Clinical trial NCT03725592: Strong Heart Water Study
Official title: Participatory Interventions to Reduce Arsenic Exposure in American Indian Communities
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Arsenic Poisoning
Keywords: arsenic
drinking water
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Columbia University
name: Missouri Breaks Industries Research, Inc.
name: National Institute Of Allergy & Infectuous Disease
First posted: 2018-10-31
Enrollment: 57
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Urine arsenic concentrations in household members
timeFrame: 6 months post-installation of the arsenic removal device
Secondary outcomes:
measure: Arsenic concentrations in filtered water
timeFrame: 6 months post-installation of the arsenic removal device
measure: Water usage from arsenic removal device
timeFrame: 6 months post-installation of the arsenic removal device
measure: Biomarkers of cardiovascular disease
timeFrame: 6 months post-installation of the arsenic removal device
measure: Biomarkers of diabetes
timeFrame: 6 months post-installation of the arsenic removal device
measure: Biomarkers of pulmonary function
timeFrame: 6 months post-installation of the arsenic removal device
measure: Biomarkers of pulmonary function
timeFrame: 6 months post-installation of the arsenic removal device
measure: Blood pressure
timeFrame: 6 months post-installation of the arsenic removal device
measure: Long-term urine arsenic concentrations in household members
timeFrame: 1 year post-installation of the arsenic removal device
measure: Long-term functionality of arsenic removal device
timeFrame: 1 year post-installation of the arsenic removal device
measure: Long-term water usage from arsenic removal device
timeFrame: 1 year post-installation of the arsenic removal device
measure: Long-term maintenance of arsenic removal device
timeFrame: 1 year post-installation of the arsenic removal device
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bloomberg School of Public Health, ICTR
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Christine Marie George, PhD
role: PRINCIPAL_INVESTIGATOR
References: