Strong Heart Water Study (SHWS)

Johns Hopkins Bloomberg School of Public Health

Status: Active, not recruiting

Conditions: Arsenic Poisoning

Treatments: Other: Standard Treatment; Behavioral: Intensive Education

Study type: Interventional

Funder types: Other

Identifiers

NCT03725592

IRB00006504

Details and patient eligibility

About

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).

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 10+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

Standard Treatment

Active Comparator group

Description:

Receives arsenic removal device and written instructions and phone calls on how to use the device (Arsenic Removal Device)

Treatment:

Other: Standard Treatment

Intensive Education

Experimental group

Description:

Receives the Standard Treatment plus in-person visits and phone calls for follow-up (Community Participatory Arsenic Mitigation)

Treatment:

Behavioral: Intensive Education

Other: Standard Treatment