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

April 4, 2023 updated by: Elijah Mbiti, Nutrition International

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1245

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Nairobi, Kenya
        • Nutrition International - Kenya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment of uncomplicated diarrhea
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 1 month
% private retailers who express intention to stock co-packs after sensitization and training.
1 month
Acceptability of caregivers
Time Frame: 12 months
% caregivers who indicate preferred treatment for uncomplicated childhood diarrhea is co-pack.at 12 months
12 months
Adoption by private sector at month 1
Time Frame: 1 month
% private retailers who stock co-pack after 1 month
1 month
Adoption by private sector at month 2
Time Frame: 2 months
% private retailers who stock co-pack after 2 months
2 months
Adoption by private sector at month 3
Time Frame: 3 months
% private retailers who stock co-pack after 3 months
3 months
Adoption by private sector at month 4
Time Frame: 4 months
% private retailers who stock co-pack after 4 months
4 months
Adoption by private sector at month 5
Time Frame: 5 months
% private retailers who stock co-pack after 5 months
5 months
Adoption by private sector at month 6
Time Frame: 6 months
% private retailers who stock co-pack after 6 months
6 months
Adoption by private sector at month 7
Time Frame: 7 months
% private retailers who stock co-pack after 7 months
7 months
Adoption by private sector at month 8
Time Frame: 8 months
% private retailers who stock co-pack after 8 months
8 months
Adoption by private sector at month 9
Time Frame: 9 months
% private retailers who stock co-pack after 9 months
9 months
Adoption by private sector at month 10
Time Frame: 10 months
% private retailers who stock co-pack after 10 months
10 months
Adoption by private sector at month 11
Time Frame: 11 months
% private retailers who stock co-pack after 11 months
11 months
Adoption by private sector at month 12
Time Frame: 12 months
% private retailers who stock co-pack after 12 months
12 months
Adoption by caregivers
Time Frame: 12 months
% caregivers who indicate having co-pack in house
12 months
Feasibility of intervention at month 1
Time Frame: 1 month
% private retailers who indicate that they can purchase/procure co-packs with ease after 1 month
1 month
Feasibility of intervention at month 2
Time Frame: 2 months
% private retailers who indicate that they can purchase/procure co-packs with ease after 2 months
2 months
Feasibility of intervention at month 3
Time Frame: 3 months
% private retailers who indicate that they can purchase/procure co-packs with ease after 3 months
3 months
Feasibility of intervention at month 4
Time Frame: 4 months
% private retailers who indicate that they can purchase/procure co-packs with ease after 4 months
4 months
Feasibility of intervention at month 5
Time Frame: 5 months
% private retailers who indicate that they can purchase/procure co-packs with ease after 5 months
5 months
Feasibility of intervention at month 6
Time Frame: 6 months
% private retailers who indicate that they can purchase/procure co-packs with ease after 6 months
6 months
Feasibility of intervention at month 7
Time Frame: 7 months
% private retailers who indicate that they can purchase/procure co-packs with ease after 7 months
7 months
Feasibility of intervention at month 8
Time Frame: 8 months
% private retailers who indicate that they can purchase/procure co-packs with ease after 8 months
8 months
Feasibility of intervention at month 9
Time Frame: 9 months
% private retailers who indicate that they can purchase/procure co-packs with ease after 9 months
9 months
Feasibility of intervention at month 10
Time Frame: 10 months
% private retailers who indicate that they can purchase/procure co-packs with ease after 10 months
10 months
Feasibility of intervention at month 11
Time Frame: 11 months
% private retailers who indicate that they can purchase/procure co-packs with ease after 11 months
11 months
Feasibility of intervention at month 12
Time Frame: 12 months
% 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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nutrition International

Investigators

  • Principal Investigator: Elijah Mbiti, MSc, Nutrition International

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

April 2, 2022

Study Completion (Actual)

April 2, 2022

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

April 2, 2020

First Posted (Actual)

April 6, 2020

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

April 4, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI-01-2006-ZNIR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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