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Utilizing Community Health Workers to Increase Use of ORS and Zinc to Treat Child Diarrhea in Uganda
Last registered on April 30, 2018

Pre-Trial

Trial Information
General Information
Title
Utilizing Community Health Workers to Increase Use of ORS and Zinc to Treat Child Diarrhea in Uganda
RCT ID
AEARCTR-0001288
Initial registration date
August 08, 2016
Last updated
April 30, 2018 7:47 PM EDT
Location(s)
Primary Investigator
Affiliation
UC Berkeley
Other Primary Investigator(s)
PI Affiliation
Makerere University
PI Affiliation
UC Berkeley
PI Affiliation
UC Berkeley
Additional Trial Information
Status
Completed
Start date
2016-06-01
End date
2017-06-30
Secondary IDs
Abstract
Oral rehydration salts (ORS) and zinc are highly effective at preventing child mortality from diarrhea yet they are widely underused throughout sub-Saharan Africa. This research aims to test the impact of a novel preemptive home-delivery intervention aimed at increasing the use of 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 BRAC's community health promoters (CHPs) 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, we 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 premptive home-delivery separately (i.e. preemptive delivery but not free and free but not preemptive delivery). In additional to informing how best to implement such a program, these interventions will allow us to quantify the extent to which price and distance/convenience are barriers to ORS and zinc use. Under certain assumptions, we will also be able to isolate for the effect of information. We 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. We will also test for differences between intervention groups. The results of the study will be used to inform program scale-up and to provide insight into the remaining barriers to ORS and zinc use.
External Link(s)
Registration Citation
Citation
Asiimwe, John et al. 2018. "Utilizing Community Health Workers to Increase Use of ORS and Zinc to Treat Child Diarrhea in Uganda." AEA RCT Registry. April 30. https://doi.org/10.1257/rct.1288-8.0
Former Citation
Asiimwe, John et al. 2018. "Utilizing Community Health Workers to Increase Use of ORS and Zinc to Treat Child Diarrhea in Uganda." AEA RCT Registry. April 30. https://www.socialscienceregistry.org/trials/1288/history/28970
Sponsors & Partners

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Experimental Details
Interventions
Intervention(s)
Group 1 — Control: No intervention will take place. Caretakers will have standard access to ORS and zinc at local health facilities and pharmacies. Some CHPs in control villages could make household visits, however offers to sell diarrhea treatment pre-emptively are rare and CHPs are generally not the source of diarrhea treatment.

Group 2 — Household Visit + Free Distribution + Preemptive Delivery: CHPs 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. CHPs will train caretakers on the dangers of diarrhea and the importance of ORS and zinc use. CHPs 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: CHPs 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. CHPs will train caretakers on the dangers of diarrhea and the importance of ORS and zinc use. CHPs 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: CHPs 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. CHPs will train caretakers on the dangers of diarrhea and the importance of ORS and zinc use. CHPs will then inform caretakers that they have ORS and zinc available for free that caretakers can retrieved from the CHPs home if needed. The average distance to the CHPs household is about 15 minutes.
Intervention Start Date
2016-09-15
Intervention End Date
2017-02-01
Primary Outcomes
Primary Outcomes (end points)
1. Self reported ORS use for diarrhea episode in last 4 weeks (primary outcome)
2. Self reported zinc use for diarrhea episode in last 4 weeks
3. Self reported antibiotic use for diarrhea episode in last 4 weeks
4. Time (days) between diarrhea initiation and ORS use for diarrhea episode in last 4 weeks
5. Time (days) between diarrhea initiation and zinc use for diarrhea episode in last 4 weeks

Robustness Checks
1. Self reported ORS use for diarrhea episode in last 7 days and for current episode
2. Self reported zinc use for diarrhea episode in last 7 days and for current episode
3. Self reported antibiotic use for diarrhea episode in last 7 days and for current episode
4. Time (days) between diarrhea initiation and ORS use for diarrhea episode in last 7 days and for current episode
5. Time (days) between diarrhea initiation and zinc use for diarrhea episode in last 7 days and for current episode
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
We will use a cluster randomized controlled trial design in 120 villages to measure the impact of the three interventions.

Phase 1 – Listing and enrollment of households: In the first phase of the research CHPs will create a list of all the households with a child under 5-years-old in their catchment area. CHPs will record names of household heads for all households with a child under-5. The 80 households listed that are closest to the CHP's home will be included in the study.

