Download Native American HPR Module - HIV/AIDS Network Coordination

HIV Prevention
Subtitle will goTools
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Research
HIV PREVENTION TOOLS AND
HOW ARE THEY USED IN HIV
PREVENTION RESEARCH
This project was supported through Federal funds from the Division of AIDS (DAIDS), National
Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and
Human Services Grant # UM01 AI068614: “Leadership Group for a Global HIV Vaccine Clinical
Trials (Office of HIV/AIDS Network Coordination) and the NorthEast Two-Spirit Society.”
Introduction
HIV prevention includes: medicines, medical devices, medical
procedures, physical barriers, and behavioral approaches.
Introduction, continued
Comprehensive HIV
prevention includes
multiple approaches
instead of just one or
two approaches.
Introduction, continued
No one HIV
prevention
approach will
be acceptable
to all people.
Research is critical to
develop and test new
prevention options that
offer people more
choices.
The best
option for one
person may not
be the best for
others.
The HIV Combination Prevention Toolbox
The toolbox is organized into two sections:
Tools and approaches
that are “medical” in
nature
Tools and approaches
that are “behavioral”
in nature
The HIV Combination Prevention Toolbox, continued
Vaccines
Treatment as Prevention
(TasP)
Post-Exposure Prophylaxis
(PEP)
HIV Prevention Toolbox
Microbicides
Pre-Exposure
Prophylaxis (PrEP)
Prevention of Motherto-Child Transmission
(PMTCT)
Medical
Harm Reduction
Education
Clean Syringes
Medical Male
Circumcision
(Needle Exchange Programs)
Condoms and Other
Barrier Methods
Sexually Transmitted
Infections (STIs)
Diagnosis and
Treatment
Behavioral/Physical Barriers
Treatment/
Prevention of Drug/
Alcohol Abuse
Introduction, continued
Vaccines
Treatment as Prevention
(TasP)
Post-Exposure Prophylaxis
(PEP)
HIV Prevention Toolbox
Microbicides
Pre-Exposure
Prophylaxis (PrEP)
Prevention of Motherto-Child Transmission
(PMTCT)
Medical
Harm Reduction
Education
Clean Syringes
Medical Male
Circumcision
(Needle Exchange Programs)
Condoms and Other
Barrier Methods
Sexually Transmitted
Infections (STIs)
Diagnosis and
Treatment
Behavioral/Physical Barriers
Treatment/
Prevention of Drug/
Alcohol Abuse
Pre-Exposure Prophylaxis (PrEP)
Introduction
The PrEP prevention approach is focused on
people who do not have HIV, but may be at
risk of exposure to HIV through sexual
contact and injection drug use (IDU).
■ With PrEP, people who are not infected with
HIV receive a prescription to take a
medication.
■ The medication may lower their risk of HIV
infection if they are exposed to HIV through
sexual contact.
Introduction, continued
Vaccines
Treatment as Prevention
(TasP)
Post-Exposure Prophylaxis
(PEP)
HIV Prevention Toolbox
Microbicides
Pre-Exposure
Prophylaxis (PrEP)
Prevention of Motherto-Child Transmission
(PMTCT)
Medical
Harm Reduction
Education
Clean Syringes
Medical Male
Circumcision
(Needle Exchange Programs)
Condoms and Other
Barrier Methods
Sexually Transmitted
Infections (STIs)
Diagnosis and
Treatment
Behavioral/Physical Barriers
Treatment/
Prevention of Drug/
Alcohol Abuse
PEP vs. PrEP
PrEP: treatment before exposure
HIV
Exposure
PEP: treatment after exposure
PrEP Progress
One recent major milestone in HIV prevention
was the approval of a daily oral medication
TDF/FTC in the United States (marketed
under the name Truvada®) for HIV prevention.
Truvada® is a combination of two
antiretroviral drugs:
■ Tenofovir disoproxil fumarate (also called
TDF, or tenofovir)
■ Emtricitabine (also called FTC)
HIV Prevention Using Truvada®
■ Truvada® (also known as TDF/FTC) is approved for daily use
for HIV prevention.
