Assessing PFAS Exposure (APEX) for Better Health

NCT07391397 | Active Not Recruiting

• 2 other identifiers: 23311531R43HL179154-01A1
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to determine whether a personalized PFAS (per- and polyfluoroalkyl substances) blood test and educational report-back can improve environmental health literacy (EHL), empower exposure reduction behaviors, and promote cardiovascular wellness among rural adults. The main questions it aims to answer are: Does receiving a personalized PFAS test result and educational report-back increase environmental health literacy among rural participants and healthcare providers? Does increased EHL lead to greater readiness and actions to reduce PFAS exposure and improve wellness outcomes (e.g., reduced stress, improved sleep, increased sense of control) Researchers will compare changes from pre- to post-intervention among participants who receive the personalized PFAS report-back to see if there are measurable improvements in knowledge, behavior, and wellbeing. Participants will: Provide a mail-in blood spot sample for PFAS testing using a validated laboratory method (Relentless Health). Complete online surveys before and after receiving results to assess PFAS knowledge, exposure behaviors, and wellness outcomes. Receive a personalized PFAS report-back summarizing individual results, exposure sources, and tailored strategies for exposure reduction. Participate in focus groups or interviews (subset only) to provide feedback on report clarity, usability, and communication preferences. This study focuses on rural adult residents of Nevada, including underserved populations who may face limited access to PFAS testing or environmental health education. Insights from this Phase I project will guide a future randomized controlled trial evaluating the intervention's broader impact on cardiovascular health and rural health equity.

Conditions

Environmental Health Effects

Keywords

PFAS; Environmental Health; EDCs

Outcome Measures

Primary Outcomes (2)

• Change in PFAS Environmental Health Literacy

  Change in PFAS-specific environmental health literacy (pre- vs post-intervention). Participants complete a 12 question survey with Likert type response options. Three subscales (4 questions each for knowledge, attitudes, and behavior) are summed separately, each with a minimum value of 4 and a maximum of 20. A higher score is considered better.

  4 weeks

• Change in response to a survey question assessing "Readiness to reduce PFAS exposure"

  Participants are asked to choose the sentence (from among 5 options) that most accurately describes their current efforts and interest in limiting their exposure to PFAS. Each sentence reflects one of 5 stages of change, in order from earlier to later (better): precontemplation, contemplation, preparation, action, and maintenance. The post-intervention stage is compared to the pre-intervention stage to identify increased, decreased, or no change in readiness to reduce PFAS exposure after completing the intervention.

  4 weeks

Secondary Outcomes (2)

• Usability, clarity, and satisfaction with the report-back materials

  4 weeks

• Identification of challenges to behavioral change

  4 weeks

Study Arms (1)

All Participants

OTHER

All participants who take the PFAS Blood Test

Behavioral: Blood Test and Report Back

Interventions

Blood Test and Report Back BEHAVIORAL

Participants take an at home blood test to test their PFAS levels and receive a report back with recommendations to reduce exposures.

All Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Residing or working in a rural area (verified via zip code and Health Resources and Services Administration classification)
• Ability to understand English and complete study activities
• Willingness to provide mail-in blood sample and complete pre- and post-surveys

You may not qualify if:

• Age\<18
• Residing in an urban or suburban area
• Does not understand English or complete study activities
• Not willing to provide a mail-in blood sample and/or complete pre- and post- surveys

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Million Marker Wellness, Inc.: lead
• Renown Health: collaborator

Study Sites (1)

Million Marker

Berkeley, California, 94704, United States

Location

Related Publications (19)

• Carignan CC, Bauer RA, Patterson A, Phomsopha T, Redman E, Stapleton HM, Higgins CP. Self-Collection Blood Test for PFASs: Comparing Volumetric Microsamplers with a Traditional Serum Approach. Environ Sci Technol. 2023 May 30;57(21):7950-7957. doi: 10.1021/acs.est.2c09852. Epub 2023 May 15.

