CompletedNot Applicable

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

Kenya1,245 participantsStarted 2021-03-01

Plain-language 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.

Who can participate

Age range

2 Months – 60 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Treatment of uncomplicated diarrhea

Timeframe: 12 months

Care-seeking in the private sector

Timeframe: 12 months

Availability of zinc and LO-ORS co-pack in the private sector

Timeframe: 12 months

Acceptability of private sector

Timeframe: 1 month

Acceptability of caregivers

Timeframe: 12 months

Adoption by private sector at month 1

Timeframe: 1 month

Adoption by private sector at month 2

Timeframe: 2 months

Adoption by private sector at month 3

Timeframe: 3 months

Trial details

NCT IDNCT04335877

SponsorNutrition International

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-02

View on ClinicalTrials.gov More Diarrhea, Infantile trials

Plain-language summary

Who can participate

Age range

2 Months – 60 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Treatment of uncomplicated diarrhea

Timeframe: 12 months

Care-seeking in the private sector

Timeframe: 12 months

Availability of zinc and LO-ORS co-pack in the private sector

Timeframe: 12 months

Acceptability of private sector

Timeframe: 1 month

Acceptability of caregivers

Timeframe: 12 months

Adoption by private sector at month 1

Timeframe: 1 month

Adoption by private sector at month 2

Timeframe: 2 months

Adoption by private sector at month 3

Timeframe: 3 months