The Impact of Pre-emptive Home Delivery of ORS + Zinc on Treatment for Child Diarrhea
- Conditions
- Diarrhea Toddler
- Interventions
- Behavioral: Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+Zinc
- Registration Number
- NCT06444633
- Lead Sponsor
- RAND
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 103920
- At least 15 years old
- Has at least one child under 5 at baseline
- Proficiency in English or Hausa
- Living in a temporary home (nomadic population)
- Does not speak English or Hausa
- Unable to give informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+Zinc Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+Zinc Wards randomized to this arm will primarily receive four intervention components as described under the "Intervention" section
- Primary Outcome Measures
Name Time Method ORS Use (cases in last 4 weeks) 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 Outcome Measures
Name Time Method Zinc + ORS use 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.
Antibiotic use 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.
Zinc use alone 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.
Time to ORS initiation 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.
Exposure to unsafe drinking water 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.
Willingness to purchase new ORS packets 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.
Child mortality; all cause and from diarrhea 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
Hospitalization from diarrhea 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
Wastage of ORS and zinc packets 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)
Number of diarrhea episodes 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.
Care seeking outside the home 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.
Trial Locations
- Locations (1)
Clinton Health Access Initiative
🇳🇬Abuja, Nigeria