Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05395663

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Pollution; Exposure

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon State University

Corvallis, Oregon, 97331, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Community health worker

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.

Primary outcomes

  1. Treatment implemented by homeowner that will reduce their exposure to arsenic, nitrate or lead in their drinking water

    Time frame: 12 months

    The homeowner has adopted behaviors that will be appropriate for reducing their exposure to arsenic, nitrate, and lead in their drinking water. This will be assessed based on the homeowners response on a survey delivered after 12 month. Appropriate treatment will be defined as the use of drinking water technology that removes the contaminant detected (e.g. reverse osmosis, distillation, arsenic removal filter, or removal of lead-based water fixtures) or switching to bottled water for drinking and cooking.

  2. Clean water sample

    Time frame: 12 months

    A water sample that is collected from their home's kitchen faucet is tested by a certified laboratory and the contaminant of concern (arsenic, nitrate, or lead) is below its maximum contaminant level (arsenic < 10ug/L; nitrate <10mg/L, and lead <15 ug/L)

  3. Well Stewardship Behaviors

    Time frame: 6 and 12 months

    This will be assessed based on questions in the homeowner survey which asks the participants what actions they take to test, treat, and maintain the water quality that is coming from their private well.

Secondary outcomes

  1. Health literacy

    Time frame: 6 months and 12 months

    • Water Environmental Literacy Level Scale - WELLS is a 6-item scale. The reference for this is: Irvin, V. L., Rohlman, D., Vaughan, A., Amantia, R., Berlin, C., & Kile, M. L. (2019). Development and Validation of an Environmental Health Literacy Assessment Screening Tool for Domestic Well Owners: The Water Environmental Literacy Level Scale (WELLS). International journal of environmental research and public health, 16(5), 881. doi:10.3390/ijerph16050881
    • Brief Health Literacy Screener (Chew Items) is a 3-item scale. The reference for this: Chew, L.D., Bradley, K.A., & Boyko, E.J. (2004). Brief questions to identify patients with inadequate health literacy. Family Medicine, 36(8): 588-594.

  2. Risk perception

    Time frame: 6 months and 12 months

    This will be assessed our homeowner survey which includes a condensed form of the RANAS (Risk, Attitude, Norms, Ability, Self-Regulation) Scales published in Flannigan et al (2015) Dissemination of well water arsenic results to homeowners in Central Maine: influences on mitigation behavior and continued risks for exposure. Sci Total Environ, 505: 1282-90.

Other outcomes

  1. Health history - Blood pressure

    Time frame: 6 months and 12 months

    National Health and Nutrition Examination Survey (NHANES) questionnaires for Blood Pressure

  2. Health history - Diabetes

    Time frame: 6 months and 12 months

    National Health and Nutrition Examination Survey (NHANES) questionnaires for Diabetes

  3. Health history - Cardiovascular

    Time frame: 6 months and 12 months

    National Health and Nutrition Examination Survey (NHANES) questionnaires for cardiovascular

  4. Health history - Cancer

    Time frame: 6 months and 12 months

    National Health and Nutrition Examination Survey (NHANES) questionnaires for cancer

  5. Health history - Reproductive Health

    Time frame: 6 months and 12 months

    National Health and Nutrition Examination Survey (NHANES) questionnaires for reproductive health

  6. Health history - Anemia

    Time frame: 6 months and 12 months

    National Health and Nutrition Examination Survey (NHANES) questionnaires for anemia

  7. Patient-Reported Quality of life

    Time frame: 6 months and 12 months

    Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale to assess health symptoms (pain, fatigue, mental health, physical health, social health and overall health

Sponsors and collaborators

Lead sponsor

Oregon State University

Other

Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)
  • Oregon Health Authority

Registry information

Official study title

Effectiveness and Scalability of a Home Health Navigator Program to Reduce Environmental Hazards

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 27, 2022
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.