Sanitation Demand Creation in Peri-Urban Slums of Lusaka, Zambia (SanDem)

April 24, 2019 updated by: Robert Aunger, London School of Hygiene and Tropical Medicine

This intervention will experimentally test the hypothesis that sanitation can be improved in a peri-urban setting using state-of-the-art behaviour change communications.

Formative research indicated that landlords are the effective decision-makers about investments in sanitation on their plots (which can include a number of tenant households as well). Landlords will therefore be the primary targets of the intervention. The study will take the form of a randomized controlled trial of the intervention evaluated at the plot level. The intervention will invite enrolled landlords to a series of meetings in which various mechanisms will be used, each designed to increase their likelihood of improving the toilet(s) on their plot. These meetings will be the main vehicle for a status-building campaign associated with increasing wealth by improving plot sanitation, understanding tenants' implicit demand, understanding the processes by which toilets can be improved, and a competition rewarding landlords that make the greatest improvements to the improvement of their toilet(s). The desired improvements will be measured via multiple primary outcomes that measure aspects of changes to hardware and software components, including indicators of hygienic quality, psychological desirability, accessibility, and ecological sustainability. This is because the investigators argue that, to have a significant impact on population-level diarrheal disease indicators, any sanitation solution must be:

  • effective at reducing exposure to pathogens (i.e., hygienic),
  • desirable (i.e., seen as valuable or humane), and
  • accessible (i.e., no one excluded), so that it can be used by all
  • for a reasonably long time (i.e., sustainable)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1085

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zambia
      • Lusaka, Zambia
        • Bauleni Compound

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Plots will be selected for inclusion in the study based on meeting the inclusion criteria. The intervention will be delivered to the landlord on each plot assigned to the intervention arm.

Intervention Inclusion Criteria:

  • Plot located in Bauleni compound
  • Adult landlord (age 18 or higher) resides on plot

Intervention Exclusion Criteria:

* None

Data will be collected from the landlord and one randomly selected tenant from all eligible adult tenants on each plot.

Data Collection Inclusion Criteria:

* Adult landlord or tenant (age 18 or higher) resides on selected plot most of the time

Data Collection Exclusion Criteria:

* None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Landlords on selected plots will receive the "Bauleni Secret" intervention. Landlords and selected tenants will be surveyed in baseline/end-line data collection.
Behavioral: Bauleni Secret
The intervention will invite enrolled landlords to a series of meetings in which various mechanisms will be used, each designed to increase their likelihood of improving the toilet(s) on their plot. These meetings will be the main vehicle for a status-building campaign associated with increasing wealth by improving plot sanitation, understanding tenants' implicit demand, understanding the processes by which toilets can be improved, and a competition rewarding landlords that make the greatest improvements to the improvement of their toilet(s).
No Intervention: Control
Landlords and selected tenants will be surveyed in baseline/end-line data collection only.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Having a hole-cover or water-sealed pan
Time Frame: 5 months after intervention begins
Reduces spread of pathogens by creating barrier between containment and above-ground environment
5 months after intervention begins
Having a latrine door that locks from the inside
Time Frame: 5 months after intervention begins
Provide safety and privacy for toilet users
5 months after intervention begins
Having a latrine door that locks from the outside
Time Frame: 5 months after intervention begins
Exclude those not living on the plot from the toilet
5 months after intervention begins
Having a rotational cleaning system in place
Time Frame: 5 months after intervention begins
To maintain hygienic condition of the toilet interface
5 months after intervention begins

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Willingness to pay
Time Frame: 5 months after intervention begins
Change in landlord stated willingness to pay for toilet improvements
5 months after intervention begins
Attitudes towards sanitation
Time Frame: 5 months after intervention begins
Scales measuring landlord attitudes towards the importance of sanitation
5 months after intervention begins
Financial preparation for toilet improvement
Time Frame: 5 months after intervention begins
Landlords report saving money, either individually or by participating in a rotating savings scheme, for toilet improvement
5 months after intervention begins
Partial construction progress towards toilet improvement
Time Frame: 5 months after intervention begins
Landlords have either amassed raw materials on the plot (concrete blocks, wood, etc.) for toilet improvement or new construction/upgrading of toilet began (hole dug for new toilet, new slab poured for flushing toilet, etc.)
5 months after intervention begins
Peri-urban Healthy Toilet Index
Time Frame: 5 months after intervention begins
A theory-based comprehensive index of on-site peri-urban sanitation status including hygienicity, accessibility, desirability, and sustainability of sanitation systems
5 months after intervention begins
Cleaning rota initiated
Time Frame: 5 months after intervention begins
Landlord reports taking any action directed at establishing a rotational cleaning system (e.g., holding a plot meeting explicitly for this purpose, posting a written rota, or otherwise tangibly indicating rota responsibilities)
5 months after intervention begins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
London School of Hygiene and Tropical Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centre for Infectious Disease Research in Zambia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert Aunger, PhD, London School of Hygiene and Tropical Medicine
  • Principal Investigator: Roma Chilengi, MD, Center for Infectious Disease Research in Zambia
  • Principal Investigator: Valerie Curtis, PhD, London School of Hygiene and Tropical Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 7, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 5, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 5, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QA_840

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) will be available with consent from the principal investigators. The study will collect only basic demographic information on individuals along with knowledge/attitudes/preferences data, so there will be little to identify individuals from the shared IPD and little that is very sensitive.

IPD Sharing Time Frame

Data will be available from approximately June 2018 for at least 5 year on study website.

IPD Sharing Access Criteria

Data will be accessible with consent from study PIs per submitted proposals and protocols.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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