Hand HygieneNCT03204175
Fit Plus: Assessing the Impact of a School-based Intervention on Toilet Quality
A study testing FIT Plus and Comparator arm in people with Hand Hygiene, run by London School of Hygiene and Tropical Medicine at 1 site in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Hygiene
- What is being tested?
- FIT Plus and Comparator arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,687 participants
- Where
- 1 sitePhilippines
- Study dates
- 10 Jul 2017to 30 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Attending study school on day of observation
Who cannot join
- No predefined exclusion criteria since individual-level data is not recorded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Control Trial of a Sanitation Operation and Management Intervention in Elementary Schools in the Philippines (Fit for School Plus)
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.
- Conditions
- Hand Hygiene
- Being tested
- FIT Plus, Comparator arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIT PlusOther
- 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
Comparator armOther
This is the same intervention as FIT Plus, but will be delivered to schools following endline data collection
| Study group | Role | What they receive |
|---|---|---|
| Fit Plus | Experimental | 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. Receives: Other: FIT Plus |
| Comparator | Active comparator | This group will receive the Fit Plus intervention after the trial is complete (January 2017) Receives: Other: Comparator arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toilet Usability Index
The Toilet Usability Index is a composite score based on toilet availability, accessibility, and privacy collected through direct observation of facilities.
Measured: 5 months after intervention delivery
Secondary outcomes (1)
Soap Use Ratio
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.
Measured: 5 months after intervention delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start10 Jul 2017
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand HygieneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8,687 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Gesellshaft fur Internationale Zusammenarbeit (GIZ) GMBH, Academic Centre for Dentistry in Amsterdam
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204175
- Sponsor's protocol ID
- 12238
- Status last verified
- Jun 2017
- First submitted
- 28 Jun 2017
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buxton H, Dimaisip-Nabuab J, Duijster D, Monse B, Benzian H, Dreibelbis R. The impact of an operation and management intervention on toilet usability in schools in the Philippines: a cluster randomised controlled trial. BMC Public Health. 2019 Dec 16;19(1):1680. doi: 10.1186/s12889-019-7833-7.
PubMed 31842809
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Control Trial of a Sanitation Operation and Management Intervention in Elementary Schools in the Philippines (Fit for School Plus)
- ClinicalTrials.gov ID
- NCT03204175
- Acronym / sponsor ID
- 12238
- Conditions
- Hand Hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,687 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Deutsche Gesellshaft fur Internationale Zusammenarbeit (GIZ) GMBH, Academic Centre for Dentistry in Amsterdam
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 29 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fit Plus | Experimental | Other: FIT PlusThe 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. |
| Comparator | Active comparator | Other: Comparator armThis group will receive the Fit Plus intervention after the trial is complete (January 2017) |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Attending study school on day of observation
Key exclusion criteria (1 listed)
- No predefined exclusion criteria since individual-level data is not recorded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Fit Plus |
| Comparator armThis is the same intervention as FIT Plus, but will be delivered to schools following endline data collection | Other | Comparator |
Primary outcome
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.
1 secondary outcome
Soap Use Ratio
Time frame: 5 months after intervention delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Derived from this study: PubMed 31842809Buxton H, Dimaisip-Nabuab J, Duijster D, Monse B, Benzian H, Dreibelbis R. The impact of an operation and management intervention on toilet usability in schools in the Philippines: a cluster randomised controlled trial. BMC Public Health. 2019 Dec 16;19(1):1680. doi: 10.1186/s12889-019-7833-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIT Plus and Comparator arm in people with Hand Hygiene, run by London School of Hygiene and Tropical Medicine at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toilet Usability Index (time frame: 5 months after intervention delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03204175, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2018; AzTrials last refreshed its copy on 31 Oct 2026.