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

Study Overview
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Brief Summary
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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.

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

Conditions
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COVID-19

Intervention / Treatment
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* Behavioral: COVID-19 Group Problem Solving
* Behavioral: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster Randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COVID-19 Group Problem Solving plus Standard of Care<br> | Behavioral: COVID-19 Group Problem Solving<br>* 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.<br>Behavioral: Standard of Care<br>* The standard of care consists of the distribution of brochures containing COVID-19 prevention information.<br>|
| Active Comparator: Standard of Care<br> | Behavioral: Standard of Care<br>* The standard of care consists of the distribution of brochures containing COVID-19 prevention information.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Change in COVID-19 Vaccination Status Assessed by a Survey |  | Baseline, 4 weeks post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Latino Day Laborers