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Clinical Trials/NCT05284773
NCT05284773
Not Yet Recruiting
N/A

Screening for Acute Malnutrition: a Cluster Randomized Trial Comparing Caregivers to Community Health Workers in Burkina Faso

University of California, San Francisco0 sites6,800 target enrollmentFebruary 15, 2030

Overview

Phase
N/A
Intervention
Not specified
Conditions
Acute Malnutrition in Childhood
Sponsor
University of California, San Francisco
Enrollment
6800
Primary Endpoint
Community-level mean mid-upper arm circumference (MUAC)
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

Brief Summary

This project includes a pilot cluster-randomized trial of the efficacy of training caregivers to screen for acute malnutrition (AM) in children aged 6-59 months using mid-upper arm circumference (MUAC) in Burkina Faso. The pilot will be conducted to establish the feasibility of procedures and preliminary outcome data to inform the sample size calculations and design of a future longer-term, fully powered cluster-randomized trial. Forty communities enrolled in the Bill & Melinda Gates Foundation-funded Child Health with Azithromycin Treatment (CHAT) trial will be randomly selected for this pilot and randomized to receive the caregiver training intervention or no additional intervention. All communities will continue to receive standard of care screening for AM according to national guidelines, which includes community-based screening for AM by community health workers using MUAC every 6 months. A baseline census will be conducted before randomization to enumerate the eligible population of caregivers and children 6-59 months old and measure MUAC. A final census with MUAC measurement will be conducted 6 months later (primary outcome). Data will be collected on all children presenting to the Centre de Santé et Promotion Sociale (CSPS) for malnutrition to track secondary outcomes.

During intervention training, we will also conduct a diagnostic accuracy study to evaluate the validity of caregiver screening by comparing the MUAC measurements of caregivers against the gold standard measurement of the experienced health personnel conducting the training. Also during training, intervention communities will be randomized to one of two training approaches: training by caregivers or training by health agents and adherence to the protocol during follow-up monitoring visits will be compared to determine effectiveness of training.

Registry
clinicaltrials.gov
Start Date
February 15, 2030
End Date
March 10, 2035
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Community-level mean mid-upper arm circumference (MUAC)

Time Frame: 6 months

Community-level mean MUAC in children 6-59 months of age as assessed during the final census after 6 months of intervention

Secondary Outcomes

  • Sensitivity(6 months)
  • Cases referred(6 months)
  • Effectiveness of caregiver training(6 months)
  • Mid-upper arm circumference (MUAC) at admission(6 months)
  • Specificity(6 months)

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