Working With Community Health Workers to Increase ORS Use in Uganda

April 4, 2019 updated by: University of California, Berkeley

Working With Community Health Workers to Increase Oral Rehydration Salt and Zinc Use to Treat Child Diarrhea in Uganda: A Cluster Randomized Controlled Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7949

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Existing standard of care.
Experimental: Free Distribute+Preemptive Delivery
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 Distribution
Caretakers of children under 5-years-old will have access to free ORS and zinc
Behavioral: Preemptive Delivery
Caretakers of children under 5-years-old will have ORS and zinc delivered to their home
Experimental: Cost Sharing + Preemptive Delivery
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
Caretakers of children under 5-years-old will have ORS and zinc delivered to their home
Experimental: Free Distribution Upon Retrieval
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
Caretakers of children under 5-years-old will have access to free ORS and zinc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral rehydration salt (ORS) use
Time Frame: Last 4 weeks
Caretaker-reported ORS use to treat a diarrhea episode in the last 4 weeks
Last 4 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral rehydration salt (ORS) use
Time Frame: Last 7 days
Caretaker-reported ORS use to treat a diarrhea episode in the last 7 days
Last 7 days
Oral rehydration salt (ORS) use
Time Frame: current diarrhea episode up to 4 weeks
Caretaker-reported ORS use to treat a current diarrhea episode
current diarrhea episode up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Berkeley

Collaborators

Makerere University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

August 9, 2016

First Submitted That Met QC Criteria

August 12, 2016

First Posted (Estimate)

August 17, 2016

Study Record Updates

Last Update Posted (Actual)

April 8, 2019

Last Update Submitted That Met QC Criteria

April 4, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZW-03-28-1983

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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