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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2011 by University of California, San Diego
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Davey Smith, MD, MAS, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01434706
First received: September 13, 2011
Last updated: September 14, 2011
Last verified: September 2011

September 13, 2011
September 14, 2011
December 2006
December 2016   (final data collection date for primary outcome measure)
Nucleic Acid Amplification Testing [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
Positive detection of presence of HIV
Same as current
Complete list of historical versions of study NCT01434706 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Implementation of Nucleic Acid Amplification Testing Screening to Identify Acute and Early HIV Infection
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.

Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Acute HIV Infection
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).
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12000
December 2016
December 2016   (final data collection date for primary outcome measure)

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.
Both
13 Years and older
No
Contact: David Rodriguez, BA 619-543-8130 dar002@ucsd.edu
Contact: Jill Kunkel, RN 619-543-3094 jkunkel@ucsd.edu
United States
 
NCT01434706
10-1414
No
Davey Smith, MD, MAS, University of California, San Diego
University of California, San Diego
National Institutes of Health (NIH)
Not Provided
University of California, San Diego
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP