NCT06146361

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
359

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 3, 2023

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2024

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 23, 2025

Completed
Last Updated

April 23, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

November 22, 2023

Results QC Date

March 7, 2025

Last Update Submit

April 3, 2025

Conditions

Keywords

Latino Day Laborers

Outcome Measures

Primary Outcomes (7)

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

    Measure of compliance with COVID vaccination guidelines.

    Baseline

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

    Post test measure of compliance with COVID vaccination guidelines.

    4 weeks post intervention

  • 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.

    Baseline

  • 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.

    4 weeks post intervention

  • 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.

    4 weeks post intervention

  • 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.

    4 weeks post intervention

  • 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.

    4 weeks post intervention

Study Arms (3)

COVID-19 Group Problem Solving

EXPERIMENTAL
Behavioral: COVID-19 Group Problem SolvingBehavioral: Standard of Care

Standard of Care

ACTIVE COMPARATOR
Behavioral: Standard of Care

Group Problem Solving Plus Booster Session

EXPERIMENTAL
Behavioral: COVID-19 Group Problem SolvingBehavioral: Standard of CareBehavioral: Booster session

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.

COVID-19 Group Problem SolvingGroup Problem Solving Plus Booster Session

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

COVID-19 Group Problem SolvingGroup Problem Solving Plus Booster SessionStandard of Care
Booster sessionBEHAVIORAL

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.

Group Problem Solving Plus Booster Session

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-identify as Hispanic or Latino
  • Be present at the corner for the purposes of looking for work

You may not qualify if:

  • Have not been previously hired to work at a corner
  • Symptoms of COVID-19 in the previous 48 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Maria E. Fernandez-Esquer, PhD
Organization
The University of Texas Health Science Center at Houston

Study Officials

  • Maria E Fernandez-Esquer, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster Randomized
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 22, 2023

First Posted

November 24, 2023

Study Start

November 3, 2023

Primary Completion

February 14, 2024

Study Completion

February 14, 2024

Last Updated

April 23, 2025

Results First Posted

April 23, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations