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Vaparshun Improving Toilet Use in Rural India

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ClinicalTrials.gov Identifier: NCT04526171
Recruitment Status : Completed
First Posted : August 25, 2020
Last Update Posted : August 27, 2020
Sponsor:
Collaborator:
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Deepak Saxena, Public Health Foundation of India

Tracking Information
First Submitted Date  ICMJE August 17, 2020
First Posted Date  ICMJE August 25, 2020
Last Update Posted Date August 27, 2020
Actual Study Start Date  ICMJE August 1, 2018
Actual Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2020)
Proportion of households where all members above the age of 5 years were reported to use the toilet the last time they defecated. [ Time Frame: A gap of 6 weeks was maintained between campaign roll out and endline data collection ]
The survey was addressed to one adult respondent per household, preferably the male or female household head
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2020)
  • Exposure to the intervention [ Time Frame: Six weeks post intervention delivery ]
    Proportion of population in intervention arm that reports attending intervention events
  • Perceptions related to toilet use [ Time Frame: Six weeks post intervention delivery ]
    Agreement with statements reflecting important campaign messages such as "Toilets are not just for women; men should use them too", "A smart person is one who uses a toilet", or (phrased negatively) "Toilet pits fill quickly if too many people in the household use them"
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vaparshun Improving Toilet Use in Rural India
Official Title  ICMJE Vaparshun Improving Toilet Use in Rural India (The 5 Star Toilet Campaign)
Brief Summary Vaparshun intervention aimed to inspire the target audience to use a toilet. It aimed to revalue their toilets by recognizing that they provide benefits associated with the motives of hoard, create, convenience (comfort) and affiliation, and provide a reward pathway for transitioning to a new toilet use routine.
Detailed Description

Our intervention consists of four different streams of activity. The outcome is that family members and men improve and use their contractor-built toilets. The activities are listed below.

  1. Create Motive:

    Toilet Makeover: Conduct a lottery and perform makeovers of select government built toilets in the village, with the involvement of the community. Demonstrate improvements in comfort (light, space, ventilation, latrine chair/handle) and aesthetics (stencil painting of door and walls).

    Challenge/Opportunity: Many of the 'contractor' toilets are built with low engagement from family members and are uncomfortable to use. People are left with toilets they are not proud of or engaged with.

    Insight (from 'makeover' trial): If families invest in creating an attractive toilet they are be more likely adopt and use them.

    Inputs: Materials for the physical and aesthetic improvement of a toilet, manuals for conducting the community event.

    Outputs: Greater engagement with, and pride in, the toilet after makeover; others in the village inspired to conduct their own makeover. Those who use the upgraded toilet find it a more comfortable experience than they had expected causing reinforcement learning.

  2. Hoard motive:

    Pit Emptying Demo and Pit Filling Estimation Demo" A community event-based discussion of the 'real' aspects related to pit filling/emptying designed to graphically overcome their perceptual barriers (e.g., squeezing a watermelon to show how little material there is in faeces).

    Challenge/Opportunity: People over-estimate the speed at which a pit fills and are uncertain about the emptying process. Therefore they hoard the 'limited' pit space by using the toilet only partially.

    Insight from FR: There are gaps between perception and reality which can be addressed. For example; water doesn't stay in the pit but seeps into the soil, faeces are composed mainly of water, decomposition reduces volume, compost doesn't smell and twin pits can be used interchangeably forever.

    Inputs: Films and 'emo-demos' (emotional demonstrations). Outputs: Participants are less anxious about pit filling and emptying.

  3. Affiliation/convenience motives:

    Community Motivational Events: Small and large community events such as street plays, films, posters and pledging activities to bring alive convenience/comfort motives by amplifying problems associated with OD and rewards of using toilets; use of affiliation through testimonials films, posters, village maps, etc.

    Challenge/Opportunity: Even if the barriers around pits and toilet comfort are addressed, it may still not be enough to motivate men with entrenched habits of OD to start using toilets.

    Insights: Convenience/comfort can be a powerful drive for toilet usage. Those who use toilets in the village (women, children and elderly) find it is much more convenient and therefore do not return to OD. However, men who are non-users may not have experienced this and need to be convinced. Affiliation can be another strong drive for toilet usage. It is possible to exploit the emerging norms of toilet use and encourage men 'not to be left behind'.

    Inputs: Scripts, props, invitations, loud hailers, audio-visual equipment, etc. Outputs: Men use toilets because they 'get' how convenient they are, and so as not to be 'left behind'.

  4. Transition to a new toilet use This would include testimonial videos of toilet users and toilet board of household members who improved their toilets. Providing certificate to households who improved their toilets.

Challenge/Opportunity: Those who use toilets for a specific period tend to stick with the habit; however, some people, especially men, do not try out the toilet or find the first experience unpleasant.

Insight: Reward the use of toilets for a specific period so new habits can form.

Inputs: Stimuli and nudges. Outputs: The entire family, especially men, form the habit of using a toilet.

In addition, village authorities will also be recruited to support delivery of the intervention.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The study was a cluster-randomised trial with 47 intervention and 47 control clusters, with a baseline and an endline survey conducted in the district of Bhavnagar, Gujarat, India. Briefly, 94 villages were randomised to intervention or control groups. We carried out a household census and from this we selected 10 households with a functional 'government' toilet for a baseline and 30 for follow up at endline using random sampling from the census list for each village. Outcomes were measured as the proportion of households where all members were reported to use the toilet and the overall usage of toilets by individuals, employing a standard questionnaire.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Behavior
Intervention  ICMJE Behavioral: Vaparshun
Participants in the intervention clusters were encouraged to improve their existing toilets.
Other Name: 5 Star Toilet Campaign
Study Arms  ICMJE
  • Experimental: Vaparshun
    In intervention clusters, two full day events, with a gap of 4 weeks between the two events, were organized at cluster level. Eligible households with a government or contract tor built toilet were invited to enroll for a toilet makeover. Intervention activities, delivered at cluster level, included films on toilet improvement, comfort and convenience of toile use, addressing pit filling anxiety and celebrating proud toilet owners by providing certificates and acknowledging them during the events.
    Intervention: Behavioral: Vaparshun
  • No Intervention: Control Arm
    No intervention was delivered to clusters in the control arm.
Publications * Schmidt WP, Chauhan K, Bhavsar P, Yasobant S, Patwardhan V, Aunger R, Mavalankar D, Saxena D, Curtis V. Cluster-randomised trial to test the effect of a behaviour change intervention on toilet use in rural India: results and methodological considerations. BMC Public Health. 2020 Sep 11;20(1):1389. doi: 10.1186/s12889-020-09501-y.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 20, 2020)
2483
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 31, 2019
Actual Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- Households with a functional government or contractor built toilet.

Exclusion Criteria:

  • Households with self built toilet.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04526171
Other Study ID Numbers  ICMJE PHFindia
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All collected IPD.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Now.
Access Criteria: Unlimited.
URL: http://dataverse.harvard.edu/dataset.xhtml?persistentId=doi:10.7910/DVN/Q3P4WX
Current Responsible Party Deepak Saxena, Public Health Foundation of India
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Public Health Foundation of India
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE London School of Hygiene and Tropical Medicine
Investigators  ICMJE
Principal Investigator: Deepak o Saxena, PhD IIPHG
PRS Account Public Health Foundation of India
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP