- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Intervention community
Two communities in rural Colombia
|
원수 저장탱크, 펌프, 여과장치(카트리지 필터 2개), UVC 살균장치(UV 램프), 음용수 저장탱크(처리되고 안전한 물), 집 안의 식수 분배 네트워크.
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.
|
간섭 없음: Control community
One community in rural Colombia
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
어린이(12세 이하) 성장
기간: 12개월에 걸친 변화
|
발육 부진, 소모 및 저체중 식별을 위한 BMI 백분위수 변경
|
12개월에 걸친 변화
|
Water quality
기간: Change over 12 months
|
Microbial load
|
Change over 12 months
|
Use of safe water
기간: Change over 12 months
|
Frequency
|
Change over 12 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
비누로 손씻기
기간: 12개월에 걸친 변화
|
빈도
|
12개월에 걸친 변화
|
물 가져오기
기간: 12개월에 걸친 변화
|
빈도
|
12개월에 걸친 변화
|
학교 출석
기간: 12개월에 걸친 변화
|
부재(일)
|
12개월에 걸친 변화
|
가정용 물 불안정 상태
기간: 12개월에 걸친 변화
|
가정용 물 불안정 경험(HWISE) 척도(점수 0-36(점수가 높을수록 불안정성이 높음))
|
12개월에 걸친 변화
|
내장 무결성
기간: 12개월에 걸친 변화
|
개선된 내장 무결성의 대리 마커로서 어린이 하위 그룹의 철분 수치에 대한 손가락 검사.
|
12개월에 걸친 변화
|
Water quality
기간: Change over 12 months
|
Turbidity (measured using a turbidimeter (NTU units)
|
Change over 12 months
|
Use of safe water
기간: 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
기간: Change over 12 months
|
Frequency; intervention group only
|
Change over 12 months
|
Use of the system
기간: 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
기간: Change over 12 months
|
Frequency
|
Change over 12 months
|
Untreated water usage
기간: 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
기간: Change over 12 months
|
Frequency
|
Change over 12 months
|
Water storage practices
기간: Change over 12 months
|
Method
|
Change over 12 months
|
Sharing of safe water to external households
기간: Change over 12 months
|
Intervention group only.
Frequency and volume of water shared with external households
|
Change over 12 months
|
Diarrhoea prevalence
기간: Change over 12 months
|
Bristol Stool Chart (Type 1(hard) - 7(soft)
|
Change over 12 months
|
Maintenance to SAFEWATER system
기간: Change over 12 months
|
Frequency (intervention group only)
|
Change over 12 months
|
Maintenance to SAFEWATER system
기간: Change over 12 months
|
Nature of maintenance; intervention group only
|
Change over 12 months
|
Satisfaction of SAFEWATER system
기간: 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
기간: 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
기간: Change over 12 months
|
Percentage completed appointments
|
Change over 12 months
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
수인성 질병에 대한 임상 시험
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University of Pennsylvania완전한Intrntl Classification of Diseases, 9th Revision, (ICD-9-CM) 410의 주진단 또는 이차진단 코드가 있는 환자(5번째 숫자가 2인 경우 제외)미국