Water QualityNCT06570005
Evaluating a Water Quality Assurance Fund Intervention in Ghana and Kenya
A study testing Water Quality Assurance Fund in people with Water Quality and Water Treatment, run by The Aquaya Institute at 2 sites in 2 countries.
Trial summary
The objective of this study is to evaluate the effects of a novel financial and capacity strengthening intervention (the 'Water Quality Assurance Fund' program) on water safety management in rural Ghana and Kenya. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Water Quality, Water Treatment, Knowledge
- What is being tested?
- Water Quality Assurance Fund
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,800 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Dec 2022to 30 Sep 2025
- 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
- The district or county government was interested in participating in the Assurance Fund program and water systems within the district/county were accessible to a partner central laboratory that was able to provide water sample collection and testing services for a fee.
- Water systems were functional.
- Water systems were piped water systems (Kenya, Ghana) or mechanized boreholes with a single tapstand (Ghana).
- Water systems could afford regular water quality testing from the selected laboratory.
Who cannot join
- Water systems did not meet above inclusion criteria.
- To be eligible to participate in household surveys, participants need to be at least 18 years of age and a customer of a eligible water system.
Trial locations and contacts
2 sites in 2 countries.
Caroline Delaire, PhD contact
2 sites in 2 countries
Ghana1 site, 1 recruiting
- Recruiting
The Aquaya Institute
Accra
Bashiru Yachori, 233246884576, bashiru@aquaya.org
Kenya1 site, 1 recruiting
- Recruiting
The Aquaya Institute
Nairobi
Peace Musonge, 32489116884, peace@aquaya.org
About this study
The objective of this study is to evaluate the effects of a novel financial and capacity strengthening intervention (the 'Water Quality Assurance Fund' program) on water safety management in rural Ghana and Kenya. The investigators hypothesize the intervention will improve water system operator knowledge, chlorination practices, and water quality at the point of collection, as well as improve consumer satisfaction, awareness, and willingness-to-pay for water that is tested and treated.
Read the detailed description
Regular water quality monitoring by water suppliers is essential for maintaining adequate treatment processes and verifying safe water quality to protect public health. Yet, many small water suppliers are unable to conduct regular water quality tests due to financial, logistical, and capacity constraints. The goals of the Water Quality Assurance Fund program are to address these constraints by incentivizing established laboratories to extend their services to these smaller water systems and, in parallel, promote the use of water quality data for better water safety management.
The objective of this study is to evaluate the effects of a novel financial and capacity strengthening intervention (the 'Water Quality Assurance Fund' program) on water safety management in rural Ghana and Kenya. As part of the intervention, written legal agreements between water systems, centralized laboratories, and the organization facilitating the Assurance Fund will provide water systems with regular water quality testing and provide laboratories a guarantee of payments if water systems fail to pay for testing services on time. The Assurance Fund program will also deliver capacity strengthening, technical guidance, and community sensitization activities.
The investigators hypothesize the intervention will improve water system operator knowledge, chlorination practices, and water quality at the point of collection, as well as improve consumer satisfaction, awareness, and willingness-to-pay for water that is tested and treated. A secondary aim is to assess implementation challenges and enabling factors associated with the expansion of water testing services by existing professional water quality laboratories to rural water suppliers.
- Conditions
- Water Quality, Water Treatment, Knowledge, Satisfaction
- Being tested
- Water Quality Assurance Fund
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water Quality Assurance FundOther
- At the water system level: Written legal agreements between water systems, centralized laboratories, and the organization facilitating the Assurance Fund will provide water systems with regular water quality testing and provide laboratories a guarantee of payments if water systems fail to pay for testing services on time (for up to three concurrent unpaid invoices). Regular debrief meetings will be held with water operators and local government authorities to discuss test results and water treatment options, and to encourage water systems to share water quality information with their consumers. Technical guidance to improve water treatment will be provided, if requested by water system operators or local government authorities.
