NCT05248399

Brief Summary

The purpose of this study is to adapt and pilot test the feasibility of implementing a corner-based risk reduction program that aims to assist Latino day laborers (LDL) in their efforts to adhere to COVID-19 mitigation practices, including receiving the COVID-19 vaccine, using personal protective equipment (PPE), and practicing social distancing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Mar 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 23, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 20, 2023

Completed
Last Updated

September 6, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

February 17, 2022

Results QC Date

June 27, 2023

Last Update Submit

August 23, 2023

Conditions

Keywords

Latino Day Laborers

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Change in COVID-19 Vaccination Status Assessed by a Survey

    Baseline, 4 weeks post intervention

Secondary Outcomes (2)

  • Change in Mask Wearing Frequency as Assessed by Change in Mean Mask Use Total Score on a Survey

    Baseline, 4 weeks post intervention

  • Change in Social Distancing as Assessed by Change in Mean Social Distancing Total Score on a Survey

    Baseline, 4 weeks post intervention

Study Arms (2)

COVID-19 Group Problem Solving plus Standard of Care

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

Standard of Care

ACTIVE COMPARATOR
Behavioral: Standard of Care

Interventions

The COVID-19 Group Problem Solving component 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 theirs and their peers' risk for COVID-19 transmission. The intervention will be developed to take place over a \~30-45-minute period in order to fit within the corner context of LDLs waiting for employment, and will be delivered by promoters from our team and the community partner agency, Fe \& Justicia Workers Center. Following the completion of the intervention, a health promoter will be trained as a navigator assist participants who wish to get vaccinated by providing them with information about near-by vaccination sites that they can visit to get vaccinated. If needed, the promotor will assist them with making their vaccine appointment.

COVID-19 Group Problem Solving plus Standard of Care

The standard of care consists of the distribution of brochures containing COVID-19 prevention information.

COVID-19 Group Problem Solving plus Standard of CareStandard of Care

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

Related Publications (1)

  • Constantin AM, Noertjojo K, Sommer I, Pizarro AB, Persad E, Durao S, Nussbaumer-Streit B, McElvenny DM, Rhodes S, Martin C, Sampson O, Jorgensen KJ, Bruschettini M. Workplace interventions to reduce the risk of SARS-CoV-2 infection outside of healthcare settings. Cochrane Database Syst Rev. 2024 Apr 10;4(4):CD015112. doi: 10.1002/14651858.CD015112.pub3.

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

February 17, 2022

First Posted

February 21, 2022

Study Start

March 23, 2022

Primary Completion

June 28, 2022

Study Completion

June 28, 2022

Last Updated

September 6, 2023

Results First Posted

July 20, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations