HIV Self-Test for HIV

N/A

Recruiting

Led By Steven A Geller

Research Sponsored by bioLytical Laboratories

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to assess how well the INSTI® HIV Self-Test works when used by regular people in the US who are not healthcare professionals. The test is meant to detect HIV antibodies in a

Who is the study for?

This trial is for individuals in the US, aged 18 or older, who can read/write English or Spanish and are willing to participate in HIV counseling. They must be able to provide a fingerstick blood sample, have an unknown HIV status, and agree to standard care testing results.

What is being tested?

The INSTI® HIV Self-Test is being evaluated for its performance by non-professionals. It's a single-use test for detecting antibodies to HIV-1 and HIV-2 using fingerstick blood. The study assesses accuracy, ease of use, and result interpretation by lay users.

What are the potential side effects?

Since this trial involves self-testing for HIV without direct medical intervention, there are no direct side effects from medications or treatments. However, discomfort from the fingerstick blood sample may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

The INSTI® HIV Self-Test usability and result interpretation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PerformanceExperimental Treatment1 Intervention

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.

Group II: Mock results interpretation study and Usability evaluationActive Control1 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.

0 / 1Eligibility criteria met