The Impact of Pre-emptive Home Delivery of ORS + Zinc on Treatment for Child Diarrhea: a Cluster Randomized Controlled Trial in Bauchi, Nigeria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- RAND
- 入组人数
- 102,650
- 试验地点
- 2
- 主要终点
- ORS Use (cases in last 4 weeks)
研究概览
简要总结
The aim of this clustered randomized controlled trial is to evaluate whether free and pre-emptive distribution of Oral Rehydration Salts (ORS) and Zinc at home increases the use of ORS to treat diarrhea cases among children under the age of 5 in Bauchi, Nigeria. The primary research questions for the study are:
- RQ1a: Does pre-emptive home delivery with free distribution of ORS and zinc coupled with information about the importance of proper treatment (henceforth referred to as "the intervention") result in greater use of ORS to treat child diarrhea (for children under the age of 5) over the 6 months following the deliveries, relative to the status quo (i.e., in the absence of such an intervention)?
- RQ1b: Does the intervention result in greater use of ORS to treat child diarrhea (for children under the age of 5) over the 12 months following the deliveries, relative to the status quo?
- RQ1.1: How much does the effect of the intervention on use of ORS to treat child diarrhea (for children under the age of 5) change over time?
All wards in Bauchi state will be randomly assigned to one of two groups:
- treatment, where all households with at least one child under the age of 5 will receive free pre-emptive ORS and zinc co-packs - with two ORS sachets and 10 zinc tablets per child - coupled with information about the importance of proper treatment
- delayed-start control, with care as usual during the evaluation period and intervention delivery post evaluation) groups.
A total of 1,732 enumeration areas (EAs) will be sampled across all wards for the study period. Within each EA, 20 eligible households will be randomly sampled for surveys during each wave of data collection: baseline, endline wave 1 (over 1-6 months post intervention), and endline wave 2 (over 7-12 months post intervention). The primary outcomes for the study include the use of ORS to treat child diarrhea over 6 months post-intervention, over 12 months post-intervention, and over each month until 12 months post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
The enumerator and the outcomes assessor will be masked to the assignment of intervention.
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 15 years old
- •Has at least one child under 5 at baseline
- •Proficiency in English or Hausa
排除标准
- •Living in a temporary home (nomadic population)
- •Does not speak English or Hausa
- •Unable to give informed consent
研究组 & 干预措施
Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+Zinc
Wards randomized to this arm will primarily receive four intervention components as described under the "Intervention" section
干预措施: Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+Zinc (Behavioral)
Delayed-start control
Wards randomly assigned to this arm will not receive any intervention until after endline data collection in completed. During the study period, the caregivers in this group will have standard access to ORS and zinc at local health facilities and pharmacies. Some community health workers in control villages could make household visits; however, any delivery of ORS or zinc in the control group is not expected as community health workers are generally not the source of diarrhea treatment.
结局指标
主要结局
ORS Use (cases in last 4 weeks)
时间窗: Each month from 1-12 months post intervention
Self-reported ORS use for a case of child diarrhea that occurred within the last 4 weeks.
次要结局
- Zinc + ORS use(1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention)
- Antibiotic use(1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention)
- Zinc use alone(1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention)
- Time to ORS initiation(1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention)
- Exposure to unsafe drinking water(1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention)
- Willingness to purchase new ORS packets(1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention)
- Child mortality; all cause and from diarrhea(1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention)
- Hospitalization from diarrhea(1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention)
- Wastage of ORS and zinc packets(1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention)
- Number of diarrhea episodes(1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention)
- Care seeking outside the home(1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention)