Vale+Tú Salud: Corner-Based 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 determine the cultural, socioeconomic, inter/personal and work-related factors that influence COVID 19 mitigation practices including social distancing, hand-washing and Personal protective equipment (PPE) use, to adapt, implement, and test Vale+Tú Salud in a cluster randomized trial to assess the extent to which LDL report increased adherence with COVID 19 mitigation practices 1 month post intervention and to promote Vale+Tú Salud just-in-time results and increase its capacity to rapidly disseminate findings among groups that serve LDL and other Latino immigrants.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria E Fernandez-Esquer, PhD; Phone Number: (713) 500-9657; Email: Maria.E.Fernandez-Esquer@uth.tmc.edu
• Study Contact Backup: Name: Cesar L Pinzon-Gomez; Phone Number: (713) 500-9614; Email: Cesar.L.PinzonGomez@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Maria E Fernandez-Esquer, PhD; Phone Number: 713-500-9657; Email: Maria.E.Fernandez-Esquer@uth.tmc.edu
      • Contact: Cesar L Pinzon-Gomez; Phone Number: (713) 500-9614; Email: Cesar.L.PinzonGomez@uth.tmc.edu

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care	Behavioral: Standard of Care; Participants will receive a COVID-19 prevention flyer and social resources list only
Experimental: COVID-19 Group Problem Solving and booster call	Behavioral: COVID-19 Group Problem Solving; Participants 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 personal commitment called "Mi Promesa" to implement COVID mitigation practices. Navigation Component will consist of providing information and linking LDLs with social service providers and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support.; Behavioral: Standard of Care; Participants will receive a COVID-19 prevention flyer and social resources list only; Behavioral: Booster session; Participants in this group will also receive a "booster phone call" 10 to 15 days after the small group intervention to provide brief prompts to encourage participants to act on their personal commitments and encourage them to seek community resources.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in COVID-19 vaccination status as assessed by a survey	Baseline, 4 weeks post intervention
Change in hand washing frequency as assessed by a survey	Baseline, 4 weeks post intervention
Percentage of participants who report contacting the gold card agency	Baseline, 4 weeks post intervention
Percentage of participants who report contacting the agency for assistance to get food	Baseline, 4 weeks post intervention
Percentage of participants who report contacting the agency for assistance for health care resources	Baseline, 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): July 3, 2025
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): February 11, 2025

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: August 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; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: HSC-SPH-20-1389 (Phase 3); 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
• product manufactured in and exported from the U.S.: No