An interventional study of NSTI® HIV Self-Test in Human Immunodeficiency Virus I Infection and Human Immunodeficiency Virus II Infection, sponsored by bioLytical Laboratories. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-20.
Sponsored by bioLytical Laboratories · Not applicable, Interventional, and Screening
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 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.
bioLytical Laboratories is the lead sponsor of 16 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INSTI® HIV ST devices are provided to the enrolled participants to conduct the self test using the provided instruction for use, unobserved. The participant records the INSTI® HIV ST results. The operator then enters the room and also interprets the participants self-test, the operator then performs the comparator test to compare the results with the INSTI® HIV ST.
Device: NSTI® HIV Self-Test
Each participant will be provided with the INSTI® HIV Self-Test(s) and asked to conduct self testing, unobserved. The participant will record their interpretation of the results. Subjects will perform the test without intervention or observation from the operator. The operator will then enter the room and also interpret the subject's self-test results then perform the comparator test. In the event of a discrepant result between the INSTI® HIV ST and comparator test, an additional venous blood sample will be collected from the subject and sent for discrepancy testing
Clinical sensitivity and specificity of the INSTI® HIV Self-Test
* Percent agreement for fingerstick blood between INSTI® HIV ST results obtained and interpreted by the subject and Comparator Test result obtained by the operator. Percent agreement will be calculated for all sites combined. * Point estimate for positive percent agreement will be calculated for all subjects. * Negative percent agreement values and 95% CIs will be calculated for all subjects.
Time frame: 1 month
Ran from Jul 2025 to primary completion in Aug 2025, 0 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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