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

Description

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

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Study Overview

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Study Details

Study overview

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.

A Study to Evaluate the Performance, Usability, and Result Interpretation of INSTI® HIV Self-Test When Performed by Observed Intended Users in the US

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

Condition
Human Immunodeficiency Virus I Infection
Intervention / Treatment

-

Contacts and Locations

Fort Lauderdale

Therafirst Medical Center, Fort Lauderdale, Florida, United States, 33308

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 18 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

bioLytical Laboratories,

Steven A Geller, PRINCIPAL_INVESTIGATOR, Centennial Medical Group

Anthony LaMarca, PRINCIPAL_INVESTIGATOR, Therafirst Medical Centers Inc.

Study Record Dates

2025-05-01