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

Behavior, Social Clinical Trial

— LENNS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04269824
• Other study ID #: 833854
• Status: Completed
• Phase: N/A
• Start date: January 5, 2020
• Est. completion date: October 22, 2021

Study information

• Verified date: November 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22700
• Est. completion date: October 22, 2021
• Est. primary completion date: September 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Behavior, Social
• Norms, Social

Intervention

Behavioral:
• Behavioral intervention package
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

Locations

Country	Name	City	State
India	Swasti	Bangalore

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in diarrhea prevalence in children under 5 years	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.	Measured 12 months after intervention
Primary	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	Change in Empirical expectations (beliefs of what other's do) regarding toilet ownership, use and maintenance	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.	Measured 12 months after intervention
Secondary	Change in the proportion of households with improved sanitation facilities	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.	Measured 12 months after intervention
Secondary	Change in normative expectations (beliefs of what other think you should do) regarding toilet ownership, use and maintenance	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.	Measured 12 months after intervention
Secondary	Change in the usable toilet facilities rates	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.	Measured 12 months after intervention