SAFEWATER Health & Behaviour Impact Field Trials; Colombia (SAFEWATER)
Primary Purpose
Water-Related Diseases
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SAFEWATER systems for drinking water disinfection
Behaviour change interventions
Sponsored by
About this trial
This is an interventional prevention trial for Water-Related Diseases focused on measuring Water, sanitation and hygiene (WASH), Water disinfection, Behaviour change, Stunting, Gut integrity, Malnutrition, Clean water technology, Diarrhoea, Child growth
Eligibility Criteria
Inclusion Criteria:
- 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:
- 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)
Sites / Locations
- Universidad de Medellin
- Centro de Ciencia y Tecnologia de Antioquia (CTA),
- Fundación Cántaro Azul, A.C
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention community
Control community
Arm Description
Two communities in rural Colombia
One community in rural Colombia
Outcomes
Primary Outcome Measures
Water quality
Microbial load
Use of safe water
Frequency
Child (12 years and under) growth
Change in BMI percentile to identify stunting, wasting and underweight
Secondary Outcome Measures
Water quality
Turbidity (measured using a turbidimeter (NTU units)
Use of safe water
Practices for drinking, hygiene and cooking i.e. what the water is used for and how
Use of the system
Frequency; intervention group only
Use of the system
Practices; intervention group only i.e. what the water is used for and how
Untreated water usage
Frequency
Untreated water usage
Practices for drinking, hygiene and cooking i.e. what the water is used for and how
Water storage practices
Frequency
Water storage practices
Method
Handwashing with soap
Frequency
Sharing of safe water to external households
Intervention group only. Frequency and volume of water shared with external households
Fetching water
Frequency
Diarrhoea prevalence
Bristol Stool Chart (Type 1(hard) - 7(soft)
School attendance
Absence (days)
Household water insecurity status
The Household Water Insecurity Experiences (HWISE) Scale (scores 0-36 (higher scores indicate greater insecurity))
Gut integrity
Fingerprick test for iron levels in a sub-group of children as a proxy marker of improved gut integrity.
Maintenance to SAFEWATER system
Frequency (intervention group only)
Maintenance to SAFEWATER system
Nature of maintenance; intervention group only
Satisfaction of SAFEWATER system
Level of satisfaction for system and water provided, including taste, colour & temperature and odour (1(satisfied) - 3(unsatisfied)) + reasons (qualitative)
Making unplanned changes to the system
Making changes for functional or aesthetical reasons which could potentially interfere with the functioning of the system (list of changes / household) - intervention group only
Study retention
Percentage completed appointments
Full Information
NCT ID
NCT04829981
First Posted
January 20, 2021
Last Updated
October 14, 2021
Sponsor
University of Ulster
Collaborators
Fundación Cántaro Azul, A.C. (NGO), Mexico, Centro de Ciencia y Tecnologia de Antioquia (CTA) (NGO), Colombia, Universidad de Medellin, Colombia, University of São Paulo, Brazil
1. Study Identification
Unique Protocol Identification Number
NCT04829981
Brief Title
SAFEWATER Health & Behaviour Impact Field Trials; Colombia
Acronym
SAFEWATER
Official Title
The Health and Behavioural Impact of Implementing SAFEWATER Systems for Drinking Water Disinfection Within Rural Communities in Colombia and Mexico; Colombia.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Ulster
Collaborators
Fundación Cántaro Azul, A.C. (NGO), Mexico, Centro de Ciencia y Tecnologia de Antioquia (CTA) (NGO), Colombia, Universidad de Medellin, Colombia, University of São Paulo, Brazil
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Water-Related Diseases
Keywords
Water, sanitation and hygiene (WASH), Water disinfection, Behaviour change, Stunting, Gut integrity, Malnutrition, Clean water technology, Diarrhoea, Child growth
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention community
Arm Type
Experimental
Arm Description
Two communities in rural Colombia
Arm Title
Control community
Arm Type
No Intervention
Arm Description
One community in rural Colombia
Intervention Type
Device
Intervention Name(s)
SAFEWATER systems for drinking water disinfection
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behaviour change interventions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Water quality
Description
Microbial load
Time Frame
Change over 12 months
Title
Use of safe water
Description
Frequency
Time Frame
Change over 12 months
Title
Child (12 years and under) growth
Description
Change in BMI percentile to identify stunting, wasting and underweight
Time Frame
Change over 12 months
Secondary Outcome Measure Information:
Title
Water quality
Description
Turbidity (measured using a turbidimeter (NTU units)
Time Frame
Change over 12 months
Title
Use of safe water
Description
Practices for drinking, hygiene and cooking i.e. what the water is used for and how
Time Frame
Change over 12 months
Title
Use of the system
Description
Frequency; intervention group only
Time Frame
Change over 12 months
Title
Use of the system
Description
Practices; intervention group only i.e. what the water is used for and how
Time Frame
Change over 12 months
Title
Untreated water usage
Description
Frequency
Time Frame
Change over 12 months
Title
Untreated water usage
Description
Practices for drinking, hygiene and cooking i.e. what the water is used for and how
Time Frame
Change over 12 months
Title
Water storage practices
Description
Frequency
Time Frame
Change over 12 months
Title
Water storage practices
Description
Method
Time Frame
Change over 12 months
Title
Handwashing with soap
Description
Frequency
Time Frame
Change over 12 months
Title
Sharing of safe water to external households
Description
Intervention group only. Frequency and volume of water shared with external households
Time Frame
Change over 12 months
Title
Fetching water
Description
Frequency
Time Frame
Change over 12 months
Title
Diarrhoea prevalence
Description
Bristol Stool Chart (Type 1(hard) - 7(soft)
Time Frame
Change over 12 months
Title
School attendance
Description
Absence (days)
Time Frame
Change over 12 months
Title
Household water insecurity status
Description
The Household Water Insecurity Experiences (HWISE) Scale (scores 0-36 (higher scores indicate greater insecurity))
Time Frame
Change over 12 months
Title
Gut integrity
Description
Fingerprick test for iron levels in a sub-group of children as a proxy marker of improved gut integrity.
Time Frame
Change over 12 months
Title
Maintenance to SAFEWATER system
Description
Frequency (intervention group only)
Time Frame
Change over 12 months
Title
Maintenance to SAFEWATER system
Description
Nature of maintenance; intervention group only
Time Frame
Change over 12 months
Title
Satisfaction of SAFEWATER system
Description
Level of satisfaction for system and water provided, including taste, colour & temperature and odour (1(satisfied) - 3(unsatisfied)) + reasons (qualitative)
Time Frame
Change over 12 months
Title
Making unplanned changes to the system
Description
Making changes for functional or aesthetical reasons which could potentially interfere with the functioning of the system (list of changes / household) - intervention group only
Time Frame
Change over 12 months
Title
Study retention
Description
Percentage completed appointments
Time Frame
Change over 12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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:
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)
Facility Information:
Facility Name
Universidad de Medellin
City
Medellín
State/Province
Antioquia
Country
Colombia
Facility Name
Centro de Ciencia y Tecnologia de Antioquia (CTA),
City
Medellín
Country
Colombia
Facility Name
Fundación Cántaro Azul, A.C
City
San Cristóbal de las Casas
State/Province
Chipas
ZIP/Postal Code
CP 29246
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
SAFEWATER Health & Behaviour Impact Field Trials; Colombia
We'll reach out to this number within 24 hrs