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Identifying Emergency Room Patients Who Have Recently Been Infected With HIV

Primary Purpose

HIV Infections

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for HIV Infections focused on measuring Questionnaires, Antibodies, Viral, Emergency Service, Hospital

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Patients may be eligible for this study if they: Are at least 18 years old. Have never tested positive for HIV.

Sites / Locations

  • UCSD

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 17, 2000
Last Updated
September 8, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00001130
Brief Title
Identifying Emergency Room Patients Who Have Recently Been Infected With HIV
Official Title
Increasing Identification of Patients With Primary HIV Infection (PHI) Through a Questionnaire Intervention in an Emergency Department (ED) Setting
Study Type
Observational

2. Study Status

Record Verification Date
January 2005
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Questionnaires, Antibodies, Viral, Emergency Service, Hospital

7. Study Design

Enrollment
200 (false)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients may be eligible for this study if they: Are at least 18 years old. Have never tested positive for HIV.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Little
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dale Lieu
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States

12. IPD Sharing Statement

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Identifying Emergency Room Patients Who Have Recently Been Infected With HIV

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