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

NCT07061912 | Completed FDA Device

• 1 other identifier: CLS-003A
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Human Immunodeficiency Virus I Infection; Human Immunodeficiency Virus II Infection

Keywords

HIV Self Test; INSTI HIV Self Test; At-Home HIV Test

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month

Study Arms (1)

Performance

EXPERIMENTAL

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

Interventions

NSTI® HIV Self-Test DEVICE

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

Performance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• bioLytical Laboratories: lead

Study Sites (1)

bioLytical Laboratories Inc.

Richmond, British Columbia, V6V 2A2, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: As there is a potential for recruiting known HIV subjects, the care providers will be blinded to the subject's status during testing procedures.
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 14, 2025
• Study Start: July 24, 2025
• Primary Completion: August 6, 2025
• Study Completion: August 6, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Locations

CA (1)