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A Study to Evaluate the Performance of INSTI® HIV Self Test When Performed by Unobserved Intended Users in the US

NCT07061912

CompletedNA

Sponsor: bioLytical Laboratories

Conditions: Human Immunodeficiency Virus I Infection, Human Immunodeficiency Virus II Infection

Interventions: NSTI® HIV Self-Test

Countries: Canada

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility 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 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. 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.

Locations (1)

Richmond, British Columbia, Canada