Vale+Tú Salud: Corner-Based Randomized Trial to Test a Latino Day Laborer Program Adapted to Prevent COVID-19

Vale+ Tu Salud: Corner-Based Randomized Trial to Test a Latino Day Laborer Program Adapted to Prevent COVID-19.

The purpose of this study is to assess the extent to which LDL report increased adherence with COVID 19 mitigation practices 1 month post intervention.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Behavioral: COVID-19 Group Problem Solving; Behavioral: Standard of Care; Behavioral: Booster session

• Study Type: Interventional
• Enrollment (Actual): 359
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Self-identify as Hispanic or Latino
• Be present at the corner for the purposes 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care	Behavioral: Standard of Care; This group will receive a COVID-19 prevention flyer and social resources list only
Experimental: COVID-19 Group Problem Solving	Behavioral: COVID-19 Group Problem Solving; This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that incorporates popular education activities aimed at developing social cohesion among LDLs, building awareness about COVID-19 risks and protective behaviors and developing a plan of action to reduce their and their peers' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods.; Behavioral: Standard of Care; This group will receive a COVID-19 prevention flyer and social resources list only
Experimental: Group Problem Solving Plus Booster Session	Behavioral: COVID-19 Group Problem Solving; This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that incorporates popular education activities aimed at developing social cohesion among LDLs, building awareness about COVID-19 risks and protective behaviors and developing a plan of action to reduce their and their peers' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods.; Behavioral: Standard of Care; This group will receive a COVID-19 prevention flyer and social resources list only; Behavioral: Booster session; Participants will have a 10 - 15 minute "booster' session about a week after engaging in the small group intervention. They will be contacted by phone and the booster will consist of brief prompts to engage participants in a discussion to encourage them to act on their personal commitments to protect themselves and others against COVID. They will also be encouraged to seek COVID related resources based on the information provided during the small group intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Compliant With COVID Vaccination Guidelines as Assessed by a Survey	Measure of compliance with COVID vaccination guidelines.	Baseline
Number of Participants Compliant With COVID Vaccination Guidelines as Assessed by a Survey	Post test measure of compliance with COVID vaccination guidelines.	4 weeks post intervention
Mask Wearing Frequency as Assessed by a Survey	Mask Wearing frequency is reported as a score, ranging from 1-4, with a higher score indicating greater mask wearing frequency.	Baseline
Mask Wearing Frequency as Assessed by a Survey	Mask Wearing frequency is reported as a score, ranging from 1-4, with a higher score indicating greater mask wearing frequency.	4 weeks post intervention
Percentage of Participants Who Contacted an Agency About the Gold Card	Percentage of participants who reported contacting a local community or health agency to request the Gold Card a local medical insurance for low income individuals living in Harris County.	4 weeks post intervention
Percentage of Participants Who Reported Contacting the Agency for Assistance to Get Food	Percentage of participants who reported seeking food assistance from a local community organization.	4 weeks post intervention
Percentage of Participants Who Reported Contacting the Agency for Assistance With Health Care Resources	Percentage of participants who reported seeking medical assistance or health advice from a local clinic or community organization.	4 weeks post intervention

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Maria E Fernandez-Esquer, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2023
• Primary Completion (Actual): February 14, 2024
• Study Completion (Actual): February 14, 2024

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: November 22, 2023
• First Posted (Actual): November 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Latino Day Laborers
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: HSC-SPH-20-1389 (phase 2); 1R01MD016328-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No