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

Diarrhea, Infantile Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04335877
• Other study ID #: NI-01-2006-ZNIR
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: April 2, 2022

Study information

• Verified date: April 2023
• Source: Nutrition International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1245
• Est. completion date: April 2, 2022
• Est. primary completion date: April 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 60 Months

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea
• Diarrhea, Infantile

Intervention

Other:
• Private sector component + modified BCC
Intervention group will be exposed to the private sector component + modified BCC and will receive current standard care

Locations

Country	Name	City	State
Kenya	Nutrition International - Kenya	Nairobi

Sponsors (1)

Lead Sponsor	Collaborator
Nutrition International

Country where clinical trial is conducted

Kenya, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Acceptability of private sector	% private retailers who express intention to stock co-packs after sensitization and training.	1 month
Primary	Acceptability of caregivers	% caregivers who indicate preferred treatment for uncomplicated childhood diarrhea is co-pack.at 12 months	12 months
Primary	Adoption by private sector at month 1	% private retailers who stock co-pack after 1 month	1 month
Primary	Adoption by private sector at month 2	% private retailers who stock co-pack after 2 months	2 months
Primary	Adoption by private sector at month 3	% private retailers who stock co-pack after 3 months	3 months
Primary	Adoption by private sector at month 4	% private retailers who stock co-pack after 4 months	4 months
Primary	Adoption by private sector at month 5	% private retailers who stock co-pack after 5 months	5 months
Primary	Adoption by private sector at month 6	% private retailers who stock co-pack after 6 months	6 months
Primary	Adoption by private sector at month 7	% private retailers who stock co-pack after 7 months	7 months
Primary	Adoption by private sector at month 8	% private retailers who stock co-pack after 8 months	8 months
Primary	Adoption by private sector at month 9	% private retailers who stock co-pack after 9 months	9 months
Primary	Adoption by private sector at month 10	% private retailers who stock co-pack after 10 months	10 months
Primary	Adoption by private sector at month 11	% private retailers who stock co-pack after 11 months	11 months
Primary	Adoption by private sector at month 12	% private retailers who stock co-pack after 12 months	12 months
Primary	Adoption by caregivers	% caregivers who indicate having co-pack in house	12 months
Primary	Feasibility of intervention at month 1	% private retailers who indicate that they can purchase/procure co-packs with ease after 1 month	1 month
Primary	Feasibility of intervention at month 2	% private retailers who indicate that they can purchase/procure co-packs with ease after 2 months	2 months
Primary	Feasibility of intervention at month 3	% private retailers who indicate that they can purchase/procure co-packs with ease after 3 months	3 months
Primary	Feasibility of intervention at month 4	% private retailers who indicate that they can purchase/procure co-packs with ease after 4 months	4 months
Primary	Feasibility of intervention at month 5	% private retailers who indicate that they can purchase/procure co-packs with ease after 5 months	5 months
Primary	Feasibility of intervention at month 6	% private retailers who indicate that they can purchase/procure co-packs with ease after 6 months	6 months
Primary	Feasibility of intervention at month 7	% private retailers who indicate that they can purchase/procure co-packs with ease after 7 months	7 months
Primary	Feasibility of intervention at month 8	% private retailers who indicate that they can purchase/procure co-packs with ease after 8 months	8 months
Primary	Feasibility of intervention at month 9	% private retailers who indicate that they can purchase/procure co-packs with ease after 9 months	9 months
Primary	Feasibility of intervention at month 10	% private retailers who indicate that they can purchase/procure co-packs with ease after 10 months	10 months
Primary	Feasibility of intervention at month 11	% private retailers who indicate that they can purchase/procure co-packs with ease after 11 months	11 months
Primary	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	Care-seeking to all sources	Change in % of caregivers who seek care for childhood diarrhea outside the home at month 12	12 months
Secondary	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
Secondary	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