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Water-Related DiseasesNCT04736615

SAFEWATER Health & Behaviour Impact Field Trials; Mexico

A study testing SAFEWATER systems for drinking water disinfection and Behavior change interventions in people with Water-Related Diseases, run by University of Ulster at 3 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Water-Related Diseases
What is being tested?
SAFEWATER systems for drinking water disinfection and Behavior change interventions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
3 sitesin 2 countries
Study dates
1 Mar 2021to 30 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

None listed.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Colombia2 sites
  • Universidad de Medellin

    Medellín, Antioquia

  • Centro de Ciencia y Tecnologia de Antioquia (CTA)

    Medellín, Colombia, Antioquia

Other trials in Colombia

Mexico1 site
  • Fundación Cántaro Azul, A.C

    San Cristóbal de las Casas, Chipas, CP 29246

Other trials in Mexico

About this study

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

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

Read more

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.

Being tested
SAFEWATER systems for drinking water disinfection, Behavior change interventions
Keywords
Water, sanitation and hygiene (WASH), Water disinfection, Behavior change, Stunting, Gut integrity, Malnutrition, Clean water technology, Diarrhoea, Child growth
Medical subject headings
Waterborne Diseases, Growth Disorders, Malnutrition, Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAFEWATER systems for drinking water disinfectionDevice

    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.

  • Behavior change interventionsBehavioural

    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.

Study groups in NCT04736615
Study groupRoleWhat they receive
Intervention communityExperimentalHouseholds will be randomly allocated to the intervention every 1-2 months over the12 month intervention
Receives: Device: SAFEWATER systems for drinking water disinfection; Behavioral: Behavior change interventions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Water quality

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

    Measured: Change over 12 months

  2. Use of safe water

    Frequency and practices for drinking, hygiene and cooking

    Measured: Change over 12 months

  3. Child (12 years and under) growth

    Change in BMI percentile to identify stunting, wasting and underweight

    Measured: Change over 12 months

Secondary outcomes (14)
  1. Untreated water usage

    Frequency and practices for drinking, hygiene and cooking

    Measured: Change over 12 months

  2. Use of the system

    Frequency and practices; intervention group only

    Measured: Change over 12 months

  3. Water storage practices

    Frequency and method

    Measured: Change over 12 months

  4. Handwashing with soap

    Frequency

    Measured: Change over 12 months

  5. Fetching water

    Frequency

    Measured: Change over 12 months

  6. Sharing of safe water to external households

    Intervention group only

    Measured: Change over 12 months

  7. Diarrhoea prevalence

    Bristol Stool Chart

    Measured: Change over 12 months

  8. School attendance

    Absence (days)

    Measured: Change over 12 months

  9. Household water insecurity status

    The Household Water Insecurity Experiences (HWISE) Scale (scores 0-36 (higher scores indicate greater insecurity))

    Measured: Change over 12 months

  10. Gut integrity

    Fingerprick test for iron levels in a sub-group of children as a proxy marker of improved gut integrity.

    Measured: Change over 12 months

  11. Maintenance to SAFEWATER system

    Frequency and nature of maintenance; Intervention group only

    Measured: Change over 12 months

  12. Satisfaction of SAFEWATER system

    Level of satisfaction for system and water provided

    Measured: Change over 12 months

  13. 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

    Measured: Change over 12 months

  14. Study retention / participation

    Intervention group only

    Measured: Change over 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2021
  2. Study start1 Mar 2021
  3. Primary completion30 Apr 2022 (estimated)
  4. Study completion30 Apr 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Model description
Stepped-wedge design, steps: 1 month
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04736615
Sponsor's protocol ID
REC/18/0064(M)
Status last verified
Oct 2021
First submitted
29 Jan 2021
Last updated
20 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing SAFEWATER systems for drinking water disinfection and Behavior change interventions in people with Water-Related Diseases, run by University of Ulster at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Colombia, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Water quality (time frame: Change over 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.

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