Screening for Acute Malnutrition: a Cluster Randomized Trial Comparing Caregivers to Community Health Workers in Burkina Faso
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 6,800
- 主要终点
- Community-level mean mid-upper arm circumference (MUAC)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Masking of participants and intervention administrators will not be possible due to the nature of the intervention. Primary outcome assessors will be masked to allocation.
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
intervention + standard of care
Caretakers of children 6-59 months old living in communities assigned to the intervention arm will be trained to detect malnutrition using MUAC on their children weekly. Caretakers living in communities assigned to the intervention will also receive usual standard of care.
干预措施: Caretaker MUAC screening - training by health workers (Other)
intervention + standard of care
Caretakers of children 6-59 months old living in communities assigned to the intervention arm will be trained to detect malnutrition using MUAC on their children weekly. Caretakers living in communities assigned to the intervention will also receive usual standard of care.
干预措施: Caretaker MUAC screening - training by caregivers (Other)
standard of care
Caretakers of children 6-59 months living in communities assigned to the standard of care arm will receive usual acute malnutrition screening. This includes biannual community-based screening by community health workers as well as weekly malnutrition days led by the Centre de Sante et Promotion Sociale (CSPS).
结局指标
主要结局
Community-level mean mid-upper arm circumference (MUAC)
时间窗: 6 months
Community-level mean MUAC in children 6-59 months of age as assessed during the final census after 6 months of intervention
次要结局
- 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)