A Study to Evaluate the Performance of INSTI® HIV Self Test When Performed by Unobserved Intended… (NCT07061912) | Clinical Trial Compass
CompletedNot Applicable
A Study to Evaluate the Performance of INSTI® HIV Self Test When Performed by Unobserved Intended Users in the US
Canada122 participantsStarted 2025-07-24
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 or known HIV positive status with less than 12 months of ART
* For known HIV positive status subjects, willingness to share ART start date
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)
* Has used a Rapid Diagnostic Test for HIV blood-based self-testing previously
* Has received any experimental HIV vaccine
* Has a bleeding disorder
* 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
* 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. …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical sensitivity and specificity of the INSTI® HIV Self-Test