Clinical trial NCT05022472: Project 2VIDA! COVID-19 Vaccine Intervention Delivery for Adults in Southern California
Official title: Project 2VIDA! SARS-CoV-2 Vaccine Intervention Delivery for Adults in Southern California
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vaccine Refusal
Covid19
Keywords: Latinx
African American
COVID-19
Community-based participatory research
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: San Ysidro Health Center
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2021-08-26
Enrollment: 1051
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The United States (U.S.) is the country with the largest number of infections and deaths due to COVID- 19 and racial/ethnic minorities are disproportionately affected. Acceptance and uptake of COVID-19 vaccines will be instrumental to ending the pandemic. To this end, 2VIDA! (SARS-CoV-2 Vaccine Intervention Delivery for Adults in Southern California) is a multilevel intervention to address individual, social, and contextual factors related to access to, and acceptance of, the COVID-19 vaccine by implementing and assessing a COVID-19 vaccination protocol among Latino and African American (AA) adults (\>18 years old) in San Diego. 2VIDA! builds on our previous CBPR efforts and centers on conducting COVID-19 Individual awareness and education, linkages to medical and supportive services, and Community Outreach and Health Promotion in the intervention sites (Phase 1); and offering the COVID-19 vaccine to Latino and AA adults (\>18 years old) in federally-qualified health centers and pop-up vaccination stations in communities highly impacted by the pandemic and identifying individual and structural barriers to COVID-19 immunization (Phase 2).

Detailed description: As of January 2021, the World Health Organization (WHO) reports that 89 million cases of COVID-19 (SARS- CoV-2) have been confirmed and have resulted in more than 1.9 million deaths globally. Currently, the United States (U.S.) is the country with the largest number of infections and deaths due to COVID-19, with a total of 22 million infections and 373,167 deaths. Furthermore, early findings that have examined COVID-19 demographics show that racial and ethnic minorities in the U.S. are bearing a disproportionate number of COVID-19 cases and deaths irrespective of geographic region. While there's no evidence that people of color (POC) have genetic or biological factors that make them more likely to be affected by COVID-19, they are more likely to have underlying health conditions, live in multi-generational homes, live in densely populated areas, have limited access to healthcare, and have jobs that are considered essential and involve interaction with the public. All of these factors contribute to higher rates of infection and adverse outcomes due to COVID-19. Although COVID-19 preventive behaviors such as hand washing, mask wearing, and social distancing have been shown to be effective in curbing the spread of the virus, acceptance and uptake of COVID-19 vaccines will be instrumental to ending the pandemic. However, public confidence in vaccination is fragile, especially among racial and ethnic minorities. To this end, we have formed an intervention working group comprised of representatives from community and academic organizations to address challenges in COVID-19 vaccination uptake among Latino and African American (AA) communities in Southern California by using a community-based participatory research (CBPR) approach. Project 2VIDA! (SARS-CoV-2 Vaccine Intervention Delivery for Adults in Southern California), is a multilevel intervention to address individual, social, and contextual factors related to access to, and acceptance of, the COVID-19 vaccine among Latino and AA adults (\>18 years old) across six highly affected communities in Southeast San Diego. 2VIDA! seeks to implement and assess a COVID-19 vaccination protocol to increase interest and uptake of COVID-19 vaccine, provide COVID-19 vaccines in the community, and establish a model for the rapid vaccination of Latino and AA adults that could be generalizable to other highly affected communities. 2VIDA! builds on our previous CBPR efforts and centers on conducting COVID-19 community outreach and health promotion, Individual awareness and education, and linkages to medical and supportive services and offering the COVID-19 vaccine to Latino and AA adults (\>18 years old) in community health centers (CHC) and mini-vaccination stations in communities highly impacted by the pandemic in San Diego County.

Eligibility criteria: Inclusion Criteria:

* age 16 years or older
* identify as Latinx and/or AA
* biologically male or female
* be a resident of one of the six communities selected for this study (National City, Lincoln Park, Logan Heights, Valencia Park, Chula Vista or San Ysidro)
* literate in English or Spanish
* no known history of severe allergic reactions to any components of the vaccine
* no history of immune disease
* not be pregnant
* no plans to move from the area in the following 30 days
* able to provide voluntary informed consent
* able to provide complete contact information for themselves and two additional contact individuals (for follow-up 2nd vaccine shot)

Exclusion Criteria:

* under 16 years old
* pregnant women
* individuals unable to consent

Primary outcomes:
measure: Change in Vaccine Hesitancy
timeFrame: Baseline (current), and follow-up (4-weeks)
Secondary outcomes:
measure: Change in Health Literacy
timeFrame: Baseline and follow-up (4-weeks)
measure: Change in COVID-19 Risk Perception (Probability and Severity)
timeFrame: Baseline and follow-up (4-weeks)
measure: Change in Preparedness and Perceived Self-efficacy
timeFrame: Baseline and follow-up (4-weeks)
measure: Access to Health Care and Utilization
timeFrame: Baseline (current)
measure: Health History
timeFrame: Baseline
Other outcomes:
measure: Affect
timeFrame: Baseline and follow-up (4-weeks)
measure: Use of Sources of Information
timeFrame: Baseline and follow-up (4-weeks)
measure: Trust in Sources of Information
timeFrame: Baseline and follow-up (4-weeks)
measure: Frequency of Information
timeFrame: Baseline and follow-up (4-weeks)
Locations:
city: Chula Vista
country: United States
facility: San Ysidro Health Chula Vista
state: California
city: San Diego
country: United States
facility: Care View Health Center
state: California
city: San Diego
country: United States
facility: San Ysidro Health Care View Health Center
state: California
city: San Diego
country: United States
facility: San Ysidro Health Euclid
state: California
city: San Diego
country: United States
facility: San Ysidro Health King-Chavez Health Center
state: California
city: San Ysidro
country: United States
facility: San Ysidro Health
state: California
Study officials:
affiliation: UC San Diego
name: Argentina E Servin, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References: