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COVID-19 Individual Awareness and Education. for Coronavirus

San Ysidro Health Chula Vista, Chula Vista, CA
Targeting 2 different conditionsCOVID-19 Individual Awareness and Education. +3 morePhase 4RecruitingLed by Argentina E Servin, MD,MPHResearch Sponsored by Argentina Servin, MD, MPH

Study Summary

This trial is testing a multilevel intervention to increase acceptance and uptake of COVID-19 vaccines among Latino and African American adults in San Diego. The intervention includes individual awareness and education, linkages to medical and supportive services, and community outreach and health promotion.

Eligible Conditions
  • Coronavirus
  • Vaccine Refusal

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You have never had an immune disease in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~past 12 months, baseline (current) and follow-up (4-weeks).
This trial's timeline: 3 weeks for screening, Varies for treatment, and past 12 months, baseline (current) and follow-up (4-weeks). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in COVID-19 Vaccine acceptance
Change in Vaccine Hesitancy
Secondary outcome measures
Access to health care and utilization
Change in COVID-19 risk perception (probability and severity)
Change in Health literacy
+4 more
Other outcome measures
Affect
Conspiracies (perceptions)
Frequency of information
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment4 Interventions
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.
Group II: Standard of careActive Control1 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.

Find a site

Who is running the clinical trial?

Argentina Servin, MD, MPHLead Sponsor
San Ysidro Health CenterOTHER
6 Previous Clinical Trials
8,523 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
331 Previous Clinical Trials
1,326,418 Total Patients Enrolled
Argentina E Servin, MD,MPHPrincipal Investigator
UC San Diego

Media Library

2VIDA! COVID-19 Vaccine Intervention Delivery (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05022472 — Phase 4
Coronavirus Research Study Groups: Intervention, Standard of care
Coronavirus Clinical Trial 2023: 2VIDA! COVID-19 Vaccine Intervention Delivery Highlights & Side Effects. Trial Name: NCT05022472 — Phase 4
2VIDA! COVID-19 Vaccine Intervention Delivery (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05022472 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How efficacious is COVID-19 Individual Awareness and Education in promoting safety among individuals?

"There is a wealth of evidence demonstrating the safety profile of COVID-19 Individual Awareness and Education, which has been approved by authorities. Therefore, it receives an assessment score of 3."

Answered by AI

Are there any volunteer opportunities associated with this research?

"Affirmative. Clinical trials data reveals that this clinical trial, which was initially listed on July 16th 2021, is still recruiting participants. 1000 patients must be enrolled from 6 different healthcare facilities."

Answered by AI

Who is eligible to participate in this research project?

"This research project will involve 1000 individuals who have previously refused the vaccine. Eligibility requirements include being aged 18-99, having no history of extreme hypersensitivity reactions to any component of the vaccination, not expecting a child in the upcoming month, biologically male or female with no record of immunological disorder."

Answered by AI

Is the age limit for participation in this investigation beyond 30 years of age?

"This clinical trial requires participants to be between 18 and 99 years old. There are 138 studies available for minors, while 908 trials include individuals older than 65."

Answered by AI

What is the current enrollment size of this clinical trial?

"Affirmative. According to the research posted on clinicaltrials.gov, this medical investigation is currently searching for 1000 patients at 6 sites and was first released on July 16th 2021 with its most recent edit occuring in mid-December of last year."

Answered by AI

What outcomes is this experiment seeking to elucidate?

"This 12-month study seeks to measure changes in Vaccine Hesitancy and will assess secondary outcomes such as Health History, Health Literacy, and Testing & Tracing. Notably, Health History captures data on pre-existing conditions that exacerbate COVID-19 infection such as diabetes mellitus or hypertension; whereas, Health Literacy gauges an individual's ability to find information about symptoms and follow authorities' advice regarding prevention behaviours. Finally, the evaluation of Testing & Tracing looks at barriers and motivations for getting tested while sharing contact details with tracing services. (Adapted from WHO COVID-19 Survey Tool & Guidance)."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
San Ysidro Health Euclid
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Project 2VIDA! COVID-19 Vaccine Intervention Delivery for Adults in Southern California
Argentina Servin, MD, MPH 2021. "Project 2VIDA! COVID-19 Vaccine Intervention Delivery for Adults in Southern California". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05022472.
~519 spots leftby Jan 2026
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