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

NCT06821113 | Recruiting

• 2 other identifiers: HSC-SPH-20-1389 (Phase 3)1R01MD016328-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19

Keywords

Latino Day Laborers

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

COVID-19 Group Problem Solving and booster call

EXPERIMENTAL

Behavioral: COVID-19 Group Problem Solving; Behavioral: Standard of Care; Behavioral: Booster session

Standard of Care

ACTIVE COMPARATOR

Behavioral: Standard of Care

Interventions

COVID-19 Group Problem Solving BEHAVIORAL

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.

COVID-19 Group Problem Solving and booster call

Standard of Care BEHAVIORAL

Participants will receive a COVID-19 prevention flyer and social resources list only

COVID-19 Group Problem Solving and booster call; Standard of Care

Booster session BEHAVIORAL

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.

COVID-19 Group Problem Solving and booster call

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Have not been previously hired to work at a corner
• Symptoms of COVID-19 in the previous 48 hours

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Maria E Fernandez-Esquer, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria E Fernandez-Esquer, PhD

CONTACT

(713) 500-9657; Maria.E.Fernandez-Esquer@uth.tmc.edu

Cesar L Pinzon-Gomez

CONTACT

(713) 500-9614; Cesar.L.PinzonGomez@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Cluster Randomized

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 11, 2025
• Study Start: July 3, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)