Recruiting

Observational Study

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06821113

Conditions

COVID-19

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

COVID-19 Group Problem Solving

Standard of Care

Booster session

Study Details

Brief summary:

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.

Conditions

COVID-19

Study ID

NCT06821113

Start date

Jul 3, 2025

Status verified date

Aug, 2025

Completion date

Nov 1, 2025

Anticipated

Primary completion date

Nov 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: COVID-19 Group Problem Solving and booster call

active comparator: Standard of Care

Interventions

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 and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support.

Standard of Care

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

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Maria E Fernandez-Esquer, PhD

(713) 500-9657Maria.E.Fernandez-Esquer@uth.tmc.edu

Cesar L Pinzon-Gomez

(713) 500-9614Cesar.L.PinzonGomez@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Maria E Fernandez-Esquer, PhD

713-500-9657Maria.E.Fernandez-Esquer@uth.tmc.edu

Cesar L Pinzon-Gomez

(713) 500-9614Cesar.L.PinzonGomez@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Aug 26, 2025

Last verified

Aug, 2025

Keywords

  • Latino Day Laborers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-08-26.