Latrine UsageNCT03274245
Evaluating a Latrine Use Intervention in Odisha, India
A study testing Intervention Package and Qualitative Research in people with Latrine Usage, run by Emory University at 1 site in India.
Trial summary
The objective of this research is to evaluate an intervention focused on increasing latrine use in rural Odisha India. The present study builds off of previous research, which resulted in the design of an intervention to increase latrine use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Latrine Usage
- What is being tested?
- Intervention Package and Qualitative Research
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,722 participants
- Where
- 1 siteIndia
- Study dates
- 30 Jan 2018to 13 Apr 2019
- 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
- Estimated 60% latrine coverage or higher
- At least 75 households
- Have a village leader willing to participate
Who cannot join
- Considered open-defecation free (ODF)
- Participants under the age of 18 will not be targeted for research-related activities, like interviews and discussions, though we will ask caregivers or other household members to provide in information about the sanitation-related behaviors of children under age 18.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementing and Evaluating a Multi-Level Intervention to Increase Latrine Use and Safe Feces Disposal Among Latrine Owning Households in Rural Puri District, Odisha, India
The objective of this research is to evaluate an intervention focused on increasing latrine use in rural Odisha India. The present study builds off of previous research, which resulted in the design of an intervention to increase latrine use. This research evaluates the intervention designed to determine if significant increases in latrine use are observed among those who received the intervention compared to those that did not. Qualitative research will supplement trial data collection to help explain findings and understand perceptions of the intervention.
Read the detailed description
The objective of this research is to evaluate an intervention focused on increasing latrine use in rural Odisha India. The present study builds off of previous research, which resulted in the design of an intervention to increase latrine use. This research evaluates the intervention designed to determine if significant increases in latrine use are observed among those who received the intervention compared to those that did not. Qualitative research will supplement trial data collection to help explain findings and understand perceptions of the intervention.
For trial data collection, household members will be engaged in a survey that asks questions about the household, the latrine use practices of their family members, and may include additional questions about social norms attitudes, and other factors influencing latrine use.
Investigators will carry out two discrete qualitative research activities both digitally recorded: in depth interviews (IDIs) and focus group discussions (FGDs). Topics to be covered during the qualitative research include: perceptions of the intervention, reasons for using/not using latrines, motivations for sanitation behaviors.
The primary objective of the study is to evaluate a multi-level, theoretically informed intervention designed to increase latrine use for defecation among all members of households that currently own a latrine.
- Conditions
- Latrine Usage
- Being tested
- Intervention Package, Qualitative Research
- Keywords
- Public Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention PackageBehavioural
- Community Level:
- Palla: songs and skits to increase knowledge of and motivation for latrine use, pit emptying, safe feces disposal;
- Transect Walk: village walk to identify and mark feces in community;
- Community meetings: sex-segregated meetings with village members to decide on an action plan to increase community cleanliness/reduce open defecation;
- Wall painting: village map noting households that use latrines always.
- Sub-Community level:
- Mothers meeting: For caregivers with children under age 5, to provide knowledge of and hardware for safe child feces disposal.
- Household Level:
- Household visits: to those with latrines to motivate use;
- Latrine repairs: for households with non-functional latrines to make functional.
Qualitative ResearchOther
For villages receiving the intervention package, investigators will engage community members through qualitative interviews to gain their perception of the intervention, what they thought of the intervention activities, what information they recall, what aspects they enjoyed or disliked, if they had barriers to attendance or participation.
For the three villages not receiving the intervention, investigators will conduct qualitative interviews to determine additional barriers and determinants of latrine use to identify other potential intervention strategies.
| Study group | Role | What they receive |
|---|---|---|
| Latrine Use | Experimental | Men and women in villages randomized to the latrine use arm will receive the intervention package that includes activities at the community and household levels, with additional activities and hardware for mothers of children under five. Receives: Behavioral: Intervention Package |
| Control Group | No intervention | Men and women in villages randomized to the control group will not receive an intervention. |
| Qualitative Research Group | Experimental | Six villages unassociated with the randomized villages will engage in qualitative research. Three villages will receive the intervention. Three villages will not receive the intervention. Receives: Behavioral: Intervention Package; Other: Qualitative Research |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Latrine Usage Rate
Latrine usage will be assessed via in-depth interviews conducted between the study team and participants. Responses to interview questions will be aggregated and categorized by common themes, and analyzed qualitatively.
Measured: Baseline, Post-Intervention (Up to 1 Year)
Secondary outcomes (1)
Change in Number of Toilets
The number of toilets in the community/village will be collected at baseline and post-intervention.
Measured: Baseline, Post-Intervention (Up to 1 Year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start30 Jan 2018
- Primary completion18 Feb 2019
- Study completion13 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Latrine UsageStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11,722 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bethany Caruso, Emory University
- Investigators
- Bethany Caruso, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274245
- Sponsor's protocol ID
- IRB00098293
- Status last verified
- Jul 2019
- First submitted
- 5 Sep 2017
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Caruso BA, Sclar GD, Routray P, Nagel CL, Majorin F, Sola S, Koehne WJ 3rd, Clasen T. Effect of a low-cost, behaviour-change intervention on latrine use and safe disposal of child faeces in rural Odisha, India: a cluster-randomised controlled trial. Lancet Planet Health. 2022 Feb;6(2):e110-e121. doi: 10.1016/S2542-5196(21)00324-7.
PubMed 35150621Caruso BA, Sclar GD, Routray P, Majorin F, Nagel C, Clasen T. A cluster-randomized multi-level intervention to increase latrine use and safe disposal of child feces in rural Odisha, India: the Sundara Grama research protocol. BMC Public Health. 2019 Mar 18;19(1):322. doi: 10.1186/s12889-019-6601-z.
