NCT02703974

Brief 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. Based on the success of the preliminary pilot, we hypothesize nudges leading to higher rates of handwashing than traditional handwashing and hygiene education programs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2016

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

February 18, 2016

Last Update Submit

November 18, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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

    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

    Weeks 4-5, Weeks 6-7, Week 12, Weeks 18-19, Weeks 24-25

Study Arms (4)

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.

Behavioral: Early handwashing stationBehavioral: 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.

Behavioral: Late handwashing stationBehavioral: 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.

Behavioral: Early handwashing stationBehavioral: 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.

Behavioral: Late handwashing stationBehavioral: Education

Interventions

A 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.

Early handwashing station + educationEarly handwashing station + nudge

A 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.

Late handwashing station + educationLate handwashing station + nudge
NudgeBEHAVIORAL

A 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.

Early handwashing station + nudgeLate handwashing station + nudge
EducationBEHAVIORAL

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.

Early handwashing station + educationLate handwashing station + education

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Save the Children

Dhaka, 1212, Bangladesh

Location

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Kamal Hossain

    Save the Children

    STUDY DIRECTOR
  • Mohini Venkatesh

    Save the Children

    STUDY DIRECTOR
  • Pavani K Ram, MD

    University at Buffalo

    STUDY DIRECTOR
  • Elise N Grover, MSPH

    University of Oklahoma

    STUDY DIRECTOR
  • Robert Dreibelbis, PhD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2016

First Posted

March 9, 2016

Study Start

March 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

November 22, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Data on individual participants will not be shared.

Locations