Phase 2 – Baseline Survey: Enumerators will use the list provided by the CHPs and travel to the 40 listed households closest to the CHP's home to conduct a baseline survey. Questionnaires will be completed by primary caretakers and will be recorded in tablet devices. Caretakers that reported a child to have had diarrhea in the past 4-weeks will be asked detailed questions about the diarrhea episode and caretaker treatment decisions. Enumerators will move on quickly from households with no recent diarrhea episode only recording very basic information.

Phase 3 – Randomization and Intervention: Villages will be randomized to 1 of the 4 groups stratified by Brac brach where the CHP reports to (20 CHPs per branch), baseline ORS use, and access to free ORS. After randomization and CHP training, each CHP will carry out the assigned intervention.

Phase 4 – Endline Survey: Four weeks after the interventions are implemented, the 80 closest households to the CHP's home will be re-visited and asked to complete a follow-up survey that will follow the same protocol as the baseline survey. Four weeks will be sufficient time for roughly 25% of children to have a diarrhea episode (Uganda DHS).



Experimental Design Details
Randomization Method
Stratified randomization will be conducted using the randtreat package in StataSE 14
Randomization Unit
Village/CHP
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
120 Villages/CHPs
Sample size: planned number of observations
Total: 9,600 households/caretakers representing 17,280 children under-5 Diarrhea Cases: 2,880 caretakers with a child with a diarrhea episode and 3300 diarrhea episodes
Sample size (or number of clusters) by treatment arms
30 villages/CHPs per group
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
With 120 villages, 80 households enrolled in each village, and 30% of children having a case of diarrhea in the past month (UDHS 2011), we expect to have a final sample of 2880 cases of diarrhea (720 per group). Assuming an intra-class correlation (ICC) of .05, we will be able to detect a minimum of an 11-percentage point increase in ORS use between each group.
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
UC Berkeley Committee for Protection of Human Subjects
IRB Approval Date
2016-03-04
IRB Approval Number
2015067639
Analysis Plan
Analysis Plan Documents
Pre-Analysis Plan_Wagner_08082016

MD5: 4a3e23a860531ecbf22a885a0f2b7caa

SHA1: bd7dd69735c5a1f9dc4cd501ba0f529a7f91947c

Uploaded At: August 08, 2016

Pre-Analysis Plan_Wagner_09272016

MD5: ccfd1ad79c6c0c5926a4ad6f6ed2f9c8

SHA1: 4d7faa08c866eaf47726856d71c7affcf62f7132

Uploaded At: September 27, 2016

Pre-Analysis Plan_Wagner_1117016

MD5: eff7bfa01ff01e8f3bd6f609a7fabc2d

SHA1: 167bce4170ee4a95227de6c43a368b2c7821b76c

Uploaded At: November 17, 2016

Pre-Analysis Plan_Wagner_01302017

MD5: 2a0e4ea77d350a879c5e746e1c259bc9

SHA1: 5edbbc64136f9da107ce28859d0997888e654b6e

Uploaded At: January 30, 2017

Pre-Analysis Plan_Wagner_04022017

MD5: d4916229ae35cd0886963bca222cc0fb

SHA1: 3999477c5ed7848176d0c69739b02bdb152355b1

Uploaded At: April 02, 2017

Stata code for tables 1-15 of analysis plan

MD5: 9854e107e9b37d5c5091c65133b35254

SHA1: ad9bce721ca92c7b62e5cbb6c384c815aa34cc99

Uploaded At: April 02, 2017

Stata code used to create variables used in analysis

MD5: b192c1e4b9d467f3237091196235f108

SHA1: 29aa2349a70f40d18c5d8b851e0ef30f052fbb20

Uploaded At: April 02, 2017

Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
Yes
Intervention Completion Date
April 15, 2017, 12:00 AM +00:00
Is data collection complete?
Yes
Data Collection Completion Date
May 16, 2017, 12:00 AM +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
118 villages (118 Community Health Workers)
Was attrition correlated with treatment status?
No
Final Sample Size: Total Number of Observations
7,949 caretakers, 2,363 cases of diarrhea
Final Sample Size (or Number of Clusters) by Treatment Arms
30 villages in control, 30 villages in Free+Delivery, 29 villages in Home Sales, 29 villages in Vouchers
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers