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

University of California San Diego logo

University of California San Diego

Status

Completed

Conditions

Acute HIV Infection

Treatments

Other: Nucleic Acid Amplification Testing

Study type

Interventional

Funder types

Other
Other U.S. Federal agency
NIH

Identifiers

NCT01434706
10-1414

Details and patient eligibility

About

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.

Enrollment

22,607 patients

Sex

All

Ages

13+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

22,607 participants in 1 patient group

Nucleic Acid Amplification Testing
Other group
Description:
Nucleic Acid Amplification Testing
Treatment:
Other: Nucleic Acid Amplification Testing

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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