Please select the eligibility criteria that correspond to the clinical trial below.
Title: To Evaluate the Impact of Three Feeding Regimens on the Recovery of Children From Uncomplicated Severe Acute Malnutrition (SAM) in India and to Use the Evidence to Inform National Policy
Brief Summary: This project aims to assess the efficacy of three options under consideration in India for home management of Severe Acute Malnutrition (SAM). The investigators propose to conduct a multi-center randomized controlled trial to determine the efficacy of two community-supported home-based regimes using centrally or locally produced Ready to Use Therapeutic Foods (RUTF) for recovery from uncomplicated SAM after 16 weeks of management, compared with an augmented home-prepared foods regimen. The trial will enroll 911 children with uncomplicated SAM and will have enough statistical power to detect a 15% or greater difference in recovery rates between either one of the intervention groups compared with comparison group.


Options:
A: Inclusion Criteria:

* Aged 5 years or older
* Documented HIV infection by HIV ELISA or HIV rapid test
* Naive to ART
* CD4 T-cell count \<100 cells/mm3 on blood test taken at screening for REALITY
* Results of screening haematology and biochemistry tests available and no contraindications to planned ART according to national guidelines
* Patient/carer provide informed consent (and children \<18 years assent, as appropriate according to their age and knowledge of HIV status)

The lower age limit is because CD4 counts are less reliable predictors of immunodeficiency under 5 years: CD4 counts are recommended by guidelines in older children.

No patient with a CD4 count above 100 cells/mm3 should have ART delayed in order to subsequently meet eligibility criteria. Rather, patients eligible for REALITY will be those testing HIV positive for the first time with a low CD4 count (i.e. those delaying presentation to care), or those who have defaulted before initiating ART and only return to care at an advanced stage of immuno-deficiency.

Exclusion Criteria:

* Contraindications to any proposed antiretroviral drugs (including integrase inhibitors), isoniazid, fluconazole, albendazole or azithromycin
* Pregnant or breastfeeding or intending to become pregnant during the first 12 weeks of the study
* Ever known to have previously received single-dose nevirapine for prevention of mother-to-child transmission (mother or child).
B: Inclusion Criteria:

* Age 6 to 59 months
* SAM, defined as Weight for height less than -3 SD of WHO standard or oedema of both feet or both.

Exclusion Criteria:

* Complicated SAM defined as child with SAM having signs of severe illness requiring hospitalization
* Known allergy to animal milk or peanuts
* Likely to leave the study area permanently in the next 16 weeks
C: Inclusion Criteria:

* All children resident in randomized villages 6-59 months

Exclusion Criteria:

* N/A
D: 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

Answer: B