Severe Acute Malnutrition Clinical Trial
Official title:
Reducing the Frequency of Follow up and Task Sharing in the Treatment of Uncomplicated Severe Acute Malnutrition: an Evaluation of Monthly Visits and Home-based Surveillance for Access-limited and High-burden Settings
This study will be conducted as a stratified cluster randomized trial. The unit of randomization will be the outpatient therapeutic feeding center. The 10 health centers will be stratified by size, and centers within a stratum will be randomized in a 1:1 ratio to one of two schedules of treatment: (1) standard weekly visits or (2) monthly visits with support for home-based surveillance.
This study will be conducted as a stratified cluster randomized trial of a monthly schedule
of follow up in the treatment of uncomplicated SAM among children aged 6 to 59 months. The
unit of randomization will be the outpatient therapeutic feeding center. The 10 health
centers supported by International Medical Corps UK (IMC-UK) will be stratified by size (±
1000 admissions per site per year), and centers within a stratum will be randomized in a 1:1
ratio to one of two schedules of treatment: (1) standard weekly visits or (2) monthly visits
with support for home-based surveillance.
Distribution of the therapeutic feeding rations, as well as medical and anthropometric
surveillance, will take place on a weekly or monthly basis until discharge according to the
random assignment of the site. Caregivers in the monthly visit group will receive additional
instruction at admission regarding home-based MUAC measurement and clinical surveillance.
Regardless of intervention assignment, all children with uncomplicated SAM will receive
standard medical care on admission as per national guidelines, and a home visit 2 months
following discharge from the nutritional program. Additional data collection, including
coverage assessment and economic costing analysis will be used to address the secondary
objectives related to the evaluation of coverage and cost-effectiveness, respectively.
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