Evaluating the INSTI® HIV Self-Test for Home Use
Official title: A Study to Evaluate the Performance, Usability, and Result Interpretation of INSTI® HIV Self-Test When Performed by Observed Intended Users in the US
Run by bioLytical Laboratories · NCT06368453 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing how well regular people can use the INSTI® HIV Self-Test at home to check for HIV and understand their results.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1700 (estimated) |
| Sponsor | bioLytical Laboratories Industry-sponsored |
| Locations | 1 site (Fort Lauderdale, Florida) |
| Trial ID | NCT06368453 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who have an unknown HIV status and are willing to participate in the study.
✕Probably not a fit
Patients who are healthcare professionals or have previously used HIV self-tests may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the performance, usability, and result interpretation of the INSTI® HIV Self-Test among lay users in the United States. It aims to determine how accurately non-professionals can use the test to detect HIV-1 and HIV-2 antibodies from a fingerstick blood sample. Participants will be recruited from the general population, focusing on those who are previously undiagnosed with HIV. The study will assess both the clinical performance of the test and the users' understanding of the results, ensuring that the instructions are clear and comprehensible.
Why it matters
Potential benefit: If successful, this study could empower individuals to self-test for HIV, leading to earlier diagnosis and treatment.
How similar studies have gone: Other studies have shown promise in evaluating self-testing methods for HIV, indicating that this approach is both relevant and potentially effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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's running
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Therafirst Medical Center
Fort Lauderdale, Florida, United States Recruiting
Study contacts
- Principal investigator: Steven A Geller — Centennial Medical Group
- Study coordinator: Ana Subramanian
- Email: asubramanian@biolytical.com
- Phone: 16042046784
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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ICVAX therapeutic DNA vaccine for people living with HIV in Hong Kong
This trial tests whether the ICVAX DNA vaccine, given with three different delivery devices, is safe and boosts HIV-specific T-cell responses in adults on stable antiretroviral therapy.
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TruPlex HIV/HepB/Syphilis Rapid Test performance and usability in real-world settings
This study tests how well the TruPlex rapid test detects HIV, hepatitis B, and syphilis using fingerstick and other blood samples, and whether trained operators find the test easy to use at point-of-care sites.
-
iStatis gonorrhea antigen test — accuracy, ease of use, and result reading
This tests whether the iStatis point-of-care gonorrhea antigen test gives accurate results and is easy for trained staff to use in people older than 16 who need STI testing.
-
TruPlex rapid test for HIV, Hepatitis B, and syphilis performance and usability
This project will test whether the TruPlex rapid test can accurately detect HIV, hepatitis B, and syphilis when used by trained healthcare workers on adults getting tested for these infections.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.