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:

1. Children aged 57-88 months at the time of initiation of the study
2. Children living in the locality defined by the study and not enrolled in school.
3. Consent from parent/guardian.

Exclusion Criteria:

1. Severely malnourished children (weight for age or height z-scores \<-3 standard deviations below the WHO growth reference standards)
2. Children found to be below 57 months and still holding an under five card or above 88 months at the time of initiation of the study or enrolled in school, based on verification of birth dates at screening
3. Children whose families plan to leave the study area before completion of the study
4. Consent not obtained from parent/guardian
5. Children suffering from diarrhea at the time of initiation of the study or with high fever, based on the report of symptoms by the parent/guardian
6. Children with severe anemia (Hb \<7.0 g/dL) as determined at the baseline blood draw.
B: Inclusion Criteria:

* Age 7-12 years (according to birth date in birth certificate).
* No evidence of concomitant severe and/or chronic illness such as acute respiratory tract infections, mental retardation and neurological deficits.
* Consent of parent to participate in the study.

Exclusion Criteria:

* history or evidence of underlying haematological-related diseases such as thalassaemia and ovalocytosis.
* menstruating females (age \>13)
C: InclusionCriteria:

* Area of residence

Exclusion Criteria:

* NONE
D: 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.

Answer: D