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

October 17, 2019 updated by: Davey Smith, MD, MAS, University of California, San Diego

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22607

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92101
        • Christie's Place
      • San Diego, California, United States, 92103
        • San Diego LGBT Community Center
      • San Diego, California, United States, 92103
        • UC San Diego AntiViral Research Center
      • San Diego, California, United States, 92103
        • UCSD Lead the Way Storefront
      • San Diego, California, United States, 92104
        • Family Health Centers of San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Nucleic Acid Amplification Testing
Other: Nucleic Acid Amplification Testing
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).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2010

Primary Completion (Actual)

April 7, 2015

Study Completion (Actual)

April 7, 2015

Study Registration Dates

First Submitted

September 13, 2011

First Submitted That Met QC Criteria

September 14, 2011

First Posted (Estimate)

September 15, 2011

Study Record Updates

Last Update Posted (Actual)

October 21, 2019

Last Update Submitted That Met QC Criteria

October 17, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-1414

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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