PubMed 30885158
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing and Evaluating a Multi-Level Intervention to Increase Latrine Use and Safe Feces Disposal Among Latrine Owning Households in Rural Puri District, Odisha, India
- ClinicalTrials.gov ID
- NCT03274245
- Acronym / sponsor ID
- IRB00098293
- Conditions
- Latrine Usage
- Keywords
- Public Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11,722 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 18 Feb 2019 (actual)
- Study completion
- 13 Apr 2019 (actual)
- First posted
- 6 Sep 2017 (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 an intervention focused on increasing latrine use in rural Odisha India. The present study builds off of previous research, which resulted in the design of an intervention to increase latrine use. This research evaluates the intervention designed to determine if significant increases in latrine use are observed among those who received the intervention compared to those that did not. Qualitative research will supplement trial data collection to help explain findings and understand perceptions of the intervention.
Detailed description
The objective of this research is to evaluate an intervention focused on increasing latrine use in rural Odisha India. The present study builds off of previous research, which resulted in the design of an intervention to increase latrine use. This research evaluates the intervention designed to determine if significant increases in latrine use are observed among those who received the intervention compared to those that did not. Qualitative research will supplement trial data collection to help explain findings and understand perceptions of the intervention.
For trial data collection, household members will be engaged in a survey that asks questions about the household, the latrine use practices of their family members, and may include additional questions about social norms attitudes, and other factors influencing latrine use.
Investigators will carry out two discrete qualitative research activities both digitally recorded: in depth interviews (IDIs) and focus group discussions (FGDs). Topics to be covered during the qualitative research include: perceptions of the intervention, reasons for using/not using latrines, motivations for sanitation behaviors.
The primary objective of the study is to evaluate a multi-level, theoretically informed intervention designed to increase latrine use for defecation among all members of households that currently own a latrine.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Latrine Use | Experimental | Behavioral: Intervention PackageMen and women in villages randomized to the latrine use arm will receive the intervention package that includes activities at the community and household levels, with additional activities and hardware for mothers of children under five. |
| Control Group | No intervention | –Men and women in villages randomized to the control group will not receive an intervention. |
| Qualitative Research Group | Experimental | Behavioral: Intervention Package, Other: Qualitative ResearchSix villages unassociated with the randomized villages will engage in qualitative research. Three villages will receive the intervention. Three villages will not receive the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Estimated 60% latrine coverage or higher
- At least 75 households
- Have a village leader willing to participate
Key exclusion criteria (2 listed)
- Considered open-defecation free (ODF)
- Participants under the age of 18 will not be targeted for research-related activities, like interviews and discussions, though we will ask caregivers or other household members to provide in information about the sanitation-related behaviors of children under age 18.
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 |
|---|---|---|
| Intervention Package* Community Level: * Palla: songs and skits to increase knowledge of and motivation for latrine use, pit emptying, safe feces disposal; * Transect Walk: village walk to identify and mark feces in community; * Community meetings: sex-segregated meetings with village members to decide on an action plan to increase community cleanliness/reduce open defecation; * Wall painting: village map noting households that use latrines always. * Sub-Community level: * Mothers meeting: For caregivers with children under age 5, to provide knowledge of and hardware for safe child feces disposal. * Household Level: * Household visits: to those with latrines to motivate use; * Latrine repairs: for households with non-functional latrines to make functional. | Behavioural | Latrine Use, Qualitative Research Group |
| Qualitative ResearchFor villages receiving the intervention package, investigators will engage community members through qualitative interviews to gain their perception of the intervention, what they thought of the intervention activities, what information they recall, what aspects they enjoyed or disliked, if they had barriers to attendance or participation. For the three villages not receiving the intervention, investigators will conduct qualitative interviews to determine additional barriers and determinants of latrine use to identify other potential intervention strategies. | Other | Qualitative Research Group |
Primary outcome
Change in Latrine Usage Rate
Time frame: Baseline, Post-Intervention (Up to 1 Year)
Latrine usage will be assessed via in-depth interviews conducted between the study team and participants. Responses to interview questions will be aggregated and categorized by common themes, and analyzed qualitatively.
1 secondary outcome
Change in Number of Toilets
Time frame: Baseline, Post-Intervention (Up to 1 Year)
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 18 Jul 2019.
- Derived from this study: PubMed 35150621Caruso BA, Sclar GD, Routray P, Nagel CL, Majorin F, Sola S, Koehne WJ 3rd, Clasen T. Effect of a low-cost, behaviour-change intervention on latrine use and safe disposal of child faeces in rural Odisha, India: a cluster-randomised controlled trial. Lancet Planet Health. 2022 Feb;6(2):e110-e121. doi: 10.1016/S2542-5196(21)00324-7.
- Derived from this study: PubMed 30885158Caruso BA, Sclar GD, Routray P, Majorin F, Nagel C, Clasen T. A cluster-randomized multi-level intervention to increase latrine use and safe disposal of child feces in rural Odisha, India: the Sundara Grama research protocol. BMC Public Health. 2019 Mar 18;19(1):322. doi: 10.1186/s12889-019-6601-z.
- Individual participant dataSharing planned: Yes
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.
Bethany Caruso, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Package and Qualitative Research in people with Latrine Usage, run by Emory University 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 3 inclusion and 2 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 18 Jul 2019. 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 Latrine Usage Rate (time frame: Baseline, Post-Intervention (Up to 1 Year)). 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 NCT03274245, which also lists 2 linked publications.
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 18 Jul 2019.