Project 2VIDA! COVID-19 Vaccine Intervention Delivery for Adults in Southern California

NCT05022472 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1051

Last updated 2025-06-06

Study results available
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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).

Conditions

  • Vaccine Refusal
  • Covid19

Interventions

BEHAVIORAL

COVID-19 Individual Awareness and Education.

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.

BEHAVIORAL

COVID-19 Community Outreach & Health Promotion.

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.

BEHAVIORAL

COVID-19 Individual Health Education & Linkages to Medical and Supportive Services.

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.

BIOLOGICAL

Pop-up community vaccination sites

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.

Sponsors & Collaborators

  • San Ysidro Health Center

    collaborator OTHER
  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH
  • Britt Skaathun

    lead OTHER

Principal Investigators

  • Argentina E Servin, MD,MPH · UC San Diego

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-16
Primary Completion
2024-03-29
Completion
2024-03-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05022472 on ClinicalTrials.gov