NCT07061912Completed
A Study to Evaluate the Performance of INSTI® HIV Self Test When Performed by Unobserved Intended Users in the US
Source: ClinicalTrials.gov · Last updated 20 Aug 2025
Brief summary (registry, in English)
The objective of this study is to evaluate the performance of INSTI® HIV Self Test with unobserved intended user population. The purpose of this study is to document if a lay person, unassisted by a healthcare worker, is able to perform the INSTI® HIV Self Test correctly and without significant risk of incorrect results. The study aims to evaluate the clinical performance (i.e., diagnostic sensitivity and specificity) of the INSTI® HIV Self-Test in a lay user population.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 122 (actual)
- First submitted
- 8 Jul 2025
- Start date
- 24 Jul 2025
- Primary completion date
- 6 Aug 2025
- Lead sponsor
- bioLytical Laboratories
- Diseases
- HIV
- NCT number
- NCT07061912
What you commit to
- Study type: Interventional
- Participants enrolled: 122
- From 24 Jul 2025 to the primary completion date, 6 Aug 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
- Has used a Rapid Diagnostic Test for HIV blood-based self-testing previously
- Has received any experimental HIV vaccine
- Known HIV positive subjects and currently on an Anti-Retroviral Treatment (ART) for 12 months or longer and/or not willing to share ART start date
Other illness
- Is a practicing medical healthcare professional (doctor, nurse or HIV Counsellor that performs HIV testing with Rapid Tests)
- Has a bleeding disorder
- 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 or known HIV positive status with less than 12 months of ART
- For known HIV positive status subjects, willingness to share ART start date
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| bioLytical Laboratories Inc. Coordinator of this site? Confirm its status | Richmond | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.