Strong Heart Water Study (SHWS)

May 7, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
57

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins Bloomberg School of Public Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Allergy and Infectious Diseases (NIAID)
Columbia University
Missouri Breaks Industries Research, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christine Marie George, PhD, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 2, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 4, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 4, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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