Vaccine RefusalPhase 42VIDA!NCT05022472
Project 2VIDA! COVID-19 Vaccine Intervention Delivery for Adults in Southern California
A Phase 4 study testing COVID-19 Individual Awareness and Education., COVID-19 Community Outreach & Health Promotion. and COVID-19 Individual Health Education & Linkages to Medical and Supportive Services. in people with Vaccine Refusal and Covid19, run by Britt Skaathun at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 16 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine Refusal, Covid19
- What is being tested?
- COVID-19 Individual Awareness and Education., COVID-19 Community Outreach & Health Promotion. and COVID-19 Individual Health Education & Linkages to Medical and Supportive Services.
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,051 participants
- Where
- 6 sitesUnited States
- Study dates
- 16 Jul 2021to 29 Mar 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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)
Who cannot join
- under 16 years old
- pregnant women
- individuals unable to consent
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
San Ysidro Health Chula Vista
Chula Vista, California, 91910
Care View Health Center
San Diego, California, 92114
San Ysidro Health Care View Health Center
San Diego, California, 92114
San Ysidro Health Euclid
San Diego, California, 92114
San Ysidro Health King-Chavez Health Center
San Diego, California, 92114
San Ysidro Health
San Ysidro, California, 92173
About this study
Official title: Project 2VIDA! SARS-CoV-2 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).
Read the 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.
- Conditions
- Vaccine Refusal, Covid19
- Being tested
- COVID-19 Individual Awareness and Education., COVID-19 Community Outreach & Health Promotion., COVID-19 Individual Health Education & Linkages to Medical and Supportive Services., Pop-up community vaccination sites
- Keywords
- Latinx, African American, COVID-19, Community-based participatory research
- Medical subject headings
- Vaccination Refusal, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 Individual Awareness and Education.Behavioural
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.Behavioural
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.Behavioural
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 sitesBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: 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 |
| Standard of care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: Baseline (current), and follow-up (4-weeks)
Secondary outcomes (5)
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).
Measured: Baseline and follow-up (4-weeks)
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).
Measured: Baseline and follow-up (4-weeks)
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).
Measured: Baseline and follow-up (4-weeks)
Access to Health Care and Utilization
Type of insurance was assessed. (Adapted from the National Health Interview Survey 2020)
Measured: Baseline (current)
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.
"Ever told by a medical provider they had a chronic illness"
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start16 Jul 2021
- Primary completion29 Mar 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vaccine RefusalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,051 participants (actual)
Sponsor and investigators
- Lead sponsor
- Britt Skaathun
- Sponsor type
- University, hospital or other
- Collaborators
- San Ysidro Health Center, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor-investigator, Britt Skaathun, University of California, San Diego
- Investigators
- Argentina E Servin, MD,MPH, Principal investigator, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022472
- Sponsor's protocol ID
- 210630S
- Other IDs
- 1R01MD016872-01
- Acronym
- 2VIDA!
- Status last verified
- May 2025
- First submitted
- 18 Aug 2021
- Last updated
- 6 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Skaathun B, I Rodriguez-Rosales C, Gahbler-Lopez G, R Furtwengler S, Salgin L, A Munoz F, M Smith D, K Stockman J, O'Bryan SE, Ramirez D, James-Price C, E Servin A. Vaccine hesitancy and economic hardship: A latent class analysis of racial and ethnic minority communities at high risk of COVID-19 infection in Southern California. Hum Vaccin Immunother. 2025 Dec;21(1):2529612. doi: 10.1080/21645515.2025.2529612. Epub 2025 Jul 10.
PubMed 40637161Skaathun B, Salgin L, Munoz FA, Talavera GA, Smith DM, Stockman JK, O'Bryan SE, Ramirez D, James-Price C, Servin AE. Study protocol: Project 2VIDA! SARS-CoV-2 vaccine intervention delivery for adults in Southern California. Front Public Health. 2024 Mar 14;12:1291332. doi: 10.3389/fpubh.2024.1291332. eCollection 2024.
PubMed 38550328
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project 2VIDA! SARS-CoV-2 Vaccine Intervention Delivery for Adults in Southern California
- ClinicalTrials.gov ID
- NCT05022472
- Acronym / sponsor ID
- 2VIDA! / 210630S
- Conditions
- Vaccine Refusal, Covid19
- Keywords
- Latinx, African American, COVID-19, Community-based participatory research
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,051 participants (actual)
- Lead sponsor
- Britt SkaathunUniversity, hospital or other
- Collaborators
- San Ysidro Health Center, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 26 Aug 2021 (actual)
- Results
- Posted 6 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | 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 sitesWe 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. |
| Standard of care | No intervention | –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. |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (3 listed)
- under 16 years old
- pregnant women
- individuals unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention |
| 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. | Behavioural | Intervention |
| 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. | Behavioural | Intervention |
| Pop-up community vaccination sitesWe 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. | Biological | Intervention |
Primary outcome
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."
5 secondary outcomes
Change in Health Literacy
Time frame: Baseline and follow-up (4-weeks)
Change in COVID-19 Risk Perception (Probability and Severity)
Time frame: Baseline and follow-up (4-weeks)
Change in Preparedness and Perceived Self-efficacy
Time frame: Baseline and follow-up (4-weeks)
Access to Health Care and Utilization
Time frame: Baseline (current)
Health History
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40637161Skaathun B, I Rodriguez-Rosales C, Gahbler-Lopez G, R Furtwengler S, Salgin L, A Munoz F, M Smith D, K Stockman J, O'Bryan SE, Ramirez D, James-Price C, E Servin A. Vaccine hesitancy and economic hardship: A latent class analysis of racial and ethnic minority communities at high risk of COVID-19 infection in Southern California. Hum Vaccin Immunother. 2025 Dec;21(1):2529612. doi: 10.1080/21645515.2025.2529612. Epub 2025 Jul 10.
- Derived from this study: PubMed 38550328Skaathun B, Salgin L, Munoz FA, Talavera GA, Smith DM, Stockman JK, O'Bryan SE, Ramirez D, James-Price C, Servin AE. Study protocol: Project 2VIDA! SARS-CoV-2 vaccine intervention delivery for adults in Southern California. Front Public Health. 2024 Mar 14;12:1291332. doi: 10.3389/fpubh.2024.1291332. eCollection 2024.
Related trials for Vaccine Refusal
Active, not recruiting
Conversational AI for Adult Flu Vaccination Decisions
Influenza, Human, Vaccine Hesitancy
Recruiting
Intrahospital Influenza Vaccination in Patients at High Cardiovascular Risk (VACC-UP)
Acute Coronary Syndrome, Heart Failure
Not yet recruiting
Development and Evaluation of a Digital Educational Intervention to Improve Vaccine Confidence and Communication Among Registered Nurses: Protocol for a Randomized Controlled Trial (VaxNurse-RCT).
Vaccine Hesitancy, Vaccine Acceptance
Active, not recruiting
Communication Strategies to Increase HPV Vaccinations
Papilloma Viral Infection, Vaccine Hesitancy
Not yet recruiting
Parents' Knowledge and Attitudes Towards Vaccinating Their Children
Vaccine Hesitancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Argentina E Servin, MD,MPH principal investigator
UC San Diego
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing COVID-19 Individual Awareness and Education., COVID-19 Community Outreach & Health Promotion. and COVID-19 Individual Health Education & Linkages to Medical and Supportive Services. in people with Vaccine Refusal and Covid19, run by Britt Skaathun at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vaccine Hesitancy (time frame: Baseline (current), and follow-up (4-weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05022472, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.