Hand DisinfectionNCT02703974
Nudging Handwashing: a Cluster-randomized Trial in Bangladesh
A study testing Early handwashing station, Late handwashing station and Nudge in people with Hand Disinfection, run by University of Oklahoma at 1 site in Bangladesh.
Trial summary
The study will collect and analyze quantitative data regarding handwashing behaviors among school-aged children to determine the impact of nudges compared to handwashing and hygiene education programs. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hand Disinfection
- What is being tested?
- Early handwashing station, Late handwashing station and Nudge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBangladesh
- Study dates
- Mar 2016to Aug 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- schools in Dhunat, Gurudaspur and Boraigram Upazilla (sub districts) of Bogra and Natore districts of Rajshahi Division that that meet the following inclusion criteria:
- No hygiene education programs in the last two years
- No handwashing stations or facilities on school grounds
- Improved sanitation/toilets facilities (latrines)
- Water supply on site or within 3-6 meters of the school
- A school population between 125-450 students, and
- A government primary school (all co-ed)
- Willingness of the school principle / head teacher and a representative of the School Management Committee (SMC) to participate in the proposed research
Who cannot join
- Located outside of Dhunat, Gurudaspur and Boraigram Upazilla (sub districts) of Bogra and Natore districts of Rajshahi Division
- Have had a hygiene education program in the last two years
- Already has handwashing stations or facilities on school grounds
- Does not have improved sanitation/toilets facilities (latrines)
- Does not have water supply on site or within 3-6 meters of the school
- Has a school population under 125 or over 450 students
- Is not a government primary school or is not co-ed
- School principle / head teacher or representative of the School Management Committee (SMC) is not willing to participate in the proposed research
Trial locations and contacts
1 site in 1 country.
About this study
The study will collect and analyze quantitative data regarding handwashing behaviors among school-aged children to determine the impact of nudges compared to handwashing and hygiene education programs.
Based on the success of the preliminary pilot, we hypothesize nudges leading to higher rates of handwashing than traditional handwashing and hygiene education programs.
Read the detailed description
This study will utilize a cluster-randomized trial design to collect quantitative data and analyze the handwashing behaviors of school-aged children.
The primary purpose of this protocol is to assess nudges as a viable method of promoting handwashing among school-aged children.
The specific objectives of this quantitative exploration are to:
- Determine if nudges can prompt significant behavior change and result in higher rates of handwashing among school-aged children in Bangladesh
- Determine if behavior change resulting from nudging is sustainable over time
- Conditions
- Hand Disinfection
- Being tested
- Early handwashing station, Late handwashing station, Nudge, Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early handwashing stationBehavioural
A handwashing station will be a dedicated location for handwashing in each selected school and will include:
- A raised concrete platform (built to child height)
- A plastic container with a lid and spigot
- Soap
The early handwashing stations will be constructed in weeks 1 and 2 of the study, after the baseline observations (Phase I) are complete.
Late handwashing stationBehavioural
A handwashing station will be a dedicated location for handwashing in each selected school and will include:
- A raised concrete platform (built to child height)
- A plastic container with a lid and spigot
- Soap
The late handwashing stations construction will begin after Phase 2 data collection has been finished at the end of week 3.
NudgeBehavioural
A nudge will be built in each randomly selected school and will consist of:
- Connecting latrines to the handwashing station via paved pathways that are painted bright colors
- Painting footprints on infrastructure guiding students to the handwashing stations and handprints on stations
The nudges will be constructed at the end of week 3 and 4, after Phase II data collection is complete within each randomly assigned nudge school.
EducationBehavioural
Hand hygiene education-based program: the hygiene promotion element will include a one month program of handwashing education involving weekly facilitator led sessions. Each session will be about 30-45 minutes long, and will cover the following topics:
- Importance of handwashing
- Method of handwashing
- Critical times of handwashing
- Finding solutions for handwashing in school and at home The sessions will involve use of flipcharts, and other IEC materials (e.g. videos) and participative learning methods.
The Hand hygiene education-based program will begin at the beginning of weeks 4 and 5, after Phase II data collection is complete in each randomly assigned education school.
| Study group | Role | What they receive |
|---|---|---|
| Early handwashing station + nudge | Experimental | This arm will include 5 randomly selected schools that will have had handwashing stations built after the baseline observation (Phase I), and nudges built after Phase II data collection. Receives: Behavioral: Early handwashing station; Behavioral: Nudge |
| Late handwashing station + nudge | Experimental | This arm will include 5 randomly selected schools that will have had handwashing stations and nudges built at the same time, after Phase II data collection. Receives: Behavioral: Late handwashing station; Behavioral: Nudge |
| Early handwashing station + education | Active comparator | This arm will include 5 randomly selected schools that will have had handwashing stations built after the baseline observation (Phase I), and will receive a Hand hygiene education-based program, after Phase II data collection is complete. Receives: Behavioral: Early handwashing station; Behavioral: Education |
| Late handwashing station + education | Active comparator | This arm will include 5 randomly selected schools that will have had handwashing stations built after Phase II data collection is complete, when the Hand hygiene education-based program will commence. Receives: Behavioral: Late handwashing station; Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the probability of handwashing with soap after a toileting event among students receiving nudge intervention compared to that of students in hygiene education group
Students will be randomized into Nudge intervention or Hygiene Education intervention at the completion of data collection in week 6, and the change in probability, or prevalence ratio, will be assessed over time, with measures at weeks 4-5, weeks 6-7, week 12, weeks 18-19 and weeks 24-25, comparing the probability of handwashing of nudge students post-toileting event to that of hygiene education students post-toileting event, measured using camera observations of the handwashing station outside of the latrine area.
