Project 2VIDA! COVID-19 Vaccine Intervention Delivery for Adults in Southern California
- Conditions
- Vaccine RefusalCovid19
- Interventions
- 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
- Registration Number
- NCT05022472
- Lead Sponsor
- Argentina Servin, MD, MPH
- 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1054
- 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)
- under 16 years old
- pregnant women
- individuals unable to consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention COVID-19 Individual Awareness and Education. 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. Intervention COVID-19 Community Outreach & Health Promotion. 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. Intervention COVID-19 Individual Health Education & Linkages to Medical and Supportive Services. 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. Intervention Pop-up community vaccination sites 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.
- Primary Outcome Measures
Name Time Method Change in Vaccine Hesitancy 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."
Change in COVID-19 Vaccine acceptance 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).
- Secondary Outcome Measures
Name Time Method Change in Health literacy 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).
Change in COVID-19 risk perception (probability and severity) 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).
Change in Preparedness and Perceived self-efficacy 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).
Testing and tracing 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).
Change in Prevention (own behaviors) 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).
Access to health care and utilization 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)
Health History 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.
Trial Locations
- Locations (6)
Care View Health Center
🇺🇸San Diego, California, United States
San Ysidro Health Care View Health Center
🇺🇸San Diego, California, United States
San Ysidro Health Euclid
🇺🇸San Diego, California, United States
San Ysidro Health Chula Vista
🇺🇸Chula Vista, California, United States
San Ysidro Health King-Chavez Health Center
🇺🇸San Diego, California, United States
San Ysidro Health
🇺🇸San Ysidro, California, United States