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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MD016328-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-19 Group Problem Solving plus Standard of Care | Experimental |
| |
| Standard of Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 Group Problem Solving | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Change in COVID-19 Vaccination Status Assessed by a Survey | Baseline, 4 weeks post intervention |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria E Fernandez-Esquer, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38597249 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Standard of Care | The Control arm will receive standard of care, which consists of the distribution of brochures containing COVID-19 prevention information. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
One of the participants who started the study and who received the Group Problem Solving intervention was found to not be a day laborer, and so that participant was excluded and their data are not included in the baseline characteristics.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Change in COVID-19 Vaccination Status Assessed by a Survey | 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. | Posted | Count of Participants | Participants | Baseline, 4 weeks post intervention |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria E Fernandez Esquer, PhD | The University of Texas Health Science Center at Houston | (713) 500-9657 | Maria.E.Fernandez-Esquer@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 25, 2021 | Jun 27, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Cluster Randomized
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|
| Standard of Care | Behavioral | The standard of care consists of the distribution of brochures containing COVID-19 prevention information. |
|
| 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 |
| BG001 | Standard of Care | The Control arm will receive standard of care, which consists of the distribution of brochures containing COVID-19 prevention information. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Standard of Care | The Control arm will receive standard of care, which consists of the distribution of brochures containing COVID-19 prevention information. |
|
|
| 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 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. | Posted | Mean | Standard Deviation | scores on a scale | 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 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 4 weeks post intervention |
|
|
|
| 0 |
| 101 |
| 0 |
| 101 |
| 0 |
| 101 |
| EG001 | Standard of Care | The Control arm will receive standard of care, which consists of the distribution of brochures containing COVID-19 prevention information. | 0 | 99 | 0 | 99 | 0 | 99 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|