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临床试验/NCT04269824
NCT04269824已完成不适用

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

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 22,700 人开始时间: 2020年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22,700
试验地点
1
主要终点
Change in exclusive toilet usage rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Change in exclusive toilet usage rate

时间窗: 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.

次要结局

  • Change in Empirical expectations (beliefs of what other's do) regarding toilet ownership, use and maintenance(Measured 12 months after intervention)
  • Change in the usable toilet facilities rates(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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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