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Welcome!
The primary study results
for Explore are now available! Please go to the Primary
Study Results section of this site to learn the results.
The HIVNET 015 study, colloquially referred
to as "Explore," is the first study to test a behavioral
intervention specifically for men who have sex with men (MSM) over an
extended period of time using HIV infection as the primary endpoint.
Many research studies have been conducted
involving populations of MSM to identify interventions which can help MSM
to reduce the frequency of sexual behaviors that put them at risk of
getting HIV. Extensive changes in risk behaviors have occurred among MSM
but, in recent years, HIV infections, other sexually transmitted diseases
and sexual risk behaviors have been increasing, emphasizing the critical
need for identifying effective prevention interventions. Explore examined
the potential of one such intervention to reduce HIV infection rates among
MSM.
From January 1999 to February 2001, 4,295
HIV-negative MSM were enrolled in six US cities: Boston, Chicago, Denver,
New York, San Francisco and Seattle. Men were eligible if they were age 16
or older and reported having engaged in anal sex with one or more men
during the past year. Study participants completed extensive
questionnaires regarding sexual behaviors, alcohol and drug use, and
occurrence of sexually transmitted diseases.
Following enrollment, study participants in
the standard treatment arm underwent HIV testing, received HIV-prevention
counseling and completed extensive questionnaires regarding sexual
behaviors, alcohol and drug use, and occurrence of sexually transmitted
diseases every six months. Study participants in the intervention
treatment arm completed the same activities as those in the standard arm,
but they received additional counseling in the form of multiple intensive
behavioral counseling sessions (with motivational interviewing and
cognitive behavior theory, for example, as key components) during the
first three to four months of their study involvement period. Afterward,
participants received "booster" sessions every three months (for
up to, on average, 3.25 years).
The Explore study closed on 31 July 2003. Since that time, the Explore primary results paper has been published in
The Lancet. (You can find that paper here.) For more information on the paper, and on the results in general, go to the
Primary Study Results page.
Explore Study Information
Some important documents associated with
Explore are being made publicly available through this website; please
refer to the "Document Center" on the right side of this page
for links to those documents. Included among the documents
are the study protocol and counseling intervention manual. Please feel
free to view and download these documents for your reference. Listed
below are the study co-chairs and principal investigators (with links to
their respective email addresses). If you need more information on the
Explore study, please contact one of the co-chairs or PIs.
Explore Study
Sites
Explore Ancillary Studies
In addition to the conducting the main study, Explore provided an opportunity for the completion of several ancillary studies, or studies that operated within Explore and depended on the Explore cohort for study participants. News regarding ancillary study research papers will appear on the
Research page as it becomes available. For more information on the ancillary studies, please contact the individuals listed next to each study, below. The ancillary studies are:
- A Study of Anal HPV Infection and
Neoplasia as Risk Factors for HIV Seroconversion Among Participants in
HIVNET 015; Joel Palefsky, M.D.
and Peter Chin-Hong, M.D.
- A Study of Human Herpesvirus 8 Among
Participants in HIVNET Protocol #015; Corey Casper, M.D.
- Prevalence and Risk Factors For
Acquisition of Pharyngeal Gonorrhea In Cohorts of Men Who Have Sex
With Men; Grant Colfax, M.D.
- A Qualitative Analysis of Explore
Counseling Sessions; Patrick Barresi,
M.P.H.
- The Impact of Traumatic Current Events
on the HIV Risk Taking Behaviors and Attitudes of Men Who Have Sex
with Men: An Inquiry into the Effects of September 11th, 2001 on
Boston's Cohort of Explore; Liz Salomon, Ed.M
- The Prevalence of Within Group Sexual
Behavior and the Impact of Group Normative Identity on the HIV Risk
Taking Behavior of Men Who Have Sex with Men; Matthew Mimiaga
Explore Eligibility Criteria
Volunteers were eligible for participation
within Explore if they met each of the following conditions:
- Male, age 16 years and older.
- Able and willing to provide written
informed consent.
- HIV-seronegative by licensed
enzyme-linked immunoabsorbent assay (ELISA) or HIV-seronegative by
Western blot (WB) if found to be HIVseropositive by licensed ELISA.
- Reports anal intercourse (receptive or
insertive, protected or unprotected) with another man in the 12 months
prior to enrollment.
- Available for the duration of the study.
- Willing and able to participate in all
scheduled study visits and tests (unwillingness to donate rectal swab
specimen is not exclusionary).
- Willing and able to provide adequate
information for locator purposes.
Volunteers were NOT eligible to participate
in Explore if any of the following conditions applied to them:
- Have been in a mutually monogamous
relationship for two years or more with a known HIV antibody negative
male. "Monogamous" is defined as a relationship in which the
members of the couple engage in sexual activities only with each
other, excluding all others.
- Have an obvious
psychological/psychiatric disorder that would invalidate the informed
consent process, or otherwise contraindicate participation in the
study.
- Have any other condition which in the
opinion of the study site Principal Investigator will interfere with
achieving the study objectives. In such cases the site Principal
Investigator will discuss the condition with the Protocol Co-chairs
and Domestic Master Contractor (DMC) Protocol Specialist prior to
participant notification.
- Were enrolled in the HIVNET 015 Pilot
Study.
- Are enrolled in HIVNET Protocol 014.
- Are enrolled in any HIV vaccine trial
(Phase I, Phase II, Phase IIB and Phase III trials), including the
AIDSVAX Phase III trial sponsored by VaxGen, Inc.
A total of 4,295 participants were enrolled
in the Explore study. For the number of participants enrolled at each
study site, please see the "Study Summary" table below.
If you would like information regarding
the study which is not available on the website, please contact one of the
study co-chairs or principal investigators, above. Clicking on a name will
open an email to that person in a new window.
The Explore study received support from the
HIV Prevention Trials Network and was sponsored by the National Institute
of Allergy and Infectious Diseases. Additional funding was provided by the
National Institute of Child Health and Human Development, and the National
Institute on Alcohol Abuse and Alcoholism, the National Institute on Drug
Abuse, the National Institute of Mental Health, and the Office of AIDS
Research, of the National Institutes of Health, US Dept of Health and
Human Services. The study was conducted through contracts with Abt
Associates Inc., Family Health International, the HVTN Central Lab, and
the Fred Hutchinson Cancer Research Center, and subcontracts with the
Denver Dept of Health and Hospitals, the Fenway Community Health Center,
the Howard Brown Health Center, the New York Blood Center (Columbia
University), the San Francisco Department of Public Health (Public Health
Foundation Inc.), and the University of Washington.
NIAID is a component of the National
Institutes of Health (NIH). NIAID supports basic and applied research to
prevent, diagnose, and treat infectious and immune-mediated illnesses,
including HIV/AIDS and other sexually transmitted diseases, illness from
potential agents of bioterrorism, tuberculosis, malaria, autoimmune
disorders, asthma and allergies.
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