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

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Recruiting

CT.gov ID

NCT06146361

Collaborator

National Institute on Minority Health and Health Disparities (NIMHD) (NIH)

360

Enrollment

Location

Arms

2.5

Anticipated Duration (Months)

142.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Behavioral: COVID-19 Group Problem Solving Behavioral: Standard of Care Behavioral: Booster session	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

360 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Cluster RandomizedCluster Randomized

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 3, 2023

Anticipated Primary Completion Date :

Dec 15, 2023

Anticipated Study Completion Date :

Jan 19, 2024

Arms and Interventions

Arm	Intervention/Treatment
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
Active Comparator: Standard of Care	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.

Arm

Intervention/Treatment

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

Active Comparator: Standard of Care

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

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.

Outcome Measures

Primary Outcome Measures

Change in COVID-19 Vaccination Status assessed by a survey [Baseline, 4 weeks post intervention]
Change in Mask Wearing frequency as assessed by a survey [Baseline, 4 weeks post intervention]
Percentage of participants who reported contacting the gold card agency [4 weeks post intervention]
Gold Card is issued by the county for medical insurance purposes
Percentage of participants who reported contacting the agency for assistance to get food [4 weeks post intervention]
Percentage of participants who reported contacting the agency for assistance with health care resources [4 weeks post intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

The University of Texas Health Science Center, Houston
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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maria Eugenia Fernandez-Esquer, Associate Professor, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT06146361

Other Study ID Numbers:

HSC-SPH-20-1389 (phase 2)
1R01MD016328-01

First Posted:

Nov 24, 2023

Last Update Posted:

Nov 24, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Maria Eugenia Fernandez-Esquer, Associate Professor, The University of Texas Health Science Center, Houston

Latino Day Laborers

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Nov 24, 2023