  PMID: 37189231 BACKGROUND

• Rochester JR, Kwiatkowski CF, Neveux I, Dabe S, Hatcher KM, Lathrop MK, Daza EJ, Eskenazi B, Grzymski JJ, Hua J. A Personalized Intervention to Increase Environmental Health Literacy and Readiness to Change in a Northern Nevada Population: Effects of Environmental Chemical Exposure Report-Back. Int J Environ Res Public Health. 2024 Jul 11;21(7):905. doi: 10.3390/ijerph21070905.

  PMID: 39063482 BACKGROUND

• Boronow KE, Cohn B, Havas L, Plumb M, Brody JG. The Effect of Individual or Study-Wide Report-Back on Knowledge, Concern, and Exposure-Reducing Behaviors Related to Endocrine-Disrupting Chemicals. Environ Health Perspect. 2023 Sep;131(9):97005. doi: 10.1289/EHP12565. Epub 2023 Sep 8.

  PMID: 37682721 BACKGROUND

• Korfmacher KS, Brody JG. Moving Forward with Reporting Back Individual Environmental Health Research Results. Environ Health Perspect. 2023 Dec;131(12):125002. doi: 10.1289/EHP12463. Epub 2023 Dec 14.

  PMID: 38095662 BACKGROUND

• Gehle KS, Crawford JL, Hatcher MT. Integrating environmental health into medical education. Am J Prev Med. 2011 Oct;41(4 Suppl 3):S296-301. doi: 10.1016/j.amepre.2011.06.007.

  PMID: 21961679 BACKGROUND

• Finn S, O'Fallon L. The Emergence of Environmental Health Literacy-From Its Roots to Its Future Potential. Environ Health Perspect. 2017 Apr;125(4):495-501. doi: 10.1289/ehp.1409337. Epub 2015 Jun 30.

  PMID: 26126293 BACKGROUND

• Johnston J, Cushing L. Chemical Exposures, Health, and Environmental Justice in Communities Living on the Fenceline of Industry. Curr Environ Health Rep. 2020 Mar;7(1):48-57. doi: 10.1007/s40572-020-00263-8.

  PMID: 31970715 BACKGROUND

• Bullard RD, Wright BH. Environmental justice for all: community perspectives on health and research needs. Toxicol Ind Health. 1993 Sep-Oct;9(5):821-41. doi: 10.1177/074823379300900508.

  PMID: 8184445 BACKGROUND

• Hill-Briggs F, Ephraim PL, Vrany EA, Davidson KW, Pekmezaris R, Salas-Lopez D, Alfano CM, Gary-Webb TL. Social Determinants of Health, Race, and Diabetes Population Health Improvement: Black/African Americans as a Population Exemplar. Curr Diab Rep. 2022 Mar;22(3):117-128. doi: 10.1007/s11892-022-01454-3. Epub 2022 Mar 3.

  PMID: 35239086 BACKGROUND

• United States Environmental Protection Agency. Biden-Harris Administration Finalizes First-Ever National Drinking Water Standard to Protect 100M People from PFAS Pollution. https://www.epa.gov/newsreleases/biden-harris-administration-finalizes-first-ever-national-drinking-water-standard (accessed 2024-06-05).

  BACKGROUND

• C8 Science Panel. C8 Probable Link Reports. C8 Science Panel. http://c8sciencepanel.org/prob_link.html (accessed 2024-06-05).

  BACKGROUND

• Fenton SE, Ducatman A, Boobis A, DeWitt JC, Lau C, Ng C, Smith JS, Roberts SM. Per- and Polyfluoroalkyl Substance Toxicity and Human Health Review: Current State of Knowledge and Strategies for Informing Future Research. Environ Toxicol Chem. 2021 Mar;40(3):606-630. doi: 10.1002/etc.4890. Epub 2020 Dec 7.

