Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000915
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
An HIV Vaccine Preparedness Study
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
HIV Vaccine Preparedness Study
Status:
COMPLETED
Status Verified Date:
1999-03
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 estimate the rate at which a certain population becomes infected with HIV The individuals examined in this study are people who are expected to take part in future studies of HIV vaccines and nonvaccine HIV prevention studies This study also examines the chances of becoming HIV-positive based on certain risk factors under conditions that are similar to the conditions that would exist in HIV vaccine and non-HIV prevention studies
Before studying the effectiveness of a potential HIV vaccine it is important to learn about the range of HIV risk behaviors in the potential participants of these studies The probability of HIV infection associated with these risk behaviors should also be examined This study is designed to increase the ability of HIVNET to put into place HIV prevention trials to increase the diversity of trial participants and to target populations at highest risk for HIV infection
Before studying the effectiveness of a potential HIV vaccine it is important to learn about the range of HIV risk behaviors in the potential participants of these studies The probability of HIV infection associated with these risk behaviors should also be examined This study is designed to increase the ability of HIVNET to put into place HIV prevention trials to increase the diversity of trial participants and to target populations at highest risk for HIV infection
Detailed Description:
Vaccine preparedness studies are necessary in order to prepare for launching preventive HIV vaccine efficacy trials It is important to gather information on the risk of HIV infection among recruited populations the extent and stability of HIV risk behaviors in these populations and the risk of HIV infection associated with risk behaviors This vaccine preparedness study is designed to expand the capacity of the HIVNET to implement HIV prevention trials increase the diversity of its participant population and further target populations at highest risk of HIV infection
Participants complete a total of 6 scheduled study visits 2 at baseline 2 at follow-up 6 months later and 2 at follow-up 12 months after enrollment Participant risk behaviors and knowledge of and attitudes toward HIV vaccine and other HIV prevention trials are assessed at each time point HIV infection status is tested by standard HIV ELISA and Western blot at follow-up as well as at participant request throughout the study Participants are instructed to recognize and report suspected primary HIV infection based on symptoms or high-risk exposures HIV pre-test risk reduction and post-test counseling is provided in accordance with CDC standards of practice Participants who become infected with HIV during the study are counseled and referred for medical and psychosocial services
Participants complete a total of 6 scheduled study visits 2 at baseline 2 at follow-up 6 months later and 2 at follow-up 12 months after enrollment Participant risk behaviors and knowledge of and attitudes toward HIV vaccine and other HIV prevention trials are assessed at each time point HIV infection status is tested by standard HIV ELISA and Western blot at follow-up as well as at participant request throughout the study Participants are instructed to recognize and report suspected primary HIV infection based on symptoms or high-risk exposures HIV pre-test risk reduction and post-test counseling is provided in accordance with CDC standards of practice Participants who become infected with HIV during the study are counseled and referred for medical and psychosocial services
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?: