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

Overview

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.

Interventions

• 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

Primary outcome measures

• ORS Use (cases in last 4 weeks) [Time frame: 1-6 months post intervention]
• ORS Use (cases in last 4 weeks) [Time frame: 1-12 months post intervention]
• ORS Use (cases in last 4 weeks) [Time frame: Each month from 1-12 months post intervention]

Secondary outcome measures (11)

• Zinc + ORS use [Time frame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention]
• Antibiotic use [Time frame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention]
• Zinc use alone [Time frame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention]
• 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]
• 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]
• 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]
• 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]
• Hospitalization from diarrhea [Time frame: 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention]
• 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]
• 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]
• 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

Nigeria · 1 center

• Clinton Health Access Initiative — Abuja

Identifiers

NCT: NCT06444633 · HCAAD201

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