- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03455530
Work Should Not Hurt You: Reduction of Hazardous Exposures in Small Businesses Through a Community Health Worker Intervention
June 23, 2025 updated by: University of Arizona
This project aims to reduce negative health outcomes in small businesses that primarily employ high-risk Latino workers by characterizing their exposures to hazardous chemicals and assessing if a community health worker (CHW) intervention is effective at decreasing these exposures.
Although preventable by definition, occupational disease and injuries are leading causes of death in the United States, with a disproportionate burden faced by Latinos.
Small businesses pose a particular risk.
They are more likely to employ low-wage Latino workers, and often use hazardous solvents including volatile organic chemicals that can cause asthma, cancer, cardiovascular, and neurological disease; yet their workers lack access to culturally and linguistically appropriate occupational health and pollution prevention information due to economic, physical, and social barriers.
CHW-led interventions and outreach in Latino communities have documented increased access to health care and health education and reduced workplace exposures among farmworkers.
CHWs are an innovative method to bridge the gap between these small business communities and other stakeholders.
The proposed project will capitalize on established partnerships between the University of Arizona, the Sonora Environmental Research Institute, Inc. and the El Rio Community Health Center.
A community-engaged research framework will be used to complete the following specific aims: 1) quantify and identify exposures to hazardous chemicals in the two high risk small business sectors common in our target area (i.e., auto repair shops and beauty salons); 2) work collaboratively with business owners, trade groups, workers and CHWs to design an industrial hygiene - enhanced CHW intervention tailored for each small business sector; and 3) conduct a cluster randomized trial to evaluate the effectiveness of the CHW intervention at reducing workplace exposures to volatile organic compounds and assess which factors led to successful utilization of exposure control strategies in both male and female-dominated businesses.
Businesses will be randomized to either an intervention or delayed intervention group, both of which will receive incentives to participate including worksite health screenings.
CHWs will work closely with business owners and employees to select and implement exposure-strategies appropriate for their worksite using a menu of complementary strategies of varying complexity and cost.
This innovative project has the potential to directly reduce occupational health disparities through a CHW intervention that moves beyond providing occupational health education.
The intervention will overcome current barriers by helping marginalized Latino workers and small business owners who may have limited education, literacy, and computer skills to understand the hazards associated with their work, and will empower them to have greater control over their occupational exposures, with the ultimate goal of preventing occupational disease and reducing health disparities.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
268
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85701
- Sonora Environmental Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- workers or owners of small businesses in select sectors (e.g., beauty salons, auto shops) in target zip codes in southern metropolitan Tucson, Arizona
Exclusion Criteria:
- age less than 18 years or people not employed in targeted sectors
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
The intervention group will receive the IH-enhanced CHW intervention before (~3 months) the other arm (Delayed Intervention Group).
|
The intervention will be derived from audits and exposure assessments and focus groups with workers and owners in the same business types (excluded from the trial) conducted in an earlier part of the study, as well as a community advisory group (e.g., Hispanic Chamber of Commerce) .
From this, we will generate educational materials specific for each small business sector.
We will provide the CHWs with a list of industry-specific control options along with potential cost savings and benefits.
For example, EPA estimates a cost saving of $13,000 per year for auto body shops that switch to the high-velocity low-pressure spray guns.
Each list will be a comprehensive menu of options that contain multiple control measures including simple controls, such as keeping the lids on the solvent containers.
|
|
Other: Delayed Intervention Group
The delayed intervention group will receive the IH-enhanced CHW intervention after (~3 months) the other arm (Intervention Group).
|
The intervention will be derived from audits and exposure assessments and focus groups with workers and owners in the same business types (excluded from the trial) conducted in an earlier part of the study, as well as a community advisory group (e.g., Hispanic Chamber of Commerce) .
From this, we will generate educational materials specific for each small business sector.
We will provide the CHWs with a list of industry-specific control options along with potential cost savings and benefits.
For example, EPA estimates a cost saving of $13,000 per year for auto body shops that switch to the high-velocity low-pressure spray guns.
Each list will be a comprehensive menu of options that contain multiple control measures including simple controls, such as keeping the lids on the solvent containers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Volatile Organic Chemical Concentrations From Pre- to Post-Intervention
Time Frame: 6 months
|
The primary outcome is the change in average total volatile organic chemical exposures for each business from pre- to post- intervention.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, Ogedegbe G, Orwig D, Ernst D, Czajkowski S; Treatment Fidelity Workgroup of the NIH Behavior Change Consortium. Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol. 2004 Sep;23(5):443-51. doi: 10.1037/0278-6133.23.5.443.
- Davidson KW, Goldstein M, Kaplan RM, Kaufmann PG, Knatterud GL, Orleans CT, Spring B, Trudeau KJ, Whitlock EP. Evidence-based behavioral medicine: what is it and how do we achieve it? Ann Behav Med. 2003 Dec;26(3):161-71. doi: 10.1207/S15324796ABM2603_01.
- Kraemer HC, Kuchler T, Spiegel D. Use and misuse of the consolidated standards of reporting trials (CONSORT) guidelines to assess research findings: comment on Coyne, Stefanek, and Palmer (2007). Psychol Bull. 2009 Mar;135(2):173-8; discussion 179-82. doi: 10.1037/0033-2909.135.2.173.
- Campbell MK, Elbourne DR, Altman DG; CONSORT group. CONSORT statement: extension to cluster randomised trials. BMJ. 2004 Mar 20;328(7441):702-8. doi: 10.1136/bmj.328.7441.702. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 21, 2020
Primary Completion (Actual)
January 22, 2024
Study Completion (Actual)
January 22, 2024
Study Registration Dates
First Submitted
February 21, 2018
First Submitted That Met QC Criteria
February 27, 2018
First Posted (Actual)
March 6, 2018
Study Record Updates
Last Update Posted (Actual)
July 10, 2025
Last Update Submitted That Met QC Criteria
June 23, 2025
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- R01ES028250 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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