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
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 13, 2011 | ||||||||
| Last Updated Date | September 14, 2011 | ||||||||
| Start Date ICMJE | December 2006 | ||||||||
| Estimated Primary Completion Date | December 2016 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Nucleic Acid Amplification Testing [ Time Frame: 10 minutes ] [ Designated as safety issue: No ] Positive detection of presence of HIV |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01434706 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Implementation of Nucleic Acid Amplification Testing Screening to Identify Acute and Early HIV Infection | ||||||||
| Official Title ICMJE | 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 | ||||||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Acute HIV Infection | ||||||||
| Intervention ICMJE | 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). |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | 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. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 12000 | ||||||||
| Estimated Completion Date | December 2016 | ||||||||
| Estimated Primary Completion Date | December 2016 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 13 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01434706 | ||||||||
| Other Study ID Numbers ICMJE | 10-1414 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Davey Smith, MD, MAS, University of California, San Diego | ||||||||
| Study Sponsor ICMJE | University of California, San Diego | ||||||||
| Collaborators ICMJE | National Institutes of Health (NIH) | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | University of California, San Diego | ||||||||
| Verification Date | September 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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