Clinical trial NCT04736615: SAFEWATER Health & Behaviour Impact Field Trials; Mexico
Official title: The Health and Behavioural Impact of Implementing SAFEWATER Systems for Drinking Water Disinfection Within Rural Communities in Colombia and Mexico; Mexico
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Water-Related Diseases
Keywords: Water, sanitation and hygiene (WASH)
Water disinfection
Behavior change
Stunting
Gut integrity
Malnutrition
Clean water technology
Diarrhoea
Child growth
Lead sponsor: University of Ulster
Sponsor class: OTHER
Collaborators: name: Fundación Cántaro Azul, A.C. (NGO), Mexico
name: Centro de Ciencia y Tecnologia de Antioquia (CTA) (NGO), Colombia
name: Universidad de Medellin, Colombia
name: University of São Paulo, Brazil
First posted: 2021-02-03
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Stepped-wedge design, steps: 1 month
Primary purpose: PREVENTION

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.


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 (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)

Primary outcomes:
measure: Water quality
timeFrame: Change over 12 months
measure: Use of safe water
timeFrame: Change over 12 months
measure: Child (12 years and under) growth
timeFrame: Change over 12 months
Secondary outcomes:
measure: Untreated water usage
timeFrame: Change over 12 months
measure: Use of the system
timeFrame: Change over 12 months
measure: Water storage practices
timeFrame: Change over 12 months
measure: Handwashing with soap
timeFrame: Change over 12 months
measure: Fetching water
timeFrame: Change over 12 months
measure: Sharing of safe water to external households
timeFrame: Change over 12 months
measure: Diarrhoea prevalence
timeFrame: Change over 12 months
measure: School attendance
timeFrame: Change over 12 months
measure: Household water insecurity status
timeFrame: Change over 12 months
measure: Gut integrity
timeFrame: Change over 12 months
measure: Maintenance to SAFEWATER system
timeFrame: Change over 12 months
measure: Satisfaction of SAFEWATER system
timeFrame: Change over 12 months
measure: Making unplanned changes to the system
timeFrame: Change over 12 months
measure: Study retention / participation
timeFrame: Change over 12 months
Other outcomes:
Locations:
city: Medellín, Colombia
country: Colombia
facility: Centro de Ciencia y Tecnologia de Antioquia (CTA)
state: Antioquia
city: Medellín
country: Colombia
facility: Universidad de Medellin
state: Antioquia
city: San Cristóbal De Las Casas
country: Mexico
facility: Fundación Cántaro Azul, A.C
state: Chipas
Study officials:
References: