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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000915 |
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.
Condition | Intervention |
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HIV Infections |
Behavioral: Vaccine preparedness |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | HIV Vaccine Preparedness Study |
Estimated Enrollment: | 4892 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Participants meet the following criteria:
For men:
For women:
See General Inclusion Criteria for required risk behaviors.
Volunteers must be:
Exclusion Criteria
Co-existing Condition:
Persons with the following symptoms or conditions are excluded:
Men at risk through anal intercourse only are excluded if they:
Men and women at risk through injection only are excluded if they:
NOTE:
Concurrent Medication:
Excluded:
Risk Behavior:
United States, California | |
Los Angeles County / Health Research Assoc / Drew Med Ctr | |
Los Angeles, California, United States, 90059 | |
United States, Illinois | |
Univ of Illinois Hosp at Chicago | |
Chicago, Illinois, United States, 60612 | |
United States, Maryland | |
Johns Hopkins Univ | |
Baltimore, Maryland, United States, 21205 | |
United States, New York | |
New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
Bronx Lebanon Hosp Ctr | |
Bronx, New York, United States, 10456 | |
New York Blood Ctr | |
Bronx, New York, United States, 10456 | |
United States, Pennsylvania | |
Univ of Pennsylvania / HIVNET | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Rhode Island | |
Miriam Hosp | |
Providence, Rhode Island, United States, 02906 |
Study Chair: | Dave Metzger | |
Study Chair: | George Seage |
Study ID Numbers: | HIVNET D01 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000915 |
Health Authority: | United States: Federal Government |
AIDS Vaccines Incidence Knowledge, Attitudes, Practice Risk-Taking |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |