Effect of Prompting the Supply of Zinc/LO-ORS Co-packs in the Private Sector Plus BCI on Childhood Diarrhea Treatment

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Diarrhea, Infantile

Intervention / Treatment
-----------------
* Other: Private sector component + modified BCC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: 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. Exclusion criteria: - None

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 60 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Private sector component + modified BCC<br>Private sector component + modified BCC + current standard of care | Other: Private sector component + modified BCC<br>* Intervention group will be exposed to the private sector component + modified BCC and will receive current standard care<br>|
| No Intervention: Control<br>Current standard of care + standard BCC | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment of uncomplicated diarrhea | change in % of caregivers who use zinc and LO-ORS co-pack to treat uncomplicated childhood diarrhea at 12 months | 12 months | 
| Care-seeking in the private sector | Change in % of caregivers seek care for uncomplicated childhood diarrhea in the private sector at 12 months | 12 months | 
| Availability of zinc and LO-ORS co-pack in the private sector | Change in % of private retailers who have stock of zinc and LO-ORS co-pack at time of visit at 12 months | 12 months | 
| Acceptability of private sector | % private retailers who express intention to stock co-packs after sensitization and training. | 1 month | 
| Acceptability of caregivers | % caregivers who indicate preferred treatment for uncomplicated childhood diarrhea is co-pack.at 12 months | 12 months | 
| Adoption by private sector at month 1 | % private retailers who stock co-pack after 1 month | 1 month | 
| Adoption by private sector at month 2 | % private retailers who stock co-pack after 2 months | 2 months | 
| Adoption by private sector at month 3 | % private retailers who stock co-pack after 3 months | 3 months | 
| Adoption by private sector at month 4 | % private retailers who stock co-pack after 4 months | 4 months | 
| Adoption by private sector at month 5 | % private retailers who stock co-pack after 5 months | 5 months | 
| Adoption by private sector at month 6 | % private retailers who stock co-pack after 6 months | 6 months | 
| Adoption by private sector at month 7 | % private retailers who stock co-pack after 7 months | 7 months | 
| Adoption by private sector at month 8 | % private retailers who stock co-pack after 8 months | 8 months | 
| Adoption by private sector at month 9 | % private retailers who stock co-pack after 9 months | 9 months | 
| Adoption by private sector at month 10 | % private retailers who stock co-pack after 10 months | 10 months | 
| Adoption by private sector at month 11 | % private retailers who stock co-pack after 11 months | 11 months | 
| Adoption by private sector at month 12 | % private retailers who stock co-pack after 12 months | 12 months | 
| Adoption by caregivers | % caregivers who indicate having co-pack in house | 12 months | 
| Feasibility of intervention at month 1 | % private retailers who indicate that they can purchase/procure co-packs with ease after 1 month | 1 month | 
| Feasibility of intervention at month 2 | % private retailers who indicate that they can purchase/procure co-packs with ease after 2 months | 2 months | 
| Feasibility of intervention at month 3 | % private retailers who indicate that they can purchase/procure co-packs with ease after 3 months | 3 months | 
| Feasibility of intervention at month 4 | % private retailers who indicate that they can purchase/procure co-packs with ease after 4 months | 4 months | 
| Feasibility of intervention at month 5 | % private retailers who indicate that they can purchase/procure co-packs with ease after 5 months | 5 months | 
| Feasibility of intervention at month 6 | % private retailers who indicate that they can purchase/procure co-packs with ease after 6 months | 6 months | 
| Feasibility of intervention at month 7 | % private retailers who indicate that they can purchase/procure co-packs with ease after 7 months | 7 months | 
| Feasibility of intervention at month 8 | % private retailers who indicate that they can purchase/procure co-packs with ease after 8 months | 8 months | 
| Feasibility of intervention at month 9 | % private retailers who indicate that they can purchase/procure co-packs with ease after 9 months | 9 months | 
| Feasibility of intervention at month 10 | % private retailers who indicate that they can purchase/procure co-packs with ease after 10 months | 10 months | 
| Feasibility of intervention at month 11 | % private retailers who indicate that they can purchase/procure co-packs with ease after 11 months | 11 months | 
| Feasibility of intervention at month 12 | % private retailers who indicate that they can purchase/procure co-packs with ease after 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Care-seeking to all sources | Change in % of caregivers who seek care for childhood diarrhea outside the home at month 12 | 12 months | 
| Prompt treatment of uncomplicated childhood diarrhoea with zinc and LO-ORS co-pack | Change in % of caregivers who use zinc and LO-ORS co-pack to treat uncomplicated childhood diarrhea within 24-h of the onset of the episode of diarrhea at 12 months | 12 months | 
| Caregivers receive information from private retailers | Change in % caregivers who indicate received information from private retailers about zinc and LO-ORS to treat uncomplicated childhood diarrhea at 12 months | 12 months |