Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy of Lipid-based Nutrient Supplements (LNS) for Pregnant and Lactating Women and Their Infants
Brief Summary: In Ghana, low micronutrient intakes among pregnant women are a major problem. The standard nutritional intervention during pregnancy is iron-folic acid tablets, but adherence is low. The investigators have pioneered the use of multiple micronutrient-fortified semi-solid pastes called Lipid-based Nutrient Supplements (LNS) (made using vegetable oil, groundnut, milk, sugar, and micronutrients), and the investigators' previous studies show that the approach could have great potential for use by pregnant and lactating women.

This study aims to evaluate the effects of LNS-P\&L designed for pregnant and lactating women and LNS-20gM designed for infants. Pregnant women (n=864) randomly selected from ante-natal clinics in Yilo and Manya Krobo districts of Ghana will be randomized to receive daily (a) Group 1: Iron/ Folic Acid tablets during pregnancy, and a tablet containing calcium (Ca) only (akin to a placebo) during lactation (6 mo), (b) Group 2: Multiple Micronutrient tablets during pregnancy and the first six months of lactation, or (c) Group 3: LNS-P\&L during pregnancy and lactation, whilst their infants receive LNS-20gM daily from 6 to 18 months. There are two primary outcomes namely:

1. Maternal primary outcome: Birth length
2. Child primary outcome: Child length-for-age z-score at 18 mo.

The investigators hypothesize that a) mean birth length and length-for-age at 18 mo will be greater in children whose mothers are in Group 2 than those whose mothers are in Group 1, and b) children whose mothers are in Group 3 will have greater birth length and length-for-age at 18 mo than the children in either of the other two groups.


Options:
A: Inclusion Criteria:

* HIV infected
* CD4 count \> 200 cells/μL
* ALT \< 2.5 x upper limit of normal (ULN)
* Hemoglobin (Hb) \> 7 g/dL
* Age \> 18 years, or \<18 years and married (considered emancipated minors in Malawi)
* Ability to give informed consent
* Evidence of HIV infection, as documented by 2 positive Enzyme-Linked Immunosorbent Assays (ELISA's); or 1 positive ELISA, and 1 Western blot (WB); or 2 separate concurrent rapid tests. These are the World Health Organization (WHO) acceptable criteria for diagnosing HIV-1 infection in adults.
* Currently pregnant (with a single or multiple fetuses)
* Gestation \< 34 weeks
* No serious current complications of pregnancy
* Intention to breastfeed
* Intention to deliver at the institution in which the study is based
* Other than HIV, no active serious infection, such as tuberculosis or other potentially serious illnesses
* No previous use of antiretrovirals including the HIVNET 012 regimen
B: Inclusion Criteria:

* signed informed consent from at least one guardian
* age 6.00 months to 14.99 months
* weight-for-age \<-2.0 Z scores
* availability during the period of the study.
* permanent resident Lungwena Health Centre catchment area

Exclusion Criteria:

* moderate or severe wasting (WHM\<80% of the reference median)
* history of peanut allergy
* history of any serious allergic reaction to any substance, requiring emergency medical care
* history of anaphylaxis
* severe illness warranting hospital referral
* concurrent participation in another clinical trial with intervention to the child
C: Inclusion Criteria:

Recruitment and primary eligibility criteria:

* Age \> 14 years.
* Ability to give informed assent or consent.
* Evidence of HIV infection, as documented by 2 positive ELISA antibody tests; or 1 positive ELISA, and 1 Western Blot; or 2 separate concurrent rapid tests.
* Currently pregnant (with a single or multiple fetuses).
* Gestation \< 30 weeks at referral from 'Call to Action' Program
* No serious current complications of pregnancy.
* Intention to breastfeed.
* Intention to deliver at the institution at which the study is based.
* Not previously enrolled in this study for an earlier pregnancy.
* Other than HIV, no active serious infection, such as tuberculosis or other potentially serious illnesses.
* No previous use of antiretrovirals including the HIVNET 012 regimen.
* Mother's CD4 count \> 250 cells/uL determined in the antenatal clinic.
* Mother's ALT \< 2.5 x ULN (upper limit of normal) determined in the antenatal clinic

Secondary eligibility criteria and treatment assignment:

* Mother who delivers outside of the institution at which the study is based must present with her infant to the study site within 36 hours of delivery.
* Mother accepts nevirapine and zidovudine+lamivudine 7-day regimen for herself and her infant.
* Infant birth weight \> 2000 g.
* No severe congenital malformations or other condition(s) not compatible with life.
* Based on clinical assessment, no maternal condition which would preclude the start of the study intervention.
D: Inclusion Criteria:

* At least 18 years of age
* No more than 20 wk of gestation
* Given Ante-natal Cards of the Ghana Health Service
* Completed the initial routine ante-natal examination at the clinics
* HIV negative or status unknown (as from the Ante-natal card)
* Free from chronic disease e.g. malignancy requiring frequent medical attention (as from the Ante-natal card)
* Residing in the Manya Krobo or Yilo Krobo district
* Prepared to sign an informed consent
* Living in the area throughout the duration of the study
* Acceptance of home visitors

Exclusion Criteria:

* Known asthmatic or history of allergy towards peanut or milk products
* Concurrent participation in another clinical trial
* Severe illness warranting hospital referral

Answer: D