NCT04269824

Brief Summary

The objective of this research is to evaluate the impact of a multi-level behavior change intervention designed to promote toilet construction, exclusive toilet use and maintenance in peri-urban communities of Tamil Nadu. The intervention leverages two years of formative research and reflects a norms and network-centric approach that will employ dynamic information dissemination to signal others' sanitation practices while also addressing other barriers to the adoption of improved sanitation practices. The study will determine whether those who received the interventions had significant improvements in toilet usage compared to those who did not. Qualitative research will help assess exposure and reactions to the intervention in these communities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22,700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration 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

January 5, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2021

Completed
Last Updated

November 26, 2021

Status Verified

November 1, 2021

Enrollment Period

1.7 years

First QC Date

February 5, 2020

Last Update Submit

November 16, 2021

Conditions

Keywords

SanitationNormsToilet UseToilet Ownership

Outcome Measures

Primary Outcomes (1)

  • Change in exclusive toilet usage rate

    Exclusive toilet use is measured using self reported use of toilet every time for defecation in the past 2 days. It will be assessed via household survey conducted by trained enumerators and respondents.

    Measured 12 months after intervention

Secondary Outcomes (4)

  • Change in Empirical expectations (beliefs of what other's do) regarding toilet ownership, use and maintenance

    Measured 12 months after intervention

  • Change in the proportion of households with improved sanitation facilities

    Measured 12 months after intervention

  • Change in normative expectations (beliefs of what other think you should do) regarding toilet ownership, use and maintenance

    Measured 12 months after intervention

  • Change in the usable toilet facilities rates

    Measured 12 months after intervention

Other Outcomes (1)

  • Change in diarrhea prevalence in children under 5 years

    Measured 12 months after intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

Residents of the peri-urban ward randomized to this group will receive the norm and network-centric intervention package that includes individual, household, group and community-level interventions. No hardware will be provided. Behavior change components will focus on shifting empirical expectations of improved sanitation behaviors in their wards as well as building capacity to achieve toilet construction and behavioral goals.

Behavioral: Behavioral intervention package

Control Group

NO INTERVENTION

Residents of these wards will not receive any intervention. They may be exposed to other WASH interventions promoted by the government and/or other parties independent of this study.

Interventions

Community mobilization and commitment events * Update factual beliefs * Establish public commitment * Update empirical expectations about toilet use Audio announcements - Disseminate norms-related messages regarding toilet use and ownership Group level \- Facilitated sex-segregated group meetings to share information and action knowledge through increased social connections Network-level social media messages - Transmit norms-related messages, and testimonials of adopters through influential social network members Household-level Counseling visits * Update empirical expectations of improved sanitation behaviors in their community * Motivate improved sanitation practices * Build capacity to achieve exclusive toilet use Stickers/decals \- Signal adoption of promoted behaviors to community members Individual-level * Update empirical expectations of improved behaviors among similar others * Set goals, track progress and maintain improved behavior

Intervention Group

Eligibility Criteria

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

You may qualify if:

  • Site: Peri-urban wards with 60% or less toilet coverage from selected town panchayats in Tamil Nadu.
  • Participants
  • Randomly selected residents of eligible wards above 18 years of age.
  • All households in the intervention wards will receive the LENNS intervention.

You may not qualify if:

  • Site: Slum wards as they will not be representative of our population of interest.
  • Wards that were included in the piloting of the intervention package.
  • Wards enrolled in any water, sanitation or hygiene intervention other than the national program, Swachh Bharat Mission (SBM)
  • Participants:
  • Persons who were reported or deemed cognitively unable to participate in the study and respond to the surveys will be excluded
  • Household members who confirm that they will not reside continuously at that address in the upcoming year
  • Specific household members who do not reside at that residency continuously.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swasti

Bangalore, India

Location

Related Publications (1)

  • Ashraf S, Bicchieri C, Delea MG, Das U, Chauhan K, Kuang J, Shpenev A, Thulin E. Norms and Social Network-Centric Behavior Change Intervention (Nam Nalavazhvu) for Improved Toilet Usage in Peri-Urban Communities of Tamil Nadu: Protocol for a Cluster-Randomized Controlled Trial. JMIR Res Protoc. 2021 May 3;10(5):e24407. doi: 10.2196/24407.

MeSH Terms

Conditions

Social Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Cristina Bicchieri, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2020

First Posted

February 17, 2020

Study Start

January 5, 2020

Primary Completion

September 5, 2021

Study Completion

October 22, 2021

Last Updated

November 26, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will share

Anonymized IPD for the surveyed respondents will be made available.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
The data will be available after the completion of the RCT and will be open access.
Access Criteria
Open access with an application form
More information

Locations