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

NCT06842732 | Recruiting DMC

• 2 other identifiers: STUDY000214024R33HD110150-03
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

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.

Conditions

Malnutrition in Children; Children Exposed to HIV

Keywords

maternally administered malnutrition monitoring system (MAMMS); infant and young child feeding practices; wasting; two-way SMS system

Outcome Measures

Primary Outcomes (1)

• Children randomized to MAMMS-IYCF will have a lower incidence of wasting, and shorter duration of wasting treatment due to early initiation of treatment.

  Assessed by measuring the incidence of healthcare worker confirmed wasting (weight-for-height z-score \<-2, nutritional edema, or MUAC \<12.5 cm for children ≥6-months of age)

  From enrollment to the end of follow-up at 180 days

Secondary Outcomes (6)

• The MAMMS-IYCF arm will have fewer hospitalizations compared to the SOC arm

  From enrollment to the end of follow up at 180 days

• The MAMMS-IYCF arm will have fewer deaths compared to the SOC arm

  From enrollment to the end of follow up at 180 days

• The MAMMS-IYCF arm will have fewer cases of severe wasting compared to the SOC arm

  From enrollment to the end of follow up at 180 days

• MAMMS-IYCF will be lower cost and more cost-effective from both provider and societal perspectives

  From enrollment to the end of follow up at 180 days

• Number of caregivers reporting their child received age appropriate feeding as defined by WHO at each study visit will be higher in the MAMMS IYCF arm compared to the SOC arm

  From enrollment to the end of follow up at 180 days

Study Arms (2)

MAMMS IYCF intervention arm

EXPERIMENTAL

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.

Behavioral: Maternal Administered Malnutrition Monitoring System - Infant and Young Child Feeding (MAMMS IYCF) intervention

Standard of care (control) arm

ACTIVE COMPARATOR

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.

Behavioral: Standard of Care (SOC)

Interventions

Standard of Care (SOC) BEHAVIORAL

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.

Standard of care (control) arm

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

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.

MAMMS IYCF intervention arm

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• \- Healthcare workers working in Homa Bay and Migori County Referral Hospitals, who have contact with pediatric inpatients

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.

Sponsors & Collaborators

• University of Washington: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Homa Bay County Referral Hospital

Homa Bay, Kenya

RECRUITING

Migori County Referral Hospital

Migori, Kenya

RECRUITING

MeSH Terms

Conditions

Child Nutrition Disorders; Cachexia

Interventions

Methods; Standard of Care

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Intervention Hierarchy (Ancestors)

Investigative Techniques; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Arianna R Means, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Kirkby Tickell, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Benson Singa, PhD

  Kenya Medical Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arianna R Means, PhD

CONTACT

206-370-0225; aerubin@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor: School of Medicine, Global Health

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 24, 2025
• Study Start: June 5, 2025
• Primary Completion (Estimated): May 5, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

KE (2)