Project 2VIDA! COVID-19 Vaccine Intervention Delivery for... | NCT05022472

NCT05022472

ID	Type	Description	Link
1R01MD016872-01	U.S. NIH Grant/Contract		View source

Status Module

Sponsor/Collaborators Module

Name	Class
San Ysidro Health Center	OTHER
National Institute on Minority Health and Health Disparities (NIMHD)	NIH

Oversight Module

Description Module

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 Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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."	Baseline (current), and follow-up (4-weeks)

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Measure	Description	Time Frame
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). 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:"

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Argentina E Servin, MD,MPH	UC San Diego	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
San Ysidro Health Chula Vista		Chula Vista	California	91910	United States
Care View Health Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38550328	Derived	Skaathun 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.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Intervention	We conducted a 2-armed randomized controlled trial (RCT) with 1,051 Latino and African American adults (≥18 years) from six communities and affiliated community health centers (CHCs). Participants were randomized to either the 2VIDA! intervention group (n=517; 3 CHCs) or control (standard of care; n=534; 3 CHCs). The 2VIDA! intervention included four components: (1) COVID-19 Individual Awareness and Education, (2) COVID-19 Community Outreach and Health Promotion, (3) Individual Health Education and Linkages to Services, and (4) Pop-up Vaccination Stations. COVID-19 Individual Awareness & Education: Peer-health educators distributed culturally competent, bilingual (English/Spanish) COVID-19 materials at community centers, door-to-door, local markets, and CBOs. Materials covered prevention, symptoms, testing, vaccines, and debunking myths, and were updated monthly. Community Outreach & Health Promotion: Educators partnered with CBOs to deliver live sessions, webinars, and social media outreach on COVID-19 topics, aiming to reach 10,000 viewers per session in each intervention community. Individual Health Education & Linkages: COVID-19 Resource Centers were set up at intervention CHCs to offer personalized education and referrals to medical/support services. Pop-up Vaccination Sites: COVID-19 vaccines were offered at CHCs and temporary community sites in intervention areas to improve access and uptake.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 10, 2021	May 5, 2025

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Intervention	We conducted a 2-armed randomized controlled trial (RCT) with 1,051 Latino and African American adults (≥18 years) from six communities and affiliated community health centers (CHCs). Participants were randomized to either the 2VIDA! intervention group (n=517; 3 CHCs) or control (standard of care; n=534; 3 CHCs). The 2VIDA! intervention included four components: (1) COVID-19 Individual Awareness and Education, (2) COVID-19 Community Outreach and Health Promotion, (3) Individual Health Education and Linkages to Services, and (4) Pop-up Vaccination Stations. COVID-19 Individual Awareness & Education: Peer-health educators distributed culturally competent, bilingual (English/Spanish) COVID-19 materials at community centers, door-to-door, local markets, and CBOs. Materials covered prevention, symptoms, testing, vaccines, and debunking myths, and were updated monthly. Community Outreach & Health Promotion: Educators partnered with CBOs to deliver live sessions, webinars, and social media outreach on COVID-19 topics, aiming to reach 10,000 viewers per session in each intervention community. Individual Health Education & Linkages: COVID-19 Resource Centers were set up at intervention CHCs to offer personalized education and referrals to medical/support services. Pop-up Vaccination Sites: COVID-19 vaccines were offered at CHCs and temporary community sites in intervention areas to improve access and uptake.
BG001	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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000517 BG001534 BG0021051

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Baseline: I believe a vaccine can help control the spread of COVID-19

Title	Measurements
Agree	OG000282 OG001387
Disagree or Neutral	OG000

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).

Posted

Count of Participants

Participants

Baseline and follow-up (4-weeks)

ID	Title	Description
OG000	Intervention	We conducted a 2-armed randomized controlled trial (RCT) with 1,051 Latino and African American adults (≥18 years) from six communities and affiliated community health centers (CHCs). Participants were randomized to either the 2VIDA! intervention group (n=517; 3 CHCs) or control (standard of care; n=534; 3 CHCs). The 2VIDA! intervention included four components: (1) COVID-19 Individual Awareness and Education, (2) COVID-19 Community Outreach and Health Promotion, (3) Individual Health Education and Linkages to Services, and (4) Pop-up Vaccination Stations. COVID-19 Individual Awareness & Education: Peer-health educators distributed culturally competent, bilingual (English/Spanish) COVID-19 materials at community centers, door-to-door, local markets, and CBOs. Materials covered prevention, symptoms, testing, vaccines, and debunking myths, and were updated monthly. Community Outreach & Health Promotion: Educators partnered with CBOs to deliver live sessions, webinars, and social media outreach on COVID-19 topics, aiming to reach 10,000 viewers per session in each intervention community. Individual Health Education & Linkages: COVID-19 Resource Centers were set up at intervention CHCs to offer personalized education and referrals to medical/support services. Pop-up Vaccination Sites: COVID-19 vaccines were offered at CHCs and temporary community sites in intervention areas to improve access and uptake.