■ Truvada® must be taken on a consistent, daily basis to be
effective as PrEP.
■ One caution that applies to any new intervention is that it could
result in less condom usage and more risky behavior that would
offset the benefits.
■ It is recommended that people who are prescribed PrEP continue
to use condoms.
HIV Prevention Using Truvada®, continued
How
Truvada® as
PrEP works
Truvada® is an antiretroviral medication (ARV)
that protects HIV-negative people from HIV
infection if they are exposed to the virus
ARVs block the action of a protein that HIV
needs to infect the body
HIV Prevention Using Truvada®, continued
Who should
use Truvada®
for HIV
prevention?
Male-assigned Two-Spirit or Native men who
have sex with men
Transgender women who have sex with men
Heterosexual couples where one partner has
HIV and the other does not
Injecting drug users (based on new recent CDC
study results)
HIV Prevention Using Truvada®, continued
Requirements
for use
Be HIV negative proven by testing prior to
starting use
Test for HIV infection at least every three
months while taking Truvada®
Commit to safer sex practices as part of a
comprehensive HIV prevention program,
including the use of condoms
Must take Truvada® daily to achieve the
maximal benefit of reduced risk of HIV
infection
PrEP Continuing Research
Some of the
goals of ongoing
PrEP research
include:
Conducting
implementation
research to
understand what
happens after more
people are prescribed
PrEP in “real world”
settings
Conducting research
in more countries
with additional
populations
Finding more effective and
additional PrEP drugs, dosing,
schedules, and delivery
mechanisms
PrEP Continuing Research, continued
A number of public and private organizations, in partnership
and individually, are working together to find PrEP solutions
that can help prevent HIV.
National Institute of
Allergy and Infectious
Diseases, National
Institutes of Health
PrEP Summary
■ PrEP is a medical
prevention approach for
people who do not have
HIV but are at risk for
HIV infection.
■ They take a specific
medication on a daily
basis to reduce the risk
of HIV infection if
exposed through sexual
contact or intravenous
drug use.
Vaccines
Introduction
A vaccine is a substance that
teaches the body’s immune system
to recognize and protect against a
disease caused by an infectious
agent or virus, often by stimulating
the body to produce antibodies and
T-cells against that infection.
A safe and effective preventive vaccine is believed to be the best way
to control the HIV/AIDS epidemic in the long term. There is a lot of
important research going on to find a safe and effective HIV vaccine.
However, there is currently no licensed vaccine against HIV or
AIDS.
Introduction, continued
Vaccines
Post-Exposure Prophylaxis
(PEP)
Pre-Exposure
Prophylaxis (PrEP)
Treatment as Prevention
(TasP)
HIV Prevention Toolbox
Microbicides
Sexually Transmitted
Infections (STIs)
Diagnosis and
Treatment
Prevention of Motherto-Child Transmission
(PMTCT)
Medical
Harm Reduction
Education
Clean Syringes
Medical Male
Circumcision
(Needle Exchange Programs)
Condoms and Other
Barrier Methods
Behavioral/Physical Barriers
Treatment/
Prevention of Drug/
Alcohol Abuse
How Does a Vaccine Work?
Teaching
the body to
recognize
HIV
Telling the
body to
sound an
alarm
Telling
fighter cells
to go into
action
Result: HIV
is
controlled
or killed
HIV Vaccines—the Future
■ Vaccines are important to control the
spread of HIV. They are not seen as a cure
for AIDS. We test vaccines in HIVnegative people because the goal is to keep
them that way.
■ However, HIV vaccines may one day be
able to prevent or delay AIDS in HIVpositive people, too.
