A Study to Evaluate the Performance, Usability, and Result Interpretation of INSTI® HIV Self-Test

NCT06368453 | Completed FDA Device

• 1 other identifier: CLS-003
• Study Type: interventional
• Target: 1,728
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the performance, usability, and result interpretation of the INSTI® HIV Self-Test (referred to INSTI® HIV ST) in the intended use population across the United States (US). The INSTI® HIV Self-Test is a single use in vitro test that is used as a self-test for the detection of antibodies to HIV-1 and HIV-2 in human fingerstick blood. This study is designed to evaluate INSTI® HIV ST performance in the hands of non-professionals and untrained lay users who are inexperienced in HIV blood-based self-testing. The study aims to: To evaluate the clinical performance (i.e., diagnostic sensitivity and specificity) of the INSTI® HIV Self-Test in a lay user population. To assess the user's comprehension of the INSTI® HIV ST results (e.g., interpreting positive, negative, and invalid results). To evaluate the usability of the INSTI® HIV ST and understand users' experience in performing the test.

Conditions

Human Immunodeficiency Virus I Infection; Human Immunodeficiency Virus II Infection

Keywords

HIV Self Test; INSTI HIV Self test; HIV-1/2 Antibody Test; In-Home HIV test

Outcome Measures

Primary Outcomes (1)

• Clinical sensitivity and specificity of the INSTI® HIV Self-Test

  The positive percent agreement (PPA) and negative percent agreement (NPA) between the INSTI® HIV ST and comparator test will be determined. The two-sided confidence interval for the PPA and NPA will be determined. The percentage of assays with INSTI® HIV ST invalid results will be determined.

  12 Months

Secondary Outcomes (1)

• The INSTI® HIV Self-Test usability and result interpretation

  12 Months

Study Arms (2)

Performance

EXPERIMENTAL

INSTI® HIV ST devices are provided to the enrolled participants to conduct the self test using the provided instruction for use while being observed by an operator. The operator records the INSTI® HIV ST results interpreted by the subjects. The operator then performs the comparator test to compare the results with the INSTI® HIV ST.

Device: INSTI® HIV Self-Test

Mock results interpretation study and Usability evaluation

NO INTERVENTION

A subset of the enrolled subjects (500 subjects) will participate in the mock results interpretation study and usability evaluation. For the mock study, the subjects will be presented with 5 mock INSTI® HIV ST devices with different results, and the subject's interpretation of each device will be recorded. The percentage of subjects who interpreted the mock results correctly for each result type will be calculated. For the INSTI® HIV ST usability evaluation, the subjects will be presented with a questionnaire. The overall results of the questionnaire will be used to determine the percentage of subjects who found the INSTI® HIV ST easy to use.

Interventions

INSTI® HIV Self-Test DEVICE

Each participant will be provided with the INSTI® HIV Self-Test and asked to conduct self testing. The operator will observe the participant and record the subject's interpretation of the results. Subjects will perform the test without intervention from the operator. The operator will then perform the comparator test and collect a fingerstick blood sample. 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

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)
• Is currently on a PrEP regimen
• Has used a Rapid Diagnostic Test for HIV blood-based self-testing previously
• Has received any experimental HIV vaccine
• Has a bleeding disorder
• Is known HIV+
• Uses Anti-Retroviral medication
• 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)

Therafirst Medical Center

Fort Lauderdale, Florida, 33308, United States

Location

Study Officials

• Steven A Geller

  Centennial Medical Group

  PRINCIPAL INVESTIGATOR

• Anthony LaMarca

  Therafirst Medical Centers Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: May 2, 2024
• Primary Completion: January 8, 2025
• Study Completion: January 8, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

US (1)