Evaluating the INSTI® HIV Self-Test for Home Use
A Study to Evaluate the Performance, Usability, and Result Interpretation of INSTI® HIV Self-Test When Performed by Observed Intended Users in the US
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | bioLytical Laboratories Industry-sponsored |
| Locations | 1 site (Fort Lauderdale, Florida) |
| Trial ID | NCT06368453 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have an unknown HIV status and are willing to participate in the study.
Not a fit: Patients who are healthcare professionals or have previously used HIV self-tests may not benefit from this study.
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 performed: Other studies have shown promise in evaluating self-testing methods for HIV, indicating that this approach is both relevant and potentially effective.
Eligibility criteria
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 this trial is running
Fort Lauderdale, Florida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.