Trial Outcomes & Findings for Vale+ Tu Salud: Corner-Based Randomized Trial to Test a Latino Day Laborer Program Adapted to Prevent COVID-19 (NCT NCT05248399)
NCT ID: NCT05248399
Last Updated: 2023-09-06
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
Baseline, 4 weeks post intervention
Results posted on
2023-09-06
Participant Flow
Participant milestones
| Measure |
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.
|
Standard of Care
The Control arm will receive standard of care, which consists of the distribution of brochures containing COVID-19 prevention information.
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
99
|
|
Overall Study
COMPLETED
|
84
|
82
|
|
Overall Study
NOT COMPLETED
|
17
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age data were not collected for 3 in the Group Problem Solving plus Standard of Care arm and for 1 in the Standard of Care arm.
Baseline characteristics by cohort
| Measure |
COVID-19 Group Problem Solving Plus Standard of Care
n=100 Participants
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.
|
Standard of Care
n=99 Participants
The Control arm will receive standard of care, which consists of the distribution of brochures containing COVID-19 prevention information.
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.4 years
STANDARD_DEVIATION 11.3 • n=97 Participants • Age data were not collected for 3 in the Group Problem Solving plus Standard of Care arm and for 1 in the Standard of Care arm.
|
44.0 years
STANDARD_DEVIATION 12.6 • n=98 Participants • Age data were not collected for 3 in the Group Problem Solving plus Standard of Care arm and for 1 in the Standard of Care arm.
|
46.7 years
STANDARD_DEVIATION 12.2 • n=195 Participants • Age data were not collected for 3 in the Group Problem Solving plus Standard of Care arm and for 1 in the Standard of Care arm.
|
|
Sex: Female, Male
Female
|
1 Participants
n=100 Participants
|
0 Participants
n=99 Participants
|
1 Participants
n=199 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=100 Participants
|
99 Participants
n=99 Participants
|
198 Participants
n=199 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
100 Participants
n=100 Participants
|
99 Participants
n=99 Participants
|
199 Participants
n=199 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=100 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=199 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=100 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=199 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=100 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=199 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=100 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=199 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=100 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=199 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=100 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=199 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=100 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=199 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=100 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=199 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
100 Participants
n=100 Participants
|
99 Participants
n=99 Participants
|
199 Participants
n=199 Participants
|
|
Region of Enrollment
United States
|
100 Participants
n=100 Participants
|
99 Participants
n=99 Participants
|
199 Participants
n=199 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 weeks post interventionPopulation: 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.
Outcome measures
| Measure |
COVID-19 Group Problem Solving Plus Standard of Care
n=81 Participants
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.
|
Standard of Care
n=80 Participants
The Control arm will receive standard of care, which consists of the distribution of brochures containing COVID-19 prevention information.
|
|---|---|---|
|
Number of Participants With Change in COVID-19 Vaccination Status Assessed by a Survey
Number of participants not vaccinated at baseline and who did not receive vaccine after baseline
|
24 Participants
|
36 Participants
|
|
Number of Participants With Change in COVID-19 Vaccination Status Assessed by a Survey
Number of participants not vaccinated at baseline and who received vaccine after baseline
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change in COVID-19 Vaccination Status Assessed by a Survey
Number of participants vaccinated at baseline and did not receive a repeat vaccine after baseline
|
49 Participants
|
36 Participants
|
|
Number of Participants With Change in COVID-19 Vaccination Status Assessed by a Survey
Number of participants vaccinated at baseline and who received a repeat vaccine after baseline
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks post interventionPopulation: 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.
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.
Outcome measures
| Measure |
COVID-19 Group Problem Solving Plus Standard of Care
n=84 Participants
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.
|
Standard of Care
n=82 Participants
The Control arm will receive standard of care, which consists of the distribution of brochures containing COVID-19 prevention information.
|
|---|---|---|
|
Change in Mask Wearing Frequency as Assessed by Change in Mean Mask Use Total Score on a Survey
|
-0.38 scores on a scale
Standard Deviation 0.95
|
-0.32 scores on a scale
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks post interventionPopulation: 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.
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.
Outcome measures
| Measure |
COVID-19 Group Problem Solving Plus Standard of Care
n=83 Participants
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.
|
Standard of Care
n=82 Participants
The Control arm will receive standard of care, which consists of the distribution of brochures containing COVID-19 prevention information.
|
|---|---|---|
|
Change in Social Distancing as Assessed by Change in Mean Social Distancing Total Score on a Survey
|
-0.13 scores on a scale
Standard Deviation 0.86
|
-0.09 scores on a scale
Standard Deviation 0.82
|
Adverse Events
COVID-19 Group Problem Solving Plus Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Maria E Fernandez Esquer, PhD
The University of Texas Health Science Center at Houston
Phone: (713) 500-9657
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place