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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 assess the extent to which LDL report increased adherence with COVID 19 mitigation practices 1 month post intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-19 Group Problem Solving | Experimental |
| |
| Standard of Care | Active Comparator |
| |
| Group Problem Solving Plus Booster Session | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 Group Problem Solving | Behavioral | This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that 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 their and their peers' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Compliant With COVID Vaccination Guidelines as Assessed by a Survey | Measure of compliance with COVID vaccination guidelines. | Baseline |
| Number of Participants Compliant With COVID Vaccination Guidelines as Assessed by a Survey | Post test measure of compliance with COVID vaccination guidelines. | 4 weeks post intervention |
| Mask Wearing Frequency as Assessed by a Survey | Mask Wearing frequency is reported as a score, ranging from 1-4, with a higher score indicating greater mask wearing frequency. | Baseline |
| Mask Wearing Frequency as Assessed by a Survey | Mask Wearing frequency is reported as a score, ranging from 1-4, with a higher score indicating greater mask wearing frequency. | 4 weeks post intervention |
| Percentage of Participants Who Contacted an Agency About the Gold Card | Percentage of participants who reported contacting a local community or health agency to request the Gold Card a local medical insurance for low income individuals living in Harris County. | 4 weeks post intervention |
| Percentage of Participants Who Reported Contacting the Agency for Assistance to Get Food | Percentage of participants who reported seeking food assistance from a local community organization. | 4 weeks post intervention |
| Percentage of Participants Who Reported Contacting the Agency for Assistance With Health Care Resources |
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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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | COVID-19 Group Problem Solving | COVID-19 Group Problem Solving: This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that 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 their and their peers' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods. Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only |
| FG001 | Group Problem Solving Plus Booster Session | COVID-19 Group Problem Solving: This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that 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 their and their peers' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods. Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only Booster session: Participants will have a 10 - 15 minute "booster' session about a week after engaging in the small group intervention. |
| FG002 | Standard of Care | Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | COVID-19 Group Problem Solving | COVID-19 Group Problem Solving: This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that 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 their and their peers' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods. Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | For age, data were not collected for 2 in the Group Problem Solving arm, for 2 in the Group Problem Solving Plus Booster Session arm, and for 2 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 Compliant With COVID Vaccination Guidelines as Assessed by a Survey | Measure of compliance with COVID vaccination guidelines. | Posted | Count of Participants | Participants | Baseline |
|
up to 30 days
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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 | COVID-19 Group Problem Solving: This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that 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 their and their peers' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods. Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only |
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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 | May 1, 2023 | Mar 4, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 1, 2023 | Mar 4, 2025 | ICF_001.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 | This group will receive a COVID-19 prevention flyer and social resources list only |
|
| Booster session | Behavioral | Participants will have a 10 - 15 minute "booster' session about a week after engaging in the small group intervention. They will be contacted by phone and the booster will consist of brief prompts to engage participants in a discussion to encourage them to act on their personal commitments to protect themselves and others against COVID. They will also be encouraged to seek COVID related resources based on the information provided during the small group intervention. |
|
Percentage of participants who reported seeking medical assistance or health advice from a local clinic or community organization. |
| 4 weeks post intervention |
| BG001 | Group Problem Solving Plus Booster Session | COVID-19 Group Problem Solving: This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that 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 their and their peers' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods. Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only Booster session: Participants will have a 10 - 15 minute "booster' session about a week after engaging in the small group intervention. |
| BG002 | Standard of Care | Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Group Problem Solving Plus Booster Session | COVID-19 Group Problem Solving: This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that 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 their and their peers' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods. Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only Booster session: Participants will have a 10 - 15 minute "booster' session about a week after engaging in the small group intervention. |
| OG002 | Standard of Care | Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only |
|
|
| Primary | Number of Participants Compliant With COVID Vaccination Guidelines as Assessed by a Survey | Post test measure of compliance with COVID vaccination guidelines. | Data were not collected for 16 in the Group Problem Solving arm, for 20 in the Group Problem Solving plus Booster Session arm, and 24 in the Standard of Care arm--this is because these participants were lost to follow up at the 4-week timepoint. | Posted | Count of Participants | Participants | 4 weeks post intervention |
|
|
|
| Primary | Mask Wearing Frequency as Assessed by a Survey | Mask Wearing frequency is reported as a score, ranging from 1-4, with a higher score indicating greater mask wearing frequency. | Data for this outcome measure were not collected for 2 in the Group Problem Solving arm and for 4 in the Group Problem Solving plus Booster Session arm--this is because these participants did not complete this survey. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | Mask Wearing Frequency as Assessed by a Survey | Mask Wearing frequency is reported as a score, ranging from 1-4, with a higher score indicating greater mask wearing frequency. | Data for this outcome measure were not collected for 16 in the Group Problem Solving arm, for 20 in the Group Problem Solving plus Booster Session arm, and for 24 in the Standard of Care arm--this is because these participants were lost to follow up at the 4-week timepoint. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks post intervention |
|
|
|
| Primary | Percentage of Participants Who Contacted an Agency About the Gold Card | Percentage of participants who reported contacting a local community or health agency to request the Gold Card a local medical insurance for low income individuals living in Harris County. | For this outcome measure, data were collected only for those who called a number on the resource sheet--for the Group Problem Solving arm, 20 called a number; for the Group Problem Solving plus Booster Session arm, 22 called a number; and for the Standard of Care arm, 7 called a number. | Posted | Count of Participants | Participants | 4 weeks post intervention |
|
|
|
| Primary | Percentage of Participants Who Reported Contacting the Agency for Assistance to Get Food | Percentage of participants who reported seeking food assistance from a local community organization. | For this outcome measure, data were collected only for those who called a number on the resource sheet--for the Group Problem Solving arm, 20 called a number; for the Group Problem Solving plus Booster Session arm, 22 called a number; and for the Standard of Care arm, 7 called a number. | Posted | Count of Participants | Participants | 4 weeks post intervention |
|
|
|
| Primary | Percentage of Participants Who Reported Contacting the Agency for Assistance With Health Care Resources | Percentage of participants who reported seeking medical assistance or health advice from a local clinic or community organization. | For this outcome measure, data were collected only for those who called a number on the resource sheet--for the Group Problem Solving arm, 20 called a number; for the Group Problem Solving plus Booster Session arm, 22 called a number; and for the Standard of Care arm, 7 called a number. | Posted | Count of Participants | Participants | 4 weeks post intervention |
|
|
|
| 0 |
| 120 |
| 0 |
| 120 |
| 0 |
| 120 |
| EG001 | Group Problem Solving Plus Booster Session | COVID-19 Group Problem Solving: This group will have three core components to be delivered at the corner by trained data collectors. Interactive dialogue component that 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 their and their peers' risk for COVID-19 transmission. Navigation Component will consist of providing information and linking LDLs with social service providers that can help buffer some of the social and economic effects of the COVID-19 pandemic and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support, defined as encouraging social networks to provide informational, emotional, appraisal, and instrumental support as cited in the Taxonomy of Behavior Change Methods. Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only Booster session: Participants will have a 10 - 15 minute "booster' session about a week after engaging in the small group intervention. | 0 | 120 | 0 | 120 | 0 | 120 |
| EG002 | Standard of Care | Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only | 0 | 119 | 0 | 119 | 0 | 119 |
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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 |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|