Water-Related DiseasesNCT04736615
SAFEWATER Health & Behaviour Impact Field Trials; Mexico
A study testing SAFEWATER systems for drinking water disinfection and Behavior change interventions in people with Water-Related Diseases, run by University of Ulster at 3 sites in 2 countries.
Trial summary
At least 1.8 billion people globally use a source of drinking water that is faecally contaminated and thus likely to lead to diarrheal illness: nearly 1,000 children die each day due to water and sanitation-related diarrhoeal diseases. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Water-Related Diseases
- What is being tested?
- SAFEWATER systems for drinking water disinfection and Behavior change interventions
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Mar 2021to 30 Apr 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Communities in rural communities without access to clean water systems
- Households where the head of the household fully understands the study information provided and is willing to provide consent.
- Households where it is feasible to install the SAFEWATER system
- Priority Criteria (Colombia only):
- Having at least one child of 12 years or under in the household
- Having previously worked with Universidad de Medellin or CTA (criteria #2 will only be implemented if households meeting #1 is exhausted)
Who cannot join
None listed.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Colombia2 sites
Universidad de Medellin
Medellín, Antioquia
Centro de Ciencia y Tecnologia de Antioquia (CTA)
Medellín, Colombia, Antioquia
Mexico1 site
Fundación Cántaro Azul, A.C
San Cristóbal de las Casas, Chipas, CP 29246
About this study
Official title: The Health and Behavioural Impact of Implementing SAFEWATER Systems for Drinking Water Disinfection Within Rural Communities in Colombia and Mexico; Mexico
At least 1.8 billion people globally use a source of drinking water that is faecally contaminated and thus likely to lead to diarrheal illness: nearly 1,000 children die each day due to water and sanitation-related diarrhoeal diseases. Diseases related to the consumption of contaminated drinking-water place a major burden on human health. In 2017, 785 million people still lacked access to an improved drinking water source, and these are mostly the poor and marginalised. Almost a quarter of those people rely on surface water that is untreated and over 90% live in rural areas. Many people are forced to rely on sources that are microbiologically unsafe, leading to a higher risk of contracting waterborne diseases, including typhoid, hepatitis A and E, polio and cholera. The objectives of the SAFEWATER project is to develop technologies to provide clean water to economically deprived communities in rural Colombia and Mexico. These water technologies will be tested under real conditions with the cooperation of the rural communities.
The SAFEWATER field trials aims to evaluate the health and behaviour impacts of implementing SAFEWATER water treatment technologies for drinking water disinfection, with a behavioral change intervention, within rural communities in Colombia and Mexico
Read more
The project has three specific objectives:
- Assess water quality improvement at household level
- Assess behaviors and test behavioral interventions
- Assess child growth and related health outcomes
Three communities in Colombia and one community in Mexico were recruited to take part in the study. Communities were selected based on factors such as current availability of clean water, accessibility, safety, community size and current activities within the communities. Pilot and feasibility studies were carried out prior to commencing field trials, thus the design of the trials vary across countries.
Mexico field trial: The trial in Mexico will use a stepped-wedge design, randomized at household level over a 12-month period (6-12 steps dependent on adherence and feasibility). All households (max n200) willing to be involved will be recruited (separate clinicaltrials.gov registration).
Colombia field trial: the trial in Colombia will use a non-randomized parallel design (2:1; intervention:control). A maximum of 84 households (54:30; intervention:control) will be recruited to take part, with families with young children (<12 years) prioritized.
Outcomes for both countries will include 1) water quality, 2) water-related behaviour (e.g. frequency of system use, uses of treated / raw water), and 3) health, e.g. diarrhoea prevalence, growth (height/weight), school attendance, water insecurity status, gut integrity.
Impact: The development and deployment of the SAFEWATER technology has the potential to impact on clean drinking water access for participating communities in Mexico and Colombia and subsequently on the health and wellbeing of those individuals involved. Additionally if successful, the work will also provide an evidence based model for the provision of improved access to clean drinking water for rural communities in developing regions more widely.
- Conditions
- Water-Related Diseases
- Being tested
- SAFEWATER systems for drinking water disinfection, Behavior change interventions
- Keywords
- Water, sanitation and hygiene (WASH), Water disinfection, Behavior change, Stunting, Gut integrity, Malnutrition, Clean water technology, Diarrhoea, Child growth
- Medical subject headings
- Waterborne Diseases, Growth Disorders, Malnutrition, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAFEWATER systems for drinking water disinfectionDevice
A domestic water purification technology, consisting of a raw water storage tank, a pump, a filtration unit (2 cartridge filters), a UVC disinfection unit (UV lamp), a storage tank for drinking water (treated and safe water), and a distribution network inside the house for drinking water.
