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

Covid19 Clinical Trial

— 2VIDA!  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05022472
• Other study ID #: 210630S
• Secondary ID: 1R01MD016872-01
• Status: Completed
• Phase: Phase 4
• Start date: July 16, 2021
• Est. completion date: March 29, 2024

Study information

• Verified date: May 2024
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 1054
• Est. completion date: March 29, 2024
• Est. primary completion date: March 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Vaccine Refusal

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	San Ysidro Health Chula Vista	Chula Vista	California
United States	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 King-Chavez Health Center	San Diego	California
United States	San Ysidro Health	San Ysidro	California

Sponsors (3)

Lead Sponsor	Collaborator
Argentina Servin, MD, MPH	National Institute on Minority Health and Health Disparities (NIMHD), San Ysidro Health Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Affect	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).	Baseline and follow-up (4-weeks)
Other	Use of sources of information	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).	Baseline and follow-up (4-weeks)
Other	Policies and interventions (perceptions)	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).	Past 12 months, baseline (current), follow-up (4-weeks)
Other	Trust in sources of information	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).	Baseline and follow-up (4-weeks)
Other	Frequency of information	Frequency in information. (Adapted from the WHO COVID-19 Survey Tool and Guidance).	Baseline and follow-up (4-weeks)
Other	Perceptions of government responses to COVID-19 pandemic	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).	Past 12 months and baseline (current)
Other	Trust in institutions (perceptions)	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).	Baseline and follow-up (4-weeks)
Other	Conspiracies (perceptions)	Perceptions related to transparency, motivations, monitoring, secrets, hidden organizations. (Adapted from the WHO COVID-19 Survey Tool and Guidance).	Past 12 months, baseline (current), follow-up (4-weeks)
Other	Resilience (perceptions)	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).	Baseline and follow-up (4-weeks)
Primary	Change in COVID-19 Vaccine acceptance	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).	Past 12 months, baseline (current) and follow-up (4-weeks).
Primary	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."	Past 12 months, baseline (current), and follow-up (4-weeks)
Secondary	Change in Health literacy	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).	Baseline and follow-up (4-weeks)
Secondary	Change in COVID-19 risk perception (probability and severity)	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).	Baseline and follow-up (4-weeks)
Secondary	Change in Preparedness and Perceived self-efficacy	Self-assessed COVID-19 self-protection and avoidance ability. (Adapted from the WHO COVID-19 Survey Tool and Guidance).	Baseline and follow-up (4-weeks)
Secondary	Change in Prevention (own behaviors)	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).	Baseline and follow-up (4-weeks)
Secondary	Testing and tracing	Barriers and drivers to getting tested and sharing names for tracing. (Adapted from the WHO COVID-19 Survey Tool and Guidance).	Past 12 months, baseline (current), follow-up (4-weeks)
Secondary	Access to health care and utilization	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)	Past 12 months and baseline (current)
Secondary	Health History	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.	Baseline