Trial Outcomes & Findings for Vale+Tú Salud: Corner-Based Randomized Trial to Test a Latino Day Laborer Program Adapted to Prevent COVID-19 (NCT NCT06146361)
NCT ID: NCT06146361
Last Updated: 2025-04-23
Results Overview
Measure of compliance with COVID vaccination guidelines.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
359 participants
Primary outcome timeframe
Baseline
Results posted on
2025-04-23
Participant Flow
Unit of analysis: street corners
Participant milestones
| Measure |
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
|
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.
|
Standard of Care
Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only
|
|---|---|---|---|
|
Overall Study
STARTED
|
120 8
|
120 8
|
119 8
|
|
Overall Study
COMPLETED
|
104 8
|
100 8
|
95 8
|
|
Overall Study
NOT COMPLETED
|
16 0
|
20 0
|
24 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
COVID-19 Group Problem Solving
n=120 Participants
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
|
Group Problem Solving Plus Booster Session
n=120 Participants
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.
|
Standard of Care
n=119 Participants
Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only
|
Total
n=359 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.4 years
STANDARD_DEVIATION 13.4 • n=118 Participants • 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.
|
43.7 years
STANDARD_DEVIATION 12.4 • n=118 Participants • 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.
|
40.3 years
STANDARD_DEVIATION 14.3 • n=117 Participants • 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.
|
42.5 years
STANDARD_DEVIATION 13.4 • n=353 Participants • 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.
|
|
Sex: Female, Male
Female
|
0 Participants
n=120 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=359 Participants
|
|
Sex: Female, Male
Male
|
120 Participants
n=120 Participants
|
120 Participants
n=120 Participants
|
119 Participants
n=119 Participants
|
359 Participants
n=359 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
120 Participants
n=120 Participants
|
120 Participants
n=120 Participants
|
119 Participants
n=119 Participants
|
359 Participants
n=359 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=120 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=359 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=120 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=359 Participants
|
|
Region of Enrollment
United States
|
120 Participants
n=120 Participants
|
120 Participants
n=120 Participants
|
119 Participants
n=119 Participants
|
359 Participants
n=359 Participants
|
PRIMARY outcome
Timeframe: BaselineMeasure of compliance with COVID vaccination guidelines.
Outcome measures
| Measure |
COVID-19 Group Problem Solving
n=120 Participants
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
|
Group Problem Solving Plus Booster Session
n=120 Participants
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.
|
Standard of Care
n=119 Participants
Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only
|
|---|---|---|---|
|
Number of Participants Compliant With COVID Vaccination Guidelines as Assessed by a Survey
|
30 Participants
|
28 Participants
|
33 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post interventionPopulation: 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.
Post test measure of compliance with COVID vaccination guidelines.
Outcome measures
| Measure |
COVID-19 Group Problem Solving
n=104 Participants
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
|
Group Problem Solving Plus Booster Session
n=100 Participants
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.
|
Standard of Care
n=95 Participants
Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only
|
|---|---|---|---|
|
Number of Participants Compliant With COVID Vaccination Guidelines as Assessed by a Survey
|
59 Participants
|
53 Participants
|
53 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
Mask Wearing frequency is reported as a score, ranging from 1-4, with a higher score indicating greater mask wearing frequency.
Outcome measures
| Measure |
COVID-19 Group Problem Solving
n=118 Participants
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
|
Group Problem Solving Plus Booster Session
n=116 Participants
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.
|
Standard of Care
n=119 Participants
Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only
|
|---|---|---|---|
|
Mask Wearing Frequency as Assessed by a Survey
|
2.050 score on a scale
Standard Deviation 0.915
|
2.109 score on a scale
Standard Deviation 0.836
|
1.927 score on a scale
Standard Deviation 0.842
|
PRIMARY outcome
Timeframe: 4 weeks post interventionPopulation: 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.
Mask Wearing frequency is reported as a score, ranging from 1-4, with a higher score indicating greater mask wearing frequency.
Outcome measures
| Measure |
COVID-19 Group Problem Solving
n=104 Participants
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
|
Group Problem Solving Plus Booster Session
n=100 Participants
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.
|
Standard of Care
n=95 Participants
Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only
|
|---|---|---|---|
|
Mask Wearing Frequency as Assessed by a Survey
|
1.720 score on a scale
Standard Deviation 0.621
|
1.798 score on a scale
Standard Deviation 0.567
|
1.632 score on a scale
Standard Deviation 0.673
|
PRIMARY outcome
Timeframe: 4 weeks post interventionPopulation: 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.
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.
Outcome measures
| Measure |
COVID-19 Group Problem Solving
n=20 Participants
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
|
Group Problem Solving Plus Booster Session
n=22 Participants
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.
|
Standard of Care
n=7 Participants
Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only
|
|---|---|---|---|
|
Percentage of Participants Who Contacted an Agency About the Gold Card
|
6 Participants
|
10 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post interventionPopulation: 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.
Percentage of participants who reported seeking food assistance from a local community organization.
Outcome measures
| Measure |
COVID-19 Group Problem Solving
n=20 Participants
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
|
Group Problem Solving Plus Booster Session
n=22 Participants
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.
|
Standard of Care
n=7 Participants
Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only
|
|---|---|---|---|
|
Percentage of Participants Who Reported Contacting the Agency for Assistance to Get Food
|
10 Participants
|
13 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post interventionPopulation: 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.
Percentage of participants who reported seeking medical assistance or health advice from a local clinic or community organization.
Outcome measures
| Measure |
COVID-19 Group Problem Solving
n=20 Participants
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
|
Group Problem Solving Plus Booster Session
n=22 Participants
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.
|
Standard of Care
n=7 Participants
Standard of Care: This group will receive a COVID-19 prevention flyer and social resources list only
|
|---|---|---|---|
|
Percentage of Participants Who Reported Contacting the Agency for Assistance With Health Care Resources
|
2 Participants
|
2 Participants
|
0 Participants
|
Adverse Events
COVID-19 Group Problem Solving
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group Problem Solving Plus Booster Session
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