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| Name | Class |
|---|---|
| Clinton Health Access Initiative, Nigeria | OTHER |
| Innovations for Poverty Action | OTHER |
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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:
All wards in Bauchi state will be randomly assigned to one of two 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delayed-start control | No Intervention | Wards randomly assigned to this arm will not receive any intervention until after endline data collection in completed. During the study period, the caregivers in this group will have standard access to ORS and zinc at local health facilities and pharmacies. Some community health workers in control villages could make household visits; however, any delivery of ORS or zinc in the control group is not expected as community health workers are generally not the source of diarrhea treatment. | |
| Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+Zinc | Experimental | Wards randomized to this arm will primarily receive four intervention components as described under the "Intervention" section |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| ORS Use (cases in last 4 weeks) | Self-reported ORS use for a case of child diarrhea that occurred within the last 4 weeks. | 1-6 months post intervention |
| ORS Use (cases in last 4 weeks) | Self-reported ORS use for a case of child diarrhea that occurred within the last 4 weeks. | 1-12 months post intervention |
| ORS Use (cases in last 4 weeks) | Self-reported ORS use for a case of child diarrhea that occurred within the last 4 weeks. | Each month from 1-12 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Zinc + ORS use | Self-reported Zinc + ORS use for a case of child diarrhea that occurred within the last 4 weeks. | 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention |
| Antibiotic use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nneka E Osadolor, Ph.D. | Contact | +234 7036838618 | onxta@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Zachary Wagner, Ph.D. | RAND | Principal Investigator |
| Stephanie Bonds, Ph.D. | RAND | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinton Health Access Initiative | Recruiting | Abuja | Nigeria |
Deidentified data will be shared in a public repository at the end of the study.
Indefinitely
Re-identification of study participants will not be permitted. Other criteria as set by the repository.
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The study is a parallel, cluster randomized controlled trial, randomizing administrative wards in Bauchi, Nigeria to treatment (receiving pre-emptive, free ORS+Zinc co-packs (2 nos) per child under 5 to households, along with information about proper use of ORS and Zinc for treating child diarrhea) or delayed-start control (receiving intervention after the end of the study period).
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The enumerator and the outcomes assessor will be masked to the assignment of intervention.
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Self-reported antibiotic use for a case of child diarrhea that occurred within the last 4 weeks.
| 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention |
| Zinc use alone | Self-reported Zinc use for a case of child diarrhea that occurred within the last 4 weeks. | 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention |
| 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. | 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention |
| Exposure to unsafe drinking water | Self-reported use of untreated water to prepare ORS for treating diarrhea experienced by a child who is exclusively breastfed. | 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 | 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. | 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 | Self-reported mortality (all cause and diarrhea) of children under 5 since intervention | 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention |
| Hospitalization from diarrhea | Self-reported hospitalization (all cause and diarrhea) of children under 5 since intervention | 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention |
| Number of diarrhea episodes | Count of episodes of diarrhea experienced by children who had at least one case of diarrhea since intervention. | 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention |
| Care seeking outside the home | Binary indicator, coded to 1 if caregiver sought care from each type of provider. | 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 | 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) | 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention |