COVID-19 Testing and Vaccination Among Spanish Speakers

NCT ID: NCT05302908

Last Updated: 2026-01-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

274 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-09

Study Completion Date

2024-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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COVID-19 Vaccinations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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NuestraSaludSegura intervention

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

Group Type EXPERIMENTAL

NuestraSaludSegura

Intervention Type BEHAVIORAL

It blends peer navigation and mHealth

delayed NuestraSaludSegura intervention

delayed-intervention group Navegantes will be trained in Year 2

Group Type EXPERIMENTAL

NuestraSaludSegura

Intervention Type BEHAVIORAL

It blends peer navigation and mHealth

Interventions

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NuestraSaludSegura

It blends peer navigation and mHealth

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott D Rhodes, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

References

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Rhodes SD, Tanner AE, Mann-Jackson L, Alonzo J, Hall MA, Bertoni AG, McCoy TP, Aguilar-Palma SK, Garcia M, Miranda D, Turner MJ. Increasing COVID-19 testing and vaccination among Spanish speakers in the USA: protocol for the development and evaluation of the Nuestra Comunidad Saludable intervention using a group-randomised trial design. BMJ Open. 2022 Nov 16;12(11):e066585. doi: 10.1136/bmjopen-2022-066585.

Reference Type DERIVED
PMID: 36385019 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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5U01MD017431

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00079510

Identifier Type: -

Identifier Source: org_study_id

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