Performance and Usability Evaluation of the Atomo HIV Self-Test
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 520
- 试验地点
- 2
- 主要终点
- Questionnaire scoring each step of performing the self-test
研究概览
简要总结
The study seeks to enroll 501+ patients to use a HIV self testing device to test for HIV in a blood sample drawn by finger prick. The purpose of the trial is to assess the usability of the device by providing participants with video and written instructions on how to correctly obtain a result from the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ATOMO Diagnostic Test
All patients will receive an ATOMO diagnostic test to use. There is no comparative arm.
干预措施: ATOMO Diagnostic Test (Device)
结局指标
主要结局
Questionnaire scoring each step of performing the self-test
时间窗: Assessed at one time point per patient (visit 1) approximately 1 hour
To assess the ability of typical self-test users to follow the test instructions and perform the test accurately and to identify any issues or difficulty they may experience whilst performing the test.
次要结局
- Questionnaire scoring each step of performing the self-test(Assessed at one time point only per patient (visit 1)approximately 1 hour)
- Comparison of self-test user result against the standard of care laboratory test for HIV(Assessed at one time point only per patient (visit 1)approximately 1 hour)
- Comparison of self-test done in the laboratory against the standard of care laboratory blood test for HIV(Assessed at one time point only per patient (visit 1)approximately 1 hour)
研究者
Dr. Mark Bloch
A/Prof
Holdsworth House Medical Practice