A Study to Evaluate the Performance, Usability, and Result Interpretation of INSTI® HIV Self-Test When Performed by Observed Intended Users in the US
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,728
- 试验地点
- 2
- 主要终点
- Clinical sensitivity and specificity of the INSTI® HIV Self-Test
研究概览
简要总结
The objective of this study is to evaluate the performance, usability, and result interpretation of the INSTI® HIV Self-Test (referred to INSTI® HIV ST) in the intended use population across the United States (US). The INSTI® HIV Self-Test is a single use in vitro test that is used as a self-test for the detection of antibodies to HIV-1 and HIV-2 in human fingerstick blood. This study is designed to evaluate INSTI® HIV ST performance in the hands of non-professionals and untrained lay users who are inexperienced in HIV blood-based self-testing.
The study aims to:
To evaluate the clinical performance (i.e., diagnostic sensitivity and specificity) of the INSTI® HIV Self-Test in a lay user population.
To assess the user's comprehension of the INSTI® HIV ST results (e.g., interpreting positive, negative, and invalid results).
To evaluate the usability of the INSTI® HIV ST and understand users' experience in performing the test.
详细描述
The objective of this study is to evaluate the performance, usability, and result interpretation of the INSTI® HIV Self-Test (referred to INSTI® HIV ST) in the intended user population across the United States (US). This study is designed to evaluate INSTI® HIV ST performance in the hands of non-professionals and untrained lay users who are inexperienced in HIV self-testing.
The study aims to:
To evaluate the clinical performance (i.e., diagnostic sensitivity and specificity) of the INSTI® HIV ST in a lay user population.
To assess the user's comprehension of the INSTI® HIV ST results (e.g., interpreting positive, negative, and invalid results).
To evaluate the usability of the INSTI® HIV ST and understand users' experience in performing the test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- Single (Care Provider)
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
- •18 years of age or older
- •Operator/study staff must complete the subject's Enrolment Questionnaire
- •Subject to sign and date the Informed Consent Form
- •Able to complete the required testing on the allocated testing day(s).
- •Able to speak/ read/write English or Spanish
- •Willingness to provide the fingerstick blood sample and if necessary, the volume of whole blood collected through venous blood draw (approximately 7 ml)
- •Willingness to participate in the study site's standard of care HIV counselling and testing program and receive the study site's standard of care test results
- •Unknown HIV Status
排除标准
- •Has participated in any prior, or concurrent trial of HIV self-tests
- •Is a practicing medical healthcare professional (doctor, nurse or HIV Counsellor that performs HIV testing with Rapid Tests)
- •Is currently on a PrEP regimen
- •Has used a Rapid Diagnostic Test for HIV blood-based self-testing previously
- •Has received any experimental HIV vaccine
- •Has a bleeding disorder
- •Is known HIV+
- •Uses Anti-Retroviral medication
- •Any condition which, in the opinion of the Operator, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion of the assessment, consent form and questionnaire etc. or bias the outcome, i.e., being unable to see / read by forgetting to bring reading glasses, being intoxicated or acute sickness, or visibly distressed.
结局指标
主要结局
Clinical sensitivity and specificity of the INSTI® HIV Self-Test
时间窗: 12 Months
The positive percent agreement (PPA) and negative percent agreement (NPA) between the INSTI® HIV ST and comparator test will be determined. The two-sided confidence interval for the PPA and NPA will be determined. The percentage of assays with INSTI® HIV ST invalid results will be determined.
次要结局
- The INSTI® HIV Self-Test usability and result interpretation(12 Months)