A Trial Testing a Two-way SMS Platform to Recognize and Prevent Wasting Among HIV-infected and HIV-exposed Uninfected Children in Kenya

Recruiting now · Not applicable

Conditions studied: Malnutrition in Children, Children Exposed to HIV

In brief

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 776 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.

Key facts

Study ID

NCT06842732

Run by

University of Washington

People needed

776

Starts

2025-06-05

Expected to finish

2027-07-15

Last updated by the study team

2026-06-18

Who can join

Age: 1 and older, up to 2. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Children with moderate or severe wasting (MUAC <12.5cm, weight-for-height z-score <-2, or nutritional edema) at the time of eligibility screening
• Children with a congenital condition that limit feeding or syndromes that prevents age-appropriate feeding
• Child is enrolled in another study that the PI judges to compromise the aims of this study
• Child's caregiver does not pass the second training after being unable to satisfactorily complete the first MUAC training.
• Child's caregiver is under the age of 18 years.

Where it is running

• Homa Bay County Referral Hospital — Homa Bay, Kenya (enrolling)
• Migori County Referral Hospital — Migori, Kenya (enrolling)

Full record on ClinicalTrials.gov

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