NCT06444633 The Impact of Pre-emptive Home Delivery of ORS + Zinc on Treatment for Child Diarrhea
| NCT ID | NCT06444633 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RAND |
| Condition | Diarrhea Toddler |
| Study Type | INTERVENTIONAL |
| Enrollment | 103,920 participants |
| Start Date | 2024-09-04 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 103,920 participants in total. It began in 2024-09-04 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Zachary Wagner, Ph.D.
PRINCIPAL INVESTIGATOR
RAND
Frequently Asked Questions
Who can join the NCT06444633 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, studying Diarrhea Toddler. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06444633 currently recruiting?
Yes, NCT06444633 is actively recruiting participants. Contact the research team at onxta@yahoo.com for enrollment information.
Where is the NCT06444633 trial being conducted?
This trial is being conducted at Abuja, Nigeria.
Who is sponsoring the NCT06444633 clinical trial?
NCT06444633 is sponsored by RAND. The principal investigator is Zachary Wagner, Ph.D. at RAND. The trial plans to enroll 103,920 participants.