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Trial of Safe Water Storage Among People Living With HIV

17 juni 2011 uppdaterad av: London School of Hygiene and Tropical Medicine

Randomized Controlled Trial of Safe Water Storage Among People Living With HIV

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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

1600

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Zambia
      • Lusaka, Zambia
        • Tropical Gastroenterology and Nutrition Group (TROPGAN), University of Zambia School of Medicine

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Safe storage device
This arm will be assigned a safe water storage device.
Enhet: 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.
Inget ingripande: Control
This arm of the trial will receive nothing until the end of the trial.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Self-reported diarrheal disease
Tidsram: 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).
18 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Weight-for-age z-score
Tidsram: 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).
18 months
E. coli and total coliforms in household drinking water
Tidsram: 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).
18 months
Salivary antibody response
Tidsram: 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).
18 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

London School of Hygiene and Tropical Medicine

Samarbetspartners

University of Zambia

Utredare

  • Huvudutredare: Joe Brown, PhD, London School of Hygiene and Tropical Medicine

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2011

Primärt slutförande (Förväntat)

1 augusti 2013

Avslutad studie (Förväntat)

1 augusti 2013

Studieregistreringsdatum

Först inskickad

14 juni 2011

Först inskickad som uppfyllde QC-kriterierna

17 juni 2011

Första postat (Uppskatta)

20 juni 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

20 juni 2011

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 juni 2011

Senast verifierad

1 juni 2011

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • QA308

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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