Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT02421302
Eligibility Criteria:
Inclusion Criteria:
* HIV-infected children aged 6 months to 12 years, including Well Nourished (WN), Moderately Acute Malnutrition (MAM) and Severe Acute Malnutrition (SAM) patients initiating on ART within 2 weeks, whose carer is aged ≥18 years and has provided informed consent.
* Malnourished HIV-infected children aged 6 months to 12 years stabilized on ART for at least 6 months and initiating on RUTF, whose carer is aged ≥18 years and has provided informed consent.
Exclusion Criteria:
1. Previous enrollment in a nutritional therapeutic program in the last 3 months
2. Children involved in an on-going nutrition study
3. Children who have previously received the tuberculin skin test (TST) or mantoux or purified protein derivative (PPD) in the last 3 months.
4. Children with clinically suspected or confirmed malignancy
5. Children exhibiting any specific food intolerance
6. Children who are vomiting profusely (over 3 times daily)
7. Children living outside 50 km radius from Infectious Diseases Institute at Mulago, Kampala
8. Children whose carers do not want to disclose their home address.
9. Children whose cause of malnutrition is compounded by congenital malformations, chromosomal disorders, metabolic disorders, congenital immune disorders, cerebral palsy
10. Children with a severe disability limiting the possibility of investigations
11. Children who plan to leave the catchment area in the next 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
12 Years
Study:
NCT02421302
Study Brief:
Protocol Section:
NCT02421302