  PMID: 33017053 BACKGROUND

• Blake BE, Fenton SE. Early life exposure to per- and polyfluoroalkyl substances (PFAS) and latent health outcomes: A review including the placenta as a target tissue and possible driver of peri- and postnatal effects. Toxicology. 2020 Oct;443:152565. doi: 10.1016/j.tox.2020.152565. Epub 2020 Aug 27.

  PMID: 32861749 BACKGROUND

• National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Division on Earth and Life Studies; Board on Population Health and Public Health Practice; Board on Environmental Studies and Toxicology; Committee on the Guidance on PFAS Testing and Health Outcomes. Guidance on PFAS Exposure, Testing, and Clinical Follow-Up. Washington (DC): National Academies Press (US); 2022 Jul 28. Available from http://www.ncbi.nlm.nih.gov/books/NBK582439/

  PMID: 35939564 BACKGROUND

• Wen ZJ, Wei YJ, Zhang YF, Zhang YF. A review of cardiovascular effects and underlying mechanisms of legacy and emerging per- and polyfluoroalkyl substances (PFAS). Arch Toxicol. 2023 May;97(5):1195-1245. doi: 10.1007/s00204-023-03477-5. Epub 2023 Mar 22.

  PMID: 36947184 BACKGROUND

• Liang Y, Zhou H, Zhang J, Li S, Shen W, Lei L. Exposure to perfluoroalkyl and polyfluoroalkyl substances and estimated glomerular filtration rate in adults: a cross-sectional study based on NHANES (2017-2018). Environ Sci Pollut Res Int. 2023 Apr;30(20):57931-57944. doi: 10.1007/s11356-023-26384-9. Epub 2023 Mar 27.

  PMID: 36971931 BACKGROUND

• Sunderland EM, Hu XC, Dassuncao C, Tokranov AK, Wagner CC, Allen JG. A review of the pathways of human exposure to poly- and perfluoroalkyl substances (PFASs) and present understanding of health effects. J Expo Sci Environ Epidemiol. 2019 Mar;29(2):131-147. doi: 10.1038/s41370-018-0094-1. Epub 2018 Nov 23.

  PMID: 30470793 BACKGROUND

• Cousins IT, Johansson JH, Salter ME, Sha B, Scheringer M. Outside the Safe Operating Space of a New Planetary Boundary for Per- and Polyfluoroalkyl Substances (PFAS). Environ Sci Technol. 2022 Aug 16;56(16):11172-11179. doi: 10.1021/acs.est.2c02765. Epub 2022 Aug 2.

  PMID: 35916421 BACKGROUND

• Gluge J , Scheringer M , Cousins IT , DeWitt JC , Goldenman G , Herzke D , Lohmann R , Ng CA , Trier X , Wang Z . An overview of the uses of per- and polyfluoroalkyl substances (PFAS). Environ Sci Process Impacts. 2020 Dec 1;22(12):2345-2373. doi: 10.1039/d0em00291g. Epub 2020 Oct 30.

  PMID: 33125022 BACKGROUND

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Carol Kwiatkowski

  Million Marker Wellness

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Environmental Health Scientist

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: February 5, 2026
• Study Start: September 1, 2025
• Primary Completion: January 31, 2026
• Study Completion: February 28, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting six months after publication
• Access Criteria: Researchers must submit an acceptable research plan (goals of the proposed research, the specific hypotheses to be examined, justification for research and methods), be affiliated with a recognized research institution, have demonstrated expertise in the area of the proposed research project, and receive independent approval from their governing institutional review board. Data will be available for use only to answer the specific question(s) indicated in the research plan. The researchers must provide a list of variable names and an outline of how research findings will be disseminated; and will be asked to sign a data-sharing agreement that commits to: 1) not attempt to identify any individual participant, 2) secure the data using appropriate software technology, 3) and destroy or return all data once analyses are complete. All final datasets will be de-identified. Final authorship on manuscripts will require review and approval by the Principal Investigators of this study.

Locations

US (1)