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Active, Not Recruiting

NCT Number: NCT03725592

Strong Heart Water Study

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Bloomberg School of Public Health, ICTR

Baltimore, Maryland, 21202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

standard treatment

Other

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.

Other names: Arsenic Removal Device

Intensive education

Behavioral

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.

Other names: Community Participatory Arsenic Mitigation

Primary outcomes

  1. Urine arsenic concentrations in household members

    Time frame: 6 months post-installation of the arsenic removal device

    (1a) urine arsenic concentrations among household members (in parts per billion, µg/L)

Secondary outcomes

  1. Arsenic concentrations in filtered water

    Time frame: 6 months post-installation of the arsenic removal device

    (2a) water arsenic concentrations from arsenic removal device (parts per billion, µg/L)

  2. Water usage from arsenic removal device

    Time frame: 6 months post-installation of the arsenic removal device

    (2b) water usage from removal device (from flow meter, in gallons)

  3. Biomarkers of cardiovascular disease

    Time frame: 6 months post-installation of the arsenic removal device

    (2c) biomarkers of cardiovascular disease (soluble adhesion molecules) in household members

  4. Biomarkers of diabetes

    Time frame: 6 months post-installation of the arsenic removal device

    (2d) biomarkers of diabetes (hemoglobin A1c) in household members

  5. Biomarkers of pulmonary function

    Time frame: 6 months post-installation of the arsenic removal device

    (2e.1) lower forced expiratory volume in 1 second (FEV1) (actual performance in liters of air, percent of predicted values)

  6. Biomarkers of pulmonary function

    Time frame: 6 months post-installation of the arsenic removal device

    (2e.2) lower forced vital capacity (FVC) among household members (actual performance in liters of air, percent of predicted values)

  7. Blood pressure

    Time frame: 6 months post-installation of the arsenic removal device

    (2f) systolic and diastolic blood pressure levels

  8. Long-term urine arsenic concentrations in household members

    Time frame: 1 year post-installation of the arsenic removal device

    (2g) long-term sustainability assessment to evaluate arsenic concentrations in urine among household members (parts per billion, µg/L)

  9. Long-term functionality of arsenic removal device

    Time frame: 1 year post-installation of the arsenic removal device

    (2h) long-term sustainability assessment to evaluate water arsenic concentrations from arsenic removal device (parts per billion, µg/L)

  10. Long-term water usage from arsenic removal device

    Time frame: 1 year post-installation of the arsenic removal device

    (2i) long-term sustainability assessment to evaluate water usage from removal device (from flow meter, in gallons)

  11. Long-term maintenance of arsenic removal device

    Time frame: 1 year post-installation of the 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)?)

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Columbia University
  • Missouri Breaks Industries Research, Inc.
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Participatory Interventions to Reduce Arsenic Exposure in American Indian Communities

Acronym: SHWS

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Oct 31, 2018
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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