SAFEWATER Health & Behaviour Impact Field Trials; Mexico

Not Applicable

• Conditions: Water-Related Diseases
• Interventions: Device: SAFEWATER systems for drinking water disinfection; Behavioral: Behavior change interventions

• Registration Number: NCT04736615
• Lead Sponsor: University of Ulster

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:

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-03
• Study Start: 2021-03-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-14
• Last Update Posted: 2021-10-20
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention community	SAFEWATER systems for drinking water disinfection	Households will be randomly allocated to the intervention every 1-2 months over the12 month intervention
Intervention community	Behavior change interventions	Households will be randomly allocated to the intervention every 1-2 months over the12 month intervention

Primary Outcome Measures

Name	Time	Method
Use of safe water	Change over 12 months	Frequency and practices for drinking, hygiene and cooking
Water quality	Change over 12 months	Microbial load and turbidity (measured using a turbidimeter (NTU units)
Child (12 years and under) growth	Change over 12 months	Change in BMI percentile to identify stunting, wasting and underweight

Secondary Outcome Measures

Name	Time	Method
Water storage practices	Change over 12 months	Frequency and method
Use of the system	Change over 12 months	Frequency and practices; intervention group only
Untreated water usage	Change over 12 months	Frequency and practices for drinking, hygiene and cooking
Handwashing with soap	Change over 12 months	Frequency
Fetching water	Change over 12 months	Frequency
Household water insecurity status	Change over 12 months	The Household Water Insecurity Experiences (HWISE) Scale (scores 0-36 (higher scores indicate greater insecurity))
Maintenance to SAFEWATER system	Change over 12 months	Frequency and nature of maintenance; Intervention group only
Making unplanned changes to the system	Change over 12 months	Making changes for functional or aesthetical reasons which could potentially interfere with the functioning of the system - intervention group only
School attendance	Change over 12 months	Absence (days)
Satisfaction of SAFEWATER system	Change over 12 months	Level of satisfaction for system and water provided
Study retention / participation	Change over 12 months	Intervention group only
Sharing of safe water to external households	Change over 12 months	Intervention group only
Diarrhoea prevalence	Change over 12 months	Bristol Stool Chart
Gut integrity	Change over 12 months	Fingerprick test for iron levels in a sub-group of children as a proxy marker of improved gut integrity.

Trial Locations

Locations (3)

Centro de Ciencia y Tecnologia de Antioquia (CTA); 🇨🇴 Medellín, Colombia, Antioquia, Colombia

Fundación Cántaro Azul, A.C; 🇲🇽 San Cristóbal De Las Casas, Chipas, Mexico

Universidad de Medellin; 🇨🇴 Medellín, Antioquia, Colombia