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Completed

NCT Number: NCT05022472

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

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).

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Key information

Conditions

Vaccine Refusal Behavior COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Health Behavior Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Treatment Adherence and Compliance Treatment Refusal Vaccination Refusal Virus Diseases

Age range

16 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

San Ysidro Health Chula Vista, Chula Vista, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COVID-19 Individual Awareness and Education.

Behavioral

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.

COVID-19 Community Outreach & Health Promotion.

Behavioral

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.

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

Behavioral

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.

Pop-up community vaccination sites

Biological

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.

Primary outcomes

  1. Change in Vaccine Hesitancy

    Time frame: Baseline (current), and follow-up (4-weeks)

    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."

Secondary outcomes

  1. Change in Health Literacy

    Time frame: Baseline and follow-up (4-weeks)

    Assessment of ease/difficulty in finding information on symptoms, finding out what to do if infected, understand what authorities say, judge reliability of information, follow recommendations, decide on prevention behaviors. (Adapted from the WHO COVID-19 Survey Tool and Guidance).

  2. Change in COVID-19 Risk Perception (Probability and Severity)

    Time frame: Baseline and follow-up (4-weeks)

    Self-assessed probability and susceptibility to of contracting COVID-19 and self-assessed severity in case of contracting COVID-19. (Adapted from the WHO COVID-19 Survey Tool and Guidance).

  3. Change in Preparedness and Perceived Self-efficacy

    Time frame: Baseline and follow-up (4-weeks)

    Self-assessed COVID-19 self-protection and avoidance ability. (Adapted from the WHO COVID-19 Survey Tool and Guidance).

  4. Access to Health Care and Utilization

    Time frame: Baseline (current)

    Type of insurance was assessed. (Adapted from the National Health Interview Survey 2020)

  5. Health History

    Time frame: Baseline

    History of having medical conditions that could exacerbate COVID-19 infection including: type 1 and type 2 diabetes mellitus, hypertension, heart conditions (e.g., coronary artery disease), obesity (e.g., body mass index of 30kg/m2 or higher but <40km/m2), severe obesity (e.g., BMI >40 kg/m2), asthma, chronic obstructive pulmonary disease (COPD), smoking.

    "Ever told by a medical provider they had a chronic illness"

Other outcomes

  1. Affect

    Time frame: Baseline and follow-up (4-weeks)

    Affect related to COVID-19 including: close, spreading, constant, fear-inducing, media hyped, helpless, stressful, etc. (Adapted from the WHO COVID-19 Survey Tool and Guidance).

    From "Close to me" (0) to "Far away from me" (7) From "Spreading slowly" (0) to "Spreading fast" (7) From "Something I think about all the time" (0) to "Something I almost never think about" (7) From "Fear-inducing" (0) to "Not fear-inducing" (7) From "Media hyped" (0) "Not media hyped" (7) From "Something that makes me feel helpless" (0) to "Something I am able to combat with my own action" (7) From "Stressful" (0) to "Not stressful" (7)

    "Please drag and drop the slider to the statements below that best represents how you feel. There are no right or wrong answers. COVID-19 to me feels:"

  2. Use of Sources of Information

    Time frame: Baseline and follow-up (4-weeks)

    Use of information sources including television, newspaper, health workers, social media, radio, health department, Centers for Disease Control and Prevention (CDC), hotlines, official websites, and celebrities. (Adapted from the WHO COVID-19 Survey Tool and Guidance).

    "How often do you use the following sources for information about COVID-19?"

  3. Trust in Sources of Information

    Time frame: Baseline and follow-up (4-weeks)

    Trust in information sources including television, newspaper, health workers, social media, radio, health department, CDC, hotlines, official websites, and celebrities. (Adapted from the WHO COVID-19 Survey Tool and Guidance).

    "How much do you trust information about COVID-19 from the following sources?"

  4. Frequency of Information

    Time frame: Baseline and follow-up (4-weeks)

    Frequency in information. (Adapted from the WHO COVID-19 Survey Tool and Guidance).

Sponsors and collaborators

Lead sponsor

Britt Skaathun

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)
  • San Ysidro Health Center

Registry information

Official study title

Project 2VIDA! SARS-CoV-2 Vaccine Intervention Delivery for Adults in Southern California

Acronym: 2VIDA!

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 26, 2021
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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