Testing of INSTI™ HIV-1 Antibody Test Kit in Volunteer Subjects at Risk for HIV Infection

Study Overview
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Brief Summary
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Each year up to 22 million persons in the US are tested for HIV. Currently available rapid tests do not provide test results for at least 30 minutes from the collection of serum and plasma from the subject. Providing accurate test results in less than a minute would make it easier to make timely decisions about treatment and counselling. This study will compare results of an experimental rapid test to existing standards to determine if the test can reliably and accurately diagnose HIV in less than one minute.

Detailed Description
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The primary objective is to determine if INSTI™ performed with finger-stick whole blood, venous whole blood, and plasma demonstrates at least 98.0% sensitivity and specificity compared to an FDA-approved HIV testing algorithm. The study will have two parts. The first part of the study will be conducted in institutions where HIV testing is routinely performed and where HIV counseling is offered [i.e. point of care (POC) centers]. The second part of the study will be conducted in a central laboratory that routinely conducts laboratory-based HIV testing using an FDA-licensed HIV-1 ELISA and Western blot test. Geographically diverse POCs will be selected in the USA. Approximately 15-20 POCs are planned. Approximately 2,500 subjects will participate in the study including 1,500 subjects with unknown HIV status and 1,000 seropositive subjects. Across these POC sites, voluntary testing of 1500 subjects with unknown HIV status is planned with at least 500 of these subjects being high risk. Samples will be obtained from consenting subjects in the voluntary testing population including high-risk and known HIV 1 seropositive individuals. Each subject is to receive an INSTI™ on finger-stick blood and parallel HIV testing of EDTA-treated venous whole blood and plasma samples will be conducted at a central laboratory. The results of INSTI™ will not be given to the subject. The subject will be given the results of the POC HIV test only, per their standard of care procedures. Subsequent subject care decisions will NOT be based on the results of INSTI™.

Official Title
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A Study to Evaluate the Point-of-Care Use and Laboratory Investigational Testing of INSTI™ HIV-1 Antibody Test Kit in Volunteer Subjects at Risk for HIV Infection

Conditions
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HIV Infections

Intervention / Treatment
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* Other: Behavioral counseling
* Device: HIV-1 Antibody Test Kit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unknown HIV status who are undergoing voluntary testing for HIV infection in a POC clinic setting or known HIV seropositive subjects willing to be re-tested. Ability to give proper informed consent, or have legal parent or guardian provide consent. Willingness to participate in a POC standard of care HIV counseling and testing program and receive POC standard of care test results Willingness to provide the necessary volume of whole blood collected through venous blood draw and finger stick (approximately 10 ml) Exclusion Criteria: Subject self-report of history of multiple myeloma Subject self-report of history of long-term anti-retroviral therapy with known low or non-existent antibody titre (sero-inversion)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Behavioral counseling|Standard-of-Care counseling at the Point-of-Care.|
|Device: HIV-1 Antibody Test Kit|Assay to detect HIV antibodies|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| INSTI™ performed with finger-stick whole blood, venous whole blood, and plasma demonstrates at least 98.0% sensitivity and specificity compared to an FDA-approved HIV testing algorithm |  | <1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of INSTI™ results that agree between finger-stick whole blood, venous whole blood, and plasma. |  | < 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV 1, AIDS, Assay, Rapid Test, HIV-1, HIV Seronegativity