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NCT Number: NCT06444633

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

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.

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Key information

Conditions

Diarrhea Toddler

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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.

Primary outcomes

  1. ORS Use (cases in last 4 weeks)

    Time frame: 1-6 months post intervention

    Self-reported ORS use for a case of child diarrhea that occurred within the last 4 weeks.

  2. ORS Use (cases in last 4 weeks)

    Time frame: 1-12 months post intervention

    Self-reported ORS use for a case of child diarrhea that occurred within the last 4 weeks.

  3. ORS Use (cases in last 4 weeks)

    Time frame: Each month from 1-12 months post intervention

    Self-reported ORS use for a case of child diarrhea that occurred within the last 4 weeks.

Secondary outcomes

  1. Zinc + ORS use

    Time frame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention

    Self-reported Zinc + ORS use for a case of child diarrhea that occurred within the last 4 weeks.

  2. Antibiotic use

    Time frame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention

    Self-reported antibiotic use for a case of child diarrhea that occurred within the last 4 weeks.

  3. Zinc use alone

    Time frame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention

    Self-reported Zinc use for a case of child diarrhea that occurred within the last 4 weeks.

  4. Time to ORS initiation

    Time frame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention

    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.

  5. Exposure to unsafe drinking water

    Time frame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention

    Self-reported use of untreated water to prepare ORS for treating diarrhea experienced by a child who is exclusively breastfed.

  6. Willingness to purchase new ORS packets

    Time frame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention

    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.

  7. Child mortality; all cause and from diarrhea

    Time frame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention

    Self-reported mortality (all cause and diarrhea) of children under 5 since intervention

  8. Hospitalization from diarrhea

    Time frame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention

    Self-reported hospitalization (all cause and diarrhea) of children under 5 since intervention

  9. Number of diarrhea episodes

    Time frame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention

    Count of episodes of diarrhea experienced by children who had at least one case of diarrhea since intervention.

  10. Care seeking outside the home

    Time frame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention

    Binary indicator, coded to 1 if caregiver sought care from each type of provider.

  11. Wastage of ORS and zinc packets

    Time frame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Nneka E Osadolor, Ph.D.

CONTACT

[email protected]

+234 7036838618

Sponsors and collaborators

Lead sponsor

RAND

Other

Collaborators

  • Clinton Health Access Initiative, Nigeria
  • Innovations for Poverty Action

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 5, 2024
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.