SAFEWATER Health & Behaviour Impact Field Trials; Colombia (SAFEWATER)

The Health and Behavioural Impact of Implementing SAFEWATER Systems for Drinking Water Disinfection Within Rural Communities in Colombia and Mexico; Colombia.

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:

1. Assess water quality improvement at household level
2. Assess behaviors and test behavioral interventions'
3. 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 Overview

• Status: Enrolling by invitation
• Conditions: Water-Related Diseases
• Intervention / Treatment: Device: SAFEWATER systems for drinking water disinfection; Behavioral: Behaviour change interventions

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Medellín, Colombia
    • Centro de Ciencia y Tecnologia de Antioquia (CTA),
  • Antioquia
    • Medellín, Antioquia, Colombia
      • Universidad de Medellin
• Mexico
  • Chipas
    • San Cristóbal de las Casas, Chipas, Mexico, CP 29246
      • Fundación Cántaro Azul, A.C

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

1. Having at least one child of 12 years or under in the household
2. Having previously worked with Universidad de Medellin or CTA (criteria #2 will only be implemented if households meeting #1 is exhausted)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention community; Two communities in rural Colombia	Device: SAFEWATER systems for drinking water disinfection; 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.; Behavioral: Behaviour change interventions; 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.
No Intervention: Control community; One community in rural Colombia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child (12 years and under) growth	Change in BMI percentile to identify stunting, wasting and underweight	Change over 12 months
Water quality	Microbial load	Change over 12 months
Use of safe water	Frequency	Change over 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Handwashing with soap	Frequency	Change over 12 months
Fetching water	Frequency	Change over 12 months
School attendance	Absence (days)	Change over 12 months
Household water insecurity status	The Household Water Insecurity Experiences (HWISE) Scale (scores 0-36 (higher scores indicate greater insecurity))	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.	Change over 12 months
Water quality	Turbidity (measured using a turbidimeter (NTU units)	Change over 12 months
Use of safe water	Practices for drinking, hygiene and cooking i.e. what the water is used for and how	Change over 12 months
Use of the system	Frequency; intervention group only	Change over 12 months
Use of the system	Practices; intervention group only i.e. what the water is used for and how	Change over 12 months
Untreated water usage	Frequency	Change over 12 months
Untreated water usage	Practices for drinking, hygiene and cooking i.e. what the water is used for and how	Change over 12 months
Water storage practices	Frequency	Change over 12 months
Water storage practices	Method	Change over 12 months
Sharing of safe water to external households	Intervention group only. Frequency and volume of water shared with external households	Change over 12 months
Diarrhoea prevalence	Bristol Stool Chart (Type 1(hard) - 7(soft)	Change over 12 months
Maintenance to SAFEWATER system	Frequency (intervention group only)	Change over 12 months
Maintenance to SAFEWATER system	Nature of maintenance; intervention group only	Change over 12 months
Satisfaction of SAFEWATER system	Level of satisfaction for system and water provided, including taste, colour & temperature and odour (1(satisfied) - 3(unsatisfied)) + reasons (qualitative)	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 (list of changes / household) - intervention group only	Change over 12 months
Study retention	Percentage completed appointments	Change over 12 months

Collaborators and Investigators

• 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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): April 30, 2022

Study Registration Dates

• First Submitted: January 20, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): October 20, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Malnutrition; Diarrhoea; Behaviour change; Stunting; Child growth; Water, sanitation and hygiene (WASH); Water disinfection; Gut integrity; Clean water technology
• Additional Relevant MeSH Terms: Infections; Waterborne Diseases
• Other Study ID Numbers: REC/18/0064 (C)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No