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VALES+Tú: Targeting Psychosocial Stressors to Reduce Latino Day Laborers (LDL) Injury Disparities

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ClinicalTrials.gov Identifier: NCT04800757
Recruitment Status : Recruiting
First Posted : March 16, 2021
Last Update Posted : October 1, 2021
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Maria Eugenia Fernandez-Esquer, The University of Texas Health Science Center, Houston

Study Description
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Brief Summary:
The purpose of this study is to determine the efficacy of VALES+Tú in reducing hazardous exposures at work and to determine the mediating effect of psychosocial stressors on VALES+Tú primary outcomes

Condition or disease Intervention/treatment Phase
Work-related Injury Behavioral: individual -Brief Motivational Intervention (BMI) Behavioral: Group (Group Problem Solving) Behavioral: Standard of Care (OSHA 10 Safety Cards) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomized
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: VALES+Tú: Targeting Psychosocial Stressors to Reduce Latino Day Laborers Injury Disparities
Actual Study Start Date : May 11, 2021
Estimated Primary Completion Date : November 15, 2021
Estimated Study Completion Date : November 15, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: individual (Brief Motivational Intervention) Behavioral: individual -Brief Motivational Intervention (BMI)
A baseline survey will be administered prior to the session.Sessions will be initiated by exploring working conditions and psychosocial factors that may influence risk for work related injuries. If the LDL is motivated to change the target behavior, a 'change plan' will be developed which involves identifying reasons for change, goals in making change, specific actions and timelines, and others who may help the person change. The final step will be the development of a personal safety plan to reduce work place risks and a discussion of the following topics: (a) how they will know if their plan is successful, (b) potential obstacles, and (c) what the worker can do if the plan does not work. Finally,each worker will be asked to write and sign a personal pledge ("Mi Promesa") to implement his own safety plan.Follow-up surveys will be conducted 4 weeks after the baseline survey.
Experimental: Group (Group Problem Solving) Behavioral: Group (Group Problem Solving)
Participant will be administered a baseline survey prior to the session.The group activity intervention will consist of a discussion between 3-4 LDL and a promotor (a peer LDL) trained as a group facilitator. The sessions are expected to last 20-30 minutes and are intended to provide an opportunity for the participants to work on a safety problem together, get to know each other, and enhance their mutual safety through mutual support.Follow-up surveys will be conducted 4 weeks after the baseline survey. Oral informed consent will be obtained prior to each follow-up survey. The follow-up surveys will reassess participants' work and injury experiences and experiences with the safety intervention they were provided - safety cards, change plan, or safety plan.
Placebo Comparator: Standard of Care Behavioral: Standard of Care (OSHA 10 Safety Cards)
Participant will be administered a baseline survey prior to the session.Participants in this standard of care control group will receive four wallet size cards with information about risk reduction strategies to deal with the four hazards responsible for most workplace fatalities in Texas: falls, struck by, heat exposure and cuts. The laminated cards are adapted from OSHA's website publicly available materials in Spanish for workers with limited literacy.


Outcome Measures
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Primary Outcome Measures :
  1. Change in work hazard exposure as assessed by a survey [ Time Frame: Baseline, 4 weeks post intervention ]
    Exposures will be reported categorically as never,sometimes,many times,all the time, does not know and refused

  2. Change in work conditions as assessed by a survey [ Time Frame: Baseline, 4 weeks post intervention ]
    Work conditions will be reported categorically as never,sometimes,many times,all the time, does not know and refused


Secondary Outcome Measures :
  1. Change in safety practices as assessed by a survey [ Time Frame: Baseline, 4 weeks post intervention ]
    safety practices will be reported categorically as never,sometimes,many times,all the time, does not know and refused

  2. Number of participants that implemented the safety plan as assessed by a survey [ Time Frame: 4 weeks post intervention ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • self-identify as Hispanic or Latino
  • be present at the corner for the purpose of looking for work

Exclusion Criteria:

  • have not been previously hired to work at a corner
  • symptoms of COVID-19 in the previous 48 hours
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04800757


Contacts
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Contact: Maria Eugenia Fernandez-Esquer, MD (713) 500-9657 Maria.E.Fernandez-Esquer@uth.tmc.edu
Contact: Yesmel A King (713)500-9614 Yesmel.king@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Maria Eugenia Fernandez-Esquer, MD    (713) 500-9657    Maria.E.Fernandez-Esquer@uth.tmc.edu   
Contact: Yesmel A King    (713)500-9614    Yesmel.king@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Maria Eugenia Fernandez-Esquer, MD The University of Texas Health Science Center, Houston
More Information
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Responsible Party: Maria Eugenia Fernandez-Esquer, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04800757    
Other Study ID Numbers: HSC-SPH-18-0337
1R01MD012928 ( U.S. NIH Grant/Contract )
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: October 1, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Eugenia Fernandez-Esquer, The University of Texas Health Science Center, Houston:
latino day laborers
Additional relevant MeSH terms:
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Wounds and Injuries