Actively Recruiting
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
Led by University of Washington · Updated on 2026-05-04
600
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a two-way text-message system called MAMMS IYCF to support caregivers in monitoring and improving the nutrition of HIV-exposed children aged 6 to 24 months in Kenya. The study aims to see if this system reduces the incidence of malnutrition, speeds recovery for malnourished children, lowers hospitalizations and deaths, and improves caregiver knowledge and behavior regarding infant feeding. It also examines the cost-effectiveness of this approach compared to standard care. Caregiver-child pairs are randomly assigned to either the MAMMS IYCF intervention or standard care. Those in the intervention receive weekly SMS messages with feeding education and prompts to measure their child's mid-upper arm circumference (MUAC) using provided tapes, reporting results back via SMS. If measurements indicate wasting, caregivers are asked to visit the clinic promptly for confirmation and treatment. The standard care group receives appointment reminders and routine nutritional screening at clinic visits. Both groups attend follow-up visits at 90 and 180 days for assessments. Participants undergo medical history surveys, clinical exams, and anthropometric measurements at enrollment and follow-ups. Caregivers complete questionnaires about feeding knowledge, trust in healthcare, and care-seeking intentions. The study tracks nutritional outcomes, hospitalizations, deaths, and caregiver engagement. Caregiver and health worker experiences with the SMS system are also explored through interviews and focus groups. The total participation duration is six months with ongoing support and monitoring throughout.
CONDITIONS
Brief Title
A Trial Testing a Two-way SMS Platform to Recognize and Prevent Wasting Among HIV-infected and HIV-exposed Uninfected Children in Kenya
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 to 24 months with a mid-upper arm circumference (MUAC) of 12.5 cm or more at recruitment
- Children living with HIV or HIV-exposed uninfected children attending early infant detection or HIV-care clinics
- Child's caregiver is willing and able to provide informed consent
- Child's caregiver can read or write or has assistance to do so
- Child's caregiver plans to remain in the study area for more than 6 months and attend follow-up visits
- Child's caregiver has access to a Safaricom phone and provides a mobile phone number
- Healthcare workers working in Homa Bay and Migori County Referral Hospitals in contact with pediatric inpatients
You will not qualify if you...
- Children with moderate or severe wasting (MUAC less than 12.5 cm, weight-for-height z-score less than -2, or nutritional edema) at screening
- Children with congenital conditions or syndromes that prevent age-appropriate feeding
- Children enrolled in another study that may interfere with this study's aims
- Child's caregiver fails the second MUAC training after initial unsuccessful training
- Child's caregiver is under 18 years old
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 6 months (180 days)
Participants are randomized to either the MAMMS-IYCF intervention or the standard of care (SOC). Those in the MAMMS-IYCF arm receive weekly two-way SMS messages prompting caregivers to measure their child's MUAC and report results, with additional health messages and support. The SOC arm receives one-way SMS reminders for routine clinical visits. Caregivers in both arms attend clinic visits for anthropometry measurements and assessments.
Weekly SMS engagement for MAMMS-IYCF arm; 2 in-person clinic visits at 90 and 180 days for all participants
Duration - Up to 6 months after enrollment
Participants attend follow-up visits at 90 and 180 days after enrollment for anthropometry measurements, health assessments, and questionnaires. Caregivers in the MAMMS-IYCF arm complete an SMS acceptability questionnaire at the final visit. Any child identified with malnutrition during follow-up is referred for treatment. Additional qualitative interviews and focus groups are conducted with caregivers and health workers to assess intervention feasibility and acceptability.
2 in-person visits at 90 and 180 days; possible additional interviews or focus groups for selected participants
Trial Site Locations
Total: 2 locations
1
Homa Bay County Referral Hospital
Homa Bay, Kenya
Actively Recruiting
2
Migori County Referral Hospital
Migori, Kenya
Actively Recruiting
Research Team
A
Arianna R Means, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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