COVID-19 Testing and Vaccination Among Spanish Speakers

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05302908
• Other study ID #: IRB00079510
• Secondary ID: 5U01MD017431
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2023
• Est. completion date: July 2024

Study information

• Verified date: January 2024
• Source: Wake Forest University Health Sciences
• Contact: Lisa L Lewis
• Phone: 336.713.5074
• Email: Lisa.Lynn.Lewis[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Vaccinations

Intervention

Behavioral:
• NuestraSaludSegura
It blends peer navigation and mHealth

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of COVID-19 testing	measured through self-report	Baseline
Primary	Number of vaccinations - Pfizer	measured through self-report	Baseline
Primary	Number of vaccinations - Moderna	measured through self-report	Baseline
Primary	Number of vaccinations - Johnson and Johnson	measured through self-report	Baseline
Primary	Doses of vaccine received - Pfizer	measured through self-report	Baseline
Primary	Doses of vaccine received - Moderna	measured through self-report	Baseline
Primary	Doses of vaccine received - Johnson and Johnson	measured through self-report	Baseline