Table 1.
Excerpt from the enhanced standard consent form that provides an overview of the BAN study
| What is the study about? |
| Mothers who have HIV can pass it to their babies. This can happen during pregnancy, around the time of delivery, and after the baby is born through breastfeeding. This study is looking for ways to prevent HIV transmission during breastfeeding. It is also looking for ways to keep HIV-infected mothers and their babies healthy. |
| There are medicines to help prevent HIV transmission from mothers to babies during pregnancy and around the time of delivery. There are also medicines to treat people infected with HIV when they become very sick. These medicines are called anti-retroviral drugs. |
| In this study we will be comparing different anti-retroviral drugs to prevent HIV transmission from mothers to babies during breastfeeding. HIV-infected mothers who are not very sick will be put in one of three groups. Some mothers will take a combination of drugs while they are breastfeeding. Other mothers will be given a drug for their babies to take every day while they are breastfeeding. The third group of mothers will not be given drugs to take while they are breastfeeding. |
| This study will also give half of the mothers a special food supplement. It will be eaten daily while breastfeeding. The purpose of this part of the study is to see if the special food supplement helps to keep mothers who have HIV healthy while they are breastfeeding. |
| Mothers will be asked to stop breastfeeding when their babies are 6 months old in order to prevent HIV transmission. Once mothers stop breastfeeding, they will be given a special weaning food to feed to their infants. The drugs and mother’s special food supplement will be stopped when the baby is weaned at 6 months. |
The findings from this study will answer three questions that will help the Government of Malawi to provide better health care to HIV-infected mothers and their babies:
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