Motivational Interviewing for Vaccine Hesitancy

(MIVacuna Trial)

No longer recruiting at 1 trial location

Overseen By Sebastien Haneuse, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston College

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if motivational interviewing, a conversation technique and type of therapy, can reduce hesitancy and increase the uptake of COVID-19 and flu vaccines among Latinx adults with mental illness. Participants will either receive standard behavioral health services without vaccine discussion or engage in sessions using motivational interviewing to address vaccine hesitancy. Individuals who identify as Latinx or speak Spanish, have recently visited a behavioral health provider, and are not up to date with their COVID-19 or flu vaccines may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance vaccine uptake in the community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that motivational interviewing is safe for addressing vaccine hesitancy?

Research has shown that motivational interviewing safely addresses concerns about vaccines. This method helps individuals discuss and resolve their doubts about vaccination. Studies have found that it significantly reduces hesitancy and encourages vaccination. Importantly, motivational interviewing employs respectful and understanding communication. It involves no medication or physical procedures, eliminating typical "side effects." This makes it a comfortable option for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using motivational interviewing to address vaccine hesitancy because it offers a personalized and empathetic approach, quite different from the standard methods like informational campaigns or direct persuasion. Motivational interviewing involves open-ended questions and active listening, encouraging individuals to explore their own reasons for hesitancy and guiding them towards making their own informed decisions about vaccination. This method is promising because it respects individual autonomy and has the potential to build trust, which might lead to higher vaccination rates compared to traditional strategies.

What evidence suggests that motivational interviewing is effective for reducing vaccine hesitancy?

Research shows that motivational interviewing (MI), which participants in this trial may receive, can help reduce vaccine hesitancy. It involves supportive conversations to address mixed feelings about vaccines. Studies have found that MI helps people make positive decisions about vaccination. Evidence also suggests that MI is particularly effective in increasing vaccination rates among underserved groups, such as the Latinx community. By focusing on understanding and addressing personal concerns, this method offers a promising way to improve vaccination rates. ^{1 2 3 4 5}

Who Is on the Research Team?

Kirsten Davison, PhD

Principal Investigator

Boston College

Are You a Good Fit for This Trial?

This trial is for Latinx adults aged 18 and older with mental illness who are not up to date on their COVID-19 or influenza vaccines. Participants must have had a behavioral health visit within the intervention period.

Inclusion Criteria

Completed an eligible behavioral health (BH) visit between the start and end dates of the intervention period.

I am not up to date with my COVID-19 and flu vaccines.

Identifies as Latinx

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Behavioral health clinicians use motivational interviewing to address vaccine hesitancy among Latinx adults with mental illness

48 months

Regular visits as part of behavioral health sessions

Follow-up

Participants are monitored for vaccine uptake and hesitancy through EHR and surveys

48 months

12 month intervals

What Are the Treatments Tested in This Trial?

Interventions

• Motivational Interviewing

Trial Overview

The study tests if motivational interviewing, along with an electronic health record (EHR) alert and a warm handoff to a nurse, can reduce vaccine hesitancy and increase vaccination rates among the target group.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 3 Interventions

Behavioral health clinicians will use motivational interviewing with eligible patients to address vaccine hesitancy

Group II: Control Active Control 1 Intervention

Control sites will adhere to standard practice in behavioral health sessions (i.e., no discussions about vaccination)

Motivational Interviewing is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Motivational Interviewing for:

• Substance Use Disorders
• Mental Health Conditions

Approved in European Union as Motivational Interviewing for:

• Addiction Treatment
• Behavioral Health Interventions

Approved in Canada as Motivational Interviewing for:

• Substance Abuse Treatment
• Mental Health Counseling

Who Is Running the Clinical Trial?

Boston College

Lead Sponsor

Trials

40

Recruited

49,300+

East Boston Neighborhood Health Center

Collaborator

Trials

1

Recruited

6,000+

Harvard School of Public Health (HSPH)

Collaborator

Trials

283

Recruited

17,030,000+

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

A new training curriculum for pediatric clinicians, developed as part of the PIVOT with MI study, effectively equips them with evidence-based communication strategies to address vaccine hesitancy among parents, with 134 clinicians participating in the training.

Over 95% of pediatric clinicians found the training components useful, indicating strong engagement and potential for improving childhood vaccination rates through better communication techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of PIVOT with MI: A motivational Interviewing-Based vaccine communication training for pediatric clinicians. O'Leary, ST., Spina, CI., Spielvogle, H., et al.[2023]

Motivational interviewing (MI) is an effective communication technique that helps patients engage in discussions about changing their health behaviors by addressing their ambivalence.

MI practitioners use specific skills and strategies to create a gap between a patient's current behaviors and their personal goals, facilitating a more productive conversation about health changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivating Behavioral Change. Tooley, EM., Kolahi, A.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12334111/

Effects of a Theory- and Evidence-Based, Motivational ...

MI has shown promise in promoting vaccination by fostering a supportive dialogue that addresses individuals' ambivalence toward vaccines [21].

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11352791/

From vaccine hesitancy to vaccine motivation - PubMed Central

Motivational Interviewing (MI) is an evidence-based communication style demonstrated to significantly reduce VH. MI guides people toward change through the ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1551714425001818

Motivational Interviewing for Vaccine Uptake in Latinx ...

Evidence suggests that Motivational interviewing (MI) may reduce vaccine hesitancy among underserved populations. This trial evaluates the effectiveness of MI ...

4.

nature.com

nature.com/articles/s41541-025-01197-8

A field test of empathetic refutational and motivational ...

In this field experiment, we assessed the effectiveness of ERI and MI on patients' vaccination attitudes and behaviors. For this, physicians ...

5.

academic.oup.com

academic.oup.com/tbm/article/15/1/ibae069/8096310

Addressing vaccine hesitancy: A systematic review comparing ...

Both education and motivational counseling are equally effective for improving vaccine uptake, but the strength of the effect for education ...