A Trial Testing a Two-way SMS Platform to Recognize and Prevent Wasting Among HIV-infected and HI… (NCT06842732) | Clinical Trial Compass
RecruitingNot Applicable
A Trial Testing a Two-way SMS Platform to Recognize and Prevent Wasting Among HIV-infected and HIV-exposed Uninfected Children in Kenya
Kenya776 participantsStarted 2025-06-05
Plain-language 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 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.
Who can participate
Age range
6 Months – 24 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses two-way SMS messaging to monitor my child's nutrition — how practical is that for our situation, and do we need a reliable phone and data connection to participate?
2The trial is focused on HIV-exposed but uninfected children as well as HIV-infected children — can you help me understand which category my child falls into, and how that affects whether this study might be relevant for us?
3Since this is a Phase NA or non-drug trial testing a text message-based platform rather than a medication, what does that mean for my child's safety, and are there any risks I should still be aware of before considering enrollment?
4The trial is measuring whether the SMS platform can catch wasting earlier and shorten treatment time — if my child is already showing signs of malnutrition, would standard nutritional care right now be a better first step than waiting to potentially join this study?
5Since this trial is based in Kenya and is currently recruiting, can you tell me whether our family's location and circumstances realistically allow us to meet whatever follow-up or monitoring visits might be required?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.
Timeframe: From enrollment to the end of follow-up at 180 days