Trial of Safe Water Storage Among People Living With HIV
|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
|Condition or disease||Intervention/treatment||Phase|
|Diarrhea Waterborne Disease HIV||Device: Safe storage device||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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).
- 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).
- 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).
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376336
|Contact: Joe Brown, PhD||+1 919 360 firstname.lastname@example.org|
|Contact: Paul Kelly, MD||+44 20 7882 email@example.com|
|Tropical Gastroenterology and Nutrition Group (TROPGAN), University of Zambia School of Medicine||Not yet recruiting|
|Principal Investigator: Paul Kelly, MD|
|Sub-Investigator: Michelo Simuyandi, MSc|
|Principal Investigator:||Joe Brown, PhD||London School of Hygiene and Tropical Medicine|