Clinical trial NCT05284773: Screening for Acute Malnutrition
Official title: Screening for Acute Malnutrition: a Cluster Randomized Trial Comparing Caregivers to Community Health Workers in Burkina Faso
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Malnutrition in Childhood
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Centre de Recherche en Sante de Nouna, Burkina Faso
First posted: 2022-03-17
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group will be randomized to intervention + standard of care; one group will be randomized to standard of care only
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Community-level mean mid-upper arm circumference (MUAC)
timeFrame: 6 months
Secondary outcomes:
measure: Sensitivity
timeFrame: 6 months
measure: Specificity
timeFrame: 6 months
measure: Cases referred
timeFrame: 6 months
measure: Mid-upper arm circumference (MUAC) at admission
timeFrame: 6 months
measure: Effectiveness of caregiver training
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Catherine Oldenbrug, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Kieran O'Brien, PhD
role: PRINCIPAL_INVESTIGATOR
References: