Zambia Exclusive Breastfeeding Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Short Duration Exclusive Breastfeeding With Abrupt Weaning to Reduce the Risk of Mother-to-Child HIV Transmission

Conditions
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HIV Infection

Intervention / Treatment
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* Other: abrupt weaning at 4 months
* Other: Continued exclusive breastfeeding


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abrupt Weaning<br>Women were counseled to abruptly wean their child at 4 months of age. | Other: abrupt weaning at 4 months<br>* abrupt weaning at 4 months<br>|
| Active Comparator: Exclusive breastfeeding per WHO guidelines<br>Women were counseled to adhere to the WHO recommendations for duration of exclusive breastfeeding. | Other: Continued exclusive breastfeeding<br>* Continued exclusive breastfeeding<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV infection detected by 4 months among children with no evidence of HIV infection at birth. |  | 24 months of age | 
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mother to Child Transmission of HIV, Postnatal HIV transmission, HIV, Breastfeeding, Perinatal HIV Transmission, HIV Seronegativity