Work Should Not Hurt You: Reduction of Hazardous Exposures in Small Businesses Through a Community Health Worker Intervention

NCT ID: NCT03455530

Last Updated: 2025-07-10

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-21

Study Completion Date

2024-01-22

Brief Summary

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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.

Detailed Description

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Conditions

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Community Health Aides Industrial Hygiene Volatile Organic Compounds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Both groups will receive a baseline exposure assessment and health screenings from El Rio Community Health Center. Then, the intervention group will receive the industrial hygiene (IH)-enhanced community health worker (CHW) intervention. After the second exposure assessment, the delayed group will receive the intervention. A third exposure assessment will be obtained to determine if exposure levels and controls are maintained in the intervention group, and to assess the intervention in the delayed group. This will help us assess sustainability of the intervention. CHWs will accompany evaluators during the first assessment but leave before data collection begins. We anticipate that the CHW intervention will be completed over a 60-day time period (range: 30-90 days).
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Data collection will be conducted by research staff blinded to the intervention condition. CHWs will only be present at the first baseline-assessment prior to data collection.

Study Groups

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Intervention Group

The intervention group will receive the IH-enhanced CHW intervention before (\~3 months) the other arm (Delayed Intervention Group).

Group Type EXPERIMENTAL

Industrial Hygiene-Enhance Community Health Worker Intervention

Intervention Type OTHER

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.

Delayed Intervention Group

The delayed intervention group will receive the IH-enhanced CHW intervention after (\~3 months) the other arm (Intervention Group).

Group Type OTHER

Industrial Hygiene-Enhance Community Health Worker Intervention

Intervention Type OTHER

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.

Interventions

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Industrial Hygiene-Enhance Community Health Worker Intervention

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sonora Environmental Research Institute, Inc.

UNKNOWN

Sponsor Role collaborator

El Rio Community Health Center

OTHER

Sponsor Role collaborator

National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role collaborator

University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sonora Environmental Research Institute

Tucson, Arizona, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 15367063 (View on PubMed)

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.

Reference Type RESULT
PMID: 14644692 (View on PubMed)

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.

Reference Type RESULT
PMID: 19254073 (View on PubMed)

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.

Reference Type RESULT
PMID: 15031246 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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R01ES028250

Identifier Type: NIH

Identifier Source: secondary_id

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R01ES028250

Identifier Type: NIH

Identifier Source: org_study_id

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