SanitationNCT03822611
Research on the Impact of Targeted Subsidies Within Open Defecation Free (ODF) Communities
A study testing Targeted Subsidy in people with Sanitation, run by The Aquaya Institute at 1 site in Ghana.
Trial summary
This study evaluates targeted subsidies as a strategy to improve sanitation infrastructure and behaviours in communities that have reached Open Defecation Free (ODF) status after a Community-Led Total Sanitation (CLTS) program. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sanitation
- What is being tested?
- Targeted Subsidy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,615 participants
- Where
- 1 siteGhana
- Study dates
- 18 Feb 2019to 31 Mar 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community was targeted by UNICEF's Community-Led Total Sanitation (CLTS) program in Tatale, Yendi, and Kpandai districts in Ghana.
- Community has Open Defecation Free (ODF) status according to local authorities.
- Community has more than 15 and less than 100 households.
Who cannot join
- Community is located less than 2 kilometers away from a community in the opposite treatment arm.
- Inclusion Criteria (for voucher recipients within study communities):
- Household is extremely poor, as identified through community consultation and/or the government's Livelihood Empowerment Against Poverty (LEAP) program.
- Household has at least one vulnerable person, i.e. who meets one of the following criteria: i) older than 65 years old, ii) person with a disability, iii) orphan or vulnerable child, iv) female head of household, v) widow(er), vi) terminally-ill persons, vii) unemployed, viii) outcast groups.
- Exclusion Criteria (for voucher recipients within study communities):
- Household owns a functional, individual (non-shared) latrine with durable sub-structure.
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates targeted subsidies as a strategy to improve sanitation infrastructure and behaviours in communities that have reached Open Defecation Free (ODF) status after a Community-Led Total Sanitation (CLTS) program. The investigator's hypothesis is that sanitation subsidies targeted at the most vulnerable households within ODF communities will increase and help sustain latrine coverage, quality, and use amongst the targeted households, and through a spill-over effect, amongst the rest of the community. Half of participating communities will receive the targeted subsidy, while the other half will not receive any treatment.
Read the detailed description
Community-Led Total Sanitation (CLTS) is a widely used approach to eradicate open defecation in rural communities in developing countries. Using emotional triggers, CLTS promotes community self-help to build household latrines. In Ghana, where CLTS is part of the government's official sanitation strategy, a community is declared "Open Defecation Free" (ODF) when 80 percent of households own a latrine.
There is however evidence that open defecation persists in so-called "ODF" communities, especially as the most vulnerable households (the poorest of the poor) cannot afford to construct or maintain durable latrines. As a result, subsidies for these vulnerable households have been proposed as a strategy to promote the construction of durable latrines and help sustain safe sanitation behaviours in communities having received CLTS.
- Conditions
- Sanitation
- Being tested
- Targeted Subsidy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted SubsidyBehavioural
Voucher
| Study group | Role | What they receive |
|---|---|---|
| Targeted Subsidy | Experimental | In these communities, households identified as vulnerable receive a voucher for a free latrine sub-structure (slab + pit lining), redeemable with local sanitation suppliers. Receives: Behavioral: Targeted Subsidy |
| No subsidy | No intervention | In these communities, no household receives a voucher. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of households owning an individual, functional latrine with full superstructure
Household ownership (yes/no) of a latrine that is i) not shared with other households ("individual"), ii) whose pit is not collapsed and not full ("functional"), and iii) with four walls (or circular walls) and a roof of any materials ("full superstructure").
Measured: Approximately 18 months
Secondary outcomes (3)
Percentage of households reporting practicing open defecation
Self report by the respondent of not always using a toilet to defecate when at home.
Measured: Approximately 18 months
Percentage of households owning an individual, functional latrine with full superstructure and durable superstructure
Household ownership (yes/no) of a latrine that is i) not shared with other households ("individual"), ii) whose pit is not collapsed and not full ("functional"), iii) with four walls (or circular walls) and a roof of any materials ("full superstructure"), iv) with a concrete/plastic slab and pit lining with plastic/rocks/bricks/concrete ("durable substructure").
Measured: Approximately 18 months
Percentage of households reporting satisfaction with latrine
Self report by the respondent of being satisfied with the latrine (s)he uses for defecation.
Measured: Approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start18 Feb 2019
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SanitationStudies of the same condition, open and under way.
