Clinical trial NCT04269824: The Norms and Networks Sanitation Study in India in Tamil Nadu, India
Official title: The Longitudinal Evaluation of Norms and Networks Study: A Cluster Randomized Controlled Trial to Promote Exclusive Toilet Use in Tamil Nadu, India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior, Social
Norms, Social
Keywords: Sanitation
Norms
Toilet Use
Toilet Ownership
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 22700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in exclusive toilet usage rate
timeFrame: Measured 12 months after intervention
Secondary outcomes:
measure: Change in Empirical expectations (beliefs of what other's do) regarding toilet ownership, use and maintenance
timeFrame: Measured 12 months after intervention
measure: Change in the proportion of households with improved sanitation facilities
timeFrame: Measured 12 months after intervention
measure: Change in normative expectations (beliefs of what other think you should do) regarding toilet ownership, use and maintenance
timeFrame: Measured 12 months after intervention
measure: Change in the usable toilet facilities rates
timeFrame: Measured 12 months after intervention
Other outcomes:
measure: Change in diarrhea prevalence in children under 5 years
timeFrame: Measured 12 months after intervention
Locations:
city: Bangalore
country: India
facility: Swasti
Study officials:
affiliation: University of Pennsylvania
name: Cristina Bicchieri, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.