An HIV Vaccine Preparedness Study
HIV Vaccine Preparedness Study
1 other identifier
interventional
4,892
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
March 1, 1999
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Participants meet the following criteria:
- HIV-seronegative.
- Available for 6 months of the study. (Note:
- Participants who plan to move from one study location to another are eligible.)
- Willing and able to provide information for locator purposes.
- Report one or more of the following risk behaviors:
- For men:
- Intravenous or intramuscular injection of any drug on an average of 3 or more days per week during the last 3 months.
- Anal intercourse (receptive or insertive) with one or more other men in the last year.
- For women:
- Intravenous or intramuscular injection of any drug on an average of 3 or more days per week during the last 3 months.
- Having a current male sex partner who is infected with HIV.
- Having a current male sex partner who has injected drugs in the last 5 years.
- Having 5 or more male sex partners in the last year.
- Diagnosis of syphilis, chlamydia, gonorrhea, first episode herpes, pelvic inflammatory disease, and/or trichomoniasis in the last year.
- +11 more criteria
You may not qualify if:
- Co-existing Condition:
- Persons with the following symptoms or conditions are excluded:
- An obvious psychological or psychiatric disorder that would preclude provision of informed consent or otherwise contraindicate study participation.
- Any condition which in the opinion of the principal investigator would interfere with achieving the study objectives.
- Men at risk through anal intercourse only are excluded if they:
- Currently have a single HIV-seronegative partner with whom they have been in a mutually monogamous relationship for at least 2 years.
- Men and women at risk through injection only are excluded if they:
- Have been participating in any methadone drug treatment program for at least the last 6 months.
- Currently obtain over 50 percent of needles/syringes for injection of drugs from a needle exchange program.
- NOTE:
- Using a needle or syringe after one or more known HIV-positive persons 2 or more times in the past 3 months.
- Using a needle or syringe after persons of unknown HIV status in the past 3 months provided the following two conditions are true:
- (1) report using a needle or syringe after someone else 2 or more different times in the past 3 months and (2) report using a needle or syringe after 3 or more different persons in the past 3 months. (This second criterion could be met in 3 episodes of injection with a single injection partner, if the participant used a needle or syringe after a different person each time. Alternatively, the criterion could be met in a single episode of injection, if the participant used a needle or syringe after 3 or more persons had used a single set of works.)
- Concurrent Medication:
- Excluded:
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Los Angeles County / Health Research Assoc / Drew Med Ctr
Los Angeles, California, 90059, United States
Univ of Illinois Hosp at Chicago
Chicago, Illinois, 60612, United States
Johns Hopkins Univ
Baltimore, Maryland, 21205, United States
New York Univ Med Ctr
New York, New York, 10016, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10456, United States
New York Blood Ctr
The Bronx, New York, 10456, United States
Univ of Pennsylvania / HIVNET
Philadelphia, Pennsylvania, 19104, United States
Miriam Hosp
Providence, Rhode Island, 02906, United States
Related Publications (1)
Woody GE, VanEtten-Lee ML, McKirnan D, Donnell D, Metzger D, Seage G 3rd, Gross M; HIVNET VPS 001 Protocol Team. Substance use among men who have sex with men: comparison with a national household survey. J Acquir Immune Defic Syndr. 2001 May 1;27(1):86-90. doi: 10.1097/00126334-200105010-00015.
PMID: 11404525BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dave Metzger
- STUDY CHAIR
George Seage
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1999-03