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

• ClinicalTrials.gov Identifier: NCT05022472
• Recruitment Status: Recruiting
• First Posted: August 26, 2021
• Last Update Posted: December 16, 2021
• Sponsor: Argentina Servin, MD, MPH
• Collaborators: San Ysidro Health Center; National Institute on Minority Health and Health Disparities (NIMHD)
• Information provided by (Responsible Party): Argentina Servin, MD, MPH, University of California, San Diego

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Vaccine Refusal; Covid19	Behavioral: 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.; Biological: Pop-up community vaccination sites	Phase 4

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official Title: Project 2VIDA! SARS-CoV-2 Vaccine Intervention Delivery for Adults in Southern California
• Actual Study Start Date: July 16, 2021
• Estimated Primary Completion Date: December 31, 2022
• Estimated Study Completion Date: January 31, 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention; 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.	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.
No Intervention: Standard of care; 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.

Outcome Measures

Primary Outcome Measures :

1. Change in COVID-19 Vaccine acceptance [ Time Frame: Past 12 months, baseline (current) and follow-up (4-weeks). ]
   Agreement with value statements of the vaccine (control COVID-19, help avoid restrictions, never accept it, should be mandatory). Indication of own barriers/drivers to getting the vaccine such as production country, recommendations, many vaccinated, free of charge, ease of access, COVID-19 risk, need if others are vaccinated.(Adapted from the World Health Organization [WHO] COVID-19 Survey Tool and Guidance).
2. Change in Vaccine Hesitancy [ Time Frame: Past 12 months, 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 Outcome Measures :

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. Change in Prevention (own behaviors) [ Time Frame: Baseline and follow-up (4-weeks) ]
   Prevention measures including: hand washing, avoiding touching face, disinfectants, home when sick, physical distancing, face mask, antibiotics, not seeing family, friends. (Adapted from the WHO COVID-19 Survey Tool and Guidance).
5. Testing and tracing [ Time Frame: Past 12 months, baseline (current), follow-up (4-weeks) ]
   Barriers and drivers to getting tested and sharing names for tracing. (Adapted from the WHO COVID-19 Survey Tool and Guidance).
6. Access to health care and utilization [ Time Frame: Past 12 months and baseline (current) ]
   5 items will be assessed: Insurance status, type of insurance, regularity and location of access to health care, receipt of services from government or community agencies. (Adapted from the National Health Interview Survey 2020)
7. 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.

Other Outcome Measures:

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).
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).
3. Policies and interventions (perceptions) [ Time Frame: Past 12 months, baseline (current), follow-up (4-weeks) ]
   Perceptions related to possible/real government policies including: COVID-19 vaccine, discrimination behaviors, testing, restrictions, quarantine, etc. (Adapted from the WHO COVID-19 Survey Tool and Guidance).
4. 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).
5. Frequency of information [ Time Frame: Baseline and follow-up (4-weeks) ]
   Frequency in information. (Adapted from the WHO COVID-19 Survey Tool and Guidance).
6. Perceptions of government responses to COVID-19 pandemic [ Time Frame: Past 12 months and baseline (current) ]
   We used the COVID-SCORE-10 scale that includes ten items and each item assesses public perceptions of a key responsibility of government during the pandemic. Responses to each item ranged from "completely disagree" for a minimum score of 1 to "completely agree" for a maximum score of 5. (Adapted from the COVID-SCORE study).
7. Trust in institutions (perceptions) [ Time Frame: Baseline and follow-up (4-weeks) ]
   Trust in ability of stakeholders to handle situations including doctor, employer, hospitals, health department, CDC, etc. (Adapted from the WHO COVID-19 Survey Tool and Guidance).
8. Conspiracies (perceptions) [ Time Frame: Past 12 months, baseline (current), follow-up (4-weeks) ]
   Perceptions related to transparency, motivations, monitoring, secrets, hidden organizations. (Adapted from the WHO COVID-19 Survey Tool and Guidance).
9. Resilience (perceptions) [ Time Frame: Baseline and follow-up (4-weeks) ]
   Perceptions related to coping with stress and recovering. Ease/difficulty in not seeing family and friends. (Adapted from the WHO COVID-19 Survey Tool and Guidance).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• age 18 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 18 years old
• pregnant women
• adults unable to consent

Contacts and Locations

Contacts

Contact: Argentina E Servin, MD,MPH; 6195767211; arservin@ucsd.edu

Locations

United States, California

San Ysidro Health Chula Vista; Recruiting

Chula Vista, California, United States, 91910

Contact: Fatima Muñoz, MD,MPH 619-662-4100 fatima.munoz@syhealth.org

Contact: Daniel Ramirez 6196224100 ext 3739 daniel.ramirez@syhealth.org

Care View Health Center; Recruiting

San Diego, California, United States, 92114

Contact: Fatima A Muñoz, MD,MPH 619-622-4100 fatima.munoz@syhealth.org

Contact: Daniel Ramirez 6196224100 ext 3739 daniel.ramirez@syhealth.org

San Ysidro Health Care View Health Center; Recruiting

San Diego, California, United States, 92114

Contact: Fatima A Muñoz, MD,MPH 619-662-4100 fatima.munoz@syhealth.org

Contact: Daniel Ramirez 6196624100 ext 3739 daniel.ramirez@syhealth.org

San Ysidro Health Euclid; Recruiting

San Diego, California, United States, 92114

Contact: Fatima Muñoz, MD,MPH 619-622-4100 fatima.munoz@syhealth.org

Contact: Daniel Ramirez 6196224100 ext 3739 daniel.ramirez@syhealth.org

San Ysidro Health King-Chavez Health Center; Recruiting

San Diego, California, United States, 92114

Contact: Fatima A Muñoz, MD,MPH 619-662-4100 fatima.munoz@syhealth.org

Contact: Daniel Ramirez 6196624100 ext 3739 daniel.ramirez@syhealth.org

San Ysidro Health; Recruiting

San Ysidro, California, United States, 92173

Contact: Fatima A Muñoz, MD,MPH 619-662-4100 fatima.munoz@syhealth.org

Contact: Daniel Ramirez 6196624100 ext 3739 daniel.ramirez@syhealth.org

Principal Investigator: Fatima A Muñoz, MD,MPH

Sponsors and Collaborators

Argentina Servin, MD, MPH

San Ysidro Health Center

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

• Principal Investigator: Argentina E Servin, MD,MPH; UC San Diego

More Information

• Responsible Party: Argentina Servin, MD, MPH, Asst Prof, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT05022472
• Other Study ID Numbers: 210630S; 1R01MD016872-01 ( U.S. NIH Grant/Contract )
• First Posted: August 26, 2021
• Last Update Posted: December 16, 2021
• Last Verified: December 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Argentina Servin, MD, MPH, University of California, San Diego:

Latinx; African American; COVID-19; Community-based participatory research

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases