Arsenic PoisoningSHWSNCT03725592
Strong Heart Water Study
A study testing Standard Treatment and Intensive Education in people with Arsenic Poisoning, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arsenic Poisoning
- What is being tested?
- Standard Treatment and Intensive Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2018to 4 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bloomberg School of Public Health, ICTR
Baltimore, Maryland, 21202
About this study
Official title: 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).
Read the 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.
- Conditions
- Arsenic Poisoning
- Being tested
- Standard Treatment, Intensive Education
- Keywords
- arsenic, drinking water
- Medical subject headings
- Arsenic Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard TreatmentOther
Also called Arsenic Removal Device
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.
Intensive EducationBehavioural
Also called Community Participatory Arsenic Mitigation
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | Active comparator | Receives arsenic removal device and written instructions and phone calls on how to use the device (Arsenic Removal Device) Receives: Other: Standard Treatment |
| Intensive Education | Experimental | Receives the Standard Treatment plus in-person visits and phone calls for follow-up (Community Participatory Arsenic Mitigation) Receives: Other: Standard Treatment; Behavioral: Intensive Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine arsenic concentrations in household members
(1a) urine arsenic concentrations among household members (in parts per billion, µg/L)
Measured: 6 months post-installation of the arsenic removal device
Secondary outcomes (11)
Arsenic concentrations in filtered water
(2a) water arsenic concentrations from arsenic removal device (parts per billion, µg/L)
Measured: 6 months post-installation of the arsenic removal device
Water usage from arsenic removal device
(2b) water usage from removal device (from flow meter, in gallons)
Measured: 6 months post-installation of the arsenic removal device
Biomarkers of cardiovascular disease
(2c) biomarkers of cardiovascular disease (soluble adhesion molecules) in household members
Measured: 6 months post-installation of the arsenic removal device
Biomarkers of diabetes
(2d) biomarkers of diabetes (hemoglobin A1c) in household members
Measured: 6 months post-installation of the arsenic removal device
Biomarkers of pulmonary function
(2e.1) lower forced expiratory volume in 1 second (FEV1) (actual performance in liters of air, percent of predicted values)
Measured: 6 months post-installation of the arsenic removal device
Biomarkers of pulmonary function
(2e.2) lower forced vital capacity (FVC) among household members (actual performance in liters of air, percent of predicted values)
Measured: 6 months post-installation of the arsenic removal device
Blood pressure
(2f) systolic and diastolic blood pressure levels
Measured: 6 months post-installation of the arsenic removal device
Long-term urine arsenic concentrations in household members
(2g) long-term sustainability assessment to evaluate arsenic concentrations in urine among household members (parts per billion, µg/L)
Measured: 1 year post-installation of the arsenic removal device
Long-term functionality of arsenic removal device
(2h) long-term sustainability assessment to evaluate water arsenic concentrations from arsenic removal device (parts per billion, µg/L)
Measured: 1 year post-installation of the arsenic removal device
Long-term water usage from arsenic removal device
(2i) long-term sustainability assessment to evaluate water usage from removal device (from flow meter, in gallons)
Measured: 1 year post-installation of the arsenic removal device
Long-term maintenance of 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)?)
Measured: 1 year post-installation of the arsenic removal device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start2 Jul 2018
- Primary completion4 May 2027 (estimated)
- Study completion4 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arsenic PoisoningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, Missouri Breaks Industries Research, Inc., National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Christine Marie George, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725592
- Sponsor's protocol ID
- IRB00006504
- Acronym
- SHWS
- Status last verified
- May 2026
- First submitted
- 6 Jul 2018
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37183246
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Participatory Interventions to Reduce Arsenic Exposure in American Indian Communities
- ClinicalTrials.gov ID
- NCT03725592
- Acronym / sponsor ID
- SHWS / IRB00006504
- Conditions
- Arsenic Poisoning
- Keywords
- arsenic, drinking water
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Columbia University, Missouri Breaks Industries Research, Inc., National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 4 May 2027 (estimated)
- Study completion
- 4 May 2027 (estimated)
- First posted
- 31 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | Active comparator | Other: Standard TreatmentReceives arsenic removal device and written instructions and phone calls on how to use the device (Arsenic Removal Device) |
| Intensive Education | Experimental | Other: Standard Treatment, Behavioral: Intensive EducationReceives the Standard Treatment plus in-person visits and phone calls for follow-up (Community Participatory Arsenic Mitigation) |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard TreatmentAlso: Arsenic Removal DeviceParticipant 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 | Intensive Education, Standard Treatment |
| Intensive EducationAlso: Community Participatory Arsenic MitigationParticipant 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. | Behavioural | Intensive Education |
Primary outcome
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)
11 secondary outcomes
Arsenic concentrations in filtered water
Time frame: 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
Biomarkers of cardiovascular disease
Time frame: 6 months post-installation of the arsenic removal device
Biomarkers of diabetes
Time frame: 6 months post-installation of the arsenic removal device
Biomarkers of pulmonary function
Time frame: 6 months post-installation of the arsenic removal device
Biomarkers of pulmonary function
Time frame: 6 months post-installation of the arsenic removal device
Blood pressure
Time frame: 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
Long-term functionality of arsenic removal device
Time frame: 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
Long-term maintenance of arsenic removal device
Time frame: 1 year post-installation of the arsenic removal device
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Derived from this study: PubMed 37183246Endres 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.
- Individual participant dataSharing planned: No
Related trials for Arsenic Poisoning
Active, not recruiting
Table-Top Water Pitcher to Reduce Arsenic Exposure Among Well Users in New Hampshire
Arsenic Poisoning, Environmental Exposure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Marie George, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Treatment and Intensive Education in people with Arsenic Poisoning, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine arsenic concentrations in household members (time frame: 6 months post-installation of the arsenic removal device). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03725592, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.