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

Acute HIV Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01434706
• Other study ID #: 10-1414
• Status: Completed
• Phase: N/A
• Start date: September 16, 2010
• Est. completion date: April 7, 2015

Study information

• Verified date: October 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22607
• Est. completion date: April 7, 2015
• Est. primary completion date: April 7, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Acute HIV Infection
• Communicable Diseases
• HIV Infections
• Infection

Intervention

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).

Locations

Country	Name	City	State
United States	Christie's Place	San Diego	California
United States	Family Health Centers of San Diego	San Diego	California
United States	San Diego LGBT Community Center	San Diego	California
United States	UC San Diego Antiviral Research Center	San Diego	California
United States	UCSD Lead the Way Storefront	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	Centers for Disease Control and Prevention, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nucleic Acid Amplification Testing	Positive detection of presence of HIV	10 minutes