Implementation of Nucleic Acid Amplification Testing Screening to Identify Acute and Early HIV Infection
This study is currently recruiting participants.
Verified September 2011 by University of California, San Diego
Sponsor:
University of California, San Diego
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
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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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
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
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 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 May 23, 2013