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).

Posted

Count of Participants

Participants

Baseline and follow-up (4-weeks)

ID	Title	Description
OG000	Intervention	We conducted a 2-armed randomized controlled trial (RCT) with 1,051 Latino and African American adults (≥18 years) from six communities and affiliated community health centers (CHCs). Participants were randomized to either the 2VIDA! intervention group (n=517; 3 CHCs) or control (standard of care; n=534; 3 CHCs). The 2VIDA! intervention included four components: (1) COVID-19 Individual Awareness and Education, (2) COVID-19 Community Outreach and Health Promotion, (3) Individual Health Education and Linkages to Services, and (4) Pop-up Vaccination Stations. COVID-19 Individual Awareness & Education: Peer-health educators distributed culturally competent, bilingual (English/Spanish) COVID-19 materials at community centers, door-to-door, local markets, and CBOs. Materials covered prevention, symptoms, testing, vaccines, and debunking myths, and were updated monthly. Community Outreach & Health Promotion: Educators partnered with CBOs to deliver live sessions, webinars, and social media outreach on COVID-19 topics, aiming to reach 10,000 viewers per session in each intervention community. Individual Health Education & Linkages: COVID-19 Resource Centers were set up at intervention CHCs to offer personalized education and referrals to medical/support services. Pop-up Vaccination Sites: COVID-19 vaccines were offered at CHCs and temporary community sites in intervention areas to improve access and uptake.

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).

Posted

Count of Participants

Participants

Baseline and follow-up (4-weeks)

ID	Title	Description
OG000	Intervention	We conducted a 2-armed randomized controlled trial (RCT) with 1,051 Latino and African American adults (≥18 years) from six communities and affiliated community health centers (CHCs). Participants were randomized to either the 2VIDA! intervention group (n=517; 3 CHCs) or control (standard of care; n=534; 3 CHCs). The 2VIDA! intervention included four components: (1) COVID-19 Individual Awareness and Education, (2) COVID-19 Community Outreach and Health Promotion, (3) Individual Health Education and Linkages to Services, and (4) Pop-up Vaccination Stations. COVID-19 Individual Awareness & Education: Peer-health educators distributed culturally competent, bilingual (English/Spanish) COVID-19 materials at community centers, door-to-door, local markets, and CBOs. Materials covered prevention, symptoms, testing, vaccines, and debunking myths, and were updated monthly. Community Outreach & Health Promotion: Educators partnered with CBOs to deliver live sessions, webinars, and social media outreach on COVID-19 topics, aiming to reach 10,000 viewers per session in each intervention community. Individual Health Education & Linkages: COVID-19 Resource Centers were set up at intervention CHCs to offer personalized education and referrals to medical/support services. Pop-up Vaccination Sites: COVID-19 vaccines were offered at CHCs and temporary community sites in intervention areas to improve access and uptake.

Secondary

Access to Health Care and Utilization

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

Posted

Count of Participants

Participants

Baseline (current)

ID	Title	Description
OG000	Intervention	We conducted a 2-armed randomized controlled trial (RCT) with 1,051 Latino and African American adults (≥18 years) from six communities and affiliated community health centers (CHCs). Participants were randomized to either the 2VIDA! intervention group (n=517; 3 CHCs) or control (standard of care; n=534; 3 CHCs). The 2VIDA! intervention included four components: (1) COVID-19 Individual Awareness and Education, (2) COVID-19 Community Outreach and Health Promotion, (3) Individual Health Education and Linkages to Services, and (4) Pop-up Vaccination Stations. COVID-19 Individual Awareness & Education: Peer-health educators distributed culturally competent, bilingual (English/Spanish) COVID-19 materials at community centers, door-to-door, local markets, and CBOs. Materials covered prevention, symptoms, testing, vaccines, and debunking myths, and were updated monthly. Community Outreach & Health Promotion: Educators partnered with CBOs to deliver live sessions, webinars, and social media outreach on COVID-19 topics, aiming to reach 10,000 viewers per session in each intervention community. Individual Health Education & Linkages: COVID-19 Resource Centers were set up at intervention CHCs to offer personalized education and referrals to medical/support services. Pop-up Vaccination Sites: COVID-19 vaccines were offered at CHCs and temporary community sites in intervention areas to improve access and uptake.
OG001

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.

