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Trial of Safe Water Storage Among People Living With HIV

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ClinicalTrials.gov Identifier: NCT01376336
Recruitment Status : Unknown
Verified June 2011 by London School of Hygiene and Tropical Medicine.
Recruitment status was:  Not yet recruiting
First Posted : June 20, 2011
Last Update Posted : June 20, 2011
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Diarrhea Waterborne Disease HIV Device: Safe storage device

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of Safe Water Storage Among People Living With HIV
Study Start Date : August 2011
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Safe storage device
This arm will be assigned a safe water storage device.
Device: Safe storage device
This device is a specially designed water storage container that is intended to reduce the likelihood of re-contamination of household stored drinking water.
No Intervention: Control
This arm of the trial will receive nothing until the end of the trial.

Outcome Measures

Primary Outcome Measures :
  1. Self-reported diarrheal disease [ Time Frame: 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).

Secondary Outcome Measures :
  1. Weight-for-age z-score [ Time Frame: 18 months ]
    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).

  2. E. coli and total coliforms in household drinking water [ Time Frame: 18 months ]
    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).

  3. Salivary antibody response [ Time Frame: 18 months ]
    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).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376336

Contact: Joe Brown, PhD +1 919 360 8752 joe.brown@lshtm.ac.uk
Contact: Paul Kelly, MD +44 20 7882 2643 m.p.kelly@qmul.ac.uk

Tropical Gastroenterology and Nutrition Group (TROPGAN), University of Zambia School of Medicine Not yet recruiting
Lusaka, Zambia
Principal Investigator: Paul Kelly, MD         
Sub-Investigator: Michelo Simuyandi, MSc         
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
University of Zambia
Principal Investigator: Joe Brown, PhD London School of Hygiene and Tropical Medicine
More Information

Responsible Party: Joe Brown/Lecturer, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01376336     History of Changes
Other Study ID Numbers: QA308
First Posted: June 20, 2011    Key Record Dates
Last Update Posted: June 20, 2011
Last Verified: June 2011

Keywords provided by London School of Hygiene and Tropical Medicine:
environmental health

Additional relevant MeSH terms:
Waterborne Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Communicable Diseases