Multilevel Intervention of COVID-19 Vaccine Uptake Among Latinos

Sponsor
San Diego State University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06156228
Collaborator
(none)
200
2
19.3

Study Details

Study Description

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 we will harness our 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 we 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Multilevel Intervention
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
We 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.We 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.
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
In order to generate evidence that reflects real-world circumstances and is generalizable to a broad patient population served by Federally Qualified Health Centers, we will evaluate our proposed intervention in a single-blind, pragmatic, cluster randomized trial, whereby 10 clinics will be randomized at a ratio of 1:1 to one of two conditions. The first being standard clinical practice and the second being the intervention which will include motivational interviews where health educators can assist with scheduling their vaccine appointments should the clinic patient opt for that. The study participants will not know whether they are placed on the intervention or control group and their care providers will also be unaware. This will ensure balance across study conditions regarding clinic patient characteristics.
Primary Purpose:
Prevention
Official Title:
Multilevel Intervention of COVID-19 Vaccine Uptake Among Latinos
Anticipated Study Start Date :
Dec 11, 2023
Anticipated Primary Completion Date :
Jul 20, 2024
Anticipated Study Completion Date :
Jul 20, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Vaccination of Latino clinic patients [1 year]

    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.

Secondary Outcome Measures

  1. Psychosocial and Individual-level outcomes [1 year]

    Test longer-term (24-mo) effectiveness of the Multilevel Intervention on psychosocial & quality of life outcomes among a subgroup of 200 Latino clinic patients.

Other Outcome Measures

  1. Implementation Assessment [1 year]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • San Diego State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Noe Crespo, Professor, Health Promotion & Behavioral Science, San Diego State University
ClinicalTrials.gov Identifier:
NCT06156228
Other Study ID Numbers:
  • HS-2022-0096
First Posted:
Dec 5, 2023
Last Update Posted:
Dec 5, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Noe Crespo, Professor, Health Promotion & Behavioral Science, San Diego State University

Study Results

No Results Posted as of Dec 5, 2023