- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04829981
SAFEWATER Health & Behaviour Impact Field Trials; Colombia (SAFEWATER)
The Health and Behavioural Impact of Implementing SAFEWATER Systems for Drinking Water Disinfection Within Rural Communities in Colombia and Mexico; Colombia.
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:
- Assess water quality improvement at household level
- Assess behaviors and test behavioral interventions'
- 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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:
- 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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention community
Two communities in rural Colombia
|
En teknologi til rensning af husholdningsvand, der består af en lagertank for råvand, en pumpe, en filtreringsenhed (2 patronfiltre), en UVC-desinfektionsenhed (UV-lampe), en lagertank til drikkevand (behandlet og sikkert vand) og en distributionsnet inde i huset til drikkevand.
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.
|
|
Ingen indgriben: Control community
One community in rural Colombia
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Barn (12 år og derunder) vækst
Tidsramme: Skift over 12 måneder
|
Ændring i BMI-percentilen for at identificere stunting, svind og undervægt
|
Skift over 12 måneder
|
|
Water quality
Tidsramme: Change over 12 months
|
Microbial load
|
Change over 12 months
|
|
Use of safe water
Tidsramme: Change over 12 months
|
Frequency
|
Change over 12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Håndvask med sæbe
Tidsramme: Skift over 12 måneder
|
Frekvens
|
Skift over 12 måneder
|
|
Henter vand
Tidsramme: Skift over 12 måneder
|
Frekvens
|
Skift over 12 måneder
|
|
Skoledeltagelse
Tidsramme: Skift over 12 måneder
|
Fravær (dage)
|
Skift over 12 måneder
|
|
Husstandens vandusikkerhedsstatus
Tidsramme: Skift over 12 måneder
|
The Household Water Insecurity Experiences (HWISE)-skalaen (score 0-36 (højere score indikerer større usikkerhed))
|
Skift over 12 måneder
|
|
Tarmintegritet
Tidsramme: Skift over 12 måneder
|
Fingerstiktest for jernniveauer i en undergruppe af børn som en proxymarkør for forbedret tarmintegritet.
|
Skift over 12 måneder
|
|
Water quality
Tidsramme: Change over 12 months
|
Turbidity (measured using a turbidimeter (NTU units)
|
Change over 12 months
|
|
Use of safe water
Tidsramme: Change over 12 months
|
Practices for drinking, hygiene and cooking i.e. what the water is used for and how
|
Change over 12 months
|
|
Use of the system
Tidsramme: Change over 12 months
|
Frequency; intervention group only
|
Change over 12 months
|
|
Use of the system
Tidsramme: Change over 12 months
|
Practices; intervention group only i.e. what the water is used for and how
|
Change over 12 months
|
|
Untreated water usage
Tidsramme: Change over 12 months
|
Frequency
|
Change over 12 months
|
|
Untreated water usage
Tidsramme: Change over 12 months
|
Practices for drinking, hygiene and cooking i.e. what the water is used for and how
|
Change over 12 months
|
|
Water storage practices
Tidsramme: Change over 12 months
|
Frequency
|
Change over 12 months
|
|
Water storage practices
Tidsramme: Change over 12 months
|
Method
|
Change over 12 months
|
|
Sharing of safe water to external households
Tidsramme: Change over 12 months
|
Intervention group only.
Frequency and volume of water shared with external households
|
Change over 12 months
|
|
Diarrhoea prevalence
Tidsramme: Change over 12 months
|
Bristol Stool Chart (Type 1(hard) - 7(soft)
|
Change over 12 months
|
|
Maintenance to SAFEWATER system
Tidsramme: Change over 12 months
|
Frequency (intervention group only)
|
Change over 12 months
|
|
Maintenance to SAFEWATER system
Tidsramme: Change over 12 months
|
Nature of maintenance; intervention group only
|
Change over 12 months
|
|
Satisfaction of SAFEWATER system
Tidsramme: Change over 12 months
|
Level of satisfaction for system and water provided, including taste, colour & temperature and odour (1(satisfied) - 3(unsatisfied)) + reasons (qualitative)
|
Change over 12 months
|
|
Making unplanned changes to the system
Tidsramme: Change over 12 months
|
Making changes for functional or aesthetical reasons which could potentially interfere with the functioning of the system (list of changes / household) - intervention group only
|
Change over 12 months
|
|
Study retention
Tidsramme: Change over 12 months
|
Percentage completed appointments
|
Change over 12 months
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- REC/18/0064 (C)
Plan for individuelle deltagerdata (IPD)
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