Vale+ Tu 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: NCT05248399
• Other study ID #: HSC-SPH-20-1389 (Rapid phase)
• Secondary ID: 1R01MD016328-01
• Status: Completed
• Phase: N/A
• Start date: March 23, 2022
• Est. completion date: June 28, 2022

Study information

• Verified date: June 2023
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 28, 2022
• Est. primary completion date: June 28, 2022
• 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
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.
• Standard of Care
The standard of care consists of the distribution of brochures containing COVID-19 prevention information.

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	Number of Participants With Change in COVID-19 Vaccination Status Assessed by a Survey		Baseline, 4 weeks post intervention
Secondary	Change in Mask Wearing Frequency as Assessed by Change in Mean Mask Use Total Score on a Survey	Participants were asked seven items measuring how often they had worn a mask in different situations (e.g. while at the corner) in the last 30 days (baseline) or since their baseline survey (one month post test). Responses were recorded as 1 = Never; 2 = Sometimes; 3 = Many Times; 4 = All the Time. Participants could refuse to answer any item or respond that the particular item did not apply to them (for example., they do not wear a mask on public transport because they do not take public transport) . These responses were treated as missing.; Mask Use score was computed as the mean score of the items with a non-missing response, and mean mask use total score could range from 1 to 4. Change in mean mask use score is reported, and change score was computed by subtracting the baseline score from the post test score, with a negative change score indicating a decrease in mask use.	Baseline, 4 weeks post intervention
Secondary	Change in Social Distancing as Assessed by Change in Mean Social Distancing Total Score on a Survey	Participants were asked six items measuring how often they had practiced Social Distancing in different situations (e.g. while at the worksite) in the last 30 days (baseline) or since their baseline survey (one month post test). Responses were recorded as 1 = Never; 2 = Sometimes; 3 = Many Times; 4 = All the Time. Participants could refuse to answer any item or respond that the particular item did not apply to them. These responses were treated as missing; Social Distancing score was computed as the mean score of the items with a non-missing response, and mean mask use total score could range from 1 to 4. Change in mean mask use score is reported and was computed by subtracting the baseline score from the post test score, with a negative change score indicating a decrease in social distancing.	Baseline, 4 weeks post intervention