and HIV Point of Care Testing (POCT) to Improve Access to Testing Among Inner City, Remote, Rural and Hard to Reach Populations in Saskatchewan
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,650
- 试验地点
- 4
- 主要终点
- Syphilis-Comparison between point of care testing and serology testing for Syphilis and HIV
研究概览
简要总结
The goal of this clinical trial is to learn about Syphilis and HIV point of care testing among inner city, remote, rural and hard to reach populations in Saskatchewan. The main question[s] it aims to answer are:
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To evaluate the field diagnostic test performance (e.g. sensitivity, specificity, predictive values) of finger prick whole blood point of care testing (POCT) when compared to standard serum based testing for syphilis POCT, HIV POCT and dual syphilis and HIV POCT.
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To evaluate the clinical utility of POCT for the prompt management and public health follow up of syphilis and HIV cases as compared to usual testing, specifically:
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Time to diagnosis
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Time to treatment
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Number of contacts exposed to untreated infections
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For HIV diagnoses, time to connection to clinical provider for ongoing management of HIV
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To evaluate the acceptability and feasibility of POCT among different populations for syphilis and HIV among at risk and/or hard to reach populations, specifically:
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Health care provider experiences of feasibility and acceptability of the POCT used in this pilot
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Client acceptability and experiences with POCT in this pilot
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Client preferences for test offered (syphilis only, HIV only, or dual test of HIV and syphilis 4. To evaluate the acceptability and feasibility of syphilis alone, HIV alone or combined syphilis/HIV POCT among at-risk and/or hard to reach populations.
Participants will be assessed for risk factors that may increase risk of infectious disease such as substance use and sexual habits. They will then be offered a choice of 1 of 3 POCT(Syphilis alone, HIV alone or a dual HIV/Syphilis test). Serology will be obtained for sexually transmitted and blood born infections (STBBI's) and then the point of care test (POCT) will be completed. Following the testing the participant will complete a short survey on their experience.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1650 consecutive individuals
- •> 16 years accessing STBBI testing at specific locations and able to provide informed consent. PLWH and persons who are syphilis positive may also eligible to participate.
排除标准
- •° Less than 16 years, unable to provide signed informed consent (e.g., intoxicated)
结局指标
主要结局
Syphilis-Comparison between point of care testing and serology testing for Syphilis and HIV
时间窗: 12-18 months
To evaluate the field diagnostic test performance of finger prick whole blood point of care testing (POCT) when compared to standard serum based testing for syphilis POCT.
Syphilis/HIV- Comparison between point of care testing and serology testing for Syphilis and HIV
时间窗: 12-18 months
Dual HIV/Syphilis-To evaluate the field diagnostic test performance of finger prick whole blood point of care testing (POCT) when compared to standard serum based testing for dual syphilis and HIV POCT.
HIV- Comparison between point of care testing and serology testing for Syphilis and HIV
时间窗: 12-18 months
HIV- To evaluate the field diagnostic test performance of finger prick whole blood point of care testing (POCT) when compared to standard serum based testing for HIV POCT.
次要结局
- Time to diagnosis-Clinical utility of POCT for management and follow up of Syphilis and HIV(12-18 months)
- Evaluate the acceptability and feasibility of POCT for syphilis and HIV(12-18 months)
- Syphilis-Comparison of acceptability and feasibility by using a patient experience survey of syphilis alone, HIV alone and dual HIV/Syphilis point of care testing among different populations.(12-18 months)
- Number of contacts-Clinical utility of POCT for management and follow up of Syphilis and HIV(12-18 months)
- Dual HIV/Syphilis-Comparison of acceptability and feasibility by using a patient experience survey of syphilis alone, HIV alone and dual HIV/Syphilis point of care testing among different populations.(12-18 months)
- HIV-Comparison of acceptability and feasibility by using a patient experience survey of syphilis alone, HIV alone and dual HIV/Syphilis point of care testing among different populations.(12-18 months)
- Time to treatment-Clinical utility of POCT for management and follow up of Syphilis and HIV(12-18 months)
- Time to connection-Clinical utility of POCT for management and follow up of Syphilis and HIV(12-18 months)