Clinical trial NCT06156228: Multilevel Intervention of COVID-19 Vaccine Uptake Among Latinos
Official title: Multilevel Intervention of COVID-19 Vaccine Uptake Among Latinos
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Vaccine Hesitancy
Keywords: Vaccine Promotion
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Investigators will implement a multilevel intervention in 10 clinics that will be randomized to either a Standard Clinical Practice consisting of standard clinic-based strategies to promote vaccine uptake among patients or a Multilevel Intervention consisting of an individualized/tailored intervention delivered by Health Educators working within the clinics plus a multi-component community intervention delivered by community promotores.
Primary purpose: PREVENTION

Brief 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.

Detailed 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).

Eligibility criteria: Inclusion Criteria:

* Be a patient of an intervention participating clinic
* Be an adult 18+
* Self identify as Latino

Exclusion Criteria:

* Be planning to move out of San Diego County in the next 2 years
* Have cognitive impairment making them unable to complete informed consent
* Have any contraindications to receiving the 4 study vaccines (COVID-19, Pneumococcal, Shingles, Influenza)

Primary outcomes:
measure: Vaccination of Latino clinic patients
timeFrame: 1 year
Secondary outcomes:
measure: Psychosocial and Individual-level outcomes
timeFrame: 1 year
Other outcomes:
measure: Implementation Assessment
timeFrame: 1 year
Locations:
city: San Diego
country: United States
facility: Family Health Centers San Diego
state: California
city: San Diego
country: United States
facility: San Diego State University Research Foundation
state: California
Study officials:
References: