The Impact of Pre-emptive Home Delivery of ORS + Zinc on Treatment for Child Diarrhea
ConditionDiarrhea Toddler
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15+
SponsorRAND
About this trial
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
This trial accepts healthy volunteersQualifiers
At least 15 years old
Has at least one child under 5 at baseline
Proficiency in English or Hausa
Disqualifiers
Living in a temporary home (nomadic population)
Does not speak English or Hausa
Unable to give informed consent
Trial design
Design model
Parallel
Treatments tested in this trial
Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+Zinc
BehavioralThe 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.
Treatment groups
103,920 Participants
are divided into 2 treatment groupsGroup A: Delayed-start controlNo intervention 0 interventions
Group B: Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+ZincExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ORS Use (cases in last 4 weeks)
Self-reported ORS use for a case of child diarrhea that occurred within the last 4 weeks.
Time frame
1-6 months post intervention2
ORS Use (cases in last 4 weeks)
Self-reported ORS use for a case of child diarrhea that occurred within the last 4 weeks.
Time frame
1-12 months post intervention3
ORS Use (cases in last 4 weeks)
Self-reported ORS use for a case of child diarrhea that occurred within the last 4 weeks.
Time frame
Each month from 1-12 months post interventionSecondary outcomes
1
Zinc + ORS use
Self-reported Zinc + ORS use for a case of child diarrhea that occurred within the last 4 weeks.
Time frame
1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention2
Antibiotic use
Self-reported antibiotic use for a case of child diarrhea that occurred within the last 4 weeks.
Time frame
1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention3
Zinc use alone
Self-reported Zinc use for a case of child diarrhea that occurred within the last 4 weeks.
Time frame
1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention4
Time to ORS initiation
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.
Time frame
1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post interventionSponsors and contacts
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RAND
Lead sponsor
Clinton Health Access Initiative, Nigeria
Collaborator
Innovations for Poverty Action
Collaborator
Source ClinicalTrials.gov