Scalability of a Home Health Navigator Program to Reduce Arsenic, Nitrate, and Lead in Private Well Water

NCT ID: NCT05395663

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-16
• Study Completion Date: 2025-06-30

Brief Summary

Approximately 34 million Americans rely on private wells to supply their drinking water. Private wells are excluded from the Safe Drinking Water Act. Consequently, people who use private wells have not benefited from pollution prevention activities mandated by this law. This is a public health concern because toxic chemicals such as arsenic, nitrate, and lead are frequently detected in drinking water provided by private wells at concentrations that exceed the Safe Drinking Water Act's maximum contaminant levels. Chronic exposure to toxics in drinking water increase the risk of several chronic diseases. Several states in the U.S. have implemented or are proposing legislative policies to require testing and treatment of private wells and it is critical that public health agencies offer a program to aid homeowners with adherence to these new policies. Subsequently, there is a need to determine if individual-level interventions would be more effective for promoting behaviors that would reduce, mitigate, or eliminate exposure to contaminated well water. Lay health care workers may be able to provide cost-effective counseling to promote environmental health decision making among homeowners that have contaminated wells. This study will involve a community efficacy trial that brings together university-based researchers, State and Local agencies, and Extension Services. The community efficacy trial will be implemented by community health navigators via the Extension service. Specifically, it will involve a randomized controlled trial in Oregon to test the acceptability, fidelity, scalability and efficacy of 2 different intervention arms to reduce harmful toxicant exposures through the adoption of appropriate well water treatment. Upon completion, it will will produce a private well safety intervention program that has been tested and modified through empirical research. By capturing the costs and retaining the most efficacious intervention components, our cooperative approach has a better chance of scalability into practice across multiple stakeholders (i.e. Extension services, state health agencies). This information has the potential to reduce health disparities in rural America that are related to a household's source of drinking water.

Conditions

Pollution; Exposure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Arm 1: Usual practice

People will receive a free well water test kit that is delivered by mail and the results from this water test. They will also be mailed material that is provided by the Oregon Health Authority's Domestic Well Stewardship Program which is the Water Well Owner's Handbook(in English or Spanish) and contaminant guides.

Group Type: ACTIVE_COMPARATOR

Community health worker

Intervention Type: BEHAVIORAL

A trained navigator (e.g. OSU Extension staff) will have 3 meetings with the participants in Arm 2. These meetings will be held in person, on the phone, or in zoom.

Arm 2: Health navigator

People will receive a free well water test kit that is delivered by mail and the results from this water test. They will also be mailed material that is provided by the Oregon Health Authority's Domestic Well Stewardship Program which is the Water Well Owner's Handbook(in English or Spanish) and contaminant guides. In addition, a trained health navigator will meet with the homeowner three times to assist the homeowner's decision-making.

Activities include: i) Interpreting results, ii) Improving health literacy and numeracy through teach-back moments, iii) Assessment of household risk for contaminants from well and septic, iv) Assessment of risk to family members, pets, livestock, etc v) Coaching to resolve ambivalence or lack of motivation and other barriers using elicit-provide-elicit motivational interviewing; vi) Assistance with decision-making and weighing financial options, and vii) Goal-setting and action plans.

Group Type: EXPERIMENTAL

Community health worker

Intervention Type: BEHAVIORAL

A trained navigator (e.g. OSU Extension staff) will have 3 meetings with the participants in Arm 2. These meetings will be held in person, on the phone, or in zoom.

Interventions

Community health worker

A trained navigator (e.g. OSU Extension staff) will have 3 meetings with the participants in Arm 2. These meetings will be held in person, on the phone, or in zoom.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Participants are eligible for the study if they 1) Reside in Oregon; 2) Are a homeowner with a private well; 3) Use a private well as the primary source of drinking water; 4) Currently live in the home with the private well and intend to live in the home for at least 12 months from now; 5) Be at least 21 years old; and 6) Be able to complete a questionnaire in English or Spanish.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health Authority

OTHER

Sponsor Role: collaborator

National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role: collaborator

Oregon State University

OTHER

Sponsor Role: lead

Responsible Party

Molly Kile

Co-Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Molly Kile, ScD

Role: PRINCIPAL_INVESTIGATOR

Oregon State University

Veronica Irvin, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon State University

Locations

Oregon State University

Corvallis, Oregon, United States

Countries

United States

References

Irvin VL, Kile ML, Lucas-Woodruff C, Cude C, Anderson L, Baylog K, Hovell MF, Choun S, Kaplan RM. An overview of the Be Well Home Health Navigator Program to reduce contaminants in well water: Design and methods. Contemp Clin Trials. 2024 May;140:107497. doi: 10.1016/j.cct.2024.107497. Epub 2024 Mar 11.

Reference Type: DERIVED

PMID: 38471641 (View on PubMed)

Other Identifiers

NIH # 5R01ES031669

Identifier Type: -

Identifier Source: org_study_id

R01ES031669

Identifier Type: NIH

Identifier Source: secondary_id

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