Summary

Eligibility
for people ages 6 months to 59 months (full criteria)
Dates
study started
completion around
Principal Investigator
by Catherine Oldenbrug, ScDKieran O'Brien, PhD

Description

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.

Official Title

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

Keywords

Acute Malnutrition in Childhood, Malnutrition, Caretaker MUAC screening - training by health workers, Caretaker MUAC screening - training by caregivers

Eligibility

For people ages 6 months to 59 months

Cluster level:

  • Enrollment in the CHAT trial
  • Location outside of the Health and Demographic Surveillance System (HDSS)
  • Population size < 2000 people
  • Verbal consent of the village leader

Individual level:

  • Residence in a village participating in the CHAT trial
  • Caregiver or guardian of children aged 6-59 months (for intervention training)
  • Age 6-59 months (for MUAC screening and some outcome assessments)
  • Verbal consent from caregiver or guardian

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05284773
Study Type
Interventional
Participants
Expecting 6800 study participants
Last Updated