NCT06146361

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

Completed NA Results posted Last updated 23 April 2025

What this trial tests

NA trial testing COVID-19 Group Problem Solving in COVID-19 in 359 participants. Completed in 14 February 2024.

Timeline

3 November 2023

Primary endpoint
14 February 2024

14 February 2024

Quick facts

Lead sponsor	The University of Texas Health Science Center, Houston
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	359
Start date	3 November 2023
Primary completion	14 February 2024
Estimated completion	14 February 2024
Sites	1 location across United States

Drugs / interventions tested

• COVID-19 Group Problem Solving
• Standard of Care
• Booster session

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

The University of Texas Health Science Center, Houston

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Measure of compliance with COVID vaccination guidelines.

Group	Value	95% CI
COVID-19 Group Problem Solving	30
Group Problem Solving Plus Booster Session	28
Standard of Care	33

Number of Participants Compliant With COVID Vaccination Guidelines as Assessed by a Survey Primary · 4 weeks post intervention

Post test measure of compliance with COVID vaccination guidelines.

Group	Value	95% CI
COVID-19 Group Problem Solving	59
Group Problem Solving Plus Booster Session	53
Standard of Care	53

Mask Wearing Frequency as Assessed by a Survey Primary · Baseline

Mask Wearing frequency is reported as a score, ranging from 1-4, with a higher score indicating greater mask wearing frequency.

Group	Value	95% CI
COVID-19 Group Problem Solving	2.050	± 0.915
Group Problem Solving Plus Booster Session	2.109	± 0.836
Standard of Care	1.927	± 0.842

Mask Wearing Frequency as Assessed by a Survey Primary · 4 weeks post intervention

Mask Wearing frequency is reported as a score, ranging from 1-4, with a higher score indicating greater mask wearing frequency.

Group	Value	95% CI
COVID-19 Group Problem Solving	1.720	± 0.621
Group Problem Solving Plus Booster Session	1.798	± 0.567
Standard of Care	1.632	± 0.673

Percentage of Participants Who Contacted an Agency About the Gold Card Primary · 4 weeks post intervention

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.

Group	Value	95% CI
COVID-19 Group Problem Solving	6
Group Problem Solving Plus Booster Session	10
Standard of Care	4

Percentage of Participants Who Reported Contacting the Agency for Assistance to Get Food Primary · 4 weeks post intervention

Percentage of participants who reported seeking food assistance from a local community organization.

Group	Value	95% CI
COVID-19 Group Problem Solving	10
Group Problem Solving Plus Booster Session	13
Standard of Care	3

Percentage of Participants Who Reported Contacting the Agency for Assistance With Health Care Resources Primary · 4 weeks post intervention

Percentage of participants who reported seeking medical assistance or health advice from a local clinic or community organization.

Group	Value	95% CI
COVID-19 Group Problem Solving	2
Group Problem Solving Plus Booster Session	2
Standard of Care	0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.