- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01376336
Trial of Safe Water Storage Among People Living With HIV
Randomized Controlled Trial of Safe Water Storage Among People Living With HIV
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Lusaka, Sambia
- Tropical Gastroenterology and Nutrition Group (TROPGAN), University of Zambia School of Medicine
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Safe storage device
This arm will be assigned a safe water storage device.
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This device is a specially designed water storage container that is intended to reduce the likelihood of re-contamination of household stored drinking water.
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Kein Eingriff: Control
This arm of the trial will receive nothing until the end of the trial.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Self-reported diarrheal disease
Zeitfenster: 18 months
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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).
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18 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Weight-for-age z-score
Zeitfenster: 18 months
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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).
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18 months
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E. coli and total coliforms in household drinking water
Zeitfenster: 18 months
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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).
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18 months
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Salivary antibody response
Zeitfenster: 18 months
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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).
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18 months
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Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Joe Brown, PhD, London School of Hygiene and Tropical Medicine
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- QA308
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