Identifying Emergency Room Patients Who Have Recently Been Infected With HIV

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT00001130
Collaborator
(none)
200
1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Official Title:
    Increasing Identification of Patients With Primary HIV Infection (PHI) Through a Questionnaire Intervention in an Emergency Department (ED) Setting

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No

      Inclusion Criteria

      Patients may be eligible for this study if they:
      • Are at least 18 years old.

      • Have never tested positive for HIV.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 UCSD San Diego California United States 92103

      Sponsors and Collaborators

      • National Institute of Allergy and Infectious Diseases (NIAID)

      Investigators

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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00001130
      Other Study ID Numbers:
      • AIEDRP AI-05-009
      • AEHIV 009
      First Posted:
      Aug 31, 2001
      Last Update Posted:
      Sep 9, 2008
      Last Verified:
      Jan 1, 2005

      Study Results

      No Results Posted as of Sep 9, 2008