- 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
- Model description
- cluster Randomized controlled trial (c-RCT)
- Masking
- None (open label)
- Enrolment
- 5,615 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Aquaya Institute
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Tetratech
- Responsible party
- Sponsor
- Investigators
- Rachel Peletz, PhD, Principal investigator, The Aquaya Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822611
- Sponsor's protocol ID
- WASHPaLS Subsidy Study
- Status last verified
- Oct 2021
- First submitted
- 25 Jan 2019
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for the primary and all secondary outcome measures as well as key confounders (demographics, wealth index, community characteristics) will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Impact of Targeted Subsidies Within Open Defecation Free (ODF) Communities
- ClinicalTrials.gov ID
- NCT03822611
- Acronym / sponsor ID
- WASHPaLS Subsidy Study
- Conditions
- Sanitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,615 participants (actual)
- Lead sponsor
- The Aquaya InstituteUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Tetratech
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 30 Jan 2019 (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.
This study evaluates targeted subsidies as a strategy to improve sanitation infrastructure and behaviours in communities that have reached Open Defecation Free (ODF) status after a Community-Led Total Sanitation (CLTS) program. The investigator's hypothesis is that sanitation subsidies targeted at the most vulnerable households within ODF communities will increase and help sustain latrine coverage, quality, and use amongst the targeted households, and through a spill-over effect, amongst the rest of the community. Half of participating communities will receive the targeted subsidy, while the other half will not receive any treatment.
Detailed description
Community-Led Total Sanitation (CLTS) is a widely used approach to eradicate open defecation in rural communities in developing countries. Using emotional triggers, CLTS promotes community self-help to build household latrines. In Ghana, where CLTS is part of the government's official sanitation strategy, a community is declared "Open Defecation Free" (ODF) when 80 percent of households own a latrine.
There is however evidence that open defecation persists in so-called "ODF" communities, especially as the most vulnerable households (the poorest of the poor) cannot afford to construct or maintain durable latrines. As a result, subsidies for these vulnerable households have been proposed as a strategy to promote the construction of durable latrines and help sustain safe sanitation behaviours in communities having received CLTS.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- cluster Randomized controlled trial (c-RCT)
| Arm | Type | Receives |
|---|---|---|
| Targeted Subsidy | Experimental | Behavioral: Targeted SubsidyIn these communities, households identified as vulnerable receive a voucher for a free latrine sub-structure (slab + pit lining), redeemable with local sanitation suppliers. |
| No subsidy | No intervention | –In these communities, no household receives a voucher. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Community was targeted by UNICEF's Community-Led Total Sanitation (CLTS) program in Tatale, Yendi, and Kpandai districts in Ghana.
- Community has Open Defecation Free (ODF) status according to local authorities.
- Community has more than 15 and less than 100 households.
Key exclusion criteria (6 listed)
- Community is located less than 2 kilometers away from a community in the opposite treatment arm.
- Household is extremely poor, as identified through community consultation and/or the government's Livelihood Empowerment Against Poverty (LEAP) program.
- Household has at least one vulnerable person, i.e. who meets one of the following criteria: i) older than 65 years old, ii) person with a disability, iii) orphan or vulnerable child, iv) female head of household, v) widow(er), vi) terminally-ill persons, vii) unemployed, viii) outcast groups.
- Household owns a functional, individual (non-shared) latrine with durable sub-structure.
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 |
|---|---|---|
| Targeted SubsidyVoucher | Behavioural | Targeted Subsidy |
Primary outcome
Percentage of households owning an individual, functional latrine with full superstructure
Time frame: Approximately 18 months
Household ownership (yes/no) of a latrine that is i) not shared with other households ("individual"), ii) whose pit is not collapsed and not full ("functional"), and iii) with four walls (or circular walls) and a roof of any materials ("full superstructure").
3 secondary outcomes
Percentage of households reporting practicing open defecation
Time frame: Approximately 18 months
Percentage of households owning an individual, functional latrine with full superstructure and durable superstructure
Time frame: Approximately 18 months
Percentage of households reporting satisfaction with latrine
Time frame: Approximately 18 months
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 4 Oct 2021.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for the primary and all secondary outcome measures as well as key confounders (demographics, wealth index, community characteristics) 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.
Rachel Peletz, PhD principal investigator
The Aquaya Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Subsidy in people with Sanitation, run by The Aquaya Institute at 1 site in Ghana.
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 6 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 4 Oct 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 Ghana. 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?
Percentage of households owning an individual, functional latrine with full superstructure (time frame: Approximately 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2021.