Vertical Transmission Study

Summary

Short courses of drugs can be given to HIV-infected pregnant women to reduce the chance of HIV infection being passed to her child either during pregnancy or during the labour process. However, children can also become infected by drinking the mother's breastmilk which contains the HIV virus. In many poor, developing countries in Africa, breastfeeding is the normal way of infant feeding and is vitally important because of the protection it gives to children from other diseases such as diarrhoea and malnutrition. Ideally there would be a way to make breastfeeding safer from HIV transmission without losing its other advantages.

A medical study recently suggested that HIV-infected women who exclusively breastfed their children i.e. gave breastmilk but without any water, tea, formula milk or any solid foods did not pass on the virus to their children to the same degree as women who MBF with these other fluids and foods. It is important to confirm whether this observation is in fact true or not. We hypothesize that exclusive breastfeeding by HIV-infected mothers carries a lower risk of HIV transmission than mixed breastfeeding.

We propose to follow 2,100 HIV-infected pregnant women and also some HIV-uninfected women from the time that they book at the clinic until 24 months of age. HIV-infected women who say they intend to breastfeed and all the HIV-uninfected women will be visited at their homes by breastfeeding counsellors both before and after delivery to support exclusive breastfeeding. HIV-infected women who choose not to breastfeed will be helped by clinic staff to safely replace all breastmilk with some other milk. An independent team will visit all mothers at their homes and collect information about the way they feed their children. Blood samples will be collected from the children at different times by a simple heel prick and the blood stored on a piece of filter paper. By testing these samples and comparing with the type of feeding at that time, we will be able to see when a child becomes infected and whether exclusive breastfeeding gives any protection.

Conditions

• HIV

Interventions

BEHAVIORAL

Infant feeding counselling and support

Counselling of appropriate feeding practices as recommended in WHO/UNICEF/UNAIDS guidelines on HIV and infant feeding. Subsequent intensive, home-based support of exclusive breastfeeding or safe replacement feeding according to mothers' selection of feeding practice. Counselling contacts with mothers varied over time. 1-2 antenatal contacts. After delivery, home visits by infant feeding counsellors 3-4 times in first 2 weeks then every 2 weeks until 6 months. Outcome data collected by separate field based team who were blinded to mothers HIV status and infant feeding practice.

Sponsors & Collaborators

• Wellcome Trust

  collaborator OTHER

• University of KwaZulu

  lead OTHER

Principal Investigators

• Hoosen M Coovadia, MB · University of KwaZulu-Natal, and University of the Witwatersand, South Africa

• Marie Louise Newell, PhD · University of KwaZulu-Natal and Institute for Child Health, University College, London

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

16 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2001-10-31

Primary Completion

2005-09-30

Completion

2006-10-31

Countries

• South Africa

Study Locations