Please select the eligibility criteria that correspond to the clinical trial below.
Title: PROMISE EBF: Promoting Infant Health and Nutrition in Sub-Saharan Africa: Safety and Efficacy of Exclusive Breastfeeding Promotion in the Era of HIV
Brief 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.


Options:
A: Inclusion Criteria:

* participants consenting for the home-based care model area
* participants who consent for household adequacy survey
* participants who consent from clinic care model area
B: Inclusion Criteria:

* Lives in a selected cluster
* Is \>= 6 months pregnant
* Has no plans to move outside of the cluster within 1 year

Exclusion Criteria:

* Reduced ability to collaborate for psychological/mental reasons
* Severely ill
* Has given birth more than 7 days ago
* Has given birth less than 7 days ago and it was a multiple birth; or the child has a severe malformation; or death of the mother or the baby.
C: Inclusion Criteria:

* \> 34 0/7 weeks gestational age
* Discharged from the newborn nursery or neonatal intensive care unit (NICU) without significant neonatal morbidity
* Singleton infant
* Nursery or NICU stay of 7 days or less
* Primiparous mother
* Maternity stay of 7 days or less
* Pediatric primary care provider from one of 3 University-affiliated pediatric practices or University-affiliated family medicine practices
* Feeding human milk (breast milk) during the maternity/newborn stay with intent to continue to breastfeed after discharge
* English speaking mother.

Exclusion Criteria:

* Newborn nursery, NICU, or maternity stay \> 7 days
* Exclusive formula feeding in the nursery or NICU
* Multiparous mother
* Any metabolic condition that requires feedings at precise intervals
* Gestational age of 33 6/7 weeks or less
* Presence of a congenital anomaly or neonatal condition that significantly affects a newborn's feeding (e.g. cleft lip or cleft palate) or sleeping (hyperexplexia - exaggerated startle reflex)
* Non-singleton newborn
D: Inclusion Criteria:

* Patient in the Maternity Unit at Mount Sinai Hospital
* Infant has a birth weight greater than or equal to 2,500 grams
* Infant has a 5-minute Apgar score greater than or equal to 7
* Self-identifies as Black/African American or Hispanic/Latina; White or minority other than Black/African American or Hispanic/Latina will be referred to a parallel study with the same protocol at Mount Sinai Hospital
* Speaks English or Spanish
* Has a working telephone

Answer: B