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

RanD

Status: Enrolling

Conditions: Diarrhea Toddler

Treatments: Behavioral: Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+Zinc

Study type: Interventional

Funder types: Other

Identifiers

NCT06444633

HCAAD201

Details and patient eligibility

About

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.

Enrollment: 103,920 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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103,920 participants in 2 patient groups

Delayed-start control

No Intervention group

Description:

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.

Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+Zinc

Experimental group

Description:

Wards randomized to this arm will primarily receive four intervention components as described under the "Intervention" section

Treatment:

Behavioral: Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+Zinc