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

Ever told by a medical provider they had a chronic illness

Posted

Count of Participants

Participants

Baseline

ID	Title	Description
OG000	Intervention	We conducted a 2-armed randomized controlled trial (RCT) with 1,051 Latino and African American adults (≥18 years) from six communities and affiliated community health centers (CHCs). Participants were randomized to either the 2VIDA! intervention group (n=517; 3 CHCs) or control (standard of care; n=534; 3 CHCs). The 2VIDA! intervention included four components: (1) COVID-19 Individual Awareness and Education, (2) COVID-19 Community Outreach and Health Promotion, (3) Individual Health Education and Linkages to Services, and (4) Pop-up Vaccination Stations. COVID-19 Individual Awareness & Education: Peer-health educators distributed culturally competent, bilingual (English/Spanish) COVID-19 materials at community centers, door-to-door, local markets, and CBOs. Materials covered prevention, symptoms, testing, vaccines, and debunking myths, and were updated monthly. Community Outreach & Health Promotion: Educators partnered with CBOs to deliver live sessions, webinars, and social media outreach on COVID-19 topics, aiming to reach 10,000 viewers per session in each intervention community. Individual Health Education & Linkages: COVID-19 Resource Centers were set up at intervention CHCs to offer personalized education and referrals to medical/support services. Pop-up Vaccination Sites: COVID-19 vaccines were offered at CHCs and temporary community sites in intervention areas to improve access and uptake.

Other Pre-specified

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).

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:"

Posted

Mean

Standard Deviation

units on a scale

Baseline and follow-up (4-weeks)

ID	Title	Description
OG000	Intervention	We conducted a 2-armed randomized controlled trial (RCT) with 1,051 Latino and African American adults (≥18 years) from six communities and affiliated community health centers (CHCs). Participants were randomized to either the 2VIDA! intervention group (n=517; 3 CHCs) or control (standard of care; n=534; 3 CHCs). The 2VIDA! intervention included four components: (1) COVID-19 Individual Awareness and Education, (2) COVID-19 Community Outreach and Health Promotion, (3) Individual Health Education and Linkages to Services, and (4) Pop-up Vaccination Stations. COVID-19 Individual Awareness & Education: Peer-health educators distributed culturally competent, bilingual (English/Spanish) COVID-19 materials at community centers, door-to-door, local markets, and CBOs. Materials covered prevention, symptoms, testing, vaccines, and debunking myths, and were updated monthly. Community Outreach & Health Promotion: Educators partnered with CBOs to deliver live sessions, webinars, and social media outreach on COVID-19 topics, aiming to reach 10,000 viewers per session in each intervention community. Individual Health Education & Linkages: COVID-19 Resource Centers were set up at intervention CHCs to offer personalized education and referrals to medical/support services. Pop-up Vaccination Sites: COVID-19 vaccines were offered at CHCs and temporary community sites in intervention areas to improve access and uptake.

Other Pre-specified

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).

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

Posted

Count of Participants

Participants

Baseline and follow-up (4-weeks)

ID	Title	Description
OG000	Intervention	We conducted a 2-armed randomized controlled trial (RCT) with 1,051 Latino and African American adults (≥18 years) from six communities and affiliated community health centers (CHCs). Participants were randomized to either the 2VIDA! intervention group (n=517; 3 CHCs) or control (standard of care; n=534; 3 CHCs). The 2VIDA! intervention included four components: (1) COVID-19 Individual Awareness and Education, (2) COVID-19 Community Outreach and Health Promotion, (3) Individual Health Education and Linkages to Services, and (4) Pop-up Vaccination Stations. COVID-19 Individual Awareness & Education: Peer-health educators distributed culturally competent, bilingual (English/Spanish) COVID-19 materials at community centers, door-to-door, local markets, and CBOs. Materials covered prevention, symptoms, testing, vaccines, and debunking myths, and were updated monthly. Community Outreach & Health Promotion: Educators partnered with CBOs to deliver live sessions, webinars, and social media outreach on COVID-19 topics, aiming to reach 10,000 viewers per session in each intervention community. Individual Health Education & Linkages: COVID-19 Resource Centers were set up at intervention CHCs to offer personalized education and referrals to medical/support services. Pop-up Vaccination Sites: COVID-19 vaccines were offered at CHCs and temporary community sites in intervention areas to improve access and uptake.

Other Pre-specified

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).

