CClinicalTrials.gg
CompletedNCT03455530Updated Jul 10, 2025Results posted

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

An interventional study of Industrial Hygiene-Enhance Community Health Worker Intervention in Community Health Aides, Industrial Hygiene and Volatile Organic Compounds, sponsored by University of Arizona. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-10.

Sponsored by University of Arizona · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
268
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Community Health Aides
  • Industrial Hygiene
  • Volatile Organic Compounds
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • age less than 18 years or people not employed in targeted sectors
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
268 participants (actual)

Study arms

  • Experimental
    Intervention Group

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

    Other: Industrial Hygiene-Enhance Community Health Worker Intervention

  • Other
    Delayed Intervention Group

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

    Other: Industrial Hygiene-Enhance Community Health Worker Intervention

Interventions

  • OtherIndustrial 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.

05

What researchers measure

Primary outcomes

  1. Change in Volatile Organic Chemical Concentrations From Pre- to Post-Intervention

    The primary outcome is the change in average total volatile organic chemical exposures for each business from pre- to post- intervention.

    Time frame: 6 months

06

Results

Posted Jul 10, 2025
Limitations and caveats
The analysis was performed by business. Workers may have changed during assessment. We were not able to recruit the initial number of businesses due to the COVID-19 pandemic.

Participant flow

Participant flow — Overall Study
MilestoneIntervention Group - Beauty SalonDelayed Intervention Group - Beauty SalonIntervention Group - Auto ShopsDelayed Intervention - Auto Shops
Started77706952
Completed68696649
Not completed9133
Withdrew: Withdrawal by subject9133

Outcome measures

PrimaryChange in Volatile Organic Chemical Concentrations From Pre- to Post-Intervention

The primary outcome is the change in average total volatile organic chemical exposures for each business from pre- to post- intervention.

Time frame:
6 months
Reported as:
Geometric mean · ppb
Change in Volatile Organic Chemical Concentrations From Pre- to Post-Intervention
ppbIntervention Group - Beauty SalonDelayed Intervention Group - Beauty SalonIntervention Group - Auto ShopsDelayed Intervention - Auto Shops
Change in Volatile Organic Chemical Concentrations From Pre- to Post-Intervention2738 (1720 to 4358)3875 (2471 to 6077)523 (267 to 1026)225 (116 to 435)
Statistical analysis
  • Intervention Group - Beauty Salon vs Delayed Intervention Group - Beauty Salon · Mixed Models Analysis · Mean difference (final values): 0.73 · 95% CI 0.45 to 1.19Ratio based on the mean difference from the log scale.
  • Intervention Group - Auto Shops vs Delayed Intervention - Auto Shops · Mixed Models Analysis · Mean difference (final values): 1.34 · 95% CI 0.55 to 3.24Ratio based on the mean difference from the log scale.

Adverse events

Collected over Two years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention Group - Beauty Salon0/77 (0%)0/77 (0%)0/77 (0%)
Delayed Intervention Group - Beauty Salon0/70 (0%)0/70 (0%)0/70 (0%)
Intervention Group - Auto Shop0/69 (0%)0/69 (0%)0/69 (0%)
Delayed Intervention Group - Auto Shop0/52 (0%)0/52 (0%)0/52 (0%)

Baseline characteristics

This is a cluster-randomized trial where the clusters were businesses. 1-4 workers participated per business.

Age, Continuous
Age, Continuous(years)Intervention Group - Beauty SalonDelayed Intervention Group - Beauty SalonIntervention Group - Auto ShopDelayed Intervention Group - Auto ShopTotal
Mean44 ± 1247 ± 1440 ± 1238 ± 1142.4 ± 12.4
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Intervention Group - Beauty SalonDelayed Intervention Group - Beauty SalonIntervention Group - Auto ShopDelayed Intervention Group - Auto ShopTotal
Male776448126
Female686243137
Unknown21115
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Intervention Group - Beauty SalonDelayed Intervention Group - Beauty SalonIntervention Group - Auto ShopDelayed Intervention Group - Auto ShopTotal
Hispanic or Latino54524737190
Not Hispanic or Latino2115211471
Unknown or Not Reported23117
Region of Enrollment
Region of Enrollment(participants)Intervention Group - Beauty SalonDelayed Intervention Group - Beauty SalonIntervention Group - Auto ShopDelayed Intervention Group - Auto ShopTotal
United States77706952268
07

Study locations

1 site
  • Sonora Environmental Research Institute
    Tucson, Arizona 85701, United States
08

References and documents

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. PubMed 15367063 ↗
  • 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. PubMed 14644692 ↗
  • 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. PubMed 19254073 ↗
  • 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. PubMed 15031246 ↗
  • Gutenkunst SL, Lothrop N, Quijada C, Chaires M, Cortez I, Sandoval F, Balgos J, Gallardo EV, Gallardo PF, Sneed S, Honan JK, Bayless K, Chaidez X, Cuevas CR, Larson JL, Camargo FJ, Ramirez DM, Ingram M, Carvajal S, Billheimer D, Wolf AM, Beamer PI. Community health worker intervention to reduce worker exposure to volatile organic compounds in small business auto and beauty shops in a marginalized community: A cluster randomized controlled trial. PLoS One. 2026 Apr 27;21(4):e0346356. doi: 10.1371/journal.pone.0346356. eCollection 2026. PubMed 42044132 ↗

Study documents

  • Study protocol · Sep 8, 2017
  • Statistical analysis plan · Jan 16, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03455530
Lead sponsor
University of Arizona
Collaborators
Sonora Environmental Research Institute, Inc., El Rio Community Health Center, National Institute of Environmental Health Sciences (NIEHS)
Responsible party
Sponsor
First posted
Mar 6, 2018
Start date
Feb 21, 2020
Primary completion
Jan 22, 2024
Completion
Jan 22, 2024
Results posted
Jul 10, 2025
Last update
Jul 10, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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