Project 2VIDA! COVID-19 Vaccine Intervention Delivery for Adults in Southern California
2VIDA!
Project 2VIDA! SARS-CoV-2 Vaccine Intervention Delivery for Adults in Southern California
2 other identifiers
interventional
1,051
1 country
6
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2021
Typical duration for phase_4
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 16, 2021
CompletedFirst Submitted
Initial submission to the registry
August 18, 2021
CompletedFirst Posted
Study publicly available on registry
August 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2024
CompletedResults Posted
Study results publicly available
June 6, 2025
CompletedJune 6, 2025
May 1, 2025
2.7 years
August 18, 2021
April 14, 2025
May 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Vaccine Hesitancy
Based on the definition of the Strategic Advisory Group of Experts (SAGE) Working Group on Vaccine Hesitancy (WG), hesitancy refers to "delay in acceptance or refusal of vaccination despite availability of vaccination services. Vaccine hesitancy is complex and context specific, varying across time, place and vaccines. It is influenced by factors such as complacency, convenience and confidence."
Baseline (current), and follow-up (4-weeks)
Secondary Outcomes (5)
Change in Health Literacy
Baseline and follow-up (4-weeks)
Change in COVID-19 Risk Perception (Probability and Severity)
Baseline and follow-up (4-weeks)
Change in Preparedness and Perceived Self-efficacy
Baseline and follow-up (4-weeks)
Access to Health Care and Utilization
Baseline (current)
Health History
Baseline
Other Outcomes (4)
Affect
Baseline and follow-up (4-weeks)
Use of Sources of Information
Baseline and follow-up (4-weeks)
Trust in Sources of Information
Baseline and follow-up (4-weeks)
- +1 more other outcomes
Study Arms (2)
Intervention
EXPERIMENTALWe 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.
Standard of care
NO INTERVENTIONThe 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.
Interventions
The 2VIDA! working group has developed culturally competent COVID-19 educational and outreach materials (available printed and electronically) in English and Spanish that are written at the 8th grade level (the average reading level of adults in the United States) that peer-health educators will distributed to community members during their visits to the participating SYH community centers, door-to-door, local supermarkets, and CBO's in the selected communities. These materials have general information on COVID-19 as well as educational information and resources regarding COVID-19 prevention, symptoms, testing, contact tracing, COVID-19 vaccine (how it works, technology used, administration \[2-dose series and importance of vaccine completion\]), safety concerns, benefits, dispelling common misconceptions and misinformation, and other topics identified based on community needs. This information will be updated monthly to ensure the most up to date information.
Peer-health educators will work with local CBO's and facilitate a combination of live broadcast sessions, pre-recorded webinars, social media posts, and other outreach activities in English and Spanish reaching community members with information on the above COVID-19 related topics as well as other identified needs such as what to do if a family member is infected and where you can get the COVID-19 vaccine. The goal is to reach 10,000 viewers (per session) in the various social media platforms in the three randomly selected communities.
SYHealth will establish a COVID-19 Resource Center within the participating health centers in the three randomly selected communities (intervention sites only) providing individual COVID-19 related health education and linkages to medical and supportive services for patients and community members in need of additional education and support regarding COVID-19 disease and COVID-19 vaccine.
We will offer the COVID-19 vaccine at the participating SYHealth community health centers and pop-up vaccination stations that will be set-up in these communities (intervention sites) as part of the interventions efforts to increase access and uptake of the COVID-19 vaccine. We have identified various open spaces (e.g., public parks) in these communities to set-up the vaccination stations. Additionally, data will be collected to assess individual, social, and contextual factors related to access, acceptance, and uptake of the COVID-19 vaccine.The survey will last approximately 10-15 minutes and will be self-administered in both English and Spanish. Following the survey participants will be offered the COVID-19 vaccine and will be made an automatic appointment for the 2nd dose (4-week follow-up) and will be asked to complete a 5 min survey during the follow-up visit.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- under 16 years old
- pregnant women
- individuals unable to consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Britt Skaathunlead
- San Ysidro Health Centercollaborator
- National Institute on Minority Health and Health Disparities (NIMHD)collaborator
Study Sites (6)
San Ysidro Health Chula Vista
Chula Vista, California, 91910, United States
Care View Health Center
San Diego, California, 92114, United States
San Ysidro Health Care View Health Center
San Diego, California, 92114, United States
San Ysidro Health Euclid
San Diego, California, 92114, United States
San Ysidro Health King-Chavez Health Center
San Diego, California, 92114, United States
San Ysidro Health
San Ysidro, California, 92173, United States
Related Publications (1)
Skaathun B, Salgin L, Munoz FA, Talavera GA, Smith DM, Stockman JK, O'Bryan SE, Ramirez D, James-Price C, Servin AE. Study protocol: Project 2VIDA! SARS-CoV-2 vaccine intervention delivery for adults in Southern California. Front Public Health. 2024 Mar 14;12:1291332. doi: 10.3389/fpubh.2024.1291332. eCollection 2024.
PMID: 38550328DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Britt Skaathun
- Organization
- UCSD
Study Officials
- PRINCIPAL INVESTIGATOR
Argentina E Servin, MD,MPH
UC San Diego
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 18, 2021
First Posted
August 26, 2021
Study Start
July 16, 2021
Primary Completion
March 29, 2024
Study Completion
March 29, 2024
Last Updated
June 6, 2025
Results First Posted
June 6, 2025
Record last verified: 2025-05