Trial of Safe Water Storage Among People Living With HIV
Randomized Controlled Trial of Safe Water Storage Among People Living With HIV
研究概览
详细说明
Specific Aim #1: To assess environmental health-related risk and outcomes in a low income peri-urban area of Zambia with a high percentage of people living with HIV/AIDS (PLWHA) (longitudinal observational cohort study and baseline) (Year 1). We will assemble a rich dataset on environmental health-related risk factors in a well defined population, with a focus on household drinking water quality and other water, sanitation, and hygiene (WSH) exposures.
Specific Aim #2: To quantify the WSH-related disease burden among PLWHA, compared with those without HIV/AIDS (individual and household level stratification) (conclusion of baseline). After nine months of data collection, we will perform an initial analysis to determine WSH-related risk by HIV status.
Specific Aim #3: To assess the impact of a water quality intervention on the longitudinal prevalence of Highly Credible Gastrointestinal Illness (HCGI) among PLWHA (randomized controlled trial, year 2). We will conduct a randomised, controlled trial of a safe water storage intervention. We will assess the health impacts of this intervention, with particular focus on the high-risk groups of PLWHA and children under 5 years of age.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Lusaka、赞比亚
- Tropical Gastroenterology and Nutrition Group (TROPGAN), University of Zambia School of Medicine
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Resident of Misisi compound, Lusaka
- Willing to participate in the study
- Is able to give informed consent and does so
- Household has one or more children who are aged 48 months or less at the start of the trial
- The household stores drinking water in the home
Exclusion Criteria:
- Not a resident of Misisi compound, Lusaka
- Unwilling to participate in the study
- Unable to give informed consent or chooses not to participate
- Household does not have one or more children aged 48 months or less at the start of the trial
- The household does not store drinking water in the home
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Safe storage device
This arm will be assigned a safe water storage device.
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This device is a specially designed water storage container that is intended to reduce the likelihood of re-contamination of household stored drinking water.
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无干预：Control
This arm of the trial will receive nothing until the end of the trial.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Self-reported diarrheal disease
大体时间：18 months
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Self-reported diarrheal disease information will be collected from each study participant monthly.
These data will be collected monthly with 24 hour, 48 hour, and 7-day recall.
Data will be assessed at 18 months (change from baseline).
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18 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Weight-for-age z-score
大体时间：18 months
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Weight-for-age z-scores will be taken for all children who are aged less than 48 months ("under 5s") at the start of the trial and monthly during the trial.
These data are useful in tracking short-term wasting, associated with diarrheal disease events.
Data will be assessed at 18 months (change from baseline).
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18 months
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E. coli and total coliforms in household drinking water
大体时间：18 months
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Microbiological indicators of fecal contamination of drinking water at the household level.
Samples will be taken from all households monthly.
Data will be assessed at 18 months (change from baseline).
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18 months
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Salivary antibody response
大体时间：18 months
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We will collect salivary samples from all consenting individuals (an additional consent form is required) to gather information on IgG and IgA response to specific diarrheal pathogens using a multiplex assay.
This measure provides useful information on both outcomes of interest (diarrheal disease) and exposure to diarrheagenic pathogens.
Samples will be taken at three time points: the beginning, midpoint, and end of the trial.
Data will be assessed at 18 months (change from baseline).
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18 months
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合作者和调查者
调查人员
- 首席研究员：Joe Brown, PhD、London School of Hygiene and Tropical Medicine
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Safe storage device的临床试验
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McGill University Health Centre/Research Institute...尚未招聘
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Cedars-Sinai Medical CenterHuntington Hospital; UniHealth Foundation; Ronald Reagan Medical Center; Torrance Memorial完全的体弱的老年人
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University of DenverNational Institute on Drug Abuse (NIDA)完全的
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St. Louis UniversityLucerno Dynamics Limited Liability Company (LLC)完全的