Identifying Emergency Room Patients Who Have Recently Been Infected With HIV

September 8, 2008 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Increasing Identification of Patients With Primary HIV Infection (PHI) Through a Questionnaire Intervention in an Emergency Department (ED) Setting

The purpose of this study is to identify patients who have early HIV infection. Patients who have been infected with HIV recently may develop flu-like symptoms within 3 to 8 weeks. Those who go to the hospital emergency room for these symptoms and who may have been exposed to HIV recently will be given a questionnaire and the opportunity to be tested for HIV.

Most people develop flu-like symptoms shortly after becoming infected with HIV, and many of these people go to a hospital emergency room for treatment. However, most doctors do not think of testing people with flu-like symptoms for HIV. This study will look at a plan to change this because it is very important to identify patients who have early HIV infection. Viral load (level of HIV in the blood) is very high during early HIV infection, and it is easy to spread HIV to others during this period. Patients who learn they are HIV-positive can stop risky behavior that might spread HIV to other people. Also, patients who find out early that they are HIV positive are able to begin anti-HIV treatment sooner, slowing the disease.

Study Overview

Status

Completed

Conditions

Detailed Description

Early identification of HIV infection is an important factor in preventing the spread of HIV. It is hoped that patients who learn their HIV status will decrease behavior that may lead to further transmission of HIV. Infectiousness of HIV is high during PHI, with some of the highest viral loads seen shortly after infection. Treatment for HIV infection now typically begins after identification of infection, but treatment during PHI may positively affect the long-term outcome of the disease. The majority of patients present with flu-like symptoms during PHI. Many seek medical attention, often in an ED setting, but rarely is the diagnosis of HIV considered. Specific screening efforts, therefore, are needed to identify infected individuals before standard ELISA testing would detect infection. This study attempts to demonstrate that administration of a questionnaire to a targeted population presenting symptomatically with viral syndrome in an inner city ED will result in increased screening for HIV and identification of patients with PHI.

Patients presenting to the UCSD ED with viral syndromes are approached by staff and asked to complete a questionnaire regarding possible recent HIV exposure. Patients with risk for recent HIV infection are offered participation in this study. Pre-test counseling includes a review of: (1) the risk of discrimination if the test is positive, (2) the implications of a positive test upon the health of the patient and that of their sexual or needle-use partners, and (3) the possibility that this test, like any laboratory test, could be wrong. Consenting patients have blood drawn for HIV RNA testing and for possible HIV p24 antigen confirmatory test. Blood is labeled with a unique identifying number and not by name. When results become available, patients go the UCSD Treatment Center to learn the results and for post-test counseling.

Study Type

Observational

Enrollment

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • UCSD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are at least 18 years old.
  • Have never tested positive for HIV.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Susan Little
  • Principal Investigator: Dale Lieu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

January 17, 2000

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

September 9, 2008

Last Update Submitted That Met QC Criteria

September 8, 2008

Last Verified

January 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIEDRP AI-05-009
  • AEHIV 009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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