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
  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: 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 University of California, San Diego:

Primary Outcome Measures:
  • Nucleic Acid Amplification Testing [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    Positive detection of presence of HIV


Estimated Enrollment: 12000
Study Start Date: December 2006
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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         
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         
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         
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         
Sponsors and Collaborators
University of California, San Diego
  More Information

Additional Information:
No publications provided

Responsible Party: Davey Smith, MD, MAS, Associate Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01434706     History of Changes
Other Study ID Numbers: 10-1414
Study First Received: September 13, 2011
Last Updated: September 14, 2011
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of California, San Diego:
HIV
acute infection
primary infection
seroconverters

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Infection
Communicable Diseases
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

ClinicalTrials.gov processed this record on October 01, 2014