COVID-19NCT06146361
Vale+Tú Salud: Corner-Based Randomized Trial to Test a Latino Day Laborer Program Adapted to Prevent COVID-19
A study testing COVID-19 Group Problem Solving and Booster session in people with COVID-19, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- COVID-19 Group Problem Solving and Booster session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 359 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2023to 14 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identify as Hispanic or Latino
- Be present at the corner for the purposes of looking for work
Who cannot join
- Have not been previously hired to work at a corner
- Symptoms of COVID-19 in the previous 48 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Vale+ Tu Salud: Corner-Based Randomized Trial to Test a Latino Day Laborer Program Adapted to Prevent COVID-19.
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.
- Conditions
- COVID-19
- Being tested
- COVID-19 Group Problem Solving, Standard of Care, Booster session
- Keywords
- Latino Day Laborers
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 Group Problem SolvingBehavioural
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 CareBehavioural
This group will receive a COVID-19 prevention flyer and social resources list only
Booster sessionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Group Problem Solving | Experimental | Not described Receives: Behavioral: COVID-19 Group Problem Solving; Behavioral: Standard of Care |
| Standard of Care | Active comparator | Not described Receives: Behavioral: Standard of Care |
| Group Problem Solving Plus Booster Session | Experimental | Not described Receives: Behavioral: COVID-19 Group Problem Solving; Behavioral: Standard of Care; Behavioral: Booster session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Compliant With COVID Vaccination Guidelines as Assessed by a Survey
Measure of compliance with COVID vaccination guidelines.
Measured: Baseline
Number of Participants Compliant With COVID Vaccination Guidelines as Assessed by a Survey
Post test measure of compliance with COVID vaccination guidelines.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 weeks post intervention
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.
Measured: 4 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start3 Nov 2023
- Primary completion14 Feb 2024
- Study completion14 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster Randomized
- Masking
- None (open label)
- Enrolment
- 359 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Maria Eugenia Fernandez-Esquer, The University of Texas Health Science Center, Houston
- Investigators
- Maria E Fernandez-Esquer, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146361
- Sponsor's protocol ID
- HSC-SPH-20-1389 (phase 2)
- Other IDs
- 1R01MD016328-01
- Status last verified
- Apr 2025
- First submitted
- 22 Nov 2023
- Last updated
- 23 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vale+ Tu Salud: Corner-Based Randomized Trial to Test a Latino Day Laborer Program Adapted to Prevent COVID-19.
- ClinicalTrials.gov ID
- NCT06146361
- Acronym / sponsor ID
- HSC-SPH-20-1389 (phase 2)
- Conditions
- COVID-19
- Keywords
- Latino Day Laborers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 359 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 14 Feb 2024 (actual)
- Study completion
- 14 Feb 2024 (actual)
- First posted
- 24 Nov 2023 (actual)
- Results
- Posted 23 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Cluster Randomized
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Group Problem Solving | Experimental | Behavioral: COVID-19 Group Problem Solving, Behavioral: Standard of Care |
| Standard of Care | Active comparator | Behavioral: Standard of Care |
| Group Problem Solving Plus Booster Session | Experimental | Behavioral: COVID-19 Group Problem Solving, Behavioral: Standard of Care, Behavioral: Booster session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Self-identify as Hispanic or Latino
- Be present at the corner for the purposes of looking for work
Key exclusion criteria (2 listed)
- Have not been previously hired to work at a corner
- Symptoms of COVID-19 in the previous 48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 Group Problem SolvingThis 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. | Behavioural | COVID-19 Group Problem Solving, Group Problem Solving Plus Booster Session |
| Standard of CareThis group will receive a COVID-19 prevention flyer and social resources list only | Behavioural | COVID-19 Group Problem Solving, Group Problem Solving Plus Booster Session, Standard of Care |
| Booster sessionParticipants 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. | Behavioural | Group Problem Solving Plus Booster Session |
Primary outcome
Number of Participants Compliant With COVID Vaccination Guidelines as Assessed by a Survey
Time frame: Baseline
Measure of compliance with COVID vaccination guidelines.
Number of Participants Compliant With COVID Vaccination Guidelines as Assessed by a Survey
Time frame: 4 weeks post intervention
Post test measure of compliance with COVID vaccination guidelines.
Mask Wearing Frequency as Assessed by a Survey
Time frame: Baseline
Mask Wearing frequency is reported as a score, ranging from 1-4, with a higher score indicating greater mask wearing frequency.
Mask Wearing Frequency as Assessed by a Survey
Time frame: 4 weeks post intervention
Mask Wearing frequency is reported as a score, ranging from 1-4, with a higher score indicating greater mask wearing frequency.
Percentage of Participants Who Contacted an Agency About the Gold Card
Time frame: 4 weeks post intervention
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.
Percentage of Participants Who Reported Contacting the Agency for Assistance to Get Food
Time frame: 4 weeks post intervention
Percentage of participants who reported seeking food assistance from a local community organization.
Percentage of Participants Who Reported Contacting the Agency for Assistance With Health Care Resources
Time frame: 4 weeks post intervention
Percentage of participants who reported seeking medical assistance or health advice from a local clinic or community organization.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria E Fernandez-Esquer, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVID-19 Group Problem Solving and Booster session in people with COVID-19, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Compliant With COVID Vaccination Guidelines as Assessed by a Survey (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.