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Rapid HIV-1 Antibody Testing during Labor and Delivery for Women of Unknown HIV Status: A Practical Guide and Model Protocol
Appendix
B
Providing Information to Women in Labor with Unknown HIV Status
Regarding Routine, Rapid HIV-1 Antibody Testing (Using an OPT-OUT Approach) and Sample Consent for Rapid HIV-1 Antibody Testing in Labor and Delivery
Settings for Women with Unknown HIV Status
(Using an OPT-IN Approach)
Providing
Information to Women in Labor with Unknown HIV Status Regarding
Routine, Rapid HIV-1 Antibody Testing
(Using an OPT-OUT Approach)
ELIGIBILITY
Pregnant women in labor and delivery settings who have no documentation
of HIV testing on prenatal record or no history of prenatal care.
How to Use This Script:
The script is meant to be a guide to help
you inform women in labor.
Background information/instructions are in regular type, suggested
wording you can use is indented.
It is important to show empathy while you are talking with the
laboring woman. You can do this through your body language and/or
by holding or touching her hand.
Ask the woman to signal you when a contraction is happening, so
you can pause until it is over.
Pause to verify understanding. Adjust your terminology as needed.
Tell
the woman that the discussion about HIV testing will be kept
confidential. Explain “confidentiality” to
her if necessary.
Before discussing HIV testing, ensure that the woman is between
contractions, that she is fairly comfortable, and that she is alone
(no family member or significant other is present in the room,
or within hearing range). Tell her that you are going to talk to
her about HIV testing, and ask if she wants her partner or family
member to be present.
INTRODUCTION
You can begin the discussion in the following way:
We
recommend HIV testing to all women in labor for whom we don’t
have records of an HIV test result during pregnancy. We do this
because so much can be done to protect the babies of women living
with HIV, and to help women live a healthier, longer life. We
have no record that you had an HIV test during this pregnancy.
There are three things I want to talk to you about:
A special HIV/AIDS test
Why this test is important for you and your
baby, AND
What happens when the test result comes back
A special HIV/AIDS test
It
is important for you and your baby that you have a “rapid” HIV
test. HIV is the virus that causes AIDS.
This test can give us results quickly.
It is a blood test that we do for all women
in labor without results from a prenatal
HIV test unless they
decline to have the
test.
Why the test is important
Human Immunodeficiency Virus (HIV) is the
virus that causes AIDS.
HIV
is a serious illness that can
affect a woman’s health
and her baby’s
health.
One of the ways
HIV is spread
is by unprotected
sex. Therefore,
all pregnant
women may be at risk
for HIV
infection.
HIV can
be
passed from a mother
to
her baby during
pregnancy,
at
delivery,
and
through breastfeeding.
If
you have HIV infection,
rapid testing
will allow
you to
get medication
during labor
and delivery
to reduce
the risk
of passing
HIV to
your baby.
Your baby
will receive
the same
medication after
birth.
Without
treatment,
the chance
the baby
will be
infected is
about 25%,
or 1 in
4 babies.
We know if women
are given
medication during
labor and
delivery and
their babies
get the
medication right
after birth,
we can
reduce the
risk of
HIV transmission
to about
10%, or
about 1 in
10 babies.
What happens when the rapid test result comes back?
You will receive a preliminary result about
an hour after your blood is drawn.
If the rapid HIV test is negative, no further
testing is needed at this time. It is most likely that you do
not have
HIV. However,
the test may not show very recent infection.
If the rapid test is negative it is OK to
breast feed your baby.
If the rapid HIV test is positive
You likely have HIV infection and your baby
may have been exposed to HIV.
The test is a screening test that provides
a preliminary result and a false-positive result can happen.
Because
of this, we always
do a second test to confirm rapid tests that
are positive
To
be safe, it is best to start medicines
to help prevent transmission of HIV
to your baby, while we wait for the confirmatory
test result.
Experts recommend several medicines
to reduce the chance your baby
will get HIV.
One is called AZT and it is given
through your
IV fluids into your vein. The
other is a pill called nevirapine.
Your doctor will decide which
medicines will be best
for you and your baby
and will discuss them with
you before starting them.
After your baby is born,
he/she will start
taking AZT syrup.
These medicines
have been studied
for use in
pregnant women
and newborns, and there
have been no
serious side effects.
Side effects
that
may occur with AZT
are vomiting,
headache,
feeling
tired,
anemia (low red blood
cell
numbers), decreased
number
of white blood cells
(these
are the cells
that
fight infection),
loss
of appetite, heartburn,
trouble
sleeping. Side
effects
of nevirapine
can be
skin reactions
or problems
with
the liver.
You
should wait until we have
the results of
the confirmatory test
before you start
breastfeeding.
If the confirmatory test is negative
You and your baby will immediately be taken
off any medication that was started.
If the test is confirmed as positive
All medication that was started to help
prevent HIV transmission will continue.
If treatment is started, a doctor
or nurse will discuss again
any consequences of taking the medication.
Your baby will need more
testing for HIV infection.
