Multilevel Intervention for Vaccine Hesitancy

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to boost vaccine confidence and uptake among Latino adults through a tailored, community-focused approach. Participants will receive personalized messages, motivational sessions, and various informational materials about vaccines such as COVID-19, influenza, pneumococcal pneumonia, and shingles. The trial compares this personalized outreach, known as a multilevel intervention, to standard clinical practices. It targets Latino adults in San Diego County who are patients at participating clinics. As an unphased trial, this study offers participants the chance to contribute to community health improvements through innovative outreach strategies.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this multilevel intervention is safe?

Research shows that the approach used in this trial is generally safe for participants. The trial uses personalized messages and motivational talks to encourage vaccination. Other studies have used these methods without causing harm.

For instance, a similar approach increased HPV vaccine rates among teens, with no reports of negative effects from the method itself. This trial does not test a new drug or vaccine; it tests educational strategies to help people accept vaccines. As a result, there are fewer safety concerns since no new medicines or treatments are involved. Overall, evidence suggests that participants should handle this intervention well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Multilevel Intervention for vaccine hesitancy because it's a more personalized approach compared to the standard outreach methods. This intervention not only delivers tailored messages about vaccinations but also involves motivational interview sessions with health educators, adding a human touch that standard practices lack. Additionally, it harnesses the power of multimedia resources, like videos and testimonials, through mail, email, and text messages to continuously engage and inform patients, potentially leading to better vaccine uptake.

What evidence suggests that this multilevel intervention is effective for increasing vaccine uptake?

Research has shown that using multiple methods can effectively increase vaccination rates. For example, one study found that these methods increased vaccine uptake by an average of 46%. In this trial, participants in the Multilevel Intervention arm will receive personalized messages and support from health educators to address concerns and encourage vaccination. Another study also demonstrated positive results in increasing vaccine uptake. These methods are especially promising in communities where many people hesitate about vaccines. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11987150/

Estimating the effects of interventions on increasing vaccination Overall, we found that the interventions across four main themes increased vaccination rates by 46.0% (95% CI: 38.5% to 53.9%), with high ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2836046

Multilevel Intervention and Human Papillomavirus ... We determined a positive vaccination outcome as having received a vaccine dose (first dose for initiation and second dose for completion) during ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06156228

Multilevel Intervention of COVID-19 Vaccine Uptake ... Test longer-term (24-mo) effectiveness of the Multilevel Intervention on psychosocial & quality of life outcomes among a subgroup of 200 Latino clinic patients.

4. nature.com nature.com/articles/s41541-025-01120-1

Systematic review and meta-analysis of interventions to ... This review aimed to systematically describe and assess the effects of interventions designed to increase uptake of recommended vaccines among pregnant persons.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2211335521003648

Multilevel determinants of COVID-19 vaccination hesitancy ... A national study conducted in October 2020 reported that 66.9% participants would vaccinate against COVID-19 when available or a few months later after the roll ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9771865/

Implementation and evaluation of a multilevel intervention ... This paper describes the implementation and evaluation of a multilevel pilot intervention study to increase uptake of the HPV vaccine among adolescent patients ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8675390/

Multilevel determinants of COVID-19 vaccination hesitancy ... A study showed that one unit increase in perceived potential harms of a COVID-19 vaccine was associated with 5% reduction in vaccine acceptance ...

8. nature.com nature.com/articles/s41598-025-94653-3

Spatial multilevel analysis of individual, household, and ... Modeling results​​ Among 5566 adults surveyed in DR, vaccine hesitancy was 12.6% (n = 699 participants) (95% CI: 11.7–13.5%). The multilevel ...