Soapy Water Handwashing Stations School Pilot Study
Last registered on April 14, 2015

Pre-Trial

Trial Information
General Information
Title
Soapy Water Handwashing Stations School Pilot Study
RCT ID
AEARCTR-0000662
Initial registration date
April 14, 2015
Last updated
April 14, 2015 9:01 AM EDT
Location(s)
Region
Primary Investigator
Affiliation
University at Buffalo
Other Primary Investigator(s)
PI Affiliation
University at Buffalo
PI Affiliation
Stanford University and Innovations for Poverty Action
PI Affiliation
Innovations for Poverty Action
Additional Trial Information
Status
In development
Start date
2015-05-04
End date
2016-09-15
Secondary IDs
Abstract
Pneumonia and diarrhea continue to be primary causes of death among children under five, accounting for 30% of child mortality in Kenya alone. Research has demonstrated that handwashing with soap prevents pneumonia and diarrhea, but lack of soap provisions and limited piped water infrastructure makes handwashing practices difficult. To make the process of handwashing more convenient, Innovations for Poverty Action has redesigned an existing tippy-tap handwashing system to create a more functional, durable, and innovative handwashing system. The result is a water-efficient, soap-frugal handwashing station that is portable and adaptable to multiple settings. The innovative soap foam dispenser conserves soap by dispensing tactile foam and the water tap is easy to use and conserves water.

This study will assess the feasibility and effectiveness of the redesigned handwashing system when coupled with a handwashing behavioral intervention in peri-urban primary schools in Kisumu, Kenya. Using a cluster-randomized trial approach that incorporates a stepped wedge design, the study seeks to understand usage and maintenance practices related the handwashing stations in primary schools in comparison to existing handwashing practices.
External Link(s)
Registration Citation
Citation
Null, Clair et al. 2015. "Soapy Water Handwashing Stations School Pilot Study." AEA RCT Registry. April 14. https://doi.org/10.1257/rct.662-1.0.
Former Citation
Null, Clair et al. 2015. "Soapy Water Handwashing Stations School Pilot Study." AEA RCT Registry. April 14. http://www.socialscienceregistry.org/trials/662/history/4112.
Sponsors & Partners

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Experimental Details
Interventions
Intervention(s)
Public primary schools will be given water-efficient, soap-frugal handwashing stations. We will also deliver a behavior change intervention to promote proper handwashing practices on the same day that the handwashing stations are delivered to the school, with the students being the main target group.
Intervention Start Date
2015-05-25
Intervention End Date
2015-09-04
Primary Outcomes
Primary Outcomes (end points)
(1) # of schools with handwashing stations (process)
(2) # of people with access to handwashing stations (process)
(3) % of users washing hands with soap after toileting (evaluation)
(4) % of handwashing stations stocked with soap and water (evaluation)
(5) % of handwashing stations that are well maintained and functional (evaluation)
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
The cluster-randomized trial methodology, with features of the stepped wedge design, will be used for the study. Schools that agree to participate in the study will receive the handwashing stations and behavior change intervention sequentially in random order until all schools have received the intervention. The stepped-wedge design will ensure that all schools eventually benefit from the intervention. The design was chosen as hygiene interventions have been shown to do more good than harm, thus it will be more ethical to ensure that all schools selected for the study eventually benefit from the intervention rather than doing nothing in control schools (Brown and Lilford, 2006). This approach will also allow a robust comparison of the effects of the intervention on handwashing behavior among schools with and without exposure to the intervention.
Based on logistical consideration and budgetary implications, we will randomly select 30 schools and divide the schools into 3 groups of 10 schools each. After baseline data collection in all schools at the beginning of the study, the intervention will be initiated in successive groups. Group 1 will receive the intervention during weeks 6-7, Group 2 during weeks 14-15, and Group 3 during weeks 22-23. Follow-up data collection will occur every 2 weeks at all schools during weeks 1-35. After week 35, follow-up data collection will be done every 6 months until month 24. Data collection activities will include interviews with the Head Teacher and WASH Teacher (a teacher dedicated to water, sanitation, and hygiene activities at the school), interviews with selected students in charge of the handwashing stations, rapid observations of water sources and handwashing stations, and structured observations of handwashing behavior.

Brown, C. A., &Lilford, R. J. (2006). The stepped wedge trial design: a systematic review. BMC Medical Research Methodology, 6.doi:10.1186/1471-2288-6-54
Experimental Design Details
Randomization Method
Randomization will be done using a reproducible random selection method from a government-provided list of schools in peri-urban sub-locations using Stata.
Randomization Unit
Schools
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
30 Schools
Sample size: planned number of observations
450 respondents
Sample size (or number of clusters) by treatment arms
10 schools per group with 3 groups, all selected schools will eventually receive the intervention
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Stanford University IRB
IRB Approval Date
2014-08-25
IRB Approval Number
31513-349 (Panel: 2)
IRB Name
Maseno University Ethics Review Committee
IRB Approval Date
2015-10-07
IRB Approval Number
MSU/DRPC/MUERC/00099/14
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports, Papers & Other Materials
Relevant Paper(s)
REPORTS & OTHER MATERIALS