The Impact of Pre-emptive Home Delivery of ORS + Zinc on Treatment for Child Diarrhea

The Impact of Pre-emptive Home Delivery of ORS + Zinc on Treatment for Child Diarrhea: a Cluster Randomized Controlled Trial in Bauchi, Nigeria

The aim of this clustered randomized controlled trial is to evaluate whether free and pre-emptive distribution of Oral Rehydration Salts (ORS) and Zinc at home increases the use of ORS to treat diarrhea cases among children under the age of 5 in Bauchi, Nigeria. The primary research questions for the study are:

• RQ1a: Does pre-emptive home delivery with free distribution of ORS and zinc coupled with information about the importance of proper treatment (henceforth referred to as "the intervention") result in greater use of ORS to treat child diarrhea (for children under the age of 5) over the 6 months following the deliveries, relative to the status quo (i.e., in the absence of such an intervention)?
• RQ1b: Does the intervention result in greater use of ORS to treat child diarrhea (for children under the age of 5) over the 12 months following the deliveries, relative to the status quo?
• RQ1.1: How much does the effect of the intervention on use of ORS to treat child diarrhea (for children under the age of 5) change over time?

All wards in Bauchi state will be randomly assigned to one of two groups:

• treatment, where all households with at least one child under the age of 5 will receive free pre-emptive ORS and zinc co-packs - with two ORS sachets and 10 zinc tablets per child - coupled with information about the importance of proper treatment
• delayed-start control, with care as usual during the evaluation period and intervention delivery post evaluation) groups.

A total of 1,732 enumeration areas (EAs) will be sampled across all wards for the study period. Within each EA, 20 eligible households will be randomly sampled for surveys during each wave of data collection: baseline, endline wave 1 (over 1-6 months post intervention), and endline wave 2 (over 7-12 months post intervention). The primary outcomes for the study include the use of ORS to treat child diarrhea over 6 months post-intervention, over 12 months post-intervention, and over each month until 12 months post-intervention.

Study Overview

• Status: Recruiting
• Conditions: Diarrhea Toddler
• Intervention / Treatment: Behavioral: Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+Zinc

• Study Type: Interventional
• Enrollment (Estimated): 103920
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nneka E Osadolor, Ph.D.; Phone Number: +234 7036838618; Email: onxta@yahoo.com

Study Locations

• Nigeria
  • Abuja, Nigeria
    • Recruiting
    • Clinton Health Access Initiative
    • Contact: Chizoba Fashanu; Phone Number: +234(0)7031331546; Email: cfashanu@clintonhealthaccess.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• At least 15 years old
• Has at least one child under 5 at baseline
• Proficiency in English or Hausa

Exclusion Criteria:

• Living in a temporary home (nomadic population)
• Does not speak English or Hausa
• Unable to give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Delayed-start control; Wards randomly assigned to this arm will not receive any intervention until after endline data collection in completed. During the study period, the caregivers in this group will have standard access to ORS and zinc at local health facilities and pharmacies. Some community health workers in control villages could make household visits; however, any delivery of ORS or zinc in the control group is not expected as community health workers are generally not the source of diarrhea treatment.
Experimental: Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+Zinc; Wards randomized to this arm will primarily receive four intervention components as described under the "Intervention" section	Behavioral: Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+Zinc; The intervention will involve the following: 1) The communities will be sensitized on the importance of ORS and Zinc use for the treatment of child diarrhea, by the Clinton Health Access Initiative (CHAI). 2) Campaigners recruited by CHAI will visit each household in their catchment area that contain at child under 5 years old. 3) During the distribution visits, the campaigners will train caregivers on the dangers of diarrhea and the importance of ORS and zinc use, among other things (including how to prepare, use, and store ORS/zinc, benefits of the treatments, recommended health behaviors such as seeking care, and encouraging basic handwashing and hygiene practices). The caregivers will also receive a flyer describing the same information in their local language, for future reference. 4) Campaigners will then distribute two ORS and zinc co-packs (each co-pack contains two sachets of ORS and 10 tablets of zinc) for free for each child under the age of five in the household.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORS Use (cases in last 4 weeks)	Self-reported ORS use for a case of child diarrhea that occurred within the last 4 weeks.	1-6 months post intervention
ORS Use (cases in last 4 weeks)	Self-reported ORS use for a case of child diarrhea that occurred within the last 4 weeks.	1-12 months post intervention
ORS Use (cases in last 4 weeks)	Self-reported ORS use for a case of child diarrhea that occurred within the last 4 weeks.	Each month from 1-12 months post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Zinc + ORS use	Self-reported Zinc + ORS use for a case of child diarrhea that occurred within the last 4 weeks.	1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Antibiotic use	Self-reported antibiotic use for a case of child diarrhea that occurred within the last 4 weeks.	1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Zinc use alone	Self-reported Zinc use for a case of child diarrhea that occurred within the last 4 weeks.	1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Time to ORS initiation	Binary and count variables; binary coded to 1 if caregiver started treatment on the same day the diarrhea began; count variable truncated to 7 days.	1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Exposure to unsafe drinking water	Self-reported use of untreated water to prepare ORS for treating diarrhea experienced by a child who is exclusively breastfed.	1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Willingness to purchase new ORS packets	Self-reported use of ORS, seeking care, and purchase of ORS among households that experienced at least twice as many diarrhea cases as the number of children under 5.	1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Child mortality; all cause and from diarrhea	Self-reported mortality (all cause and diarrhea) of children under 5 since intervention	1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Hospitalization from diarrhea	Self-reported hospitalization (all cause and diarrhea) of children under 5 since intervention	1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Number of diarrhea episodes	Count of episodes of diarrhea experienced by children who had at least one case of diarrhea since intervention.	1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Care seeking outside the home	Binary indicator, coded to 1 if caregiver sought care from each type of provider.	1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Wastage of ORS and zinc packets	Binary indicator, coded to 1 for each type of wastage (co-packs being lost, co-packs being stolen, co-packs used for non-diarrhea reasons, co-packs given away)	1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention

Collaborators and Investigators

• Sponsor: RAND
• Collaborators: Innovations for Poverty Action; Clinton Health Access Initiative, Nigeria
• Investigators: Principal Investigator: Zachary Wagner, Ph.D., RAND; Principal Investigator: Stephanie Bonds, Ph.D., RAND

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: May 24, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Zinc; Child Diarrhea; Oral Rehydration Salts
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: HCAAD201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data will be shared in a public repository at the end of the study.
• IPD Sharing Time Frame: Indefinitely
• IPD Sharing Access Criteria: Re-identification of study participants will not be permitted. Other criteria as set by the repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No