Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vaparshun Improving Toilet Use in Rural India

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Behavior Behavioral: Vaparshun Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2483 participants
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
Official Title: Vaparshun Improving Toilet Use in Rural India (The 5 Star Toilet Campaign)
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : March 31, 2019

Arm Intervention/treatment
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.
Behavioral: Vaparshun
Participants in the intervention clusters were encouraged to improve their existing toilets.
Other Name: 5 Star Toilet Campaign

No Intervention: Control Arm
No intervention was delivered to clusters in the control arm.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Exposure to the intervention [ Time Frame: Six weeks post intervention delivery ]
    Proportion of population in intervention arm that reports attending intervention events

  2. 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"



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Households with a functional government or contractor built toilet.

Exclusion Criteria:

  • Households with self built toilet.

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): NCT04526171


Locations
Layout table for location information
India
Indian Institute of Public Health/ Public Health Foundation of India
Gandhinagar, Gujarat, India, 382042
Sponsors and Collaborators
Public Health Foundation of India
London School of Hygiene and Tropical Medicine
Investigators
Layout table for investigator information
Principal Investigator: Deepak o Saxena, PhD IIPHG
  Study Documents (Full-Text)

Documents provided by Deepak Saxena, Public Health Foundation of India:
Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Deepak Saxena, Professor, Public Health Foundation of India
ClinicalTrials.gov Identifier: NCT04526171    
Other Study ID Numbers: PHFindia
First Posted: August 25, 2020    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected IPD.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Now.
Access Criteria: Unlimited.
URL: http://dataverse.harvard.edu/dataset.xhtml?persistentId=doi:10.7910/DVN/Q3P4WX

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Deepak Saxena, Public Health Foundation of India:
sanitation
toilet
behavior
evaluation