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| Name | Class |
|---|---|
| Columbia University | OTHER |
| Missouri Breaks Industries Research, Inc. | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Treatment | Active Comparator | Receives arsenic removal device and written instructions and phone calls on how to use the device (Arsenic Removal Device) |
|
| Intensive Education | Experimental | Receives the Standard Treatment plus in-person visits and phone calls for follow-up (Community Participatory Arsenic Mitigation) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Treatment | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Urine arsenic concentrations in household members | (1a) urine arsenic concentrations among household members (in parts per billion, µg/L) | 6 months post-installation of the arsenic removal device |
| Measure | Description | Time Frame |
|---|---|---|
| Arsenic concentrations in filtered water | (2a) water arsenic concentrations from arsenic removal device (parts per billion, µg/L) | 6 months post-installation of the arsenic removal device |
| Water usage from arsenic removal device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Marie George, PhD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bloomberg School of Public Health, ICTR | Baltimore | Maryland | 21202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37183246 | Derived | Endres K, Zacher T, Richards F, Bear Robe L, Powers M, Yracheta J, Harvey D, Best LG, Red Cloud R, Black Bear A, Ristau S, Aurand D, Skinner L, Perin J, Cuny C, Gross M, Thomas ED, Rule A, Schwab K, Moulton LH, O'Leary M, Navas-Acien A, George CM. Behavioral determinants of arsenic-safe water use among Great Plains Indian Nation private well users: results from the Community-Led Strong Heart Water Study Arsenic Mitigation Program. Environ Health. 2023 May 15;22(1):42. doi: 10.1186/s12940-023-00965-0. |
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| ID | Term |
|---|---|
| D020261 | Arsenic Poisoning |
| ID | Term |
|---|---|
| D020260 | Heavy Metal Poisoning, Nervous System |
| D020258 | Neurotoxicity Syndromes |
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
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Recruit and prospectively follow 300 households and 600 participants (2 per household) to one of 2 study arms (150 households per arm). Each arm will receive arsenic removal devices. However the Standard Arm will only be provided with written instructions on how to use the arsenic removal device and follow-up phone calls, while the Intensive Education Arm will receive up to 5 additional in-visits and phone calls to provide support regarding the health implications of arsenic and the proper use and maintenance of the arsenic removal device.
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| Intensive Education | Behavioral | 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. |
|
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(2b) water usage from removal device (from flow meter, in gallons)
| 6 months post-installation of the arsenic removal device |
| Biomarkers of cardiovascular disease | (2c) biomarkers of cardiovascular disease (soluble adhesion molecules) in household members | 6 months post-installation of the arsenic removal device |
| Biomarkers of diabetes | (2d) biomarkers of diabetes (hemoglobin A1c) in household members | 6 months post-installation of the arsenic removal device |
| Biomarkers of pulmonary function | (2e.1) lower forced expiratory volume in 1 second (FEV1) (actual performance in liters of air, percent of predicted values) | 6 months post-installation of the arsenic removal device |
| Biomarkers of pulmonary function | (2e.2) lower forced vital capacity (FVC) among household members (actual performance in liters of air, percent of predicted values) | 6 months post-installation of the arsenic removal device |
| Blood pressure | (2f) systolic and diastolic blood pressure levels | 6 months post-installation of the arsenic removal device |
| Long-term urine arsenic concentrations in household members | (2g) long-term sustainability assessment to evaluate arsenic concentrations in urine among household members (parts per billion, µg/L) | 1 year post-installation of the arsenic removal device |
| Long-term functionality of arsenic removal device | (2h) long-term sustainability assessment to evaluate water arsenic concentrations from arsenic removal device (parts per billion, µg/L) | 1 year post-installation of the arsenic removal device |
| Long-term water usage from arsenic removal device | (2i) long-term sustainability assessment to evaluate water usage from removal device (from flow meter, in gallons) | 1 year post-installation of the arsenic removal device |
| Long-term maintenance of 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)?) | 1 year post-installation of the arsenic removal device |
| D064419 | Chemically-Induced Disorders |