Strong Heart Water Study (SHWS)

February 19, 2024 updated by: Johns Hopkins Bloomberg School of Public Health

Participatory Interventions to Reduce Arsenic Exposure in American Indian Communities

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Johns Hopkins Bloomberg School of Public Health, ICTR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Treatment
Receives arsenic removal device and written instructions and phone calls on how to use the device (Arsenic Removal Device)
Other: Standard Treatment
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
Experimental: Intensive Education
Receives the Standard Treatment plus in-person visits and phone calls for follow-up (Community Participatory Arsenic Mitigation)
Other: Standard Treatment
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
Behavioral: Intensive Education
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months post-installation of the arsenic removal device

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months post-installation of the arsenic removal device
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)
6 months post-installation of the arsenic removal device
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
6 months post-installation of the arsenic removal device
Biomarkers of diabetes
Time Frame: 6 months post-installation of the arsenic removal device
(2d) biomarkers of diabetes (hemoglobin A1c) in household members
6 months post-installation of the arsenic removal device
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 months post-installation of the arsenic removal device
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)
6 months post-installation of the arsenic removal device
Blood pressure
Time Frame: 6 months post-installation of the arsenic removal device
(2f) systolic and diastolic blood pressure levels
6 months post-installation of the arsenic removal device
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)
1 year post-installation of the arsenic removal device
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)
1 year post-installation of the arsenic removal device
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)
1 year post-installation of the arsenic removal device
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)?)
1 year post-installation of the arsenic removal device

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

Columbia University
Missouri Breaks Industries Research, Inc.

Investigators

  • Principal Investigator: Christine Marie George, PhD, Johns Hopkins Bloomberg School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2018

Primary Completion (Estimated)

May 4, 2024

Study Completion (Estimated)

May 4, 2024

Study Registration Dates

First Submitted

July 6, 2018

First Submitted That Met QC Criteria

October 29, 2018

First Posted (Actual)

October 31, 2018

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00006504

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arsenic Poisoning

Clinical Trials on Standard Treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe