Strong Heart Water Study

NCT03725592 | Active Not Recruiting DMC

• 1 other identifier: IRB00006504
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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).

Conditions

Arsenic Poisoning

Keywords

arsenic; drinking water

Outcome Measures

Primary Outcomes (1)

• Urine arsenic concentrations in household members

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

  6 months post-installation of the arsenic removal device

Secondary Outcomes (11)

• Arsenic concentrations in filtered water

  6 months post-installation of the arsenic removal device

• Water usage from arsenic removal device

  6 months post-installation of the arsenic removal device

• Biomarkers of cardiovascular disease

  6 months post-installation of the arsenic removal device

• Biomarkers of diabetes

  6 months post-installation of the arsenic removal device

• Biomarkers of pulmonary function

  6 months post-installation of the arsenic removal device

Study Arms (2)

Standard Treatment

ACTIVE COMPARATOR

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

Other: Standard Treatment

Intensive Education

EXPERIMENTAL

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

Other: Standard Treatment; Behavioral: Intensive Education

Interventions

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.

Also known as: Arsenic Removal Device

Intensive Education; Standard Treatment

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.

Also known as: Community Participatory Arsenic Mitigation

Intensive Education

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Columbia University: collaborator
• Missouri Breaks Industries Research, Inc.: collaborator
• National Institute Of Allergy & Infectuous Disease: collaborator

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health, ICTR

Baltimore, Maryland, 21202, United States

Location

Related Publications (1)

• Endres K, Zacher T, Richards F, Bear Robe L, Powers M, Yracheta J, Harvey D, Best LG, Red Cloud R, Black Bear A, Ristau S, Aurand D, Skinner L, Perin J, Cuny C, Gross M, Thomas ED, Rule A, Schwab K, Moulton LH, O'Leary M, Navas-Acien A, George CM. Behavioral determinants of arsenic-safe water use among Great Plains Indian Nation private well users: results from the Community-Led Strong Heart Water Study Arsenic Mitigation Program. Environ Health. 2023 May 15;22(1):42. doi: 10.1186/s12940-023-00965-0.

  PMID: 37183246 DERIVED

MeSH Terms

Conditions

Arsenic Poisoning

Condition Hierarchy (Ancestors)

Heavy Metal Poisoning, Nervous System; Neurotoxicity Syndromes; Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Study Officials

• Christine Marie George, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: October 31, 2018
• Study Start: July 2, 2018
• Primary Completion: May 4, 2026
• Study Completion: May 4, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)