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DiarrheaSanDemNCT03174015

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

A study testing Bauleni Secret in people with Diarrhea, run by London School of Hygiene and Tropical Medicine at 1 site in Zambia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diarrhea
What is being tested?
Bauleni Secret
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,085 participants
Where
1 siteZambia
Study dates
7 Aug 2017to 5 Mar 2018
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
  • Healthy volunteers accepted
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

Zambia1 site

  • Bauleni Compound

    Lusaka

Other trials in Zambia

About this study

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)
Conditions
Diarrhea
Being tested
Bauleni Secret
Keywords
Sanitation, Demand, Peri-urban, Behavior Change, Lusaka, Zambia
Medical subject headings
Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bauleni SecretBehavioural

    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).

Study groups in NCT03174015
Study groupRoleWhat they receive
InterventionExperimentalLandlords on selected plots will receive the "Bauleni Secret" intervention. Landlords and selected tenants will be surveyed in baseline/end-line data collection.
Receives: Behavioral: Bauleni Secret
ControlNo interventionLandlords and selected tenants will be surveyed in baseline/end-line data collection only.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Having a hole-cover or water-sealed pan

    Reduces spread of pathogens by creating barrier between containment and above-ground environment

    Measured: 5 months after intervention begins

  2. Having a latrine door that locks from the inside

    Provide safety and privacy for toilet users

    Measured: 5 months after intervention begins

  3. Having a latrine door that locks from the outside

    Exclude those not living on the plot from the toilet

    Measured: 5 months after intervention begins

  4. Having a rotational cleaning system in place

    To maintain hygienic condition of the toilet interface

    Measured: 5 months after intervention begins

Secondary outcomes (6)

  1. Willingness to pay

    Change in landlord stated willingness to pay for toilet improvements

    Measured: 5 months after intervention begins

  2. Attitudes towards sanitation

    Scales measuring landlord attitudes towards the importance of sanitation

    Measured: 5 months after intervention begins

  3. Financial preparation for toilet improvement

    Landlords report saving money, either individually or by participating in a rotating savings scheme, for toilet improvement

    Measured: 5 months after intervention begins

  4. Partial construction progress towards toilet improvement

    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.)

    Measured: 5 months after intervention begins

  5. Peri-urban Healthy Toilet Index

    A theory-based comprehensive index of on-site peri-urban sanitation status including hygienicity, accessibility, desirability, and sustainability of sanitation systems

    Measured: 5 months after intervention begins

  6. Cleaning rota initiated

    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)

    Measured: 5 months after intervention begins

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2017
  2. Study start7 Aug 2017
  3. Primary completion5 Mar 2018
  4. Study completion5 Mar 2018

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
A random sample of plots will be selected in Bauleni Compound and invited to participate. Intervention allocation will also be randomized, with approximately equal numbers of plots allocated to the intervention and control arms. Within the chosen plots, resident landlord households will receive the intervention and resident landlord households and one randomly selected tenant household will be chosen for data collection for both intervention and control plots.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,085 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03174015
Sponsor's protocol ID
QA_840
Acronym
SanDem
Status last verified
Apr 2019
First submitted
22 Feb 2017
Last updated
25 Apr 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Tidwell JB, Chipungu J, Bosomprah S, Aunger R, Curtis V, Chilengi R. Effect of a behaviour change intervention on the quality of peri-urban sanitation in Lusaka, Zambia: a randomised controlled trial. Lancet Planet Health. 2019 Apr;3(4):e187-e196. doi: 10.1016/S2542-5196(19)30036-1.

    PubMed 31029230

Questions about this trial

What is this clinical trial studying?

A study testing Bauleni Secret in people with Diarrhea, run by London School of Hygiene and Tropical Medicine at 1 site in Zambia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 25 Apr 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 Zambia. 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?

Having a hole-cover or water-sealed pan (time frame: 5 months after intervention begins). The study lists 4 primary outcomes in all. 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 NCT03174015, 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 25 Apr 2019.

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