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

NCT01434706 | Completed

• 1 other identifier: 10-1414
• Study Type: interventional
• Target: 22,607
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Acute HIV Infection

Keywords

HIV; acute infection; primary infection; seroconverters

Outcome Measures

Primary Outcomes (1)

• Nucleic Acid Amplification Testing

  Positive detection of presence of HIV

  10 minutes

Study Arms (1)

Nucleic Acid Amplification Testing

OTHER

Nucleic Acid Amplification Testing

Other: Nucleic Acid Amplification Testing

Interventions

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).

Nucleic Acid Amplification Testing

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Refusal to participate.
• Unable to provide informed consent.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institutes of Health (NIH): collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (5)

Christie's Place

San Diego, California, 92101, United States

Location

San Diego LGBT Community Center

San Diego, California, 92103, United States

Location

UC San Diego Antiviral Research Center

San Diego, California, 92103, United States

Location

UCSD Lead the Way Storefront

San Diego, California, 92103, United States

Location

Family Health Centers of San Diego

San Diego, California, 92104, United States

Location

Related Links

• The Early Test

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicinie

Study Record Dates

• First Submitted: September 13, 2011
• First Posted: September 15, 2011
• Study Start: September 16, 2010
• Primary Completion: April 7, 2015
• Study Completion: April 7, 2015
• Last Updated: October 21, 2019

Record last verified: 2019-10

Locations

US (5)