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.
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
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.
Parallel
Maternal Administered Malnutrition Monitoring System - Infant and Young Child Feeding (MAMMS IYCF) intervention
BehavioralAll 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.
Standard of Care (SOC)
BehavioralTo 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.
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) and the mean duration of treatment defined as the number of days between enrollment in malnutrition treatment to the last treatment visit
The MAMMS-IYCF arm will have fewer hospitalizations compared to the SOC arm
Assessed by calculating the number of hospitalizations reported in both arms throughout the data collection period and compared
The MAMMS-IYCF arm will have fewer deaths compared to the SOC arm
Assessed by recording and comparing the number of deaths reported in each arm throughout the duration of data collection
The MAMMS-IYCF arm will have fewer cases of severe wasting compared to the SOC arm
Assessed by comparing the number of cases of wasting (calculated by a MUAC measurement less than or equal to 12.5cm or weight-for-length Z-score less than or equal to 2) reported in both arms.
MAMMS-IYCF will be lower cost and more cost-effective from both provider and societal perspectives
The incremental costs of implementing MAMMS-IYCF above the SOC will be calculated using activity-based micro- costing to assess both economic and financial costs from the payer (health system) perspective.
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University of Washington
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator