NCT02870491

Brief Summary

The purpose of this study is to assess how free distribution and preemptive home delivery of oral rehydration salts (ORS) by community health workers affects ORS use. The investigators will measure the impact of the combination of the two interventions (free distribution + pre-emptive home delivery) as well as the impact of each intervention separately (free distribution without home delivery and pre-emptive home delivery without free distribution).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,949

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

10 months

First QC Date

August 9, 2016

Last Update Submit

April 4, 2019

Conditions

Keywords

Child DiarrheaCluster Randomized Controlled TrialOral RehydrationORSZincBracCommunity Health WorkersUganda

Outcome Measures

Primary Outcomes (1)

  • Oral rehydration salt (ORS) use

    Caretaker-reported ORS use to treat a diarrhea episode in the last 4 weeks

    Last 4 weeks

Secondary Outcomes (4)

  • Oral rehydration salt (ORS) with Zinc use

    Last 4 weeks

  • Antibiotic use

    Last 4 weeks

  • Time to Oral rehydration salt (ORS) use

    Last 4 weeks

  • Time to zinc use

    Last 4 weeks

Other Outcomes (2)

  • Oral rehydration salt (ORS) use

    Last 7 days

  • Oral rehydration salt (ORS) use

    current diarrhea episode up to 4 weeks

Study Arms (4)

Control

NO INTERVENTION

Existing standard of care.

Free Distribute+Preemptive Delivery

EXPERIMENTAL

Community health workers (CHWs) will deliver oral rehydration salts (ORS) and zinc for free to all households in their catchment area with a child under 5-years-old at the beginning of the study.

Behavioral: Free DistributionBehavioral: Preemptive Delivery

Cost Sharing + Preemptive Delivery

EXPERIMENTAL

CHWs will visit all households with a child under 5-years-old at the beginning of the study and offer to sell ORS and zinc to caretakers at the time of the visit for them to store in their homes.

Behavioral: Preemptive Delivery

Free Distribution Upon Retrieval

EXPERIMENTAL

CHWs will visit all households with a child under 5-years-old at the beginning of the study and inform caretakers that they have ORS and zinc available for free that caretakers can retrieved from the CHWs home if needed.

Behavioral: Free Distribution

Interventions

Caretakers of children under 5-years-old will have access to free ORS and zinc

Free Distribute+Preemptive DeliveryFree Distribution Upon Retrieval

Caretakers of children under 5-years-old will have ORS and zinc delivered to their home

Cost Sharing + Preemptive DeliveryFree Distribute+Preemptive Delivery

Eligibility Criteria

AgeUp to 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 0-59 months that reside on a village recruited to participate in the study will be included in the intervention. Only children with a diarrhea episode 4-weeks prior to data collection will be included in the analysis.

You may not qualify if:

  • Children without a diarrhea episode in the weeks prior to data collection will be excluded from the analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diarrhea, InfantileDiarrheaDehydration

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsWater-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2016

First Posted

August 17, 2016

Study Start

August 1, 2016

Primary Completion

June 1, 2017

Study Completion

January 1, 2019

Last Updated

April 8, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will share

Data will be made available to the public after the results are published