Randomized Controlled Trial of Safe Water Storage Among People Living With HIV
试验速览
- 阶段
- 不适用
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- Self-reported diarrheal disease
研究概览
简要总结
Environmental health-related pathogens include faecal-oral, diarrhoeagenic microbes that may be transmitted via drinking water and are related to sanitation and hygiene. Previous research has suggested that safeguarding household drinking water against recontamination may be a critical intervention that can reduce risks of diarrheal diseases and may be especially important for people living with HIV/AIDS (PLWHA) and other vulnerable populations (Clasen et al. 2007). The investigators propose here a randomised, controlled trial of a household safe storage container for drinking water in a well defined, HIV-impacted population in peri-urban Lusaka, Zambia. After a baseline data collection period (9 months) half of all households (150 households) will be given a safe water storage container specifically designed to prevent recontamination of water in household use. All households will be followed for an additional 9 months. Results of this study will help determine whether this promising water quality intervention can reduce diarrhoea and related outcomes in this and similar vulnerable populations.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Self-reported diarrheal disease
时间窗: 18 months
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).
次要结局
- Weight-for-age z-score(18 months)
- E. coli and total coliforms in household drinking water(18 months)
- Salivary antibody response(18 months)