COVID-19 Testing and Vaccination Among Spanish Speakers

December 23, 2025 updated by: Wake Forest University Health Sciences

Identifying and Addressing Critical Social, Ethical, and Behavioral Factors Associated With COVID-19 Testing and Vaccination Among Spanish Speakers

Latinx communities are disproportionately affected by the COVID-19 pandemic, with Spanish-speaking Latinx communities carrying even heavier burdens of infection, hospitalization, and mortality. Major barriers to COVID-19 testing and vaccination exist, and a profound need remains to understand and address the social, ethical, and behavioral implications (SEBI) of COVID-19 testing and vaccination within Latinx communities. Our community-academic partnership proposes a rigorous mixed-methods, community-based participatory research study to better understand the SEBI of COVID-19 testing and vaccination and to refine and test a novel and culturally congruent intervention that integrates two evidenced-based strategies - peer navigation and mHealth - to increase COVID-19 testing and vaccination within Spanish-speaking Latinx communities.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A profound need remains to understand the social, ethical, and behavioral implications (SEBI) of COVID-19 testing and vaccination interventions within Spanish-speaking Latinx communities. The proposal is a conceptually integrated community-based participatory research (CBPR) study that includes systematic data collection on the multilevel factors that influence COVID-19 testing and vaccination; refinement of an efficacious intervention that uses complementary theory-based strategies (i.e., peer navigation and mHealth); intervention implementation and evaluation using a longitudinal group-randomized trial design; and dissemination of findings.

Study Type

Interventional

Enrollment (Actual)

274

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria: To be eligible to participate in the in the NuestraSaludSegura intervention as a Navegante:

  • participant must self-identify as Hispanic/Latinx
  • participant must be Spanish speaking
  • participant reports having been vaccinated against COVID-19
  • participant must be ≥18 years of age
  • participant must provide informed consent

Inclusion Criteria: To be eligible to participate in the interviews as a Social Network Member:

  • participant must self-identify as Hispanic/Latinx
  • participant must be Spanish speaking
  • participant must be ≥ 18 years of age
  • participant must provide informed consent

Exclusion Criteria:

  • less than 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NuestraSaludSegura intervention
Intervention-group Navegantes will be trained and supported for 6 months of implementation in Years 1-2
Behavioral: NuestraSaludSegura
It blends peer navigation and mHealth
Experimental: delayed NuestraSaludSegura intervention
delayed-intervention group Navegantes will be trained in Year 2
Behavioral: NuestraSaludSegura
It blends peer navigation and mHealth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Ever Tested
Time Frame: Baseline
Number of Subjects Ever Tested
Baseline
Number of Subjects Ever Vaccinated
Time Frame: Baseline
Number of Subjects Ever Vaccinated
Baseline
Number of Subjects Up to Date on Recommended Doses
Time Frame: Baseline
Number of Subjects Up to Date on Recommended Doses
Baseline
Number of Doses Received
Time Frame: Baseline
Number of Doses Received
Baseline
Number of Subjects Ever Tested
Time Frame: Month 6
Number of Subjects Ever Tested
Month 6
Number of Subjects Ever Vaccinated
Time Frame: Month 6
Number of Subjects Ever Vaccinated
Month 6
Number of Subjects Up to Date on Recommended Doses
Time Frame: Month 6
Number of Subjects Up to Date on Recommended Doses
Month 6
Number of Doses Received
Time Frame: Month 6
Number of Doses Received
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Scott D Rhodes, PhD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2023

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

November 30, 2024

Study Registration Dates

First Submitted

March 29, 2022

First Submitted That Met QC Criteria

March 29, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

December 23, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00079510
  • 5U01MD017431 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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