- At the community level: Community engagement, primarily at the onset, to inform the community about the water quality testing program and answer questions.
| Study group | Role | What they receive |
|---|---|---|
| Assurance Fund Intervention Arm 1 | Experimental | In this study arm, intervention activities will start after initial baseline data collection. Receives: Other: Water Quality Assurance Fund |
| Assurance Fund Intervention Arm 2 | Experimental | The intervention activities are the same as those described in Arm 1. However, in this study arm, the intervention activities will start 6 months later than those in Arm 1. This arm will serve as a controlled comparison during those initial 6 months. Receives: Other: Water Quality Assurance Fund |
| Assurance Fund Intervention Arm 3 | Experimental | The intervention activities are the same as those described in Arm 1. However, in this study arm, the intervention activities will start 12 months later than those in Arm 1. This arm will serve as a controlled comparison during those initial 12 months. Receives: Other: Water Quality Assurance Fund |
| Non-randomized Arm | Experimental | In Ghana only, there is a fourth study arm that will receive the intervention one month prior to Arm 1. This group was non-randomly selected and will primarily serve to support qualitative lessons learned from the Assurance Fund program. Receives: Other: Water Quality Assurance Fund |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate free chlorine residual in water at the point of collection
Free chlorine residual in water at the point of collection above targeted levels of 0.2 mg/L.
Measured: Baseline, 6-months, 12-months, 18-months, 24-months
Secondary outcomes (9)
Detectable free chlorine residual in water at the point of collection
Free chlorine residual in water at the point of collection above detectable levels of 0.1 mg/L.
Measured: Baseline, 6-months, 12-months, 18-months, 24-months
E. coli in water at the point of collection
- coli in water at point of collection (binary and categorical).
Measured: Baseline, 6-months, 12-months, 18-months, 24-months
Water system operator knowledge
Water system operator knowledge related to water quality (score out of 32 points on a knowledge assessment).
Measured: Baseline, 12-months, 24-months
Consumer awareness
Household respondent is aware enrolled water is tested or treated
Measured: Baseline, 12-months, 24-months
Consumer satisfaction
Household respondent is satisfied with water supplier. They will be considered satisfied if they report they are either very satisfied or somewhat satisfied with the water supplier. They will be considered dissatisfied if they report they are either very dissatisfied or somewhat dissatisfied with the water supplier.
Measured: Baseline, 12-months, 24-months
Willingness-to-pay
Stated willingness-to-pay for treated and tested water for standpipe and private tap users (% increase and absolute increase in local currency).
Measured: Baseline, 12-months, 24-months
Adequate free chlorine residual in household stored water
Free chlorine residual in household stored water above targeted levels of 0.2 mg/L.
Measured: Baseline, 12-months, 24-months
Detectable free chlorine residual in household stored water
Free chlorine residual in household stored water above detectable levels of 0.1 mg/L.
Measured: Baseline, 12-months, 24-months
E. coli in household stored water
- coli in household stored water (binary and categorical).
Measured: Baseline, 12-months, 24-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start6 Dec 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Water QualityStudies 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
- Sequential
- Model description
- Stepped-wedge Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 4,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Aquaya Institute
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Conrad N. Hilton Foundation, The Leona M. and Harry B. Helmsley Charitable Trust, Kwame Nkrumah University of Science and Technology, Water Mission
- Responsible party
- Sponsor
- Investigators
- Valerie Bauza, PhD, Principal investigator, The Aquaya Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570005
- Sponsor's protocol ID
- REAL-Water Assurance Fund
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Water Quality Assurance Fund Intervention in Ghana and Kenya
- ClinicalTrials.gov ID
- NCT06570005
- Acronym / sponsor ID
- REAL-Water Assurance Fund
- Conditions
- Water Quality, Water Treatment, Knowledge, Satisfaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,800 participants (estimated)
- Lead sponsor
- The Aquaya InstituteUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Conrad N. Hilton Foundation, The Leona M. and Harry B. Helmsley Charitable Trust, Kwame Nkrumah University of Science and Technology, Water Mission
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 26 Aug 2024 (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 study is to evaluate the effects of a novel financial and capacity strengthening intervention (the 'Water Quality Assurance Fund' program) on water safety management in rural Ghana and Kenya. The investigators hypothesize the intervention will improve water system operator knowledge, chlorination practices, and water quality at the point of collection, as well as improve consumer satisfaction, awareness, and willingness-to-pay for water that is tested and treated.
Detailed description
Regular water quality monitoring by water suppliers is essential for maintaining adequate treatment processes and verifying safe water quality to protect public health. Yet, many small water suppliers are unable to conduct regular water quality tests due to financial, logistical, and capacity constraints. The goals of the Water Quality Assurance Fund program are to address these constraints by incentivizing established laboratories to extend their services to these smaller water systems and, in parallel, promote the use of water quality data for better water safety management.
The objective of this study is to evaluate the effects of a novel financial and capacity strengthening intervention (the 'Water Quality Assurance Fund' program) on water safety management in rural Ghana and Kenya. As part of the intervention, written legal agreements between water systems, centralized laboratories, and the organization facilitating the Assurance Fund will provide water systems with regular water quality testing and provide laboratories a guarantee of payments if water systems fail to pay for testing services on time. The Assurance Fund program will also deliver capacity strengthening, technical guidance, and community sensitization activities.
