Clinical trial NCT05302908: 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
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Vaccinations
Keywords: COVID-19
Vaccinations
Spanish-speaking
Latinx
Hispanic/Latino populations
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-03-31
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of COVID-19 testing
timeFrame: Baseline
measure: Number of vaccinations - Pfizer
timeFrame: Baseline
measure: Number of vaccinations - Moderna
timeFrame: Baseline
measure: Number of vaccinations - Johnson and Johnson
timeFrame: Baseline
measure: Doses of vaccine received - Pfizer
timeFrame: Baseline
measure: Doses of vaccine received - Moderna
timeFrame: Baseline
measure: Doses of vaccine received - Johnson and Johnson
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Scott D Rhodes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.