NCT04526171

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,483

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

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

Study Start

First participant enrolled

August 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 25, 2020

Completed
Last Updated

August 27, 2020

Status Verified

August 1, 2020

Enrollment Period

7 months

First QC Date

August 17, 2020

Last Update Submit

August 25, 2020

Conditions

Behavior

Keywords

sanitationtoiletbehaviorevaluation

Outcome Measures

Primary Outcomes (1)

  • Proportion of households where all members above the age of 5 years were reported to use the toilet the last time they defecated.

    The survey was addressed to one adult respondent per household, preferably the male or female household head

    A gap of 6 weeks was maintained between campaign roll out and endline data collection

Secondary Outcomes (2)

  • Exposure to the intervention

    Six weeks post intervention delivery

  • Perceptions related to toilet use

    Six weeks post intervention delivery

Study Arms (2)

Vaparshun

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

No intervention was delivered to clusters in the control arm.

Interventions

VaparshunBEHAVIORAL

Participants in the intervention clusters were encouraged to improve their existing toilets.

Also known as: 5 Star Toilet Campaign
Vaparshun

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Households with a functional government or contractor built toilet.

You may not qualify if:

  • Households with self built toilet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indian Institute of Public Health/ Public Health Foundation of India

Gandhinagar, Gujarat, 382042, India

Location

Related Publications (1)

  • 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.

    PMID: 32917160DERIVED

Related Links

MeSH Terms

Conditions

Behavior

Study Officials

  • Deepak o Saxena, PhD

    IIPHG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 17, 2020

First Posted

August 25, 2020

Study Start

August 1, 2018

Primary Completion

February 28, 2019

Study Completion

March 31, 2019

Last Updated

August 27, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

All collected IPD.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Now.
Access Criteria
Unlimited.
More information

Available IPD Datasets

Individual Participant Data Set Access

Locations

IN(1)