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New treatment option for Malnutrition in Children
Official title A Trial Testing a Two-way SMS Platform to Recognize and Prevent Wasting Among HIV-infected and HIV-exposed Uninfected Children in Kenya
ClinicalTrials.gov ID: NCT06842732
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 24. Healthy volunteers may be eligible.
You may be able to join if
- (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...
- 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
You likely can't join 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.
See the full eligibility 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 (healthcare workers): \- Healthcare workers working in Homa Bay and Migori County Referral Hospitals, who have contact with...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Homa Bay, Kenya
- Migori, Kenya
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 24 months. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Homa Bay, Kenya; Migori, Kenya. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.