Behavior, SocialLENNSNCT04269824
The Norms and Networks Sanitation Study in India in Tamil Nadu, India
A study testing Behavioral intervention package in people with Behavior, Social and Norms, Social, run by University of Pennsylvania at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Behavior, Social, Norms, Social
- What is being tested?
- Behavioral intervention package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22,700 participants
- Where
- 1 siteIndia
- Study dates
- 5 Jan 2020to 22 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Longitudinal Evaluation of Norms and Networks Study: A Cluster Randomized Controlled Trial to Promote Exclusive Toilet Use 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.
Read the 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.
- Conditions
- Behavior, Social, Norms, Social
- Being tested
- Behavioral intervention package
- Keywords
- Sanitation, Norms, Toilet Use, Toilet Ownership
- Medical subject headings
- Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral intervention packageBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Behavioral: Behavioral intervention package |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured 12 months after intervention
Secondary outcomes (4)
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: Measured 12 months after intervention
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: Measured 12 months after intervention
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: Measured 12 months after intervention
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: Measured 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start5 Jan 2020
- Primary completion5 Sep 2021
- Study completion22 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behavior, SocialStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22,700 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristina Bicchieri, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269824
- Sponsor's protocol ID
- 833854
- Acronym
- LENNS
- Status last verified
- Nov 2021
- First submitted
- 5 Feb 2020
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized IPD for the surveyed respondents will be made available.
Publications
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.
PubMed 33938805
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Longitudinal Evaluation of Norms and Networks Study: A Cluster Randomized Controlled Trial to Promote Exclusive Toilet Use in Tamil Nadu, India
- ClinicalTrials.gov ID
- NCT04269824
- Acronym / sponsor ID
- LENNS / 833854
- Conditions
- Behavior, Social, Norms, Social
- Keywords
- Sanitation, Norms, Toilet Use, Toilet Ownership
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22,700 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 5 Sep 2021 (actual)
- Study completion
- 22 Oct 2021 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Behavioral intervention packageResidents 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral intervention packageCommunity 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 | Behavioural | Intervention Group |
Primary outcome
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.
4 secondary outcomes
Change in Empirical expectations (beliefs of what other's do) regarding toilet ownership, use and maintenance
Time frame: Measured 12 months after intervention
Change in the proportion of households with improved sanitation facilities
Time frame: Measured 12 months after intervention
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
Change in the usable toilet facilities rates
Time frame: Measured 12 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
- Derived from this study: PubMed 33938805Ashraf 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.
- Individual participant dataSharing planned: Yes. Anonymized IPD for the surveyed respondents will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina Bicchieri, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral intervention package in people with Behavior, Social and Norms, Social, run by University of Pennsylvania at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in exclusive toilet usage rate (time frame: Measured 12 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04269824, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2021.