Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03455530
Other study ID # R01ES028250
Secondary ID R01ES028250
Status Completed
Phase N/A
First received
Last updated
Start date February 21, 2020
Est. completion date January 22, 2024

Study information

Verified date March 2024
Source University of Arizona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 268
Est. completion date January 22, 2024
Est. primary completion date January 22, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
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.

Locations

Country Name City State
United States Sonora Environmental Research Institute Tucson Arizona

Sponsors (4)

Lead Sponsor Collaborator
University of Arizona El Rio Community Health Center, National Institute of Environmental Health Sciences (NIEHS), Sonora Environmental Research Institute, Inc.

Country where clinical trial is conducted

United States, 

References & 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 a — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT01241890 - Prevention of CF Exacerbation in Childhood: PREVEC Study N/A
Recruiting NCT04407325 - Tuberculosis Screening in Paraguayan Prisons N/A
Recruiting NCT04081428 - Using Breath, Cell Free DNA and Image Analysis to PRedIct Normal TissUe and Tumour Response During Prostate Cancer SBRT
Recruiting NCT06175429 - Prognostic Value of Exhaled Isoprene Levels for Morbidity and Functional Outcome in Cardiosurgical Patients
Completed NCT01239238 - Reduction of Asthma Exacerbation Rate in Children by Non-invasive Monitoring of Inflammatory Markers in Exhaled Breath (Condensate): the RASTER Study N/A
Completed NCT04856995 - Effect of Surgical Smoke on Air Quality
Recruiting NCT05982912 - VOC in Breath Samples for the Diagnosis of IPA
Completed NCT03435198 - Biomarkers in Exhaled Breath of Glucose Fluctuation in Type 1 Diabetes
Not yet recruiting NCT03967652 - Cancer Diagnoses From Exhaled Breath With Na-nose
Recruiting NCT04226079 - Volatile Organic Compounds (VOCs) of Exhaled Breath in Patients With GI Bleeding
Recruiting NCT05412758 - Augmented Response of Volatile Biomarkers in Assessment of Oesophagogastric Cancer (AROMA 1 / BIORESOURCE) N/A
Recruiting NCT03414580 - Analysis of Volatile Organic Compounds in the Exhaled Air in Inflammatory Bowel Disease
Recruiting NCT05819996 - Addressing Tetrachloroethylene Exposure in an Impacted Community N/A