SAFEWATER Health & Behaviour Impact Field Trials; Colombia

NCT ID: NCT04829981

Last Updated: 2021-10-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-04-30

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.

Conditions

Water-Related Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention community

Two communities in rural Colombia

Group Type: EXPERIMENTAL

SAFEWATER systems for drinking water disinfection

Intervention Type: 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.

Behaviour change interventions

Intervention Type: 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.

Control community

One community in rural Colombia

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

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:

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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundación Cántaro Azul, A.C. (NGO), Mexico

UNKNOWN

Sponsor Role: collaborator

Centro de Ciencia y Tecnologia de Antioquia (CTA) (NGO), Colombia

UNKNOWN

Sponsor Role: collaborator

Universidad de Medellin, Colombia

UNKNOWN

Sponsor Role: collaborator

University of São Paulo, Brazil

UNKNOWN

Sponsor Role: collaborator

University of Ulster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universidad de Medellin

Medellín, Antioquia, Colombia

Centro de Ciencia y Tecnologia de Antioquia (CTA),

Medellín, , Colombia

Fundación Cántaro Azul, A.C

San Cristóbal de las Casas, Chipas, Mexico

Countries

Colombia; Mexico

Other Identifiers

REC/18/0064 (C)

Identifier Type: -

Identifier Source: org_study_id