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

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.

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Key information

Conditions

Acute HIV Infection

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Christie's Place, San Diego, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nucleic Acid Amplification Testing

Other

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).

Primary outcomes

Nucleic Acid Amplification Testing

Time frame: 10 minutes

Positive detection of presence of HIV

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

Centers for Disease Control and Prevention
National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: Sep 15, 2011
Registry last updated: Oct 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed