Training caregivers to screen for relapse among children who have recovered from severe acute malnutrition: study protocol for a feasibility trial

BACKGROUND: Children with severe acute malnutrition (SAM) have a high risk of mortality and morbidity. After recovery from an initial episode of SAM, the risk of relapse can be high, although estimates vary across settings. Post-recovery surveillance for relapsed SAM in Burkina Faso consists of monthly clinic-based follow-up visits. However, adherence to the follow-up schedule can be variable, and children with missed surveillance visits may have delayed diagnoses of relapse. Here, we describe the protocol for a feasibility trial design to provide preliminary evidence to support the training of caregivers to screen for relapsed acute malnutrition using mid-upper arm circumference (MUAC) screening at home. METHODS: This feasibility trial will enroll 200 caregiver-child dyads in which the child has recovered in the past month from an episode of SAM in Boromo, Burkina Faso. Eligible children had an initial episode of SAM that they recovered from per Burkinabè guidelines (weight-for-height Z-score, WHZ ≥ -2 and/or MUAC ≥ 12.5 cm, depending on the admission criteria). Caregiver-child dyads are randomized to either weekly screening using a standard MUAC tape plus standard of care follow-up or standard of care alone, which consists of monthly clinic-based screening for relapse for 3 months. Caregiver-child dyads are followed for 6 months. Primary feasibility endpoints include acceptability, time for training, enrollment potential and refusals, adherence to the follow-up protocol, and adherence to the screening protocol. Clinical endpoints, measured to inform the design of a full-scale trial, include the proportion of children relapsing, anthropometric measurements at 6 months, hospitalization, and vital status. DISCUSSION: This feasibility trial will generate data to support the development and full-scale testing of an intervention to train caregivers to screen for relapsed acute malnutrition using MUAC. TRIAL REGISTRATION: This trial is registered at clinicaltrials.gov (NCT05932992), first posted 27 June 2023.