Strong Heart Water Study

N/AActive Not RecruitingNCT03725592

Johns Hopkins Bloomberg School of Public Health57 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Arsenic Poisoning

Interventions

Standard TreatmentOTHER

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.

Intensive EducationBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 10 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Johns Hopkins Bloomberg School of Public Health, ICTR

Baltimore, Maryland, United States