You
will be referred to a physician
for your own medical
care—there
are also medications to help keep you healthy longer. You will
also be referred to a health care provider who will take care of
your baby’s medical needs.
HIV test results
are confidential.
There are
laws to protect
the rights
of people with
HIV and
to prevent
discrimination.
Conduct rapid HIV testing and document the result clearly in the
medical record.
If
the woman declines HIV testing, probe for her reasons and help
her address her concerns. If she still declines
testing, document
her refusal clearly in the medical record and
communicate to her baby’s pediatrician that her HIV status
is unknown.
Sample
Consent for Rapid HIV-1 Antibody Testing in Labor and Delivery
Settings for Women with Unknown HIV Status (Using an OPT-IN Approach)
This is a sample consent form (OPT-IN) from the Francois Xavier Bagnoud Center
for use in New Jersey. Recognizing that a number of jurisdictions may still
require written, signed informed consent for HIV testing (an OPT-IN approach),
this sample informed consent document may be useful during the transition to
a more routine (OPT-OUT) approach to HIV testing in labor and delivery.
INTRODUCTION
New Jersey law mandates that all pregnant women be counseled about
HIV infection and be offered the HIV/AIDS test. In our hospital,
we follow this recommendation because so much can be done to protect
the baby.
I have four things I am going to talk to you about
A special HIV/AIDS test
Why this test is important for you and your baby
How HIV is transmitted
What happens when the test result comes back
A special HIV/AIDS test
It is important
for you and your baby that we offer you what is called a “rapid” HIV
test. Human Immunodeficiency Virus (HIV) is the virus that
causes AIDS.
This test can give us results quickly.
It is a blood test. It is voluntary, and your consent is required
before the test can be done.
Why the test is important
HIV can be passed from a mother to her baby during pregnancy,
at delivery, and through breastfeeding.
If you have HIV infection, rapid testing will allow you to
get medication during labor and delivery to reduce the risk of
passing
HIV to your baby.
Your baby will receive the same medication after birth.
Without
treatment, the chance the baby will be infected is
about 25%, or 1 in 4 babies.
We know if women are given medication during labor and delivery
and their babies get the medication right after birth, we can
reduce the risk of HIV transmission to about 10%, or about 1
in 10 babies.
What is HIV and how is it transmitted
HIV is the virus that causes AIDS.
HIV is
a serious illness that can affect a woman’s health
and her baby’s health.
One of the ways HIV is spread is by unprotected sexual intercourse.
Therefore, all pregnant women may be at risk for HIV infection.
HIV can be passed from a mother to her baby during pregnancy,
at delivery, and through breastfeeding.
What happens when the rapid test result comes back
You will receive a preliminary result about an hour after
your blood is drawn.
If the rapid HIV test is negative, no further testing is needed
at this time. It most likely means that you do not have HIV.
However, the test may not show recent infection.
If the rapid test is negative it is OK to breast feed your
baby.
If the rapid HIV test is positive
You likely have HIV infection and your baby may have been exposed to HIV.
The test is a screening test that provides a preliminary result.
A false-positive result can happen.
We always do a second test to confirm rapid tests that are
positive.
But
if your test result is positive, it is be best to start
treatment to help prevent transmission of HIV to your baby, while
we wait for
the confirmatory test result
We will need your permission to start medications if the preliminary
test is positive.
Experts recommend several medicines to reduce the chance your
baby will get HIV. One is called AZT. We give it to you in your
IV fluids
through your vein. The other is a pill called nevirapine.
Your doctor will decide which medicines will be best for you
and your baby.
After your baby is born, he/she will start taking AZT syrup.
These medicines have been studied in pregnant women and newborns
and there have been no serious side effects.
Side effects that may occur with AZT are vomiting, headache,
feeling tired, anemia (low red blood cell numbers), decreased
number of white
blood cells that fight infection, loss of appetite, heartburn,
trouble sleeping. Side effects of nevirapine can be skin reactions
or problems
with the liver.
You should wait until we have the results of the confirmatory
test before you start breastfeeding.
If the confirmatory test is negative
You and your baby will immediately be taken off any medication
that was started.
If the test is confirmed as positive
All medication that was started to help prevent HIV transmission
will continue.
If treatment is started, a doctor or nurse will discuss
with you again any consequences of taking the medication.
Your baby will need more testing for HIV infection.
You
will be referred to a physician for your on-going medical
care.
You will also
be referred to a health care provider who
will take
care of your baby’s medical needs.
HIV test results are confidential. There are laws to protect
the rights of people with HIV and prevent discrimination.
Sample Informed Consent Form
Please sign your name below once you have read (or have had explained
to you) and understand:
Antiretroviral
medication may reduce the risk of HIV transmission to my baby
and this medication will be started if my preliminary
HIV test result is positive.
A positive preliminary test will be confirmed with additional
testing.
Refusing to be tested will not jeopardize my ongoing care or
services.
I have been given written information about everything told to
me.
I consent to be tested for HIV infection using a rapid test
If my preliminary HIV test is positive, I consent to have antiretroviral
medication started during labor and for my baby after birth
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