A Study to Evaluate the Performance, Usability, and Result Interpretation of INSTI® HIV Self-Test
Completed · Not applicable
Conditions studied: Human Immunodeficiency Virus I Infection, Human Immunodeficiency Virus II Infection
In brief
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.
Key facts
- Study ID
- NCT06368453
- Run by
- bioLytical Laboratories
- People needed
- 1728
- Starts
- 2024-05-02
- Expected to finish
- 2025-01-08
- Last updated by the study team
- 2025-07-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Therafirst Medical Center — Fort Lauderdale, Florida, United States
Full record on ClinicalTrials.gov
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