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COVID-19 Testing and Vaccination Among Spanish Speakers

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status

Completed

Conditions

COVID-19
Vaccinations

Treatments

Behavioral: NuestraSaludSegura

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05302908
5U01MD017431 (U.S. NIH Grant/Contract)
IRB00079510

Details and patient eligibility

About

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.

Full 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.

Enrollment

274 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

274 participants in 2 patient groups

NuestraSaludSegura intervention
Experimental group
Description:
Intervention-group Navegantes will be trained and supported for 6 months of implementation in Years 1-2
Treatment:
Behavioral: NuestraSaludSegura
delayed NuestraSaludSegura intervention
Experimental group
Description:
delayed-intervention group Navegantes will be trained in Year 2
Treatment:
Behavioral: NuestraSaludSegura

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Lisa L Lewis; Scott D Rhodes, PhD

Data sourced from clinicaltrials.gov

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