Strong Heart Water Study

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Participatory Interventions to Reduce Arsenic Exposure in American Indian Communities

Conditions
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Arsenic Poisoning

Intervention / Treatment
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* Other: Standard Treatment
* Behavioral: Intensive Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Arsenic levels in household drinking water must be ≥10 µg/L Households must have ≥1 adult ≥18 years of age eligible and willing to participate. Household must have an active well on the property that is used for drinking water. Household must have indoor plumbing and a permanent heat source. Participant must plan to reside in the household for the next year, must reside in the residence for ≥4 days/week, and year round (i.e. all seasons). ≥1 household members must identify as American Indian. Household must be willing to grant study members access to the interior of their household for screening and data collection. Exclusion Criteria: Arsenic levels in household drinking water <10 µg/L Households with no adult ≥18 years of age eligible and willing to participate. Households without an active well on the property that is used for drinking water (i.e. connected to municipal water supply). Households without indoor plumbing and/or a permanent heat source. Participant planning to reside in the household <1 year, residing in the residence for <4 days/week, or not year round (i.e. not during all seasons). No household member identifies as American Indian. Household unwilling to grant study members access to the interior of their household for screening and data collection.

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Treatment<br>Receives arsenic removal device and written instructions and phone calls on how to use the device (Arsenic Removal Device) | Other: Standard Treatment<br>* 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.<br>* Other names: Arsenic Removal Device;|
| Experimental: Intensive Education<br>Receives the Standard Treatment plus in-person visits and phone calls for follow-up (Community Participatory Arsenic Mitigation) | Other: Standard Treatment<br>* 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.<br>* Other names: Arsenic Removal Device;Behavioral: Intensive Education<br>* 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.<br>* Other names: Community Participatory Arsenic Mitigation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | (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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arsenic, drinking water