SAFEWATER Health & Behaviour Impact Field Trials; Mexico

Water-Related Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04736615
• Other study ID #: REC/18/0064(M)
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: October 2021
• Source: University of Ulster
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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 (Colombia only):

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)

Related Conditions & MeSH terms

• Water-Related Diseases
• Waterborne Diseases

Intervention

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:
• Behavior 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.

Locations

Country	Name	City	State
Colombia	Universidad de Medellin	Medellín	Antioquia
Colombia	Centro de Ciencia y Tecnologia de Antioquia (CTA)	Medellín, Colombia	Antioquia
Mexico	Fundación Cántaro Azul, A.C	San Cristóbal De Las Casas	Chipas

Sponsors (5)

Lead Sponsor	Collaborator
University of Ulster	Centro de Ciencia y Tecnologia de Antioquia (CTA) (NGO), Colombia, Fundación Cántaro Azul, A.C. (NGO), Mexico, Universidad de Medellin, Colombia, University of São Paulo, Brazil

Countries where clinical trial is conducted

Colombia,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Water quality	Microbial load and turbidity (measured using a turbidimeter (NTU units)	Change over 12 months
Primary	Use of safe water	Frequency and practices for drinking, hygiene and cooking	Change over 12 months
Primary	Child (12 years and under) growth	Change in BMI percentile to identify stunting, wasting and underweight	Change over 12 months
Secondary	Untreated water usage	Frequency and practices for drinking, hygiene and cooking	Change over 12 months
Secondary	Use of the system	Frequency and practices; intervention group only	Change over 12 months
Secondary	Water storage practices	Frequency and method	Change over 12 months
Secondary	Handwashing with soap	Frequency	Change over 12 months
Secondary	Fetching water	Frequency	Change over 12 months
Secondary	Sharing of safe water to external households	Intervention group only	Change over 12 months
Secondary	Diarrhoea prevalence	Bristol Stool Chart	Change over 12 months
Secondary	School attendance	Absence (days)	Change over 12 months
Secondary	Household water insecurity status	The Household Water Insecurity Experiences (HWISE) Scale (scores 0-36 (higher scores indicate greater insecurity))	Change over 12 months
Secondary	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
Secondary	Maintenance to SAFEWATER system	Frequency and nature of maintenance; Intervention group only	Change over 12 months
Secondary	Satisfaction of SAFEWATER system	Level of satisfaction for system and water provided	Change over 12 months
Secondary	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	Change over 12 months
Secondary	Study retention / participation	Intervention group only	Change over 12 months