Clinical trial NCT04335877: Effect of Prompting the Supply of Zinc/LO-ORS Co-packs in the Private Sector Plus BCI on Childhood Diarrhea Treatment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhea, Infantile
Lead sponsor: Nutrition International
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 1245
Sex: ALL
Minimum age (years): 2
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Treatment of uncomplicated diarrhea
timeFrame: 12 months
measure: Care-seeking in the private sector
timeFrame: 12 months
measure: Availability of zinc and LO-ORS co-pack in the private sector
timeFrame: 12 months
measure: Acceptability of private sector
timeFrame: 1 month
measure: Acceptability of caregivers
timeFrame: 12 months
measure: Adoption by private sector at month 1
timeFrame: 1 month
measure: Adoption by private sector at month 2
timeFrame: 2 months
measure: Adoption by private sector at month 3
timeFrame: 3 months
measure: Adoption by private sector at month 4
timeFrame: 4 months
measure: Adoption by private sector at month 5
timeFrame: 5 months
measure: Adoption by private sector at month 6
timeFrame: 6 months
measure: Adoption by private sector at month 7
timeFrame: 7 months
measure: Adoption by private sector at month 8
timeFrame: 8 months
measure: Adoption by private sector at month 9
timeFrame: 9 months
measure: Adoption by private sector at month 10
timeFrame: 10 months
measure: Adoption by private sector at month 11
timeFrame: 11 months
measure: Adoption by private sector at month 12
timeFrame: 12 months
measure: Adoption by caregivers
timeFrame: 12 months
measure: Feasibility of intervention at month 1
timeFrame: 1 month
measure: Feasibility of intervention at month 2
timeFrame: 2 months
measure: Feasibility of intervention at month 3
timeFrame: 3 months
measure: Feasibility of intervention at month 4
timeFrame: 4 months
measure: Feasibility of intervention at month 5
timeFrame: 5 months
measure: Feasibility of intervention at month 6
timeFrame: 6 months
measure: Feasibility of intervention at month 7
timeFrame: 7 months
measure: Feasibility of intervention at month 8
timeFrame: 8 months
measure: Feasibility of intervention at month 9
timeFrame: 9 months
measure: Feasibility of intervention at month 10
timeFrame: 10 months
measure: Feasibility of intervention at month 11
timeFrame: 11 months
measure: Feasibility of intervention at month 12
timeFrame: 12 months
Secondary outcomes:
measure: Care-seeking to all sources
timeFrame: 12 months
measure: Prompt treatment of uncomplicated childhood diarrhoea with zinc and LO-ORS co-pack
timeFrame: 12 months
measure: Caregivers receive information from private retailers
timeFrame: 12 months
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Nutrition International - Kenya
Study officials:
affiliation: Nutrition International
name: Elijah Mbiti, MSc
role: PRINCIPAL_INVESTIGATOR
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