Multilevel Intervention of COVID-19 Vaccine Uptake Among Latinos

NCT06156228 | Terminated

• 1 other identifier: HS-2022-0096
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 2

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.

Conditions

Vaccine Hesitancy

Keywords

Vaccine Promotion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Psychosocial and Individual-level outcomes

  1 year

Other Outcomes (1)

• Implementation Assessment

  1 year

Study Arms (2)

Multilevel Intervention

EXPERIMENTAL

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

Standard Clinical Practice

NO INTERVENTION

Standard clinical practice consisting of generic patient outreach to promote vaccine uptake among Latino patients.

Interventions

Multilevel Intervention BEHAVIORAL

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.

Multilevel Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• San Diego State University: lead

Study Sites (2)

Family Health Centers San Diego

San Diego, California, 92102, United States

Location

San Diego State University Research Foundation

San Diego, California, 92182, United States

Location

MeSH Terms

Conditions

Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: In order to generate evidence that reflects real-world circumstances and is generalizable to a broad patient population served by Federally Qualified Health Centers, Investigators 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 5, 2023
• Study Start: March 6, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

US (2)