NCT06368453Completed
A Study to Evaluate the Performance, Usability, and Result Interpretation of INSTI® HIV Self-Test
A Study to Evaluate the Performance, Usability, and Result Interpretation of INSTI® HIV Self-Test When Performed by Observed Intended Users in the US
Source: ClinicalTrials.gov · Last updated 11 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1728 (actual)
- First submitted
- 11 Apr 2024
- Start date
- 2 May 2024
- Primary completion date
- 8 Jan 2025
- Lead sponsor
- bioLytical Laboratories
- Diseases
- HIV
- NCT number
- NCT06368453
What you commit to
- Study type: Interventional
- Participants enrolled: 1728
- From 2 May 2024 to the primary completion date, 8 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has participated in any prior, or concurrent trial of HIV self-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
- Uses Anti-Retroviral medication
Other illness
- Is a practicing medical healthcare professional (doctor, nurse or HIV Counsellor that performs HIV testing with Rapid Tests)
- Has a bleeding disorder
- Is known HIV+
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Therafirst Medical Center Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.