HIV Vaccines—the Future, continued
How an
HIV vaccine
might work
HIV
possible
benefits
•
•
•
•
Prevent infection in most people
Prevent infection in some people
Prevent disease progression after infection
Delay or prevent the onset of AIDS
• Even if a vaccine only protects some people, it would
have a major impact on controlling the HIV/AIDS
epidemic
• A partially effective vaccine could decrease the
number of people who get infected with HIV
• There would be fewer HIV-infected people at risk to
pass the virus on to others
Challenges in Developing an HIV Vaccine
■ HIV can “hide” from the immune system that protects the body
■ HIV infection attacks the same immune cells that the body uses to
defend itself against infection
■ There are many different varieties of HIV
■ HIV changes rapidly, even in a single person
■ There is no good model for testing HIV vaccines in animals,
because HIV impacts people in ways that are different from the
animal versions
■ We have no human example of someone who has naturally cleared
an HIV infection, so we are not sure what the immune response is
that would be needed for protection; we have to do better than
“mother nature”
Vaccines Continuing Research
“A vaccine offers the world’s best hope for not
just easing…AIDS but also ending it. The past
has shown us the power of vaccines in
changing the course of human history.”
Vaccines Continuing Research, continued
A number of public and private organizations, in partnership
and individually, are working together to find a vaccine that
could end the epidemic.
National Institute of Allergy
and Infectious Diseases,
National Institutes of Health
HIV Vaccine Trials Network (HVTN) is an international
collaboration that conducts all phases of clinical studies, from
evaluating experimental vaccines for safety and the ability to
stimulate immune responses, to testing vaccine efficacy.
Vaccines Summary
A vaccine uses a
substance that teaches
the body’s immune
system to recognize
and protect against a
disease caused by an
infectious agent or
virus, often by
stimulating the body to
produce antibodies and
T-cells against that
infection.
Microbicides
Introduction
A microbicide is designed to reduce the
risk of HIV transmission during vaginal
and anal sex. Microbicides can include:
■ Creams, gels, films, and suppositories that
can be used in the vagina or rectum
■ Intra-vaginal rings that release drugs
gradually over time and that may only need
to be replaced monthly
Introduction, continued
■ Most microbicides being tested today
contain antiretroviral (ARV) drugs.
■ These drugs have been shown to protect
HIV-negative people from HIV infection if
they are exposed to the virus.
■ They can prevent the growth of HIV—
therefore, infection.
■ Some ARVs block the action of a protein
that HIV needs to infect the body.
Introduction, continued
Vaccines
Treatment as Prevention
(TasP)
Post-Exposure Prophylaxis
(PEP)
HIV Prevention Toolbox
Microbicides
Pre-Exposure
Prophylaxis (PrEP)
Prevention of Motherto-Child Transmission
(PMTCT)
Medical
Harm Reduction
Education
Clean Syringes
Medical Male
Circumcision
(Needle Exchange Programs)
Condoms and Other
Barrier Methods
Sexually Transmitted
Infections (STIs)
Diagnosis and
Treatment
Behavioral/Physical Barriers
Treatment/
Prevention of Drug/
Alcohol Abuse
Why Are Microbicides Important?
Vaginal
microbicides
Designed to protect women during vaginal
intercourse
Rectal
microbicides
Designed to protect both men and women
during anal sex
Why Are Microbicides Important? continued
“If proven effective…microbicides could
protect against HIV in people who are unable
or reluctant to use condoms. Unlike condoms,
they could provide an alternative way to
reduce risk that is not controlled by one’s
sexual partner and possibly enhance sexual
pleasure, helping to motivate consistent use.”
Why Are Microbicides Important? continued
Microbicides and
women
For women around
the world, some
prevention tools are
not practical. Women
often are not socially
or economically able
to:
Insist that partners use condoms
Have only one sexual partner
Get themselves or their partners treatment for sexually
transmitted infections (STIs)
Vaginal and rectal microbicides do not necessarily require a
partner's cooperation, so women could have the ability to
protect themselves.
Why Are Microbicides Important? continued
Microbicides and
men
Make up 60% of all new HIV infections
In the U.S., men who
have sex with men:
Represent more than 50% of the people currently living
with HIV
Globally, are 19 times more likely to be infected with HIV
than the general population
Consistent condom use is reported as a problem for many
men. Microbicides offer a unique alternative and could be
formulated like a lubricant, which many men already use
for anal sex.
