Actively Recruiting
A Trial Testing a Two-way SMS Platform to Recognize and Prevent Wasting Among HIV-infected and HIV-exposed Uninfected Children in Kenya
Led by University of Washington · Updated on 2026-05-04
600
Participants Needed
2
Research Sites
107 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this study is to test if a two-way text-message (SMS) maternally administered malnutrition monitoring system (MAMMS) that delivers infant and young child feeding (IYCF) education and supports caregivers in monitoring their child's nutritional status at home can improve nutritional outcomes for HIV-exposed children. The aims include 1) to determine whether the MAMMS IYCF intervention lowers the incidence of malnutrition, leads to a shorter time to recover for those that become malnourished and results in a lower incidence of hospitalizations, severe malnutrition and death, 2) to determine the cost and cost-effectiveness of the MAMMS IYCF intervention, and 3) to determine the effect of the MAMMS IYCF intervention on the behavior and attitudes of participants through change in age-appropriate feeding, IYCF knowledge, trust in the healthcare system, and intention to seek care if the child becomes wasted. The study team will enroll 600 caregiver-child pairs aged between 6 and 24 months in Migori and Homa Bay County, Kenya. Each caregiver-child pair will be randomly assigned to either the MAMMS IYCF intervention or standard of care (SOC) and followed for 180 days (about 6 months). Caregivers assigned to the intervention arm will be asked to respond to weekly messages with the color of the MUAC tape after measuring their child's arm after being trained on how to use the MUAC measuring tape. Weekly messages will include IYCF education and other age-appropriate child health related information. Caregivers in the SOC arm will receive clinic appointment and study visit reminders only. Caregivers in the intervention arm and the SOC arm will be asked to attend the study clinic for follow-up visits at Day 90 and Day 180. At enrollment and follow-up visits, the study team will administer a survey including a child's medical history, a standardized child clinical examination, and anthropometry.
CONDITIONS
Official Title
A Trial Testing a Two-way SMS Platform to Recognize and Prevent Wasting Among HIV-infected and HIV-exposed Uninfected Children in Kenya
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 to 24 months with a MUAC of at least 12.5 cm at recruitment
- Children living with HIV or HIV-exposed uninfected seen as outpatients at participating clinics
- Child's caregiver willing and able to provide informed consent
- Child's caregiver can read or write or has assistance to do so
- Child's caregiver plans to stay in the area and return for 6-month follow-up visits
- Child's caregiver has access to a Safaricom phone and provides a mobile phone number
- Healthcare workers in Homa Bay and Migori County Referral Hospitals who have contact with pediatric inpatients
You will not qualify if you...
- Children with moderate or severe wasting (MUAC less than 12.5 cm, weight-for-height z-score below -2, or nutritional edema) at screening
- Children with congenital conditions or syndromes that limit or prevent age-appropriate feeding
- Children enrolled in another study that may interfere with this study's aims
- Child's caregiver fails the second MUAC training after not completing the first satisfactorily
- Child's caregiver is younger than 18 years old
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Homa Bay County Referral Hospital
Homa Bay, Kenya
Actively Recruiting
2
Migori County Referral Hospital
Migori, Kenya
Actively Recruiting
Research Team
A
Arianna R Means, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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