Intensive Education for Arsenic Poisoning

(SHWS Trial)

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins Bloomberg School of Public Health

Disqualifiers: Municipal water, No indoor plumbing, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best methods to reduce arsenic exposure for American Indian communities in North and South Dakota. It tests two approaches: a standard treatment using an arsenic removal device with instructions, and an intensive education option (known as Problem-Solving Education or Postpartum Education) that includes additional support through visits and follow-up calls. Suitable participants have drinking water with high arsenic levels and live in a household with an active well. Participants should identify as American Indian and be willing to allow researchers to visit their homes for the study. As an unphased trial, this study offers participants the chance to contribute to vital research that could significantly enhance community health.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that this trial focuses on reducing arsenic exposure, not on testing a new drug or medical treatment. The trial employs two methods: a standard treatment and an intensive education program, both designed to help lower arsenic levels in drinking water.

The intensive education program offers additional support through in-person visits and phone calls to ensure proper use of arsenic removal devices. Studies have shown that high levels of arsenic in water can harm health. This trial aims to lower those levels, which could be beneficial.

Since this trial involves education and device use to reduce arsenic, it does not present direct safety concerns like those associated with a new drug. The main safety focus is ensuring correct device usage to avoid arsenic exposure. No evidence suggests that the education or device use itself is unsafe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to tackling arsenic poisoning through intensive education. Unlike the standard treatment, which involves providing an arsenic removal device and basic instructions, this trial adds an extra layer of support with in-person visits and regular follow-up phone calls. This hands-on approach, known as Community Participatory Arsenic Mitigation, aims to empower individuals with deeper knowledge and better compliance, potentially leading to more effective arsenic removal from drinking water. By focusing on education and community engagement, researchers hope to uncover insights that could lead to more successful long-term outcomes in arsenic mitigation efforts.

What evidence suggests that this trial's treatments could be effective in reducing arsenic exposure?

Research has shown that educating people about arsenic and using devices to remove it can lower arsenic exposure in communities. Arsenic is a harmful substance that can cause serious health issues like cancer, heart disease, and skin problems. In this trial, participants in the Intensive Education arm will receive the Standard Treatment, which includes an arsenic removal device and written instructions, along with additional in-person visits and follow-up phone calls to ensure proper device use. Studies suggest that direct engagement helps people better understand and manage arsenic exposure risks. This approach is crucial in areas where drinking water is contaminated with arsenic. ^{6 7 8 9 10}

Who Is on the Research Team?

Christine Marie George, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Are You a Good Fit for This Trial?

The Strong Heart Water Study is for American Indian adults with arsenic levels in their household drinking water of ≥10 µg/L. Participants must be willing to participate, have indoor plumbing and a permanent heat source, plan to stay in the home for at least a year, live there most of the week throughout all seasons, and allow access for data collection.

Inclusion Criteria

Arsenic levels in household drinking water must be ≥10 µg/L

Household must have indoor plumbing and a permanent heat source

There is at least one adult in my household willing to join the study.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Installation of arsenic removal devices and implementation of educational interventions

6 months

In-person visits and phone calls

Follow-up

Participants are monitored for arsenic levels and health biomarkers post-intervention

6 months

Phone calls and in-person visits

Long-term Follow-up

Assessment of long-term sustainability and effectiveness of arsenic removal devices

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Intensive Education
• Standard Treatment

Trial Overview This study aims to assess how effective multi-level interventions are at reducing arsenic exposure among American Indians. It involves comparing standard treatment methods against intensive education programs designed specifically for these communities.

How Is the Trial Designed?

Group I: Intensive Education Experimental Treatment 2 Interventions

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

Group II: Standard Treatment Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Missouri Breaks Industries Research, Inc.

Collaborator

Trials

8

Recruited

2,100+

National Institute Of Allergy & Infectuous Disease

Collaborator

Trials

1

Recruited

60+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5554459/

Associations between prenatal arsenic exposure with ... With respect to its frequency, toxicity, and potential for human exposure, arsenic holds the highest ranking since 1997 on the US Agency for ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03725592

Study Details | NCT03725592 | Strong Heart Water Study Arsenic Removal Device. Behavioral : Intensive Education. Participant ... Poisoning. Chemically-Induced Disorders. Arsenic Poisoning. Plan for Individual ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37517496/

Associations between area-level arsenic exposure and ... Methods: Data for arsenic violations in PWS, defined as ... Arsenic* / toxicity; Birth Weight; Child; Cohort Studies; Drinking Water ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0272775724000190

Still Waters Run Deep: Groundwater Contamination and ... Arsenic poisoning or so-called arsenicosis, has been linked, amongst others, to illnesses inducing kidney and heart failure, mental illnesses, cancer, skin- ...

5. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1596599/full

Global, regional, and national burden of unintentional ... ... poisons. Furthermore, the limited availability of emergency medical resources in low-SDI countries further exacerbates poisoning outcomes.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25682472/

Postnatal arsenic exposure and attention impairment in school ... In conclusion, UA levels were associated with impaired attention/cognitive function, even at levels considered safe. These results provide additional evidence ...

7. researchgate.net researchgate.net/publication/372735998_Associations_between_area-level_arsenic_exposure_and_adverse_birth_outcomes_An_Echo-wide_cohort_analysis

Associations between area-level arsenic exposure and ... Our study did not identify associations between preconception and prenatal arsenic exposure, defined by drinking water exceedances, and adverse birth outcomes.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6357795/

A Prospective Cohort Study Examining the Associations of ... We observed 203 fetal losses and 20 neonatal deaths. Higher arsenic exposure was associated with a slightly decreased mortality rate up to the middle of the ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0272775711000719

Poisoning the mind: Arsenic contamination of drinking ... This study examines the effect of arsenic contamination of tubewells, the primary source of drinking water at home, on the learning outcome of school-going ...

10. stacks.cdc.gov stacks.cdc.gov/view/cdc/216001

Associations Between Prenatal Arsenic Exposure with ... BACKGROUND: Chronic arsenic exposure is a public health concern in many parts of the world, with elevated concentrations in groundwater posing a threat to ...