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Working With Community Health Workers to Increase ORS Use in Uganda

Primary Purpose

Infantile Diarrhea, Diarrhea, Dehydration

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Free Distribution
Preemptive Delivery
Sponsored by
University of California, Berkeley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Infantile Diarrhea focused on measuring Child Diarrhea, Cluster Randomized Controlled Trial, Oral Rehydration, ORS, Zinc, Brac, Community Health Workers, Uganda

Eligibility Criteria

undefined - 59 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Arm Label

    Control

    Free Distribute+Preemptive Delivery

    Cost Sharing + Preemptive Delivery

    Free Distribution Upon Retrieval

    Arm Description

    Existing standard of care.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Oral rehydration salt (ORS) use
    Caretaker-reported ORS use to treat a diarrhea episode in the last 4 weeks

    Secondary Outcome Measures

    Oral rehydration salt (ORS) with Zinc use
    Caretaker-reported ORS + zinc use to treat a diarrhea episode in the last 4 weeks
    Antibiotic use
    Caretaker-reported antibiotic use to treat a diarrhea episode in the last 4 weeks
    Time to Oral rehydration salt (ORS) use
    Caretaker-reported time from diarrhea initiation to ORS use
    Time to zinc use
    Caretaker-reported time from diarrhea initiation to zinc use

    Full Information

    First Posted
    August 9, 2016
    Last Updated
    April 4, 2019
    Sponsor
    University of California, Berkeley
    Collaborators
    Makerere University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02870491
    Brief Title
    Working With Community Health Workers to Increase ORS Use in Uganda
    Official Title
    Working With Community Health Workers to Increase Oral Rehydration Salt and Zinc Use to Treat Child Diarrhea in Uganda: A Cluster Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2016 (undefined)
    Primary Completion Date
    June 2017 (Actual)
    Study Completion Date
    January 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, Berkeley
    Collaborators
    Makerere University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).
    Detailed Description
    This research aims to test the impact of a novel preemptive home-delivery intervention aimed at increasing the use of oral rehydration salts (ORS) and zinc for child diarrhea in Uganda. The intervention aims to increase availability of ORS and zinc and reduce barriers to access by having community health workers (CHWs) deliver the products directly to households for free prior to a diarrhea episode. Under this set-up, the products will be readily available for free immediately after a child comes down with diarrhea. Moreover, the investigators will disentangle the mechanisms through which the intervention could change product use by using a multi-armed approach that tests for the impact of free distribution and preemptive home-delivery separately (i.e. preemptive delivery but not free and free but not preemptive delivery). The investigators will use a four-arm cluster randomized controlled trial designed to measure the impact of each of the three interventions on ORS and zinc use for treating child diarrhea relative to a control group. The investigators will enroll 120 CHWs (each located in a different village) and randomly assign each to 1 of 4 groups: Group 1 - Control: No intervention will take place. Caretakers will have standard access to ORS and zinc at local health facilities and pharmacies. Some CHWs in control villages could make household visits, however offers to sell diarrhea treatment preemptively are rare and CHWs are generally not the source of diarrhea treatment. Group 2 - Household Visit + Free Distribution + Preemptive Delivery: CHWs will be provided a small incentive to visit all of the households in their catchment area that contain a child under 5-years-old (roughly 100 households) at the beginning of the study. CHWs will train caretakers on the dangers of diarrhea and the importance of ORS and zinc use. CHWs will then offer to give ORS and zinc to caretakers for free to store in their homes. Group 3 - Household Visit + Cost Sharing + Preemptive Delivery: CHWs will be provided a small incentive to visit all of the households in their catchment area that contain a child under 5-years-old at the beginning of the study. CHWs will train caretakers on the dangers of diarrhea and the importance of ORS and zinc use. CHWs will then offer to sell ORS and zinc to caretakers at their standard subsidized price (roughly USD$0.40 in total per treatment course) to store in their homes. Group 4 - Household Visit + Free Distribution Upon Retrieval: CHWs will be provided a small incentive to visit all of the households in their catchment area that contain a child under 5-years-old at the beginning of the study. CHWs will train caretakers on the dangers of diarrhea and the importance of ORS and zinc use. CHWs will then inform caretakers that they have ORS and zinc available for free that caretakers can retrieved from the CHWs home if needed. The average distance to the CHWs household is about 15 minutes. Groups 2-4 compared to Group 1 measures the impact of each of the different ways of arranging the program. Group 3 compared to Group 2 measures the price effect. Group 4 compared to Group 2 measures the distance/convenience effect. Group 2 compared to Group 1 measures the combination of the price and distance/convenience effect.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infantile Diarrhea, Diarrhea, Dehydration
    Keywords
    Child Diarrhea, Cluster Randomized Controlled Trial, Oral Rehydration, ORS, Zinc, Brac, Community Health Workers, Uganda

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    7949 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Existing standard of care.
    Arm Title
    Free Distribute+Preemptive Delivery
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Cost Sharing + Preemptive Delivery
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Free Distribution Upon Retrieval
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Free Distribution
    Intervention Description
    Caretakers of children under 5-years-old will have access to free ORS and zinc
    Intervention Type
    Behavioral
    Intervention Name(s)
    Preemptive Delivery
    Intervention Description
    Caretakers of children under 5-years-old will have ORS and zinc delivered to their home
    Primary Outcome Measure Information:
    Title
    Oral rehydration salt (ORS) use
    Description
    Caretaker-reported ORS use to treat a diarrhea episode in the last 4 weeks
    Time Frame
    Last 4 weeks
    Secondary Outcome Measure Information:
    Title
    Oral rehydration salt (ORS) with Zinc use
    Description
    Caretaker-reported ORS + zinc use to treat a diarrhea episode in the last 4 weeks
    Time Frame
    Last 4 weeks
    Title
    Antibiotic use
    Description
    Caretaker-reported antibiotic use to treat a diarrhea episode in the last 4 weeks
    Time Frame
    Last 4 weeks
    Title
    Time to Oral rehydration salt (ORS) use
    Description
    Caretaker-reported time from diarrhea initiation to ORS use
    Time Frame
    Last 4 weeks
    Title
    Time to zinc use
    Description
    Caretaker-reported time from diarrhea initiation to zinc use
    Time Frame
    Last 4 weeks
    Other Pre-specified Outcome Measures:
    Title
    Oral rehydration salt (ORS) use
    Description
    Caretaker-reported ORS use to treat a diarrhea episode in the last 7 days
    Time Frame
    Last 7 days
    Title
    Oral rehydration salt (ORS) use
    Description
    Caretaker-reported ORS use to treat a current diarrhea episode
    Time Frame
    current diarrhea episode up to 4 weeks

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    59 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: Children without a diarrhea episode in the weeks prior to data collection will be excluded from the analysis.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Data will be made available to the public after the results are published

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