Behavior change interventionsBehavioural
Targeting behaviors around the use of the technology and water more generally. Behavioral interventions will be data-driven (i.e., dependent on the problems that arise) but are likely to include household and community-level activities.
| Study group | Role | What they receive |
|---|---|---|
| Intervention community | Experimental | Households will be randomly allocated to the intervention every 1-2 months over the12 month intervention Receives: Device: SAFEWATER systems for drinking water disinfection; Behavioral: Behavior change interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Water quality
Microbial load and turbidity (measured using a turbidimeter (NTU units)
Measured: Change over 12 months
Use of safe water
Frequency and practices for drinking, hygiene and cooking
Measured: Change over 12 months
Child (12 years and under) growth
Change in BMI percentile to identify stunting, wasting and underweight
Measured: Change over 12 months
Secondary outcomes (14)
Untreated water usage
Frequency and practices for drinking, hygiene and cooking
Measured: Change over 12 months
Use of the system
Frequency and practices; intervention group only
Measured: Change over 12 months
Water storage practices
Frequency and method
Measured: Change over 12 months
Handwashing with soap
Frequency
Measured: Change over 12 months
Fetching water
Frequency
Measured: Change over 12 months
Sharing of safe water to external households
Intervention group only
Measured: Change over 12 months
Diarrhoea prevalence
Bristol Stool Chart
Measured: Change over 12 months
School attendance
Absence (days)
Measured: Change over 12 months
Household water insecurity status
The Household Water Insecurity Experiences (HWISE) Scale (scores 0-36 (higher scores indicate greater insecurity))
Measured: Change over 12 months
Gut integrity
Fingerprick test for iron levels in a sub-group of children as a proxy marker of improved gut integrity.
Measured: Change over 12 months
Maintenance to SAFEWATER system
Frequency and nature of maintenance; Intervention group only
Measured: Change over 12 months
Satisfaction of SAFEWATER system
Level of satisfaction for system and water provided
Measured: Change over 12 months
Making unplanned changes to the system
Making changes for functional or aesthetical reasons which could potentially interfere with the functioning of the system - intervention group only
Measured: Change over 12 months
Study retention / participation
Intervention group only
Measured: Change over 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start1 Mar 2021
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Water-Related DiseasesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Stepped-wedge design, steps: 1 month
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Cántaro Azul, A.C. (NGO), Mexico, Centro de Ciencia y Tecnologia de Antioquia (CTA) (NGO), Colombia, Universidad de Medellin, Colombia, University of Sao Paulo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736615
- Sponsor's protocol ID
- REC/18/0064(M)
- Status last verified
- Oct 2021
- First submitted
- 29 Jan 2021
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Health and Behavioural Impact of Implementing SAFEWATER Systems for Drinking Water Disinfection Within Rural Communities in Colombia and Mexico; Mexico
- ClinicalTrials.gov ID
- NCT04736615
- Acronym / sponsor ID
- REC/18/0064(M)
- Conditions
- Water-Related Diseases
- Keywords
- Water, sanitation and hygiene (WASH), Water disinfection, Behavior change, Stunting, Gut integrity, Malnutrition, Clean water technology, Diarrhoea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Fundación Cántaro Azul, A.C. (NGO), Mexico, Centro de Ciencia y Tecnologia de Antioquia (CTA) (NGO), Colombia, Universidad de Medellin, Colombia, University of Sao Paulo
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 3 Feb 2021 (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.
At least 1.8 billion people globally use a source of drinking water that is faecally contaminated and thus likely to lead to diarrheal illness: nearly 1,000 children die each day due to water and sanitation-related diarrhoeal diseases. Diseases related to the consumption of contaminated drinking-water place a major burden on human health. In 2017, 785 million people still lacked access to an improved drinking water source, and these are mostly the poor and marginalised. Almost a quarter of those people rely on surface water that is untreated and over 90% live in rural areas. Many people are forced to rely on sources that are microbiologically unsafe, leading to a higher risk of contracting waterborne diseases, including typhoid, hepatitis A and E, polio and cholera. The objectives of the SAFEWATER project is to develop technologies to provide clean water to economically deprived communities in rural Colombia and Mexico. These water technologies will be tested under real conditions with the cooperation of the rural communities.
