Phase 4
N=1,051
Project 2VIDA! COVID-19 Vaccine Intervention Delivery for Adults in Southern California
Vaccine Refusal · Covid19
Bottom Line
View on ClinicalTrials.gov: NCT05022472 ↗Enrolled (actual)
1,051
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Change in Vaccine Hesitancy — 282; 387; 57; 48 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- COVID-19 Individual Awareness and Education. (Behavioral); COVID-19 Community Outreach & Health Promotion. (Behavioral); COVID-19 Individual Health Education & Linkages to Medical and Supportive Services. (Behavioral); Pop-up community vaccination sites (Biological)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Britt Skaathun
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Vaccine Hesitancy |
282; 387; 57; 48; 0; 0 | — |
| SECONDARY Change in Health Literacy |
258; 323; 81; 112; 265; 337 | — |
| SECONDARY Change in COVID-19 Risk Perception (Probability and Severity) |
160; 222; 179; 213; 0; 0 | — |
| SECONDARY Change in Preparedness and Perceived Self-efficacy |
161; 238; 178; 197; 0; 0 | — |
| SECONDARY Access to Health Care and Utilization |
126; 339; 80; 42; 120; 47 | — |
| SECONDARY Health History |
161; 320; 149; 97; 29; 18 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT05022472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.