Zambia Exclusive Breastfeeding Study
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional

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.
    

Intervention name(s): abrupt weaning at 4 months; Continued exclusive breastfeeding
Intervention type(s): Other; Other
Intervention description(s): abrupt weaning at 4 months; Continued exclusive breastfeeding
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Mother to Child Transmission of HIV; Postnatal HIV transmission; HIV; Breastfeeding; Perinatal HIV Transmission; HIV Seronegativity