The SAFEWATER field trials aims to evaluate the health and behaviour impacts of implementing SAFEWATER water treatment technologies for drinking water disinfection, with a behavioral change intervention, within rural communities in Colombia and Mexico
The project has three specific objectives:
- Assess water quality improvement at household level
- Assess behaviors and test behavioral interventions
- Assess child growth and related health outcomes
Three communities in Colombia and one community in Mexico were recruited to take part in the study. Communities were selected based on factors such as current availability of clean water, accessibility, safety, community size and current activities within the communities. Pilot and feasibility studies were carried out prior to commencing field trials, thus the design of the trials vary across countries.
Mexico field trial: The trial in Mexico will use a stepped-wedge design, randomized at household level over a 12-month period (6-12 steps dependent on adherence and feasibility). All households (max n200) willing to be involved will be recruited (separate clinicaltrials.gov registration).
Colombia field trial: the trial in Colombia will use a non-randomized parallel design (2:1; intervention:control). A maximum of 84 households (54:30; intervention:control) will be recruited to take part, with families with young children (<12 years) prioritized.
Outcomes for both countries will include 1) water quality, 2) water-related behaviour (e.g. frequency of system use, uses of treated / raw water), and 3) health, e.g. diarrhoea prevalence, growth (height/weight), school attendance, water insecurity status, gut integrity.
Impact: The development and deployment of the SAFEWATER technology has the potential to impact on clean drinking water access for participating communities in Mexico and Colombia and subsequently on the health and wellbeing of those individuals involved. Additionally if successful, the work will also provide an evidence based model for the provision of improved access to clean drinking water for rural communities in developing regions more widely.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Stepped-wedge design, steps: 1 month
| Arm | Type | Receives |
|---|---|---|
| Intervention community | Experimental | Device: SAFEWATER systems for drinking water disinfection, Behavioral: Behavior change interventionsHouseholds will be randomly allocated to the intervention every 1-2 months over the12 month intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Communities in rural communities without access to clean water systems
- Households where the head of the household fully understands the study information provided and is willing to provide consent.
- Households where it is feasible to install the SAFEWATER system
- Having at least one child of 12 years or under in the household
- Having previously worked with Universidad de Medellin or CTA (criteria #2 will only be implemented if households meeting #1 is exhausted)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| SAFEWATER systems for drinking water disinfectionA domestic water purification technology, consisting of a raw water storage tank, a pump, a filtration unit (2 cartridge filters), a UVC disinfection unit (UV lamp), a storage tank for drinking water (treated and safe water), and a distribution network inside the house for drinking water. | Device | Intervention community |
| Behavior change interventionsTargeting behaviors around the use of the technology and water more generally. Behavioral interventions will be data-driven (i.e., dependent on the problems that arise) but are likely to include household and community-level activities. | Behavioural | Intervention community |
Primary outcome
Water quality
Time frame: Change over 12 months
Microbial load and turbidity (measured using a turbidimeter (NTU units)
Use of safe water
Time frame: Change over 12 months
Frequency and practices for drinking, hygiene and cooking
Child (12 years and under) growth
Time frame: Change over 12 months
Change in BMI percentile to identify stunting, wasting and underweight
14 secondary outcomes
Untreated water usage
Time frame: Change over 12 months
Use of the system
Time frame: Change over 12 months
Water storage practices
Time frame: Change over 12 months
Handwashing with soap
Time frame: Change over 12 months
Fetching water
Time frame: Change over 12 months
Sharing of safe water to external households
Time frame: Change over 12 months
Diarrhoea prevalence
Time frame: Change over 12 months
School attendance
Time frame: Change over 12 months
Household water insecurity status
Time frame: Change over 12 months
Gut integrity
Time frame: Change over 12 months
Maintenance to SAFEWATER system
Time frame: Change over 12 months
Satisfaction of SAFEWATER system
Time frame: Change over 12 months
Making unplanned changes to the system
Time frame: Change over 12 months
Study retention / participation
Time frame: Change over 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAFEWATER systems for drinking water disinfection and Behavior change interventions in people with Water-Related Diseases, run by University of Ulster at 3 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 6 inclusion and 0 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 20 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 3 sites in Colombia, Mexico. 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?
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?
Water quality (time frame: Change over 12 months). The study lists 3 primary outcomes in all. 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 20 Oct 2021.