The Norms and Networks Sanitation Study in India in Tamil Nadu, India (LENNS)
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|ClinicalTrials.gov Identifier: NCT04269824|
Recruitment Status : Active, not recruiting
First Posted : February 17, 2020
Last Update Posted : May 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Behavior, Social Norms, Social||Behavioral: Behavioral intervention package||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22763 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Longitudinal Evaluation of Norms and Networks Study: A Cluster Randomized Controlled Trial to Promote Exclusive Toilet Use in Tamil Nadu, India|
|Actual Study Start Date :||January 5, 2020|
|Estimated Primary Completion Date :||March 25, 2021|
|Estimated Study Completion Date :||July 30, 2021|
Experimental: Intervention Group
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
Community mobilization and commitment events
Audio announcements - Disseminate norms-related messages regarding toilet use and ownership
- 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
- Signal adoption of promoted behaviors to community members
No Intervention: Control Group
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04269824
|Principal Investigator:||Cristina Bicchieri, PhD||University of Pennsylvania|