Clinical trial NCT06444633: The Impact of Pre-emptive Home Delivery of ORS + Zinc on Treatment for Child Diarrhea
Official title: The Impact of Pre-emptive Home Delivery of ORS + Zinc on Treatment for Child Diarrhea: a Cluster Randomized Controlled Trial in Bauchi, Nigeria
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diarrhea Toddler
Keywords: Oral Rehydration Salts
Child Diarrhea
Zinc
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Clinton Health Access Initiative, Nigeria
name: Innovations for Poverty Action
First posted: 2024-06-05
Enrollment: 103920
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a parallel, cluster randomized controlled trial, randomizing administrative wards in Bauchi, Nigeria to treatment (receiving pre-emptive, free ORS+Zinc co-packs (2 nos) per child under 5 to households, along with information about proper use of ORS and Zinc for treating child diarrhea) or delayed-start control (receiving intervention after the end of the study period).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: ORS Use (cases in last 4 weeks)
timeFrame: 1-6 months post intervention
measure: ORS Use (cases in last 4 weeks)
timeFrame: 1-12 months post intervention
measure: ORS Use (cases in last 4 weeks)
timeFrame: Each month from 1-12 months post intervention
Secondary outcomes:
measure: Zinc + ORS use
timeFrame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
measure: Antibiotic use
timeFrame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
measure: Zinc use alone
timeFrame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
measure: Time to ORS initiation
timeFrame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
measure: Exposure to unsafe drinking water
timeFrame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
measure: Willingness to purchase new ORS packets
timeFrame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
measure: Child mortality; all cause and from diarrhea
timeFrame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
measure: Hospitalization from diarrhea
timeFrame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
measure: Number of diarrhea episodes
timeFrame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
measure: Care seeking outside the home
timeFrame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
measure: Wastage of ORS and zinc packets
timeFrame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
Other outcomes:
Locations:
city: Abuja
country: Nigeria
facility: Clinton Health Access Initiative
Study officials:
affiliation: RAND
name: Zachary Wagner, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: RAND
name: Stephanie Bonds, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: