NCT06842732 A Trial Testing a Two-way SMS Platform to Recognize and Prevent Wasting Among HIV-infected and HIV-exposed Uninfected Children in Kenya

Eligibility & Interventions

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This trial targets 600 participants in total. It began in 2025-06-05 with a primary completion date of 2027-05-05.

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria (HIV-exposed caregiver-child pairs): * Children aged 6 to 24 months all-inclusive with a MUAC ≥ 12.5cm at the date of recruitment * Children living with HIV or HIV-exposed uninfected children seen as outpatients in early infant detection (EID) or HIV-care clinics at the participating hospitals * The child's caregiver is willing and able to provide informed consent * The child's caregiver can read or write or has someone to help them read or write * The child's caregiver is planning to remain in the catchment area with their child for \> 6 months and willing to return to the health facility for 6-month follow up visits * The child's caregiver has access to a Safaricom phone line and provides a mobile phone number Inclusion Criteria (healthcare workers): \- Healthcare workers working in Homa Bay and Migori County Referral Hospitals, who have contact with pediatric inpatients Exclusion Criteria: * 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.

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