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

NCT ID: NCT06146361

Last Updated: 2025-04-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

359 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-03

Study Completion Date

2024-02-14

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster Randomized
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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COVID-19 Group Problem Solving

Group Type EXPERIMENTAL

COVID-19 Group Problem Solving

Intervention Type BEHAVIORAL

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.

Standard of Care

Intervention Type BEHAVIORAL

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

Standard of Care

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type BEHAVIORAL

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

Group Problem Solving Plus Booster Session

Group Type EXPERIMENTAL

COVID-19 Group Problem Solving

Intervention Type BEHAVIORAL

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.

Standard of Care

Intervention Type BEHAVIORAL

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

Booster session

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Standard of Care

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Maria Eugenia Fernandez-Esquer

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria E Fernandez-Esquer, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1R01MD016328-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC-SPH-20-1389 (phase 2)

Identifier Type: -

Identifier Source: org_study_id

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