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

NCT06368453 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1728

Last updated 2025-07-11

No results posted yet for this study

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

Interventions

DEVICE

INSTI® HIV Self-Test

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.

Sponsors & Collaborators

  • bioLytical Laboratories

    lead INDUSTRY

Principal Investigators

  • Steven A Geller · Centennial Medical Group

  • Anthony LaMarca · Therafirst Medical Centers Inc.

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-02
Primary Completion
2025-01-08
Completion
2025-01-08
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06368453 on ClinicalTrials.gov