Multilevel Intervention of COVID-19 Vaccine Uptake Among Latinos

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Vaccine Hesitancy
• Intervention / Treatment: Behavioral: Multilevel Intervention

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).

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92102
      • Family Health Centers San Diego
    • San Diego, California, United States, 92182
      • San Diego State University Research Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multilevel Intervention; The Multilevel Intervention condition will receive tailored and targeted messages about vaccination. Health educators will also deliver motivational interview sessions to patients eligible to receive the vaccines during the first 6 months of the study. To supplement these encounters, health educators will also send patients mail, emails and/or text message-based informational materials (including videos, testimonials, and resources) that reinforce the benfits of vaccines.	Behavioral: Multilevel Intervention; Clinic patients from the randomly assigned intervention clinics will be provided with additional vaccine information and will have the opportunity to ask any questions they might have about any of the 4 study focused vaccines (COVID-19, Shingles, Pneumococcal, Influenza). Health educators will provide them with additional information, address any misinformation and disinformation and will offer to schedule their vaccine appointment(s) for them.
No Intervention: Standard Clinical Practice; Standard clinical practice consisting of generic patient outreach to promote vaccine uptake among Latino patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccination of Latino clinic patients	Test Multilevel Intervention effectiveness at baseline, 6-months & 12-months on Latino patient's vaccine uptake for COVID-19, Pneumococcal, Shingles and Influenza vs. Latino patients receiving Standard Clinical Practice.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychosocial and Individual-level outcomes	Test longer-term (24-mo) effectiveness of the Multilevel Intervention on psychosocial & quality of life outcomes among a subgroup of 200 Latino clinic patients.	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation Assessment	Assess implementation process & fidelity, including intervention acceptability & perceived feasibility by patients, clinic staff, community agencies and stakeholders at baseline, 3 month, 6 month and 12 month timepoints.	1 year

Collaborators and Investigators

• Sponsor: San Diego State University

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 5, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Vaccine Promotion
• Other Study ID Numbers: HS-2022-0096

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No