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

57 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Christine Marie George, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+