SAFEWATER Health & Behaviour Impact Field Trials; Mexico

NCT04736615 | Unknown

• 1 other identifier: REC/18/0064(M)
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 3

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. 1.Assess water quality improvement at household level
2. 2.Assess behaviors and test behavioral interventions
3. 3.Assess child growth and related health outcomes

Conditions

Water-Related Diseases

Keywords

Water, sanitation and hygiene (WASH); Water disinfection; Behavior change; Stunting; Gut integrity; Malnutrition; Clean water technology; Diarrhoea; Child growth

Outcome Measures

Primary Outcomes (3)

• Water quality

  Microbial load and turbidity (measured using a turbidimeter (NTU units)

  Change over 12 months

• Use of safe water

  Frequency and practices for drinking, hygiene and cooking

  Change over 12 months

• Child (12 years and under) growth

  Change in BMI percentile to identify stunting, wasting and underweight

  Change over 12 months

Secondary Outcomes (14)

• Untreated water usage

  Change over 12 months

• Use of the system

  Change over 12 months

• Water storage practices

  Change over 12 months

• Handwashing with soap

  Change over 12 months

• Fetching water

  Change over 12 months

Study Arms (1)

Intervention community

EXPERIMENTAL

Households will be randomly allocated to the intervention every 1-2 months over the12 month intervention

Device: SAFEWATER systems for drinking water disinfection; Behavioral: Behavior change interventions

Interventions

SAFEWATER systems for drinking water disinfection DEVICE

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 community

Behavior change interventions BEHAVIORAL

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.

Intervention community

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• University of Ulster: lead
• Fundación Cántaro Azul, A.C. (NGO), Mexico: collaborator
• Centro de Ciencia y Tecnologia de Antioquia (CTA) (NGO), Colombia: collaborator
• Universidad de Medellin, Colombia: collaborator
• University of Sao Paulo: collaborator

Study Sites (3)

Universidad de Medellin

Medellín, Antioquia, Colombia

Location

Centro de Ciencia y Tecnologia de Antioquia (CTA)

Medellín, Colombia, Antioquia, Colombia

Location

Fundación Cántaro Azul, A.C

San Cristóbal de las Casas, Chipas, CP 29246, Mexico

Location

MeSH Terms

Conditions

Waterborne Diseases; Growth Disorders; Malnutrition; Diarrhea

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped-wedge design, steps: 1 month

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 3, 2021
• Study Start: March 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: October 20, 2021

Record last verified: 2021-10

Locations

ME (1); CO (2)