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Zambia Exclusive Breastfeeding Study

This study is ongoing, but not recruiting participants.
Study NCT00310726.   Last updated on November 25, 2008.   Information provided by Boston Medical Center

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Descriptive Information Fields
Brief Title  Zambia Exclusive Breastfeeding Study
Official Title  Short Duration Exclusive Breastfeeding With Abrupt Weaning to Reduce the Risk of Mother-to-Child HIV Transmission
Brief Summary

The study is designed as a randomized, controlled trial with specific observational objectives. All HIV-seropositive pregnant subjects electing to breastfeed their child will be counselled to exclusively breastfeed through 4 months of age. All live-born children will be randomized (1:1) at birth to one of two counseling programs: A) to encourage abrupt weaning at 4 months of age, or B) to encourage exclusive breastfeeding through 6 months of age with the introduction of typical weaning foods ad lib.

Detailed Description

It is well established that infants breast fed by their HIV-infected mothers are at risk of acquiring HIV infection through breast milk. However, in low resource settings, where the HIV epidemic now predominates, breast feeding cannot simply be replaced by breast milk substitutes since alternatives to breast milk are unavailable, unaffordable and unsafe. With this application we aim to test the safety and efficacy of short duration exclusive breast feeding to minimize risks of HIV transmission without increasing risks of non-HIV infant mortality. We propose a 5-year study of HIV-positive mothers and their children to be conducted in two urban primary health care clinics in Lusaka, Zambia. All HIV-positive women and their infants will be offered the two-dose nevirapine intervention and will be counseled about the risks and benefits of infant feeding options. Women who indicate their decision to breast feed will be eligible for enrollment into the study. A culturally appropriate, affordable and sustainable breast feeding education and support program to encourage exclusive breast feeding will be developed, and all women who elect to breast feed will be encouraged to exclusively breast feed to 4 months. Half of the women will be randomized to a counseling program which will encourage abrupt weaning to full replacement feeding at 4 months, and half will be randomized to a program to encourage continued breast feeding after 4 months with the usual introduction of weaning foods. Children will be followed for two years with regular medical histories, physical exams and clinical sampling. The primary objective of the study, based on the random assignment, is to compare HIV transmission rates and under-2 year mortality rates in children who abruptly wean at four months of age versus children who are weaned according to local practice. The second primary objective, based on observational comparisons, is to compare HIV transmission among infants whose mothers adhere to recommendations to exclusively breast feed with those who do not. Secondary objectives are to describe acute and chronic effects of abrupt weaning on child morbidity. The study proposes to test an inexpensive and potentially sustainable public health intervention to reduce HIV transmission through breast feeding while preserving benefits of breast feeding for other aspects of child health in a very low resource setting.

Study Phase
Study Type  Interventional
Study Design  Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  HIV infection detected by 4 months among children with no evidence of HIV infection at birth.
Survival to 2 years of age without HIV-infection.
Magnitude of the reduction in mother-to-child HIV transmission and the magnitude of the increase in non-HIV-related under-2-year mortality, attributable to cessation of breastfeeding at 4 months.
HIV infections detected by 2 years among children with no evidence of HIV infection at 4 months
Mortality in children aged 4-24 months among uninfected children
Secondary Outcome Measure 
Condition  HIV Infection
Intervention  Behavioral: Abrupt weaning at 4 months of age
MEDLINE PMIDs 16340483,   16267740,   16184038,   15905728,   15802979,   12791866,   12097549,   15296810
Links Related Info This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  1200
Start Date  May 2001
Completion Date March 2007
Eligibility Criteria 

Inclusion Criteria:

  • HIV-positive pregnant women identified through VCT
  • After counseling about the risks and benefits of feeding alternatives report that it is their intended decision to breastfeed
  • Live within the catchment area of George or Chawama clinic
  • Are between 30 - 34 wks gestation. (To insure that opportunity exists to receive a minimum of 2 lactation counseling sessions prior to delivery)
  • Do not have any significant presenting illness that requires hospitalization
  • Agree to adhere to the requirements of study participation (including exclusive breastfeeding and randomization into one of two infant feeding groups at four months).
  • Willing to inform a household member (preferably husband/father) of HIV-status.

Exclusion Criteria:

  • Lives outside of catchment area;
  • Have known major illnesses likely to influence pregnancy outcome including diabetes, severe renal or heart disease, or active tuberculosis, prior to randomization;
  • Does not intend to breastfeed;
  • Prior enrollment in this study or concurrent enrollment in another study
Gender Female
Ages 18 Years to 40 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  Zambia
Administrative Information Fields
NCT ID  NCT00310726
Organization ID R01-HD39611
Secondary IDs †† HD39611
Study Sponsor  Boston Medical Center
Collaborators †† US Agency for International Development
National Institutes of Health (NIH)
Investigators 
Principal Investigator:     Louise Kuhn, PhD     Gertrude H. Sergievsky Center, and Department of Epidemiology, Mailman School of Public Health, Columbia University    
Principal Investigator:     Donald M Thea, MD, MSc     Department of International Health, Boston University School of Public Health    
Information Provided By Boston Medical Center
Verification Date March 2006
First Received Date  April 3, 2006
Last Updated Date November 25, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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