Vale+ Program for Coronavirus Prevention

Overseen By Cesar L Pinzon-Gomez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Not hired at corner, COVID-19 symptoms

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to understand factors influencing behavior in preventing COVID-19, such as mask-wearing and social distancing. Participants will engage in group problem-solving sessions to determine if these sessions improve safety habits. The trial includes two groups: one receives special group sessions and follow-up calls, while the other receives standard advice. It is open to Hispanic or Latino individuals seeking work on street corners. Participants should not have experienced COVID-19 symptoms in the past two days. As an unphased trial, this study offers a unique opportunity to contribute to important research on community health behaviors.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this program is safe for COVID-19 prevention?

Research shows that the COVID-19 Group Problem Solving treatment helps people adhere to safety practices like social distancing and wearing masks. Studies have found that ignoring these guidelines can increase the risk of infection. This treatment does not involve medication or vaccines, which often raise concerns about side effects. Instead, it uses methods to improve adherence to health guidelines.

Since this trial focuses on changing behavior rather than testing a new drug or vaccine, the safety risks are generally low. Sources report no negative effects from this type of approach, suggesting it is likely safe and aims to help people adopt safer behaviors during the pandemic. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the COVID-19 Group Problem Solving program because it offers a novel approach to coronavirus prevention by focusing on behavioral strategies rather than medication. Unlike standard treatments that typically involve vaccines or antiviral drugs, this program emphasizes collaborative problem-solving to promote preventative behaviors and enhance community resilience. The inclusion of a booster call adds an extra layer of support, ensuring participants stay engaged and motivated. This method could complement existing medical interventions by addressing the social and psychological aspects of disease prevention, potentially leading to more comprehensive public health strategies.

What evidence suggests that this trial's treatments could be effective for COVID-19 prevention?

Research has shown that strategies like identifying cases, isolating them, and tracing contacts can help control the spread of COVID-19. This approach reduces transmission and protects communities. Studies emphasize the importance of infection prevention measures, such as social distancing, hand-washing, and wearing personal protective equipment (PPE), which are crucial for lowering the risk of COVID-19. In this trial, the COVID-19 Group Problem Solving treatment, one of the study arms, focuses on these strategies to help people adhere to preventive practices. Early findings suggest that these group interventions could enhance community safety by encouraging effective COVID-19 prevention behaviors. ^{2 6 7 8 9}

Who Is on the Research Team?

Maria E Fernandez-Esquer, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for Latino Day Laborers (LDL) and focuses on understanding how cultural, social, and work factors affect COVID-19 safety practices. Participants will help test a program aimed at improving adherence to measures like social distancing and PPE use.

Inclusion Criteria

Self-identify as Hispanic or Latino

Be present at the corner for the purposes of looking for work

Exclusion Criteria

Have not been previously hired to work at a corner

I have had COVID-19 symptoms in the last 2 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation and testing of Vale+Tú Salud to assess adherence to COVID-19 mitigation practices

1 month

Follow-up

Participants are monitored for adherence to COVID-19 mitigation practices post-intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Booster session
• COVID-19 Group Problem Solving
• Standard of Care

Trial Overview The study tests 'Vale+Tú Salud', an adapted program for LDLs to prevent COVID-19 spread. It includes group problem-solving sessions, standard care advice, and booster sessions to reinforce behaviors.

How Is the Trial Designed?

Group I: COVID-19 Group Problem Solving and booster call Experimental Treatment 3 Interventions

Group II: Standard of Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9490164/

COVID-19 and preventive strategy - PMC The purpose of this review is to summarize the peer-reviewed and preprint literature on the epidemiology, transmission, clinical presentation, and available ...

2. nature.com nature.com/articles/s41598-023-31709-2

A global analysis of the effectiveness of policy responses to ... Vaccinations have not solved the problem of increasing COVID-19 case counts, but have been strongly associated with the falling mortality rate.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9470909/

COVID-19: National Pandemic Management Strategies ... The most effective approach is at least the combination of case detection and isolation, and contact tracing or containment measures.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0195670124003116

Infection prevention and control risk factors for SARS-CoV ... By September 2020, health workers accounted for 2.5% of all COVID-19 cases, suggesting that the progressive implementation of infection prevention and control ( ...

5. nam.edu nam.edu/perspectives/patients-families-and-communities-covid-19-impact-assessment-lessons-learned-and-compelling-needs/

Patients, Families, and Communities COVID-19 Impact ... The virus has taken a tremendous toll on the health of these groups, with 45,655,635 cases, 3,223,806 hospitalizations, and 740,348 deaths in the United States ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9444812/

Safety surveillance and challenges in accelerated COVID-19 ... These data demonstrated that Spikevax was 93% effective in preventing COVID-19, with 55 cases of COVID-19 occurring in the vaccine group and 744 COVID-19 cases ...

7. cdc.gov cdc.gov/covid/php/surveillance/index.html

Surveillance and Data Analytics | COVID-19 This page provides an overview of COVID-19 data and trends over time. Other COVID-19 related data visualizations (previously on CDC's COVID ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12211853/

Interventions to improve patient safety during the COVID-19 ... The COVID-19 pandemic exacerbated problems in patient safety, especially in medication safety, diagnostic safety, surgical safety, healthcare- ...

9. who.int who.int/news-room/spotlight/the-impact-of-covid-19-on-global-health-goals

The impact of COVID-19 on global health goals Exploring the impact of COVID-19 through excess mortality, its impact on vulnerable populations and progress towards global health goals.