RecruitingNot ApplicableNCT06842732

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

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

Sponsor

University of Washington

Enrollment

600 participants

Start Date

Jun 5, 2025

Study Type

INTERVENTIONAL

Conditions

Malnutrition in Children Children Exposed to HIV

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

Min Age: 6 MonthsMax Age: 24 Months

Plain Language Summary

Simplified for easier understanding

This study is testing whether a two-way text messaging (SMS) platform can help caregivers in Kenya recognize early signs of malnutrition and prevent dangerous weight loss in young children who are living with HIV or were exposed to HIV at birth. **You may be eligible if...** - Your child is between 6 and 24 months old and attends an HIV clinic - Your child is either HIV-positive or was exposed to HIV but is not infected - Your child's mid-upper arm measurement is at least 12.5 cm (a sign of adequate nutrition) - You are willing and able to give consent - You can read or write, or have someone to help you - You own or have access to a mobile phone that can receive and send text messages **You may NOT be eligible if...** - Your child does not attend an HIV-related outpatient clinic - You are unable to use a mobile phone or participate in SMS communication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMaternal Administered Malnutrition Monitoring System - Infant and Young Child Feeding (MAMMS IYCF) intervention

All caregivers randomized to the MAMMS-IYCF arm will be given two MUAC tapes after being trained by skilled study staff and their contact information will be entered into the online MAMMS-IYCF platform. The frequency of messages will be weekly. This will be a two-way SMS system, including health messages on age appropriate IYCF. These messages will also prompt caregivers to measure their child's MUAC, return the color outcome of the measurement to the clinic via the SMS system, and they will also be able to ask any health questions that they may have through the SMS. During follow-up, any caregiver who returns a MUAC measurement via SMS that suggests their child is wasted, will receive an SMS response asking them to come to the clinic with their child as soon as possible. At this visit, the wasting status of the child will be confirmed by a study staff, and if treatment is indicated they will be enrolled into nutritional care provided by MOH nutritionists.

BEHAVIORALStandard of Care (SOC)

To promote high fidelity to current guidelines, all families randomized to the SOC arm will be enrolled into a one-way SMS service that will send them automated reminders before necessary routine EID or HIV care visits and research clinic appointments on day 90 and 180. During these routine clinic visits, study staff will ensure that the MUAC of SOC children are measured, and that treating clinicians (MOH nutritionists) are made aware if wasting is identified. Staff will ensure that SOC children are enrolled into nutritional care if they are wasted. This additional support means it is likely that SOC children in this study will receive care that is more adherent to current recommendations than is typical for many children. This enhanced SOC is necessary to ensure we are comparing the MAMMS-IYCF to current guidelines. The SMS messaging service will be free of cost to the caregivers as they will not incur any charges to send or receive messages while enrolled in the trial.