Clinical trial NCT01376336: Trial of Safe Water Storage Among People Living With HIV
Official title: Randomized Controlled Trial of Safe Water Storage Among People Living With HIV
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diarrhea
Waterborne Disease
HIV
Keywords: environmental health
diarrhea
water
HIV
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: University of Zambia
First posted: 2011-06-20
Enrollment: 1600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-reported diarrheal disease
timeFrame: 18 months
Secondary outcomes:
measure: Weight-for-age z-score
timeFrame: 18 months
measure: E. coli and total coliforms in household drinking water
timeFrame: 18 months
measure: Salivary antibody response
timeFrame: 18 months
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Tropical Gastroenterology and Nutrition Group (TROPGAN), University of Zambia School of Medicine
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Joe Brown, PhD
role: PRINCIPAL_INVESTIGATOR
References: