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Recruiting NCT06821113

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

No phase Interventional COVID-19

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: COVID-19 Group Problem Solving, Standard of Care, Booster session.
Who it may be relevant to
Registry conditions: COVID-19. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

The purpose of this study is to determine the cultural, socioeconomic, inter/personal and work-related factors that influence COVID 19 mitigation practices including social distancing, hand-washing and Personal protective equipment (PPE) use, to adapt, implement, and test Vale+Tú Salud in a cluster randomized trial to assess the extent to which LDL report increased adherence with COVID 19 mitigation practices 1 month post intervention and to promote Vale+Tú Salud just-in-time results and increase its capacity to rapidly disseminate findings among groups that serve LDL and other Latino immigrants.

Interventions

  • Behavioral COVID-19 Group Problem Solving
    Participants 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 personal commitment called "Mi Promesa" to implement COVID mitigation practices. Navigation Component will consist of providing information and linking LDLs with social service providers an
  • Behavioral Standard of Care
    Participants will receive a COVID-19 prevention flyer and social resources list only
  • Behavioral Booster session
    Participants in this group will also receive a "booster phone call" 10 to 15 days after the small group intervention to provide brief prompts to encourage participants to act on their personal commitments and encourage them to seek community resources.

Primary outcome measures

  • Change in COVID-19 vaccination status as assessed by a survey [Time frame: Baseline, 4 weeks post intervention]
  • Change in hand washing frequency as assessed by a survey [Time frame: Baseline, 4 weeks post intervention]
  • Percentage of participants who report contacting the gold card agency [Time frame: Baseline, 4 weeks post intervention]
  • Percentage of participants who report contacting the agency for assistance to get food [Time frame: Baseline, 4 weeks post intervention]
  • Percentage of participants who report contacting the agency for assistance for health care resources [Time frame: Baseline, 4 weeks post intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT06821113 · HSC-SPH-20-1389 (Phase 3) · 1R01MD016328-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