Measured: Weeks 6-7, Week 12, Weeks 18-19, Weeks 24-25
Secondary outcomes (3)
Change in the probability of handwashing with soap after a toileting event among students who received the early handwashing station intervention compared to students who received the late handwashing station intervention
Students will be randomized into early handwashing station intervention (built in weeks 1-2) or late handwashing station intervention (built in weeks 3 and 4), and the change in probability, or prevalence ratio, will be assessed at week 2-3 and week 4-5, comparing the probability of handwashing of the early handwashing station students post-toileting event to that of the late handwashing station students post-toileting event, measured using camera observations of the handwashing station outside of the latrine area.
Measured: Weeks 2-3, Weeks 4-5
Change in the probability of handwashing with soap after a toileting event within the nudge intervention group, comparing students in the early handwashing station intervention to students in the late handwashing station intervention
In order to assess if the timing of the handwashing station building influences handwashing, the change in probability, or prevalence ratio, will be assessed over time, with observations at weeks 4-5, weeks 6-7, week 12, weeks 18-19 and weeks 24-25 within the Nudge group, comparing the probability of handwashing among students who received the early handwashing station (built in weeks 1 and 2) to the probability of handwashing among those students who received the late handwashing stations (built in weeks 3 and 4), measured using camera observations of the handwashing station outside of the latrine area.
Measured: Weeks 4-5, Weeks 6-7, Week 12, Weeks 18-19, Weeks 24-25
Change in the probability of handwashing with soap after a toileting event within the hygiene education intervention group, comparing students in the early handwashing station intervention to students in the late handwashing station intervention
In order to assess if the timing of the handwashing station building influences handwashing, the change in probability, or prevalence ratio, will be assessed over time, with observations at weeks 4-5, weeks 6-7, week 12, weeks 18-19 and weeks 24-25 within the Hygiene Education group, comparing the probability of handwashing among students who received the early handwashing station (built in weeks 1 and 2) to the probability of handwashing among those students who received the late handwashing stations (built in weeks 3 and 4), measured using camera observations of the handwashing station outside of the latrine area.
Measured: Weeks 4-5, Weeks 6-7, Week 12, Weeks 18-19, Weeks 24-25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand DisinfectionStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Save the Children, University at Buffalo
- Responsible party
- Sponsor
- Investigators
- Kamal Hossain, Study director, Save the ChildrenMohini Venkatesh, Study director, Save the ChildrenPavani K Ram, MD, Study director, University at BuffaloElise N Grover, MSPH, Study director, University of OklahomaRobert Dreibelbis, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703974
- Sponsor's protocol ID
- 6304
- Status last verified
- Nov 2016
- First submitted
- 18 Feb 2016
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data on individual participants will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nudging Handwashing: a Cluster-randomized Trial in Bangladesh
- ClinicalTrials.gov ID
- NCT02703974
- Acronym / sponsor ID
- 6304
- Conditions
- Hand Disinfection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Save the Children, University at Buffalo
- Study start
- Mar 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 9 Mar 2016 (estimated)
- 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.
The study will collect and analyze quantitative data regarding handwashing behaviors among school-aged children to determine the impact of nudges compared to handwashing and hygiene education programs.
Based on the success of the preliminary pilot, we hypothesize nudges leading to higher rates of handwashing than traditional handwashing and hygiene education programs.
Detailed description
This study will utilize a cluster-randomized trial design to collect quantitative data and analyze the handwashing behaviors of school-aged children.
The primary purpose of this protocol is to assess nudges as a viable method of promoting handwashing among school-aged children.
