PROMISE EBF: Safety and Efficacy of Exclusive Breastfeeding Promotion in the Era of HIV in Sub-Saharan Africa
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|ClinicalTrials.gov Identifier: NCT00397150|
Recruitment Status : Completed
First Posted : November 8, 2006
Results First Posted : February 24, 2015
Last Update Posted : February 24, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Diarrhea||Behavioral: Peer-support for exclusive breastfeeding||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2579 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||PROMISE EBF: Promoting Infant Health and Nutrition in Sub-Saharan Africa: Safety and Efficacy of Exclusive Breastfeeding Promotion in the Era of HIV|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||April 2011|
Peer-support for exclusive breastfeeding
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
No Intervention: No intervention
- Exclusive Breastfeeding Rates in Burkina Faso [ Time Frame: at 3 months of age ]The EBF prevalences (24-h recall) at 12 weeks in the intervention and control clusters.
- Infant Morbidity, 2 Week Diarrhoea Prevalence [ Time Frame: at 3 months of age ]
- Exclusive Breastfeeding Rates in Uganda [ Time Frame: at 3 months of age ]The EBF prevalences (24-h recall) at 12 weeks in the intervention and control clusters.
- Exclusive Breastfeeding Rates in South Africa [ Time Frame: at 3 months of age ]The EBF prevalences based on 24-h recall at 12 weeks in the intervention and control clusters.
- Growth [ Time Frame: (up to 6 months of age) ]
- Per Protocol Analysis of EBF Rates [ Time Frame: at 3 months of age ]
- Per Protocol Analysis of Infant Morbidity [ Time Frame: at 3 months of age ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00397150
|Bobo-Dioulasso, Burkina Faso|
|School of Public Health, University of the Western Cape (UWC)|
|Cape Town, South Africa|
|Dept of Paediatrics and Child Health, Makerere University|
|Dept of Paediatrics and Child Health, University of Zambia, School of Medicine (UNZA/SOM)|
|Principal Investigator:||Thorkild Tylleskar, MD, PHD||Centre For International Health|