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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by Davey Smith, MD, MAS, University of California, San Diego.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01434706
First Posted: September 15, 2011
Last Update Posted: December 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Davey Smith, MD, MAS, University of California, San Diego
  Purpose
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.

Condition Intervention Phase
Acute HIV Infection Other: Nucleic Acid Amplification Testing Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official 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

Resource links provided by NLM:


Further study details as provided by Davey Smith, MD, MAS, University of California, San Diego:

Primary Outcome Measures:
  • Nucleic Acid Amplification Testing [ Time Frame: 10 minutes ]
    Positive detection of presence of HIV


Estimated Enrollment: 12000
Study Start Date: December 2006
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Nucleic Acid Amplification Testing
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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01434706


Contacts
Contact: David Rodriguez, BA 619-543-8130 dar002@ucsd.edu
Contact: Jill Kunkel, RN 619-543-3094 jkunkel@ucsd.edu

Locations
United States, California
Christie's Place Recruiting
San Diego, California, United States, 92101
Contact: David Rodriguez, BA    619-543-8130    dar002@ucsd.edu   
Contact: Jill Kunkel, RN    619-543-3094    jkunkel@ucsd.edu   
Principal Investigator: Davey Smith, MD, MAS         
San Diego LGBT Community Center Recruiting
San Diego, California, United States, 92103
Contact: David Rodriguez, BA    619-543-8130    dar02@ucsd.edu   
Contact: Jill Kunkel, RN    619-543-3094    jkunkel@ucsd.edu   
Principal Investigator: Davey Smith, MD, MAS         
UC San Diego Antiviral Research Center Recruiting
San Diego, California, United States, 92103
Contact: David Rodriguez, BA    619-543-8130    dar02@ucsd.edu   
Contact: Jill Kunkel, RN    619-543-3094    jkunkel@ucsd.edu   
Principal Investigator: Davey Smith, MD, MAS         
UCSD Lead the Way Storefront Recruiting
San Diego, California, United States, 92103
Contact: David Rodriguez, BA    619-543-8130    dar02@ucsd.edu   
Contact: Jill Kunkel, RN    619-543-3094    jkunkel@ucsd.edu   
Principal Investigator: Davey Smith, MD, MAS         
Family Health Centers of San Diego Recruiting
San Diego, California, United States, 92104
Contact: David Rodriguez, BA    619-543-8130    dar002@ucsd.edu   
Contact: Jill Kunkel, RN    619-543-3094    jkunkel@ucsd.edu   
Principal Investigator: Davey Smith, MD, MAS         
Sponsors and Collaborators
University of California, San Diego
National Institutes of Health (NIH)
Centers for Disease Control and Prevention
  More Information

Additional Information:
Responsible Party: Davey Smith, MD, MAS, Professor of Medicinie, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01434706     History of Changes
Other Study ID Numbers: 10-1414
First Submitted: September 13, 2011
First Posted: September 15, 2011
Last Update Posted: December 4, 2014
Last Verified: December 2014

Keywords provided by Davey Smith, MD, MAS, University of California, San Diego:
HIV
acute infection
primary infection
seroconverters

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases


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