The investigators hypothesize the intervention will improve water system operator knowledge, chlorination practices, and water quality at the point of collection, as well as improve consumer satisfaction, awareness, and willingness-to-pay for water that is tested and treated. A secondary aim is to assess implementation challenges and enabling factors associated with the expansion of water testing services by existing professional water quality laboratories to rural water suppliers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Stepped-wedge Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Assurance Fund Intervention Arm 1 | Experimental | Other: Water Quality Assurance FundIn this study arm, intervention activities will start after initial baseline data collection. |
| Assurance Fund Intervention Arm 2 | Experimental | Other: Water Quality Assurance FundThe intervention activities are the same as those described in Arm 1. However, in this study arm, the intervention activities will start 6 months later than those in Arm 1. This arm will serve as a controlled comparison during those initial 6 months. |
| Assurance Fund Intervention Arm 3 | Experimental | Other: Water Quality Assurance FundThe intervention activities are the same as those described in Arm 1. However, in this study arm, the intervention activities will start 12 months later than those in Arm 1. This arm will serve as a controlled comparison during those initial 12 months. |
| Non-randomized Arm | Experimental | Other: Water Quality Assurance FundIn Ghana only, there is a fourth study arm that will receive the intervention one month prior to Arm 1. This group was non-randomly selected and will primarily serve to support qualitative lessons learned from the Assurance Fund program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The district or county government was interested in participating in the Assurance Fund program and water systems within the district/county were accessible to a partner central laboratory that was able to provide water sample collection and testing services for a fee.
- Water systems were functional.
- Water systems were piped water systems (Kenya, Ghana) or mechanized boreholes with a single tapstand (Ghana).
- Water systems could afford regular water quality testing from the selected laboratory.
Key exclusion criteria (2 listed)
- Water systems did not meet above inclusion criteria.
- To be eligible to participate in household surveys, participants need to be at least 18 years of age and a customer of a eligible water system.
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 |
|---|---|---|
| Water Quality Assurance Fund* At the water system level: Written legal agreements between water systems, centralized laboratories, and the organization facilitating the Assurance Fund will provide water systems with regular water quality testing and provide laboratories a guarantee of payments if water systems fail to pay for testing services on time (for up to three concurrent unpaid invoices). Regular debrief meetings will be held with water operators and local government authorities to discuss test results and water treatment options, and to encourage water systems to share water quality information with their consumers. Technical guidance to improve water treatment will be provided, if requested by water system operators or local government authorities. * At the community level: Community engagement, primarily at the onset, to inform the community about the water quality testing program and answer questions. | Other | Assurance Fund Intervention Arm 1, Assurance Fund Intervention Arm 2, Assurance Fund Intervention Arm 3, Non-randomized Arm |
Primary outcome
Adequate free chlorine residual in water at the point of collection
Time frame: Baseline, 6-months, 12-months, 18-months, 24-months
Free chlorine residual in water at the point of collection above targeted levels of 0.2 mg/L.
9 secondary outcomes
Detectable free chlorine residual in water at the point of collection
Time frame: Baseline, 6-months, 12-months, 18-months, 24-months
E. coli in water at the point of collection
Time frame: Baseline, 6-months, 12-months, 18-months, 24-months
Water system operator knowledge
Time frame: Baseline, 12-months, 24-months
Consumer awareness
Time frame: Baseline, 12-months, 24-months
Consumer satisfaction
Time frame: Baseline, 12-months, 24-months
Willingness-to-pay
Time frame: Baseline, 12-months, 24-months
Adequate free chlorine residual in household stored water
Time frame: Baseline, 12-months, 24-months
Detectable free chlorine residual in household stored water
Time frame: Baseline, 12-months, 24-months
E. coli in household stored water
Time frame: Baseline, 12-months, 24-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: Yes. De-identified individual participant data 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.
Caroline Delaire, PhD contact
Valerie Bauza, PhD principal investigator
The Aquaya Institute
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water Quality Assurance Fund in people with Water Quality and Water Treatment, run by The Aquaya Institute at 2 sites in 2 countries.
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 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: status not confirmed, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ghana, Kenya. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valerie Bauza, PhD (4148011025, valerie@aquaya.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequate free chlorine residual in water at the point of collection (time frame: Baseline, 6-months, 12-months, 18-months, 24-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 26 Aug 2024.