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Completed

NCT Number: NCT04269824

The Norms and Networks Sanitation Study in India in Tamil Nadu, India

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Swasti

Bangalore, India

About this study

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.

For this cluster-randomized trial, communities will be engaged in two rounds of surveys to assess toilet ownership, toilet usage practices of their family members and include additional questions about beliefs, norms and other factors influencing toilet use. Investigators will also conduct a process evaluation to monitor change from baseline to endline and identify successful pathways of or bottle-necks to the adoption of improved sanitation behaviors. These indicators will include fidelity indicators to assess the quality of intervention delivery, level of community participation, behavioral antecedents, contextual changes in community and household conditions that may facilitate improved behavioral adoption and/or outcomes (e.g., exclusive toilet use). They will also conduct qualitative research using observations and semi-structured interviews with respondents and stakeholders to assess exposure and reactions to the intervention. They will also assess spillover in the control wards using mixed-method assessment tools.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Behavioral intervention package

Behavioral

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

Primary outcomes

  1. Change in exclusive toilet usage rate

    Time frame: Measured 12 months after intervention

    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.

Secondary outcomes

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

    Time frame: Measured 12 months after intervention

    Empirical expectation of toilet ownership, use and maintenance refers to individual's self reported belief of the prevalence of other's toilet ownership, use and maintenance respectively in their own community. It will be assessed via household survey using pre-tested indicators.

  2. Change in the proportion of households with improved sanitation facilities

    Time frame: Measured 12 months after intervention

    An improved sanitation facility is defined as one that hygienically separates human excreta from human contact (WHO/UNICEF JMP 2019). It will be assessed through a household survey and direct observations of the sanitation facility by the surveyors.

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

    Time frame: Measured 12 months after intervention

    Normative expectation of toilet ownership, use and maintenance refers to individual's belief of the prevalence of whether the toilet ownership, use and maintenance is approved by others in their community. It will be assessed via household survey using pre-tested indicators.

  4. Change in the usable toilet facilities rates

    Time frame: Measured 12 months after intervention

    Usable or functional toilet facility will be defined according using WHO/UNICEF JMP 2019 definitions and ascertained during direct observations of toilet facilities during household surveys.

Other outcomes

  1. Change in diarrhea prevalence in children under 5 years

    Time frame: Measured 12 months after intervention

    Diarrhea is defined as 3+ loose or watery stools in 24 hours or 1+ stools with blood in 24 hours. This outcome will be assessed via a household survey conducted between the trained enumerators and participants.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

The Longitudinal Evaluation of Norms and Networks Study: A Cluster Randomized Controlled Trial to Promote Exclusive Toilet Use in Tamil Nadu, India

Acronym: LENNS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 17, 2020
Registry last updated
Nov 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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