NCT03725592

Strong Heart Water Study

Participatory Interventions to Reduce Arsenic Exposure in American Indian Communities

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Arsenic Poisoning

Interventions

Type	Name	Description
OTHER	Standard Treatment	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.
BEHAVIORAL	Intensive Education	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.

Timeline

• Start date: 2018-07-02
• Primary completion: 2026-05-04
• Completion: 2026-05-04
• First posted: 2018-10-31
• Last updated: 2025-05-13

Locations

1 site across 1 country: United States