Pollution; ExposureNCT05395663
Scalability of a Home Health Navigator Program to Reduce Arsenic, Nitrate, and Lead in Private Well Water
A study testing Community health worker in people with Pollution; Exposure, run by Oregon State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pollution; Exposure
- What is being tested?
- Community health worker
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2022to Jun 2025
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Scalability of a Home Health Navigator Program to Reduce Environmental Hazards
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
- Being tested
- Community health worker
- Keywords
- drinking water, arsenic, nitrate, lead, environmental pollution, ground water, home environment, water wells, health promotion, water pollutant, water pollution, water treatment, water purification, chemical water pollution, underground water, water quality, environmental carcinogens, environmental health, environmental exposure, environmental pollutant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community health workerBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Usual practice | Active comparator | 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. Receives: Behavioral: Community health worker |
| Arm 2: Health navigator | Experimental | 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. Receives: Behavioral: Community health worker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment implemented by homeowner that will reduce their exposure to arsenic, nitrate or lead in their drinking water
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.
Measured: 12 months
Clean water sample
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)
Measured: 12 months
Well Stewardship Behaviors
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.
Measured: 6 and 12 months
Secondary outcomes (2)
Health literacy
- 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.
Measured: 6 months and 12 months
Risk perception
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.
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start16 Jun 2022
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (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 Pollution; ExposureStudies 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
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon State University
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health Authority, National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Principal investigator, Molly Kile, Oregon State University
- Investigators
- Molly Kile, ScD, Principal investigator, Oregon State UniversityVeronica Irvin, PhD, Principal investigator, Oregon State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395663
- Sponsor's protocol ID
- NIH # 5R01ES031669
- Other IDs
- R01ES031669
- Status last verified
- Mar 2025
- First submitted
- 10 May 2022
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38471641
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Scalability of a Home Health Navigator Program to Reduce Environmental Hazards
- ClinicalTrials.gov ID
- NCT05395663
- Acronym / sponsor ID
- NIH # 5R01ES031669
- Conditions
- Pollution; Exposure
- Keywords
- drinking water, arsenic, nitrate, lead, environmental pollution, ground water, home environment, water wells
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Oregon State UniversityUniversity, hospital or other
- Collaborators
- Oregon Health Authority, National Institute of Environmental Health Sciences (NIEHS)
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 27 May 2022 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Usual practice | Active comparator | Behavioral: Community health workerPeople 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. |
| Arm 2: Health navigator | Experimental | Behavioral: Community health workerPeople 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Community health workerA 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. | Behavioural | Arm 1: Usual practice, Arm 2: Health navigator |
Primary outcome
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.
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)
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.
2 secondary outcomes
Health literacy
Time frame: 6 months and 12 months
Risk perception
Time frame: 6 months and 12 months
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 18 Mar 2025.
- Derived from this study: PubMed 38471641Irvin 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.
- Individual participant dataSharing planned: Undecided
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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.
Molly Kile, ScD principal investigator
Oregon State University
Veronica Irvin, PhD principal investigator
Oregon State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community health worker in people with Pollution; Exposure, run by Oregon State University 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?
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 18 Mar 2025. 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?
Treatment implemented by homeowner that will reduce their exposure to arsenic, nitrate or lead in their drinking water (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT05395663, 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 18 Mar 2025.