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OpenTrials
Completed

NCT Number: NCT05302908

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Vaccinations Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NuestraSaludSegura

Behavioral

It blends peer navigation and mHealth

Primary outcomes

  1. Number of Subjects Ever Tested

    Time frame: Baseline

    Number of Subjects Ever Tested

  2. Number of Subjects Ever Vaccinated

    Time frame: Baseline

    Number of Subjects Ever Vaccinated

  3. Number of Subjects Up to Date on Recommended Doses

    Time frame: Baseline

    Number of Subjects Up to Date on Recommended Doses

  4. Number of Doses Received

    Time frame: Baseline

    Number of Doses Received

  5. Number of Subjects Ever Tested

    Time frame: Month 6

    Number of Subjects Ever Tested

  6. Number of Subjects Ever Vaccinated

    Time frame: Month 6

    Number of Subjects Ever Vaccinated

  7. Number of Subjects Up to Date on Recommended Doses

    Time frame: Month 6

    Number of Subjects Up to Date on Recommended Doses

  8. Number of Doses Received

    Time frame: Month 6

    Number of Doses Received

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 31, 2022
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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