What is the Be A Hero - The Vaccine Preparedness Study (VPS)?
In 1995, the domestic HPTU sites implemented a multi-center Vaccine Preparedness
Study (VPS) to determine feasibility of conducting an HIV vaccine efficacy trial.
The study, completed in April 1997, enrolled 4,892 participants at high risk of HIV
infection (gay men, injection drug users and women at heterosexual risk) in a
prospective cohort study which simulated the size and study procedures of a
large-scale vaccine trial. The research goals of VPS were to:
determine seroincidence and cofactors for transmission in the context of behavioral
interventions that will be available to vaccine trial participants;
assess knowledge, attitudes and willingness of participants to participate in
vaccine and non-vaccine prevention trials;
identify effective and efficient methods to rapidly recruit and retain individuals
at risk for HIV infection;
develop reliable, valid, consistent and cost-effective measures to quantify risk
behaviors;
develop reliable and efficient procedures for obtaining truly informed consent for
participation in vaccine trials;
develop and evaluate risk reduction measures that will be provided to vaccine trial
participants;
characterize clinical, epidemiological, virological and immunological outcomes of
participants who become infected with HIV;
determine if highly exposed but uninfected participants have immunologic responses
to HIV; and
determine the feasibility of home collection of oral fluid and blood for diagnosis
of early HIV infection.
What were the findings?
Seroincidence across the domestic sites was 1.4%, and in Seattle 1.0% (per year).
Additionally, the Seattle HPTU site had a retention rate of 90% after 18 months of
follow-up (the duration of the VPS or "Be A Hero" study).
With similar scientific goals, the nine international HPTU sites recruited more than
8,000 participants in cohorts of female commercial sex workers, gay men, STD clinic
patients, long-distance truck drivers, factory workers and pregnant women. The
annual seroincidence at these sites ranged from less than 1% to greater than 12%,
with one year follow-up rates ranging from 70-90%. HIV strains isolated from
participants in the diverse cohorts have been characterized and represent all the
major subtypes or clades of HIV.
How can I get more information about this study?
If you have further questions about this or any of our research studies, feel
free to contact us. You can also click on the
links below to read the abstracts of the journal articles that were written
based on data gathered during the Be A Hero - Vaccine Preparedness Study:
2003
- Herpes Simplex Virus Type 2 Infection as
a Risk Factor for Human
Immunodeficiency Virus Acquisition in Men Who Have Sex with Men
(2003)
- Randomized, controlled evaluation of a
prototype informed consent process for HIV vaccine efficacy trials
(2003)
2002
-
HIV-1 infection in individuals with the CCR5-Delta32/Delta32 genotype: acquisition
of syncytium-inducing virus at seroconversion. (2002)
-
Correlates of Prevalent and Incident Kaposi's Sarcoma-Associated Herpesvirus
Infection in Men Who Have Sex with Men. (2002)
2001
-
Are US populations appropriate for trials of human immunodeficiency virus vaccine?
The HIVNET Vaccine Preparedness Study. (2001)
-
Early human immunodeficiency virus (HIV) infection in the HIV Network for Prevention
Trials Vaccine Preparedness Cohort: risk behaviors, symptoms, and early plasma and
genital tract virus load. (2001)
2000
-
Readiness for HIV vaccine trials: changes in willingness and knowledge among
high-risk populations in the HIV network for prevention trials. The HIVNET Vaccine
Preparedness Study Protocol Team. (2000)
-
Randomized controlled trial of audio computer-assisted self-interviewing: utility
and acceptability in longitudinal studies. HIVNET Vaccine Preparedness Study
Protocol Team. (2000)
1999
-
Correlates of condom failure in a sexually active cohort of men who have sex with
men. (1999)
-
Use of reality "female condoms" for anal sex by US men who have sex with men. HIVNET
Vaccine Preparedness Study Protocol Team. (1999)
-
Non-injection substance use correlates with risky sex among men having sex with men:
data from HIVNET. (1999)
1998
-
Readiness of high-risk populations in the HIV Network for Prevention Trials to
participate in HIV vaccine efficacy trials in the United States. (1998)
-
Incidence of HIV and sexually transmitted diseases (STD) in a cohort of HIV-negative
men who have sex with men (MSM). (1998)
-
Rectal microbicides for U.S. gay men. Are clinical trials needed? Are they feasible?
HIVNET Vaccine Preparedness Study Protocol Team. (1998)
We are no longer enrolling for this study, but if you are interested
in participating in HIV prevention research, please explore our research
page that lists studies that we are currently enrolling for.
Thank You
to all of our
Be A Hero Study
Volunteers!
