Johns Hopkins Bloomberg School of Public Health, ICTR
Baltimore, Maryland, 21202, United States
NCT Number: NCT03725592
Develop and evaluate the effectiveness of multi-level participatory interventions in reducing arsenic exposure among American Indian (AI) communities from North and South Dakota who participated in the Strong Heart Study (SHS).
This study is active but is not currently recruiting participants.
10 year and older
All sexes
Interventional
Not applicable
Baltimore, Maryland, 21202, United States
Design, implement, and evaluate multi-level participatory interventions that can lead to a sustained reduction in arsenic exposure in adults and children in Cheyenne River, Oglala, and Spirit Lake communities in North/South Dakota by: 1) building local capacity at the tribal and community levels to ensure the long-term sustainability of the interventions. 2) conduct a 2-arm cluster-randomized controlled trial comparing arsenic removal device only to removal device and intensive education and promotion among 300 households, 600 participants.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participant households receive a point of use arsenic removal device and a replacement filter. Households are also provided with an instruction manual on how to use the device.
Other names: Arsenic Removal Device
Participant households receive up to five additional in-person visits and phone calls to provide support regarding the health implications of arsenic and the proper use and maintenance of the arsenic removal device.
Other names: Community Participatory Arsenic Mitigation
Time frame: 6 months post-installation of the arsenic removal device
(1a) urine arsenic concentrations among household members (in parts per billion, µg/L)
Time frame: 6 months post-installation of the arsenic removal device
(2a) water arsenic concentrations from arsenic removal device (parts per billion, µg/L)
Time frame: 6 months post-installation of the arsenic removal device
(2b) water usage from removal device (from flow meter, in gallons)
Time frame: 6 months post-installation of the arsenic removal device
(2c) biomarkers of cardiovascular disease (soluble adhesion molecules) in household members
Time frame: 6 months post-installation of the arsenic removal device
(2d) biomarkers of diabetes (hemoglobin A1c) in household members
Time frame: 6 months post-installation of the arsenic removal device
(2e.1) lower forced expiratory volume in 1 second (FEV1) (actual performance in liters of air, percent of predicted values)
Time frame: 6 months post-installation of the arsenic removal device
(2e.2) lower forced vital capacity (FVC) among household members (actual performance in liters of air, percent of predicted values)
Time frame: 6 months post-installation of the arsenic removal device
(2f) systolic and diastolic blood pressure levels
Time frame: 1 year post-installation of the arsenic removal device
(2g) long-term sustainability assessment to evaluate arsenic concentrations in urine among household members (parts per billion, µg/L)
Time frame: 1 year post-installation of the arsenic removal device
(2h) long-term sustainability assessment to evaluate water arsenic concentrations from arsenic removal device (parts per billion, µg/L)
Time frame: 1 year post-installation of the arsenic removal device
(2i) long-term sustainability assessment to evaluate water usage from removal device (from flow meter, in gallons)
Time frame: 1 year post-installation of the arsenic removal device
(2j) long-term sustainability assessment to evaluate self-reported maintenance of the arsenic removal device (Did household change the device filter when indicated by light on spigot? Does household have replacement filter(s) available for subsequent filter change(s)?)
Johns Hopkins Bloomberg School of Public Health
Other
Participatory Interventions to Reduce Arsenic Exposure in American Indian Communities
Acronym: SHWS
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