NCT03455530

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
2 years until next milestone

Study Start

First participant enrolled

February 21, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2024

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 10, 2025

Completed
Last Updated

July 10, 2025

Status Verified

March 1, 2024

Enrollment Period

3.9 years

First QC Date

February 21, 2018

Results QC Date

May 30, 2025

Last Update Submit

June 23, 2025

Conditions

Outcome Measures

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.

    6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Delayed Intervention Group

OTHER

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

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 GroupIntervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • workers or owners of small businesses in select sectors (e.g., beauty salons, auto shops) in target zip codes in southern metropolitan Tucson, Arizona

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sonora Environmental Research Institute

Tucson, Arizona, 85701, United States

Location

Related Publications (4)

  • 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.

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.

Results Point of Contact

Title
Dr. Paloma Beamer
Organization
University of Arizona

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2018

First Posted

March 6, 2018

Study Start

February 21, 2020

Primary Completion

January 22, 2024

Study Completion

January 22, 2024

Last Updated

July 10, 2025

Results First Posted

July 10, 2025

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations