Multilevel Intervention for Vaccine Hesitancy

Recruiting at 1 trial location

Overseen By Noe C Crespo, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: San Diego State University

Disqualifiers: Cognitive impairment, Vaccine contraindications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults over 18 who identify as Latino and are patients at participating clinics. It's designed to help those with high COVID-19 risks, aiming to overcome vaccine hesitancy within this community by using tailored interventions.

Inclusion Criteria

Be a patient of an intervention participating clinic

Self identify as Latino

Exclusion Criteria

Be planning to move out of San Diego County in the next 2 years

I am unable to understand or sign the consent form due to cognitive issues.

I have no allergies or conditions that prevent me from getting vaccines for COVID-19, pneumonia, shingles, and flu.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Multilevel Intervention

Participants receive tailored and targeted messages about vaccination, including motivational interview sessions and informational materials over the first 6 months.

6 months

Multiple visits (in-person and virtual)

Standard Clinical Practice

Participants receive generic patient outreach to promote vaccine uptake.

6 months

Follow-up

Participants are monitored for vaccine uptake and psychosocial outcomes at 6-month and 12-month intervals.

12 months

Long-term Follow-up

Test longer-term effectiveness of the Multilevel Intervention on psychosocial and quality of life outcomes among a subgroup of Latino clinic patients.

24 months

Treatment Details

Interventions

• Multilevel Intervention

Trial Overview The study tests a multilevel intervention strategy to increase vaccine uptake among Latinos. This involves collaboration with community partners and aims to create a scalable model that can be applied in other settings facing public health challenges.

Participant Groups

Group I: Multilevel Intervention Experimental Treatment 1 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.

Group II: Standard Clinical Practice Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials

182

Recruited

119,000+