- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Intervention community
Two communities in rural Colombia
|
Eine Hauswasseraufbereitungstechnologie, bestehend aus einem Rohwasserspeichertank, einer Pumpe, einer Filtereinheit (2 Patronenfilter), einer UVC-Desinfektionseinheit (UV-Lampe), einem Speichertank für Trinkwasser (aufbereitetes und sicheres Wasser) und a Verteilungsnetz im Haus für Trinkwasser.
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.
|
Kein Eingriff: Control community
One community in rural Colombia
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Wachstum von Kindern (12 Jahre und jünger).
Zeitfenster: Änderung über 12 Monate
|
Änderung des BMI-Perzentils zur Identifizierung von Wachstumsverzögerung, Auszehrung und Untergewicht
|
Änderung über 12 Monate
|
Water quality
Zeitfenster: Change over 12 months
|
Microbial load
|
Change over 12 months
|
Use of safe water
Zeitfenster: Change over 12 months
|
Frequency
|
Change over 12 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Händewaschen mit Seife
Zeitfenster: Änderung über 12 Monate
|
Frequenz
|
Änderung über 12 Monate
|
Wasser holen
Zeitfenster: Änderung über 12 Monate
|
Frequenz
|
Änderung über 12 Monate
|
Schulbesuch
Zeitfenster: Änderung über 12 Monate
|
Abwesenheit (Tage)
|
Änderung über 12 Monate
|
Status der Haushaltswasserunsicherheit
Zeitfenster: Änderung über 12 Monate
|
Die HWISE-Skala (Household Water Insecurity Experiences) (Werte 0–36 (höhere Werte bedeuten größere Unsicherheit))
|
Änderung über 12 Monate
|
Darmintegrität
Zeitfenster: Änderung über 12 Monate
|
Fingerstichtest zur Bestimmung des Eisenspiegels bei einer Untergruppe von Kindern als Proxy-Marker für eine verbesserte Darmintegrität.
|
Änderung über 12 Monate
|
Water quality
Zeitfenster: Change over 12 months
|
Turbidity (measured using a turbidimeter (NTU units)
|
Change over 12 months
|
Use of safe water
Zeitfenster: 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
Zeitfenster: Change over 12 months
|
Frequency; intervention group only
|
Change over 12 months
|
Use of the system
Zeitfenster: 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
Zeitfenster: Change over 12 months
|
Frequency
|
Change over 12 months
|
Untreated water usage
Zeitfenster: 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
Zeitfenster: Change over 12 months
|
Frequency
|
Change over 12 months
|
Water storage practices
Zeitfenster: Change over 12 months
|
Method
|
Change over 12 months
|
Sharing of safe water to external households
Zeitfenster: Change over 12 months
|
Intervention group only.
Frequency and volume of water shared with external households
|
Change over 12 months
|
Diarrhoea prevalence
Zeitfenster: Change over 12 months
|
Bristol Stool Chart (Type 1(hard) - 7(soft)
|
Change over 12 months
|
Maintenance to SAFEWATER system
Zeitfenster: Change over 12 months
|
Frequency (intervention group only)
|
Change over 12 months
|
Maintenance to SAFEWATER system
Zeitfenster: Change over 12 months
|
Nature of maintenance; intervention group only
|
Change over 12 months
|
Satisfaction of SAFEWATER system
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Change over 12 months
|
Percentage completed appointments
|
Change over 12 months
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- REC/18/0064 (C)
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