The specific objectives of this quantitative exploration are to:
- Determine if nudges can prompt significant behavior change and result in higher rates of handwashing among school-aged children in Bangladesh
- Determine if behavior change resulting from nudging is sustainable over time
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Early handwashing station + nudge | Experimental | Behavioral: Early handwashing station, Behavioral: NudgeThis arm will include 5 randomly selected schools that will have had handwashing stations built after the baseline observation (Phase I), and nudges built after Phase II data collection. |
| Late handwashing station + nudge | Experimental | Behavioral: Late handwashing station, Behavioral: NudgeThis arm will include 5 randomly selected schools that will have had handwashing stations and nudges built at the same time, after Phase II data collection. |
| Early handwashing station + education | Active comparator | Behavioral: Early handwashing station, Behavioral: EducationThis arm will include 5 randomly selected schools that will have had handwashing stations built after the baseline observation (Phase I), and will receive a Hand hygiene education-based program, after Phase II data collection is complete. |
| Late handwashing station + education | Active comparator | Behavioral: Late handwashing station, Behavioral: EducationThis arm will include 5 randomly selected schools that will have had handwashing stations built after Phase II data collection is complete, when the Hand hygiene education-based program will commence. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- schools in Dhunat, Gurudaspur and Boraigram Upazilla (sub districts) of Bogra and Natore districts of Rajshahi Division that that meet the following inclusion criteria:
Key exclusion criteria (8 listed)
- Located outside of Dhunat, Gurudaspur and Boraigram Upazilla (sub districts) of Bogra and Natore districts of Rajshahi Division
- Have had a hygiene education program in the last two years
- Already has handwashing stations or facilities on school grounds
- Does not have improved sanitation/toilets facilities (latrines)
- Does not have water supply on site or within 3-6 meters of the school
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 |
|---|---|---|
| Early handwashing stationA handwashing station will be a dedicated location for handwashing in each selected school and will include: 1. A raised concrete platform (built to child height) 2. A plastic container with a lid and spigot 3. Soap The early handwashing stations will be constructed in weeks 1 and 2 of the study, after the baseline observations (Phase I) are complete. | Behavioural | Early handwashing station + education, Early handwashing station + nudge |
| Late handwashing stationA handwashing station will be a dedicated location for handwashing in each selected school and will include: 1. A raised concrete platform (built to child height) 2. A plastic container with a lid and spigot 3. Soap The late handwashing stations construction will begin after Phase 2 data collection has been finished at the end of week 3. | Behavioural | Late handwashing station + education, Late handwashing station + nudge |
| NudgeA nudge will be built in each randomly selected school and will consist of: 1. Connecting latrines to the handwashing station via paved pathways that are painted bright colors 2. Painting footprints on infrastructure guiding students to the handwashing stations and handprints on stations The nudges will be constructed at the end of week 3 and 4, after Phase II data collection is complete within each randomly assigned nudge school. | Behavioural | Early handwashing station + nudge, Late handwashing station + nudge |
| EducationHand hygiene education-based program: the hygiene promotion element will include a one month program of handwashing education involving weekly facilitator led sessions. Each session will be about 30-45 minutes long, and will cover the following topics: * Importance of handwashing * Method of handwashing * Critical times of handwashing * Finding solutions for handwashing in school and at home The sessions will involve use of flipcharts, and other IEC materials (e.g. videos) and participative learning methods. The Hand hygiene education-based program will begin at the beginning of weeks 4 and 5, after Phase II data collection is complete in each randomly assigned education school. | Behavioural | Early handwashing station + education, Late handwashing station + education |
Primary outcome
Change in the probability of handwashing with soap after a toileting event among students receiving nudge intervention compared to that of students in hygiene education group
Time frame: Weeks 6-7, Week 12, Weeks 18-19, Weeks 24-25
Students will be randomized into Nudge intervention or Hygiene Education intervention at the completion of data collection in week 6, and the change in probability, or prevalence ratio, will be assessed over time, with measures at weeks 4-5, weeks 6-7, week 12, weeks 18-19 and weeks 24-25, comparing the probability of handwashing of nudge students post-toileting event to that of hygiene education students post-toileting event, measured using camera observations of the handwashing station outside of the latrine area.
3 secondary outcomes
Change in the probability of handwashing with soap after a toileting event among students who received the early handwashing station intervention compared to students who received the late handwashing station intervention
Time frame: Weeks 2-3, Weeks 4-5
Change in the probability of handwashing with soap after a toileting event within the nudge intervention group, comparing students in the early handwashing station intervention to students in the late handwashing station intervention
Time frame: Weeks 4-5, Weeks 6-7, Week 12, Weeks 18-19, Weeks 24-25
Change in the probability of handwashing with soap after a toileting event within the hygiene education intervention group, comparing students in the early handwashing station intervention to students in the late handwashing station intervention
Time frame: Weeks 4-5, Weeks 6-7, Week 12, Weeks 18-19, Weeks 24-25
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 22 Nov 2016.
- Individual participant dataSharing planned: No. Data on individual participants will not be shared.
Related trials for Hand Disinfection
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Hand, Hygiene Practices and Knowledge
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.
Kamal Hossain study director
Save the Children
Mohini Venkatesh study director
Save the Children
Pavani K Ram, MD study director
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early handwashing station, Late handwashing station and Nudge in people with Hand Disinfection, run by University of Oklahoma at 1 site in Bangladesh.
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 8 inclusion and 8 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 22 Nov 2016. 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 Bangladesh. 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?
Change in the probability of handwashing with soap after a toileting event among students receiving nudge intervention compared to that of students in hygiene education group (time frame: Weeks 6-7, Week 12, Weeks 18-19, Weeks 24-25). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2016.