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
- 1
- 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
- •The inclusion criteria are informed by the indications for HIV testing contained in the National HIV Testing Policy, which states that HIV testing is indicated in the following groups: MSM; people who inject drugs; people with multiple sex partners or recent partner change; people having travelled to countries of high prevalence and engaged in risk behavior; people from high prevalence countries; partners of the above; and partners of people living with HIV infection.
- •Recruitment will be restricted to people who satisfy the following criteria:
- •Attending health clinic or community-based testing study sites
- •Aged 18 years or more
- •Requesting HIV testing and/or in whom HIV testing is indicated
- •Willing and able to give their own informed consent
- •Willing to participate in and comply with the study procedures
排除标准
- •The following people will be excluded from the study:
- •People in whom HIV testing is not indicated or not appropriate
- •People not fluent in English in whom provision of informed consent or compliance with the study procedures may be problematic
- •People who have participated in the study previously
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