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

Posted

Count of Participants

Participants

Baseline and follow-up (4-weeks)

ID	Title	Description
OG000	Intervention	We conducted a 2-armed randomized controlled trial (RCT) with 1,051 Latino and African American adults (≥18 years) from six communities and affiliated community health centers (CHCs). Participants were randomized to either the 2VIDA! intervention group (n=517; 3 CHCs) or control (standard of care; n=534; 3 CHCs). The 2VIDA! intervention included four components: (1) COVID-19 Individual Awareness and Education, (2) COVID-19 Community Outreach and Health Promotion, (3) Individual Health Education and Linkages to Services, and (4) Pop-up Vaccination Stations. COVID-19 Individual Awareness & Education: Peer-health educators distributed culturally competent, bilingual (English/Spanish) COVID-19 materials at community centers, door-to-door, local markets, and CBOs. Materials covered prevention, symptoms, testing, vaccines, and debunking myths, and were updated monthly. Community Outreach & Health Promotion: Educators partnered with CBOs to deliver live sessions, webinars, and social media outreach on COVID-19 topics, aiming to reach 10,000 viewers per session in each intervention community. Individual Health Education & Linkages: COVID-19 Resource Centers were set up at intervention CHCs to offer personalized education and referrals to medical/support services. Pop-up Vaccination Sites: COVID-19 vaccines were offered at CHCs and temporary community sites in intervention areas to improve access and uptake.

Other Pre-specified

Frequency of Information

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

Posted

Count of Participants

Participants

Baseline and follow-up (4-weeks)

ID	Title	Description
OG000	Intervention	We conducted a 2-armed randomized controlled trial (RCT) with 1,051 Latino and African American adults (≥18 years) from six communities and affiliated community health centers (CHCs). Participants were randomized to either the 2VIDA! intervention group (n=517; 3 CHCs) or control (standard of care; n=534; 3 CHCs). The 2VIDA! intervention included four components: (1) COVID-19 Individual Awareness and Education, (2) COVID-19 Community Outreach and Health Promotion, (3) Individual Health Education and Linkages to Services, and (4) Pop-up Vaccination Stations. COVID-19 Individual Awareness & Education: Peer-health educators distributed culturally competent, bilingual (English/Spanish) COVID-19 materials at community centers, door-to-door, local markets, and CBOs. Materials covered prevention, symptoms, testing, vaccines, and debunking myths, and were updated monthly. Community Outreach & Health Promotion: Educators partnered with CBOs to deliver live sessions, webinars, and social media outreach on COVID-19 topics, aiming to reach 10,000 viewers per session in each intervention community. Individual Health Education & Linkages: COVID-19 Resource Centers were set up at intervention CHCs to offer personalized education and referrals to medical/support services. Pop-up Vaccination Sites: COVID-19 vaccines were offered at CHCs and temporary community sites in intervention areas to improve access and uptake.
OG001

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Intervention	We conducted a 2-armed randomized controlled trial (RCT) with 1,051 Latino and African American adults (≥18 years) from six communities and affiliated community health centers (CHCs). Participants were randomized to either the 2VIDA! intervention group (n=517; 3 CHCs) or control (standard of care; n=534; 3 CHCs). The 2VIDA! intervention included four components: (1) COVID-19 Individual Awareness and Education, (2) COVID-19 Community Outreach and Health Promotion, (3) Individual Health Education and Linkages to Services, and (4) Pop-up Vaccination Stations. COVID-19 Individual Awareness & Education: Peer-health educators distributed culturally competent, bilingual (English/Spanish) COVID-19 materials at community centers, door-to-door, local markets, and CBOs. Materials covered prevention, symptoms, testing, vaccines, and debunking myths, and were updated monthly. Community Outreach & Health Promotion: Educators partnered with CBOs to deliver live sessions, webinars, and social media outreach on COVID-19 topics, aiming to reach 10,000 viewers per session in each intervention community. Individual Health Education & Linkages: COVID-19 Resource Centers were set up at intervention CHCs to offer personalized education and referrals to medical/support services. Pop-up Vaccination Sites: COVID-19 vaccines were offered at CHCs and temporary community sites in intervention areas to improve access and uptake.	0	517	0	517	0	517
EG001	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.	0	534	0	534	0	534

First MCP Posted Date

ID	Term
D000072758	Vaccination Refusal
D000086382	COVID-19

Ancestor Terms

ID	Term
D016312	Treatment Refusal
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases
D018352	Coronavirus Infections
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D004522	Educational Status
D006293	Health Promotion

Ancestor Terms

ID	Term
D012959	Socioeconomic Factors
D011154	Population Characteristics
D006266	Health Education
D011314	Preventive Health Services
D006296	Health Services
D005159	Health Care Facilities Workforce and Services