Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT06156228 |
| Other study ID # |
HS-2022-0096 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 6, 2024 |
| Est. completion date |
April 30, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
San Diego State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study is significant as it targets a population that has exceptionally high rates of
morbidity and mortality due to COVID-19, influenza, pneumococcal pneumonia and shingles; and
who demonstrate significant mistrust towards the vaccines. It is innovative in that
investigators will harness the research team's extensive experience in developing multi-level
and tailored interventions working with community partners to increase adult vaccine uptake
among Latinos. Through this project the investigators will develop the experience and
infrastructure for a scalable community-academic model that can be deployed and adapted to
other communities (especially those with prevalent vaccine resistance) and other emerging
public health threats. There is great potential for short- and long-term public
health/economic impact in increasing adult vaccine uptake among high risk populations such as
Latinos. This work will contribute to the body of evidence for effective behavioral- and
community-based strategies to improve the health of Latinos.
Description:
COVID-19 disparities are central to its local and national spread. Since the emergence of the
novel coronavirus (SARS-CoV-2), there have been over 104.8 million confirmed cases worldwide,
with the U.S. leading in number cases and deaths (as of this writing, >26.6 mil and 455K+,
respectively)1 and California leading the U.S. with >3.3 mil cases.1 COVID-19 (the disease
caused by SARS-CoV-2) is spread primarily from person-to-person through close and sustained
contact with an infected individual. Unfortunately, the U.S. response to the pandemic has
largely been left to state and local governments, which has resulted in mixed results.
Ethnic/racial minority individuals are at an increased risk of acquiring SARS-CoV-2 infection
compared to Whites, and demonstrate worse clinical outcomes from COVID-19. For example,
Latinos experience a 2.5 times higher death rate from COVID-19 compared to Whites.2 In
California, Latinos account for the highest percent of COVID-19 cases (55%) and deaths (46%)
despite similar population percentages as Whites (38.9% vs. 36.6%, respectively).3 In San
Diego County, Latinos have the highest case rates (56.3%) compared to any other ethnic
group.4 These data show profound and clear disparities affecting Latinos in California and
San Diego County.
Determinants of COVID-19 disparities among Latinos are the result of pervasive systemic
socioeconomic disparities. Latinos are disproportionately represented in occupations deemed
as 'essential' (78%)5 and suffer from high rates of poverty (18.3%) compared to Whites (59%
and 8.7%, respectively).6 Together, these factors place Latinos at a greater need to continue
working outside the home, thereby increasing risk of exposure to SARS-CoV-2. In addition, due
to both economic and cultural factors, Latinos may live in smaller housing units with
multi-generational households which makes practicing social distancing dificult.7 Latinos
also have higher rates of obesity, hypertension and type 2 diabetes; all of which are known
risk factors for severe COVID-19 complications.8 Lastly, due to educational disparities and
historical distrust of government entities,9 Latinos may be more vulnerable to misinformation
regarding COVID-19, and thus not adopt or adhere to preventive recommendations.10 These
disparities highlight the urgent need to reduce the COVID-19 burden among Latinos.
Vaccine hesitancy and mistrust among Latinos can further exacerbate the burden of COVID-19
experienced by this group. To date, the national response to the COVID-19 pandemic and
subsequent vaccination rollout has been largely inadequate. Common cited concerns of the
COVID-19 vaccine include the speed at which they were developed and approved, the newness of
the mRNA-based technology (Moderna & Pfizer), the relatively short-term efficacy and safety
data available, and the risk of potential side effects. To compound these concerns, social
media and other platforms (e.g., Facebook & YouTube) have been used to propagate
misinformation regarding COVID-19 and the COVID-19 vaccines. These factors, in combination,
have degraded the trust of Latinos for the COVID-19 vaccine. Thus, it is clear that Latinos
are a priority group to implement strategies to increase trust in the COVID-19 vaccine and
increase COVID-19 vaccine uptake. FHCSD provides an ideal setting to conduct research
centered on establishing effective methods for reaching and serving large numbers of Latinos.
More recently, it has become apparent that COVID-19 vaccination will be a yearly and seasonal
vaccine, similar to influenza. Given this, it is important to leverage vaccination efforts
and communication campaigns that target multiple vaccines. These include: COVID-19,
influenza, pneumococcal pneumonia and shingles. Evidence indicates that similar ethnic
disparities exist for flu (11), pneumococcal pneumonia (12), and shingles (13).
