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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06146361
Enrollment
359
Registered
2023-11-24
Start date
2023-11-03
Completion date
2024-02-14
Last updated
2025-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

Latino Day Laborers

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.

Interventions

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.

BEHAVIORALStandard of Care

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

BEHAVIORALBooster 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.

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Cluster Randomized

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Compliant With COVID Vaccination Guidelines as Assessed by a SurveyBaselineMeasure of compliance with COVID vaccination guidelines.
Mask Wearing Frequency as Assessed by a SurveyBaselineMask Wearing frequency is reported as a score, ranging from 1-4, with a higher score indicating greater mask wearing frequency.
Percentage of Participants Who Contacted an Agency About the Gold Card4 weeks post interventionPercentage 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.
Percentage of Participants Who Reported Contacting the Agency for Assistance to Get Food4 weeks post interventionPercentage of participants who reported seeking food assistance from a local community organization.
Percentage of Participants Who Reported Contacting the Agency for Assistance With Health Care Resources4 weeks post interventionPercentage of participants who reported seeking medical assistance or health advice from a local clinic or community organization.

Countries

United States

Participant flow

Participants by arm

ArmCount
COVID-19 Group Problem Solving
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. Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only
120
Group Problem Solving Plus Booster Session
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. Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only Booster session: Participants will have a 10 - 15 minute booster' session about a week after engaging in the small group intervention.
120
Standard of Care
Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only
119
Total359

Baseline characteristics

CharacteristicCOVID-19 Group Problem SolvingGroup Problem Solving Plus Booster SessionStandard of CareTotal
Age, Continuous43.4 years
STANDARD_DEVIATION 13.4
43.7 years
STANDARD_DEVIATION 12.4
40.3 years
STANDARD_DEVIATION 14.3
42.5 years
STANDARD_DEVIATION 13.4
Ethnicity (NIH/OMB)
Hispanic or Latino
120 Participants120 Participants119 Participants359 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Region of Enrollment
United States
120 Participants120 Participants119 Participants359 Participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Male
120 Participants120 Participants119 Participants359 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 1200 / 1200 / 119
other
Total, other adverse events
0 / 1200 / 1200 / 119
serious
Total, serious adverse events
0 / 1200 / 1200 / 119

Outcome results

Primary

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.

Time frame: 4 weeks post intervention

Population: Data for this outcome measure were not collected for 16 in the Group Problem Solving arm, for 20 in the Group Problem Solving plus Booster Session arm, and for 24 in the Standard of Care arm--this is because these participants were lost to follow up at the 4-week timepoint.

ArmMeasureValue (MEAN)Dispersion
COVID-19 Group Problem SolvingMask Wearing Frequency as Assessed by a Survey1.720 score on a scaleStandard Deviation 0.621
Group Problem Solving Plus Booster SessionMask Wearing Frequency as Assessed by a Survey1.798 score on a scaleStandard Deviation 0.567
Standard of CareMask Wearing Frequency as Assessed by a Survey1.632 score on a scaleStandard Deviation 0.673
Primary

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.

Time frame: Baseline

Population: Data for this outcome measure were not collected for 2 in the Group Problem Solving arm and for 4 in the Group Problem Solving plus Booster Session arm--this is because these participants did not complete this survey.

ArmMeasureValue (MEAN)Dispersion
COVID-19 Group Problem SolvingMask Wearing Frequency as Assessed by a Survey2.050 score on a scaleStandard Deviation 0.915
Group Problem Solving Plus Booster SessionMask Wearing Frequency as Assessed by a Survey2.109 score on a scaleStandard Deviation 0.836
Standard of CareMask Wearing Frequency as Assessed by a Survey1.927 score on a scaleStandard Deviation 0.842
Primary

Number of Participants Compliant With COVID Vaccination Guidelines as Assessed by a Survey

Measure of compliance with COVID vaccination guidelines.

Time frame: Baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
COVID-19 Group Problem SolvingNumber of Participants Compliant With COVID Vaccination Guidelines as Assessed by a Survey30 Participants
Group Problem Solving Plus Booster SessionNumber of Participants Compliant With COVID Vaccination Guidelines as Assessed by a Survey28 Participants
Standard of CareNumber of Participants Compliant With COVID Vaccination Guidelines as Assessed by a Survey33 Participants
Primary

Number of Participants Compliant With COVID Vaccination Guidelines as Assessed by a Survey

Post test measure of compliance with COVID vaccination guidelines.

Time frame: 4 weeks post intervention

Population: Data were not collected for 16 in the Group Problem Solving arm, for 20 in the Group Problem Solving plus Booster Session arm, and 24 in the Standard of Care arm--this is because these participants were lost to follow up at the 4-week timepoint.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
COVID-19 Group Problem SolvingNumber of Participants Compliant With COVID Vaccination Guidelines as Assessed by a Survey59 Participants
Group Problem Solving Plus Booster SessionNumber of Participants Compliant With COVID Vaccination Guidelines as Assessed by a Survey53 Participants
Standard of CareNumber of Participants Compliant With COVID Vaccination Guidelines as Assessed by a Survey53 Participants
Primary

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.

Time frame: 4 weeks post intervention

Population: For this outcome measure, data were collected only for those who called a number on the resource sheet--for the Group Problem Solving arm, 20 called a number; for the Group Problem Solving plus Booster Session arm, 22 called a number; and for the Standard of Care arm, 7 called a number.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
COVID-19 Group Problem SolvingPercentage of Participants Who Contacted an Agency About the Gold Card6 Participants
Group Problem Solving Plus Booster SessionPercentage of Participants Who Contacted an Agency About the Gold Card10 Participants
Standard of CarePercentage of Participants Who Contacted an Agency About the Gold Card4 Participants
Primary

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.

Time frame: 4 weeks post intervention

Population: For this outcome measure, data were collected only for those who called a number on the resource sheet--for the Group Problem Solving arm, 20 called a number; for the Group Problem Solving plus Booster Session arm, 22 called a number; and for the Standard of Care arm, 7 called a number.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
COVID-19 Group Problem SolvingPercentage of Participants Who Reported Contacting the Agency for Assistance to Get Food10 Participants
Group Problem Solving Plus Booster SessionPercentage of Participants Who Reported Contacting the Agency for Assistance to Get Food13 Participants
Standard of CarePercentage of Participants Who Reported Contacting the Agency for Assistance to Get Food3 Participants
Primary

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.

Time frame: 4 weeks post intervention

Population: For this outcome measure, data were collected only for those who called a number on the resource sheet--for the Group Problem Solving arm, 20 called a number; for the Group Problem Solving plus Booster Session arm, 22 called a number; and for the Standard of Care arm, 7 called a number.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
COVID-19 Group Problem SolvingPercentage of Participants Who Reported Contacting the Agency for Assistance With Health Care Resources2 Participants
Group Problem Solving Plus Booster SessionPercentage of Participants Who Reported Contacting the Agency for Assistance With Health Care Resources2 Participants
Standard of CarePercentage of Participants Who Reported Contacting the Agency for Assistance With Health Care Resources0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026