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Fit Plus: Assessing the Impact of a School-based Intervention on Toilet Quality

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ClinicalTrials.gov Identifier: NCT03204175
Recruitment Status : Completed
First Posted : June 29, 2017
Last Update Posted : March 12, 2018
Sponsor:
Collaborators:
Deutsche Gesellshaft fur Internationale Zusammenarbeit (GIZ) GMBH
Academic Centre for Dentistry in Amsterdam
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Brief Summary:
This study will assess the impact of a school-based water, sanitation, and hygiene management intervention on toilet use and pupil handwashing in the Philippines.

Condition or disease Intervention/treatment Phase
Hand Hygiene Other: FIT Plus Other: Comparator arm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8687 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Randomised Control Trial of a Sanitation Operation and Management Intervention in Elementary Schools in the Philippines (Fit for School Plus)
Actual Study Start Date : July 10, 2017
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : November 30, 2017

Arm Intervention/treatment
Experimental: Fit Plus
The experimental arm will receive the Fit For School expanded intervention, which addresses pupil handwashing, toothbrushing, and school sanitation maintenance. Interventions will begin in July 2017.
Other: FIT Plus
  • Group handwashing facilities
  • Daily group handwashing and toothbrushing activities
  • Sanitation operation and maintenance manuals for school officials
  • Toilet cleaning consumable
  • Toilet and handwashing station maintenance kits
  • Soap, toothbrushes, and toothpaste

Active Comparator: Comparator
This group will receive the Fit Plus intervention after the trial is complete (January 2017)
Other: Comparator arm
This is the same intervention as FIT Plus, but will be delivered to schools following endline data collection




Primary Outcome Measures :
  1. Toilet Usability Index [ Time Frame: 5 months after intervention delivery ]
    The Toilet Usability Index is a composite score based on toilet availability, accessibility, and privacy collected through direct observation of facilities.


Secondary Outcome Measures :
  1. Soap Use Ratio [ Time Frame: 5 months after intervention delivery ]
    The secondary outcome measure is the soap-use ratio per toilet, which will be calculated based on the weight of soap used in one day divided by the number of toileting events in the same day.



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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Attending study school on day of observation

Exclusion Criteria:

  • No predefined exclusion criteria since individual-level data is not recorded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03204175


Locations
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Philippines
GIZ / Fit For School
Manila, Philippines
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Deutsche Gesellshaft fur Internationale Zusammenarbeit (GIZ) GMBH
Academic Centre for Dentistry in Amsterdam

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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT03204175     History of Changes
Other Study ID Numbers: 12238
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No