Effectiveness-Implementation Research to Assess the Effect of Prompting the Supply of Zinc/LO-ORS Co-packs Through the Private Sector Coupled With Behavior Change Intervention on the Treatment of Uncomplicated Childhood Diarrhoea in Kenya
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,245
- 试验地点
- 1
- 主要终点
- Adoption by private sector at month 2
研究概览
简要总结
This study assesses whether prompting the supply of zinc and LO-ORS co-packs in the private sector coupled with behavior change communication (BCC) has an effect on the treatment of uncomplicated childhood diarrhea. In addition the study will evaluate the acceptability, adoption, feasibility and coverage of the intervention model. One group of children and caregivers will receive the current standard of care and will be exposed to standard BCC and the second group will be exposed to the private sector component and to a modified BCC.
详细描述
Diarrhoea accounts for 7% of all under-five deaths in Kenya. Recent experiences in other countries show that the private health sector can be successfully harnessed to improve diarrhoea treatment coverage.
This study assesses the effect of prompting the supply of zinc and low-osmolarity oral rehydration salts (LO-ORS) co-packs in the private sector coupled with increasing the demand for co-packs among caregivers on: 1) the treatment of uncomplicated childhood diarrhoea, 2) care-seeking in the private sector, and 3) availability of co-packs in the private sector.
The target population will be children under five years of age and their caregivers in Vihiga County. The study will use a effectiveness-implementation hybrid design with two arms: 1) children and caregivers from areas that receive the current standard of care and will be exposed to standard BCC and 2) children and caregivers from areas where the private sector component will be implemented and that will be exposed to a modified BCC. Two of the five existing sub-counties in Vihiga will be selected by convenience to be assigned to one of the two study arms. The selection will take into account geographical distance between the two sub-counties (i.e. maximizing the distance between the two counties to minimize cross-pollination between the two study groups), rural vs urban population, and number of operational community units and CHV in each sub-county. All private sector retailers within each sub-county will be identified with assistance from wholesalers. Retailers will be invited to participate in the study via sensitization meetings.
Baseline and endline assessments will be conducted at the household level to collect information on care-seeking practices, availability of the co-pack in the household, treatment of diarrhoea, and whether caregivers received information from shopkeepers on using the co-pack. Monitoring of process indicators will be conducted throughout the intervention period. The monitoring process will also be used to evaluate the adoption and feasibility of the implementation model. In addition, the endline survey will be used to evaluate the acceptability, adoption, and coverage of the implementation model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children under 5 years of age who live in the selected areas to be included in the study are eligible to participate. All children in area selected for the intervention will be exposed to the private sector component and the modified BCC.
- •In addition, all private sites (shops, kiosks, chemists) in the intervention area will be eligible to participate in the study.
排除标准
- 未提供
研究组 & 干预措施
Private sector component + modified BCC
Private sector component + modified BCC + current standard of care
干预措施: Private sector component + modified BCC (Other)
Control
Current standard of care + standard BCC
结局指标
主要结局
Adoption by private sector at month 2
时间窗: 2 months
% private retailers who stock co-pack after 2 months
Care-seeking in the private sector
时间窗: 12 months
Change in % of caregivers seek care for uncomplicated childhood diarrhea in the private sector at 12 months
Adoption by private sector at month 4
时间窗: 4 months
% private retailers who stock co-pack after 4 months
Availability of zinc and LO-ORS co-pack in the private sector
时间窗: 12 months
Change in % of private retailers who have stock of zinc and LO-ORS co-pack at time of visit at 12 months
Treatment of uncomplicated diarrhea
时间窗: 12 months
change in % of caregivers who use zinc and LO-ORS co-pack to treat uncomplicated childhood diarrhea at 12 months
Acceptability of private sector
时间窗: 1 month
% private retailers who express intention to stock co-packs after sensitization and training.
Acceptability of caregivers
时间窗: 12 months
% caregivers who indicate preferred treatment for uncomplicated childhood diarrhea is co-pack.at 12 months
Adoption by private sector at month 1
时间窗: 1 month
% private retailers who stock co-pack after 1 month
Adoption by private sector at month 6
时间窗: 6 months
% private retailers who stock co-pack after 6 months
Adoption by private sector at month 7
时间窗: 7 months
% private retailers who stock co-pack after 7 months
Adoption by private sector at month 8
时间窗: 8 months
% private retailers who stock co-pack after 8 months
Adoption by private sector at month 3
时间窗: 3 months
% private retailers who stock co-pack after 3 months
Adoption by private sector at month 12
时间窗: 12 months
% private retailers who stock co-pack after 12 months
Feasibility of intervention at month 8
时间窗: 8 months
% private retailers who indicate that they can purchase/procure co-packs with ease after 8 months
Feasibility of intervention at month 9
时间窗: 9 months
% private retailers who indicate that they can purchase/procure co-packs with ease after 9 months
Adoption by private sector at month 9
时间窗: 9 months
% private retailers who stock co-pack after 9 months
Adoption by caregivers
时间窗: 12 months
% caregivers who indicate having co-pack in house
Feasibility of intervention at month 1
时间窗: 1 month
% private retailers who indicate that they can purchase/procure co-packs with ease after 1 month
Feasibility of intervention at month 4
时间窗: 4 months
% private retailers who indicate that they can purchase/procure co-packs with ease after 4 months
Feasibility of intervention at month 11
时间窗: 11 months
% private retailers who indicate that they can purchase/procure co-packs with ease after 11 months
Adoption by private sector at month 5
时间窗: 5 months
% private retailers who stock co-pack after 5 months
Adoption by private sector at month 11
时间窗: 11 months
% private retailers who stock co-pack after 11 months
Feasibility of intervention at month 6
时间窗: 6 months
% private retailers who indicate that they can purchase/procure co-packs with ease after 6 months
Adoption by private sector at month 10
时间窗: 10 months
% private retailers who stock co-pack after 10 months
Feasibility of intervention at month 5
时间窗: 5 months
% private retailers who indicate that they can purchase/procure co-packs with ease after 5 months
Feasibility of intervention at month 2
时间窗: 2 months
% private retailers who indicate that they can purchase/procure co-packs with ease after 2 months
Feasibility of intervention at month 3
时间窗: 3 months
% private retailers who indicate that they can purchase/procure co-packs with ease after 3 months
Feasibility of intervention at month 7
时间窗: 7 months
% private retailers who indicate that they can purchase/procure co-packs with ease after 7 months
Feasibility of intervention at month 10
时间窗: 10 months
% private retailers who indicate that they can purchase/procure co-packs with ease after 10 months
Feasibility of intervention at month 12
时间窗: 12 months
% private retailers who indicate that they can purchase/procure co-packs with ease after 12 months
次要结局
- Care-seeking to all sources(12 months)
- Caregivers receive information from private retailers(12 months)
- Prompt treatment of uncomplicated childhood diarrhoea with zinc and LO-ORS co-pack(12 months)
研究者
Elijah Mbiti
Senior Program Officer
Nutrition International