Clinical trial NCT04995874: Supplementation Trial of KOKO Plus Among HIV Exposed Children in Accra
Official title: Supplementation Trial of KOKO Plus Among HIV Exposed Children in Accra
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Infections
Nutrition Poor
Child Development
Keywords: HIV-Exposed
Nutrient Status
KOKOPlus
Lead sponsor: Noguchi Memorial Institute for Medical Research
Sponsor class: OTHER
Collaborators: name: International Food Policy Research Institute
First posted: 2021-08-09
Enrollment: 649
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall aim of the research is to conduct a randomised controlled trial of KOKOPlus in young HIV exposed children attending HIV clinics in Accra, Ghana to test the effectiveness of KOKOPlus over a period of 6 months to improve nutritional status and child development in HIV exposed children 6-18 months of age in Accra

Detailed description: The specific objectives are to accomplish the following

1. To test the effectiveness of KOKOPlus to improve the nutritional status of HIV exposed infants aged 6-18 months.
2. To measure and compare nutritional status in intervention and control arms by monitoring growth in terms of height and weight over the period of 6 months
3. To measure and compare micronutrient status of intervention and control arms by comparing baseline midline and endline measurements of hemoglobin levels.
4. To measure and compare morbidity rates of intervention and control arms.
5. To measure and compare rates of achievement of child development goals between intervention and control arms using a standardized tool, the Caregiver Reported Early Development Instrument (CREDI).
6. To understand and record experiences relating to the use of KOKOPlus of mothers/caregivers in the intervention arm through focus group discussion

Eligibility criteria: Inclusion Criteria:

* Mother-infant dyads; HIV positive mothers and children between 6 and 12 months of age attending antiretroviral (ART) Clinics and child HIV Clinics.

Exclusion Criteria:

* Mothers who decline to participate in the study

Children with severe acute malnutrition (mid-upper arm circumference \<115 mm or a weight-for-height/length \<-3 Z-scores of the WHO growth standards).

Children on hospital admission

Children with diagnosed or apparent congenital conditions such as encephalitis, cleft palate, hole in heart, which negatively affect the child's ability to eat and/or growth.

Primary outcomes:
measure: Anthropometry
timeFrame: 6 months
measure: Haemoglobin
timeFrame: 6 months
measure: Child developmental Milestones achieved
timeFrame: 6 months
Secondary outcomes:
measure: Morbidity
timeFrame: 6 months
Other outcomes:
Locations:
city: Accra
country: Ghana
facility: 37 Military Hospital
state: Greater Accra
city: Accra
country: Ghana
facility: Greater Accra Regional Hospital
state: Greater Accra
city: Accra
country: Ghana
facility: Korle-bu Teaching Hospital
state: Greater Accra
city: Accra
country: Ghana
facility: Princess Marie Louise Children's Hospital
state: Greater Accra
city: Ashaiman
country: Ghana
facility: Ashaiman Polyclinic
state: Greater Accra
city: Tema
country: Ghana
facility: Tema General Hospital
state: Greater Accra
Study officials:
affiliation: Noguchi Memorial Institute for Medical Research
name: Gloria K Folson
role: PRINCIPAL_INVESTIGATOR
References: