NuestraSaludSegura Program for COVID-19 Testing and Vaccination

Overseen By Scott D Rhodes, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Under 18 years

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand and improve COVID-19 testing and vaccination in Spanish-speaking Latinx communities, who have been hit hard by the pandemic. It combines two strategies: peer navigation and mobile health (mHealth) to support these communities. Participants will help refine and test this new approach, called the NuestraSaludSegura Program. The trial seeks Spanish-speaking Hispanic/Latinx individuals who have been vaccinated against COVID-19.

As an unphased trial, this study offers participants the opportunity to contribute to innovative community health solutions.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on COVID-19 testing and vaccination, so it's unlikely that your medications would be affected, but you should confirm with the trial organizers.

What prior data suggests that the NuestraSaludSegura intervention is safe?

Research has shown that the NuestraSaludSegura program is a new method being tested to improve COVID-19 testing and vaccination in Latinx communities. This program emphasizes community engagement and education, not medication or vaccines, so it doesn't carry the same safety concerns. Previous studies found no harm or side effects because it isn't a drug or vaccine. Instead, it trains peer navigators to help people access COVID-19 testing and vaccination more easily.

As a community support program, the safety risks are very low, unlike a medical treatment. Those considering joining this trial can expect to focus on learning and support rather than any physical treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the NuestraSaludSegura program because it introduces a community-centered approach to COVID-19 testing and vaccination. Unlike other methods that rely heavily on healthcare facilities, this program trains community health workers, or "Navegantes," to engage directly with the community. This personalized touch aims to increase access and trust, particularly in underserved areas, potentially improving vaccination rates and early detection of COVID-19. By empowering local leaders, the program hopes to create lasting health improvements beyond the pandemic.

What evidence suggests that the NuestraSaludSegura intervention is effective for increasing COVID-19 testing and vaccination in Latinx communities?

Research shows that the NuestraSaludSegura program aims to overcome obstacles to COVID-19 testing and vaccination in Latinx communities. This trial will evaluate two approaches: the immediate NuestraSaludSegura intervention and a delayed intervention. The program uses two proven methods: guidance from community members and mobile health support. Previous studies have shown that these methods help people access healthcare and improve vaccination rates. By making information easier to understand and more culturally relevant, the program aims to increase COVID-19 testing and vaccination among Spanish-speaking Latinx individuals. Although no direct data exists yet on this specific program, the methods it employs have succeeded in similar health efforts. ^{1 5 6 7 8}

Who Is on the Research Team?

Scott D Rhodes, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for Spanish-speaking individuals who are at least 18 years old and self-identify as Hispanic/Latinx. They must provide informed consent to participate. For certain parts of the study, participants also need to have received a COVID-19 vaccination.

Inclusion Criteria

To join the NuestraSaludSegura intervention as a Navegante, you must identify yourself as Hispanic/Latinx.

You have received the COVID-19 vaccine.

participant must provide informed consent

Exclusion Criteria

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Implementation

Implementation of a culturally congruent intervention using peer navigation and mHealth to increase COVID-19 testing and vaccination

12 weeks

Evaluation

Evaluation of the intervention using a longitudinal group-randomized trial design

8 weeks

Follow-up

Participants are monitored for the effectiveness of the intervention in increasing COVID-19 testing and vaccination

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NuestraSaludSegura

Trial Overview

The study aims to understand barriers faced by Latinx communities in accessing COVID-19 testing and vaccinations. It will test 'NuestraSaludSegura', which combines peer navigation with mobile health (mHealth) strategies, designed specifically for Spanish speakers.

How Is the Trial Designed?

Group I: delayed NuestraSaludSegura intervention Experimental Treatment 1 Intervention

delayed-intervention group Navegantes will be trained in Year 2

Group II: NuestraSaludSegura intervention Experimental Treatment 1 Intervention

Intervention-group Navegantes will be trained and supported for 6 months of implementation in Years 1-2

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

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/PMC7931245/

Clinical Outcomes of a COVID-19 Vaccine - PubMed Central

Second, our results show that the effectiveness of a COVID-19 vaccine will be shaped significantly by the success or failure of efforts to quickly and ...

2.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/08/NCT05302908/Prot_SAP_001.pdf

Project Summary (limit to 5 pages)

... vaccination and immediately translates this understanding to NuestraSaludSegura ... 19 testing and vaccination; perceived COVID-19 testing and vaccine access;.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11372784/

Evaluation of the COVID-19 vaccine effectiveness on the ...

In addition, the adjusted vaccine effectiveness against severe outcome was 33% (95% CI: 19%- 44%), 34% (95% CI: 20%- 45%) and 20% (95% CI: -29%- ...

4.

cdc.gov

cdc.gov/covid/php/surveillance/vaccine-effectiveness.html

Vaccine Effectiveness | COVID-19

CDC's COVID-19 vaccine effectiveness program evaluates current COVID-19 vaccines by: Assessing real-world COVID-19 vaccine effectiveness in key ...

5.

view-hub.org

view-hub.org/sites/default/files/2021-07/COVID%2019%20VE%20Team%20Literature%20Review%20-%20Summary%20Table.pdf

Results of COVID-19 Vaccine Effectiveness Studies: An ...

Preliminary Data on Vaccine Effectiveness and Supplementary Opinion on the Strategy ... to 12.4% in week 19 following the vaccination program. For.

6.

scienceopen.com

scienceopen.com/document_file/5456de78-1d28-4cf5-b356-d6899bd383a9/PubMedCentral/5456de78-1d28-4cf5-b356-d6899bd383a9.pdf

BMJ Open is committed to open peer review. As part of this ...

We will collect qualitative data to expand our understanding of social, ethical, and behavioral implications (SEBI) of COVID-19 testing and ...

7.

sph.unc.edu

sph.unc.edu/wp-content/uploads/sites/112/2022/04/Scott-Rhodes_CV-2022.pdf

wake forest school of medicine

(SEBI) of COVID-19 testing and vaccination and refine and test NuestraSaludSegura (Our Safe ... communities to analyze and interpret data and get to outcomes.

8.

withpower.com

withpower.com/trial/maraviroc-atorvastatin-for-post-covid-syndrome-ad3f0

Maraviroc + Atorvastatin for Post-COVID Syndrome

Prior Safety DataThis treatment has passed at least one previous human trial ... NuestraSaludSegura Program for COVID-19 Testing and Vaccination. Unbiased ...