Challenges in Developing Microbicides
■ Dependence on behavioral prevention
tools, such as condoms
■ Cultural and regional preferences
■ Lack of current combination microbicides
that would prevent HIV, other STIs,
and/or provide a form of contraception
■ Unsuccessful early trials of vaginal
microbicides that resulted in changes to
product development and a move toward
emphasis on products containing ARVs
Microbicides Continuing Research
Develop products
that:
• Are/are not ARV based
• Are contraceptive, non-contraceptive, and broad
spectrum against several sexually transmitted diseases
• Designed for both vaginal and/or rectal use
Conduct more
research on:
•
•
•
•
Drug resistance
Alternate dosing
Delivery methods (for example, the vaginal ring)
Impacts on pregnancy and breastfeeding
Understand issues
around:
•
•
•
•
Accessing and availability
Cost
Regular HIV testing requirements
Need for prescriptions for ARV-based microbicides
Microbicides Continuing Research, continued
■ Rectal microbicides research is in the early phase of clinical
development due in part to scientific challenges related to the
biology of the rectum and cultural reluctance to address anal sex.
■ Three Phase I studies evaluating the rectal safety of microbicides
have been completed to date.
■ A number of public and private organizations, in partnership and
individually, are working together to find microbicides can help
prevent HIV.
■ The Microbicide Trials Network (MTN) is
funded by the National Institute of Allergy
and Infectious Diseases, National Institutes
of Health.
Microbicides Summary
Microbicides are
products being
developed and tested for
use in the vagina or
rectum to reduce the risk
of HIV transmission
during vaginal and anal
sex.
Summary
HIV prevention research
is important to find safe
and effective approaches
to prevent the spread of
HIV. These approaches
can include:
■ Promoting awareness,
understanding, and
dialogue
■ Supporting research
■ Developing new
prevention technologies
CONCLUSION
This project was supported through Federal funds from the Division of AIDS (DAIDS), National
Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and
Human Services Grant # UM01 AI068614: “Leadership Group for a Global HIV Vaccine Clinical
Trials (Office of HIV/AIDS Network Coordination) and the NorthEast Two-Spirit Society.”
Conclusion
■ You have now completed the
workshop about HIV (Human
Immunodeficiency Virus) prevention
research tools.
■ These important research tools are
designed to find safe and effective
methods to prevent HIV and AIDS
(Acquired Immunodeficiency
Syndrome).
■ Preventing HIV is our best hope for
stopping the AIDS epidemic.
What Is HIV Prevention and the HIV Combination
Prevention Toolbox?
Different HIV prevention approaches need to be tested to find
out what works best. Identifying and offering more options will
allow people to determine which options fit their lifestyle, their
needs, and the needs of their family and friends. Ongoing HIV
prevention research supports:
■ More HIV prevention options
■ More combination HIV prevention
options
■ More diverse research participants
to enlarge the understanding of
what works
What Are HIV Prevention Tools and How Are They
Used in HIV Prevention Research?
HIV prevention research is important to find
safe and effective approaches to prevent the
spread of HIV. These approaches can include:
■ Promoting awareness, understanding, and
dialogue
■ Supporting research
■ Developing new prevention technologies
What Are HIV Prevention Tools and How Are They
Used in HIV Prevention Research? continued
Three important medical
HIV prevention tools
are:
Microbicides
Preexposure
prophylaxis
(PrEP)
Vaccines
For More Information
For more information on HIV prevention research, visit:
■
■
■
■
■
■
■
AVAC http://www.avac.org/
Be The Generation http://www.bethegeneration.org/
HANC/Legacy https://www.hanc.info
HIV Prevention Trials Network http://www.hptn.org/
HIV Vaccines Trials Network http://www.hvtn.org/
Microbicides Trials Network http://www.mtnstopshiv.org/
NorthEast Two-Spirit Society http://ne2ss.org
Questions?...and
Thank You!