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 December 2014 by University of California, San Diego
Sponsor:
University of California, San Diego
Collaborators:
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: December 2, 2014
Last verified: December 2014
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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:
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: | 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| 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
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 | |
| 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 | |
| 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 | |
| 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 | |
Sponsors and Collaborators
University of California, San Diego
More Information
Additional Information:
No publications provided
| 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 |
| Study First Received: | September 13, 2011 |
| Last Updated: | December 2, 2014 |
| 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:
|
Acquired Immunodeficiency Syndrome HIV Infections Communicable Diseases Infection Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections |
RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases |
ClinicalTrials.gov processed this record on February 27, 2015