Multilevel Vaccine Intervention for COVID-19
(2VIDA! Trial)

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen byArgentina E Servin, MD,MPH

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Argentina Servin, MD, MPH

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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).

Research Team

Argentina E Servin, MD,MPH

Principal Investigator

UC San Diego

Eligibility Criteria

The trial is for Latino and African American adults over 18 years old living in specific communities of Southern California. Participants must not have immune diseases, severe allergies to vaccine components, or be pregnant. They should be able to consent and provide contact information.

Inclusion Criteria

No history of immune disease

I am 16 years old or older.

I identify as either male or female.

See 8 more

Exclusion Criteria

I am unable to give consent by myself.

I am younger than 16 years old.

Pregnant women

Treatment Details

Interventions

2VIDA! COVID-19 Vaccine Intervention Delivery (Vaccine)
COVID-19 Community Outreach & Health Promotion (Behavioral Intervention)
COVID-19 Individual Awareness and Education (Behavioral Intervention)
COVID-19 Individual Health Education & Linkages to Medical and Supportive Services (Behavioral Intervention)
Pop-up community vaccination sites (Procedure)

Trial OverviewProject 2VIDA! tests a multilevel approach to increase COVID-19 vaccine uptake among minorities by providing education, community outreach, health services linkages, and pop-up vaccination sites in areas heavily impacted by the pandemic.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment4 Interventions

We will use a 2-armed randomized controlled trial (RCT) where Latino and AA adults \>18 years or older from six participating communities and surrounding community health centers (CHC) will be assigned to the 2 VIDA! intervention (n=3 CHC; N=500 participants) or to the control site (e.g., standard of care) (n=3 CHC; N=500 participants). The two major components of the 2VIDA! intervention are: COVID-19 Individual Awareness and Education, COVID-19 Community Outreach and Health Promotion, COVID-19 Individual Health Education and Linkages to Medical and Supportive Services, and pop-up vaccination stations in Latino and AA communities.

Group II: Standard of careActive Control1 Intervention

The standard of care for vaccine delivery at the control sites. This includes individuals who make an appointment on their own or receive the vaccine at a health center and may receive information about the vaccine from their primary healthcare provider.