Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Control Trial of Complementary Food to Prevent Undernutrition Among At-Risk Infants in Fort San Michel, Haiti
Brief Summary: This randomized, controlled effectiveness study examines Nutributter programming within an integrated package of maternal and child health services offered by Haiti's Ministry of Health (MSPP) to prevent undernutrition among young children in Haiti. The aim of the process evaluation is to better understand the uptake of Nutributter® as a complementary food in the diets of young children and its feasibility and acceptability as part of MSPP's package of services. This project is being carried out at a public hospital in Fort San Michel, an impoverished community outside of Cap Haitien, Haiti.


Options:
A: Inclusion Criteria:

1. Age \> 16 years (if \<18 years old, living independently from parents)
2. Documentation of HIV status must come from two assays. Assays include DNA PCR, HIV RNA, Western blot, or rapid HIV antibody test
3. Confirmed pregnancy by positive serum or urine pregnancy test or ultrasound
4. Estimated gestational age between 12 and 28 weeks (based on first day of last menstrual period with physical exam confirmation and ultrasound confirmation) at time of enrollment
5. Residency within 30 km of the study site
6. Willing to provide informed consent

Exclusion Criteria:

1. Current or prior use of HAART
2. Exposure to single-dose NVP (alone or with zidovudine or zidovudine/lamivudine or other abbreviated monotherapy or dual therapy for PMTCT) less than 24 months prior to enrollment
3. Prior dose-limited toxicity to TS within 14 days of study enrollment
4. Receipt of any contraindicated medications within 14 days of study enrollment (See Appendix III.)
5. Active tuberculosis or other WHO Stage 4 diseases
6. Screening laboratory values:

   1. Hemoglobin: \<7.5 g/dL (Note: Women found to have a hemoglobin \<7.5 at screening may receive iron and folic acid and/or a blood transfusion at the physician's discretion. If a repeat hemoglobin is ≥7.5 g/dL, the woman may be considered for study inclusion.)
   2. Absolute neutrophil count (ANC): \<750/mm3
   3. Platelet count: \<50,000/mm3
   4. ALT: \>225 U/L (\>5.0x ULN)
   5. AST: \>225 U/L (\>5.0x ULN)
   6. Bilirubin (total): \> 2.5x ULN
   7. Creatinine: \> 1.8x ULN
7. Known cardiac conduction abnormalities or structural heart defect

NOTE: A woman will be excluded from study participation during the current pregnancy if she goes into labor, experiences ruptured membranes or develops active tuberculosis or a WHO stage 4 condition following study enrollment but prior to study drug initiation.
B: Inclusion Criteria:

* All the women of child-bearing age (15-44 years) living in the study area (4 100) will be visited monthly to assess early pregnancy and will be invited to participate in the trial.

Exclusion Criteria:

* planning to move outside the district within the 2 years following the start of the trial.
* regularly using a contraceptive method.
* already pregnant at the start of the trial.
C: Inclusion Criteria:

* Signed informed consent from at least one guardian
* Ages 5.50 months to 6.49 months
* Availability during the period of the study
* Permanent resident of the area

Exclusion Criteria:

* WHZ \< -2.0 z-scores or presence of oedema
* History of peanut allergy
* Severe illness warranting hospital referral
* Concurrent participation of the child in another clinical trial with intervention to the child
D: Inclusion Criteria:

* Infants 6 to 12 months old
* Lives in Fort San Michel

Exclusion Criteria:

* Moderately or severely malnourished
* Peanut allergy

Answer: D