Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001130
Status:
COMPLETED
Last Update Posted:
2008-09-09
First Post:
2000-01-17
Brief Title:
Identifying Emergency Room Patients Who Have Recently Been Infected With HIV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Increasing Identification of Patients With Primary HIV Infection PHI Through a Questionnaire Intervention in an Emergency Department ED Setting
Status:
COMPLETED
Status Verified Date:
2005-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AEHIV 009 | None | None | None |