COVID-19 Testing and Vaccination Among Spanish Speakers
Primary Purpose
COVID-19, Vaccinations
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NuestraSaludSegura
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring COVID-19, Vaccinations, Spanish-speaking, Latinx, Hispanic/Latino populations
Eligibility 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
Sites / Locations
- Wake Forest University Health SciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Spanish-speaking Latinx communities
Arm Description
Individual in-depth interviews with Spanish-speaking Latinx participants
Outcomes
Primary Outcome Measures
Number of COVID-19 testing
measured through self-report
Number of vaccinations - Pfizer
measured through self-report
Number of vaccinations - Moderna
measured through self-report
Number of vaccinations - Johnson and Johnson
measured through self-report
Doses of vaccine received - Pfizer
measured through self-report
Doses of vaccine received - Moderna
measured through self-report
Doses of vaccine received - Johnson and Johnson
measured through self-report
Secondary Outcome Measures
Full Information
NCT ID
NCT05302908
First Posted
March 29, 2022
Last Updated
March 27, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05302908
Brief Title
COVID-19 Testing and Vaccination Among Spanish Speakers
Official Title
Identifying and Addressing Critical Social, Ethical, and Behavioral Factors Associated With COVID-19 Testing and Vaccination Among Spanish Speakers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Vaccinations
Keywords
COVID-19, Vaccinations, Spanish-speaking, Latinx, Hispanic/Latino populations
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Spanish-speaking Latinx communities
Arm Type
Experimental
Arm Description
Individual in-depth interviews with Spanish-speaking Latinx participants
Intervention Type
Behavioral
Intervention Name(s)
NuestraSaludSegura
Intervention Description
It blends peer navigation and mHealth
Primary Outcome Measure Information:
Title
Number of COVID-19 testing
Description
measured through self-report
Time Frame
Baseline
Title
Number of vaccinations - Pfizer
Description
measured through self-report
Time Frame
Baseline
Title
Number of vaccinations - Moderna
Description
measured through self-report
Time Frame
Baseline
Title
Number of vaccinations - Johnson and Johnson
Description
measured through self-report
Time Frame
Baseline
Title
Doses of vaccine received - Pfizer
Description
measured through self-report
Time Frame
Baseline
Title
Doses of vaccine received - Moderna
Description
measured through self-report
Time Frame
Baseline
Title
Doses of vaccine received - Johnson and Johnson
Description
measured through self-report
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa L Lewis
Phone
336.713.5074
Email
Lisa.Lynn.Lewis@wakehealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Scott D Rhodes, PhD
Phone
336-713-5080
Email
srhodes@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott D Rhodes, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36385019
Citation
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.
Results Reference
derived
Learn more about this trial
COVID-19 Testing and Vaccination Among Spanish Speakers
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