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

NCT07061912 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2025-08-20

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • bioLytical Laboratories

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-24
Primary Completion
2025-08-06
Completion
2025-08-06
FDA Device
Yes

Countries

  • Canada

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 NCT07061912 on ClinicalTrials.gov