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

• 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.

• You and your baby will immediately be taken off any medication that was started.

• 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)

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.

• 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.

• 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.

• 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:

1. 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.
2. A positive preliminary test will be confirmed with additional testing.
3. Refusing to be tested will not jeopardize my ongoing care or services.
4. I have been given written information about everything told to me.