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

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.

The study population will be based on a general all-comers group of subjects. This includes both unknown HIV status and potentially known HIV positive status subjects.

The number of valid positives from the comparator test will be monitored during the course of the study. When the comparator test reaches 10 valid positive results, the INSTI® HIV ST results for the same 10 subjects will be checked to see if they are also valid. If not, additional subjects will be recruited until there are at least 10 valid INSTI® HIV ST results within the comparator valid positive test results. Once the threshold has been reached recruiting will end. For known HIV positive subjects, site(s) will be requested to provide HIV-1/2 viral load and/or CD4 count laboratory results if available. Additionally, known HIV positive subjects on Anti-Retroviral Treatment (ART) should be on medication for less than 12 months.

The study will initially recruit HIV unknown status subjects, at 50% of total enrollment (i.e., 50 out of 100 subjects) if the 10 HIV positives is deemed unattainable then HIV known subjects may be recruited to make up the 10 total HIV positives.

The study is designed to evaluate INSTI® HIV ST performance when used unobserved by non-professional, untrained intended users that are inexperienced in self-testing.

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.