An HIV Vaccine Preparedness Study

Not Applicable

Completed

• Conditions: HIV Infections

• Registration Number: NCT00000915
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

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.

Study Timeline

• Status Verified: 1999-03
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4892

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (8)

Bronx Lebanon Hosp Ctr; 🇺🇸 Bronx, New York, United States

New York Blood Ctr; 🇺🇸 Bronx, New York, United States

Univ of Pennsylvania / HIVNET; 🇺🇸 Philadelphia, Pennsylvania, United States

Los Angeles County / Health Research Assoc / Drew Med Ctr; 🇺🇸 Los Angeles, California, United States

Univ of Illinois Hosp at Chicago; 🇺🇸 Chicago, Illinois, United States

Johns Hopkins Univ; 🇺🇸 Baltimore, Maryland, United States

New York Univ Med Ctr; 🇺🇸 New York, New York, United States

Miriam Hosp; 🇺🇸 Providence, Rhode Island, United States