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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05248399
Enrollment
200
Registered
2022-02-21
Start date
2022-03-23
Completion date
2022-06-28
Last updated
2023-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

Latino Day Laborers

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.

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.

BEHAVIORALStandard of Care

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

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Cluster Randomized

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of Participants With Change in COVID-19 Vaccination Status Assessed by a SurveyBaseline, 4 weeks post intervention

Secondary

MeasureTime frameDescription
Change in Mask Wearing Frequency as Assessed by Change in Mean Mask Use Total Score on a SurveyBaseline, 4 weeks post interventionParticipants 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.
Change in Social Distancing as Assessed by Change in Mean Social Distancing Total Score on a SurveyBaseline, 4 weeks post interventionParticipants 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
COVID-19 Group Problem Solving Plus Standard of Care
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. The Group Problem Solving arm will also receive standard of care, which consists of the distribution of brochures containing COVID-19 prevention information.
100
Standard of Care
The Control arm will receive standard of care, which consists of the distribution of brochures containing COVID-19 prevention information.
99
Total199

Baseline characteristics

CharacteristicCOVID-19 Group Problem Solving Plus Standard of CareTotalStandard of Care
Age, Continuous49.4 years
STANDARD_DEVIATION 11.3
46.7 years
STANDARD_DEVIATION 12.2
44.0 years
STANDARD_DEVIATION 12.6
Ethnicity (NIH/OMB)
Hispanic or Latino
100 Participants199 Participants99 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
100 Participants199 Participants99 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
United States
100 Participants199 Participants99 Participants
Sex: Female, Male
Female
1 Participants1 Participants0 Participants
Sex: Female, Male
Male
99 Participants198 Participants99 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1010 / 99
other
Total, other adverse events
0 / 1010 / 99
serious
Total, serious adverse events
0 / 1010 / 99

Outcome results

Primary

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

Time frame: Baseline, 4 weeks post intervention

Population: Baseline and 4 week data were only collected for 81 in the COVID-19 Group Problem Solving plus Standard of Care arm and for 80 in the Standard of Care arm.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
COVID-19 Group Problem Solving Plus Standard of CareNumber of Participants With Change in COVID-19 Vaccination Status Assessed by a SurveyNumber of participants not vaccinated at baseline and who did not receive vaccine after baseline24 Participants
COVID-19 Group Problem Solving Plus Standard of CareNumber of Participants With Change in COVID-19 Vaccination Status Assessed by a SurveyNumber of participants not vaccinated at baseline and who received vaccine after baseline1 Participants
COVID-19 Group Problem Solving Plus Standard of CareNumber of Participants With Change in COVID-19 Vaccination Status Assessed by a SurveyNumber of participants vaccinated at baseline and did not receive a repeat vaccine after baseline49 Participants
COVID-19 Group Problem Solving Plus Standard of CareNumber of Participants With Change in COVID-19 Vaccination Status Assessed by a SurveyNumber of participants vaccinated at baseline and who received a repeat vaccine after baseline7 Participants
Standard of CareNumber of Participants With Change in COVID-19 Vaccination Status Assessed by a SurveyNumber of participants vaccinated at baseline and who received a repeat vaccine after baseline8 Participants
Standard of CareNumber of Participants With Change in COVID-19 Vaccination Status Assessed by a SurveyNumber of participants not vaccinated at baseline and who did not receive vaccine after baseline36 Participants
Standard of CareNumber of Participants With Change in COVID-19 Vaccination Status Assessed by a SurveyNumber of participants vaccinated at baseline and did not receive a repeat vaccine after baseline36 Participants
Standard of CareNumber of Participants With Change in COVID-19 Vaccination Status Assessed by a SurveyNumber of participants not vaccinated at baseline and who received vaccine after baseline0 Participants
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.

Time frame: Baseline, 4 weeks post intervention

Population: Baseline and 4 week data were only collected for 84 in the COVID-19 Group Problem Solving plus Standard of Care arm and for 82 in the Standard of Care arm.

ArmMeasureValue (MEAN)Dispersion
COVID-19 Group Problem Solving Plus Standard of CareChange in Mask Wearing Frequency as Assessed by Change in Mean Mask Use Total Score on a Survey-0.38 scores on a scaleStandard Deviation 0.95
Standard of CareChange in Mask Wearing Frequency as Assessed by Change in Mean Mask Use Total Score on a Survey-0.32 scores on a scaleStandard Deviation 0.8
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.

Time frame: Baseline, 4 weeks post intervention

Population: Baseline and 4 week data were only collected for 83 in the COVID-19 Group Problem Solving plus Standard of Care arm and for 82 in the Standard of Care arm.

ArmMeasureValue (MEAN)Dispersion
COVID-19 Group Problem Solving Plus Standard of CareChange in Social Distancing as Assessed by Change in Mean Social Distancing Total Score on a Survey-0.13 scores on a scaleStandard Deviation 0.86
Standard of CareChange in Social Distancing as Assessed by Change in Mean Social Distancing Total Score on a Survey-0.09 scores on a scaleStandard Deviation 0.82

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026