PROMISE EBF: Safety and Efficacy of Exclusive Breastfeeding Promotion in the Era of HIV in Sub-Saharan Africa

Summary

The objective of the project is to develop and test an intervention to promote exclusive breastfeeding (EBF), to assess its impact on infant health in African contexts where a high prevalence of HIV is a barrier, and to strengthen the evidence base regarding the optimal duration for EBF.

Promotion of EBF is the most effective child health intervention currently feasible for implementation at the population level in low-income countries. It can lower infant mortality by 13%, and by an additional 2% were it not for the fact that breastfeeding transmits HIV. Only recently proven to be possible in hot and even dry climates, EBF without even offering water is still little appreciated by mothers or supported by health workers. EBF rates are especially low in Africa but the potential for rapid implementation may be high. A few studies elsewhere suggest that peer counselling can often achieve dramatic increases. Thus the investigators will run the first randomised trial to develop and test models for applying this approach in four African countries and to quantify health benefits, cost-effectiveness, and implications for the health care system.

While experts realize that the HIV threat ought not to present much of a biological constraint to promoting EBF, in heavily affected countries it does represent a cultural constraint. Overcoming this will require the development of a safe and effective means of promoting EBF that is HIV-sensitive by taking into account the need to minimise postnatal HIV transmission.

Another scientific constraint to the promotion of exclusive breastfeeding for six months, as recommended by the World Health Organization (WHO), is uncertainty about its impact on the micronutrient status of infants. In a substudy, the investigators will carefully follow markers of infant micronutrient status to see how they vary by feeding pattern, including EBF, for a longer period than has been examined previously.

Conditions

• Diarrhea

Interventions

BEHAVIORAL

Peer-support for exclusive breastfeeding

Counselling to support exclusive breastfeeding up to the age of 6 months of age by the use of peer-counsellors in the local community

Sponsors & Collaborators

• European Union

  collaborator OTHER

• The Norwegian Programme for Development, Research and Higher Education

  collaborator OTHER

• University of Bergen

  collaborator OTHER

• Université Montpellier

  collaborator OTHER

• Uppsala University

  collaborator OTHER

• Centre Muraz

  collaborator OTHER

• Makerere University

  collaborator OTHER

• University of Zambia

  collaborator OTHER

• University of the Western Cape

  collaborator OTHER

• Centre For International Health

  lead OTHER

Principal Investigators

• Thorkild Tylleskar, MD, PHD · Centre For International Health

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2006-11-30

Primary Completion

2008-07-31

Completion

2011-04-30

Countries

• Burkina Faso
• South Africa
• Uganda
• Zambia

Study Locations