COVID-19NCT06821113
Vale+Tú Salud: Corner-Based 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 determine the cultural, socioeconomic, inter/personal and work-related factors that influence COVID 19 mitigation practices including social distancing, hand-washing and Personal protective equipment (PPE) use, to adapt, implement, and test Vale+Tú Salud in a cluster randomized trial to… 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
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2025to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Maria E Fernandez-Esquer, PhD, 713-500-9657, Maria.E.Fernandez-Esquer@uth.tmc.edu
Cesar L Pinzon-Gomez, (713) 500-9614, Cesar.L.PinzonGomez@uth.tmc.edu
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 determine the cultural, socioeconomic, inter/personal and work-related factors that influence COVID 19 mitigation practices including social distancing, hand-washing and Personal protective equipment (PPE) use, to adapt, implement, and test Vale+Tú Salud in a cluster randomized trial to assess the extent to which LDL report increased adherence with COVID 19 mitigation practices 1 month post intervention and to promote Vale+Tú Salud just-in-time results and increase its capacity to rapidly disseminate findings among groups that serve LDL and other Latino immigrants.
- 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
Participants 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 personal commitment called "Mi Promesa" to implement COVID mitigation practices. Navigation Component will consist of providing information and linking LDLs with social service providers and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support.
Standard of CareBehavioural
Participants will receive a COVID-19 prevention flyer and social resources list only
Booster sessionBehavioural
Participants in this group will also receive a "booster phone call" 10 to 15 days after the small group intervention to provide brief prompts to encourage participants to act on their personal commitments and encourage them to seek community resources.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Group Problem Solving and booster call | Experimental | Not described Receives: Behavioral: COVID-19 Group Problem Solving; Behavioral: Standard of Care; Behavioral: Booster session |
| Standard of Care | Active comparator | Not described Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in COVID-19 vaccination status as assessed by a survey
Measured: Baseline, 4 weeks post intervention
Change in hand washing frequency as assessed by a survey
Measured: Baseline, 4 weeks post intervention
Percentage of participants who report contacting the gold card agency
Measured: Baseline, 4 weeks post intervention
Percentage of participants who report contacting the agency for assistance to get food
Measured: Baseline, 4 weeks post intervention
Percentage of participants who report contacting the agency for assistance for health care resources
Measured: Baseline, 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 posted11 Feb 2025
- Study start3 Jul 2025
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- 150 participants (estimated)
Sponsor and investigators
- 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
- NCT06821113
- Sponsor's protocol ID
- HSC-SPH-20-1389 (Phase 3)
- Other IDs
- 1R01MD016328-01
- Status last verified
- Aug 2025
- First submitted
- 7 Feb 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- 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 26 Aug 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
- NCT06821113
- Acronym / sponsor ID
- HSC-SPH-20-1389 (Phase 3)
- Conditions
- COVID-19
- Keywords
- Latino Day Laborers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- 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 Jul 2025 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
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 determine the cultural, socioeconomic, inter/personal and work-related factors that influence COVID 19 mitigation practices including social distancing, hand-washing and Personal protective equipment (PPE) use, to adapt, implement, and test Vale+Tú Salud in a cluster randomized trial to assess the extent to which LDL report increased adherence with COVID 19 mitigation practices 1 month post intervention and to promote Vale+Tú Salud just-in-time results and increase its capacity to rapidly disseminate findings among groups that serve LDL and other Latino immigrants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster Randomized
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Group Problem Solving and booster call | Experimental | Behavioral: COVID-19 Group Problem Solving, Behavioral: Standard of Care, Behavioral: Booster session |
| Standard of Care | Active comparator | Behavioral: Standard of Care |
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 SolvingParticipants 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 personal commitment called "Mi Promesa" to implement COVID mitigation practices. Navigation Component will consist of providing information and linking LDLs with social service providers and the "Multiplicador de salud"/Health Multiplier component that builds from the theoretical and practice-based method of mobilizing social networks and social support. | Behavioural | COVID-19 Group Problem Solving and booster call |
| Standard of CareParticipants will receive a COVID-19 prevention flyer and social resources list only | Behavioural | COVID-19 Group Problem Solving and booster call, Standard of Care |
| Booster sessionParticipants in this group will also receive a "booster phone call" 10 to 15 days after the small group intervention to provide brief prompts to encourage participants to act on their personal commitments and encourage them to seek community resources. | Behavioural | COVID-19 Group Problem Solving and booster call |
Primary outcome
Change in COVID-19 vaccination status as assessed by a survey
Time frame: Baseline, 4 weeks post intervention
Change in hand washing frequency as assessed by a survey
Time frame: Baseline, 4 weeks post intervention
Percentage of participants who report contacting the gold card agency
Time frame: Baseline, 4 weeks post intervention
Percentage of participants who report contacting the agency for assistance to get food
Time frame: Baseline, 4 weeks post intervention
Percentage of participants who report contacting the agency for assistance for health care resources
Time frame: Baseline, 4 weeks post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- 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.
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: looking for participants now, as of the sponsor's last update on 26 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria E Fernandez-Esquer, PhD ((713) 500-9657, Maria.E.Fernandez-Esquer@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in COVID-19 vaccination status as assessed by a survey (time frame: Baseline, 4 weeks post intervention). The study lists 5 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 26 Aug 2025.