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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06146361
• Other study ID #: HSC-SPH-20-1389 (phase 2)
• Secondary ID: 1R01MD016328-01
• Status: Completed
• Phase: N/A
• Start date: November 3, 2023
• Est. completion date: February 14, 2024

Study information

• Verified date: February 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 359
• Est. completion date: February 14, 2024
• Est. primary completion date: February 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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.
• 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. 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

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