Implementation of Nucleic Acid Amplification Testing Screening to Identify Acute and Early HIV Infection

Study Overview
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Brief Summary
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The investigators propose to study the impact of nucleic acid amplification testing (NAT) screening for acute Human Immunodeficiency Virus (HIV) and Hepatitis C (HCV) infections and Less-Sensitive Enzyme linked Immunoassay (LS-EIA) or 'detuned' testing Vironostika, Trinity Biotech BED, or Ortho-Clinical Diagnostic Vistros ECi for early HIV infection in conjunction with routine rapid HIV testing at HIV counseling and testing sites and venues in the San Diego county. The overarching goal of this study is to develop and implement a system to identify, notify and engage into care those individuals with recent HIV infection in order to better define the HIV and Hepatitis C Virus (HCV) epidemics in the San Diego county and to evaluate and characterize HIV transmission dynamics within the San Diego population.

Official Title
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NAT: The Early Test Program: Implementation of NAT Screening to Identify Acute and Early HIV Infection at San Diego Public HIV Counseling and Testing Sites

Conditions
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Acute HIV Infection

Intervention / Treatment
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* Other: Nucleic Acid Amplification Testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persons presenting for HIV testing to Public Health Department HIV testing site. Men and women >13 years of age. Those who are 13 or older and younger than 18 should be an emancipated minor or have consent given by their legal representative. Participants 18 and over must be able to provide written consent. Participants should be available for follow up for a period of at least 2 weeks after enrollment Exclusion Criteria: Refusal to participate. Unable to provide informed consent.

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Nucleic Acid Amplification Testing<br>Nucleic Acid Amplification Testing | Other: Nucleic Acid Amplification Testing<br>* The Gen-Probe Transcription-Mediated Amplification (TMA) technology exponentially amplifies captured HIV-1 and HCV RNA in blood samples. The Gen-Probe system is available in two commercially available FDA approved products; 1) the Procleix assay is a multiplex system that is used to screen the blood supply for HIV and HCV. This assay will allow the simultaneous detection of all known HIV-1 subtypes with sensitivities designed to reduce the window period of false negative results from standard HIV antibody testing (EIA), while maintaining the ability to discriminate positive from negative specimens, even at very low copy numbers (Giachetti, Linnen et al., 2002).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nucleic Acid Amplification Testing | Positive detection of presence of HIV | 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, acute infection, primary infection, seroconverters