Motivational Interviewing for Vaccine Hesitancy

(MIVacuna Trial)

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

6000 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to test whether modified behavioral health services, integrating motivational interviewing, will reduce vaccine hesitancy and increase uptake for the COVID-19 and influenza vaccines among Latinx adults with mental illness.

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 data supports the effectiveness of the treatment Motivational Interviewing for reducing vaccine hesitancy?

Research shows that motivational interviewing (MI) can improve communication skills and confidence among healthcare providers, helping them address vaccine hesitancy effectively. Studies have demonstrated significant improvements in MI skills and knowledge after training, suggesting that MI can be a useful tool in encouraging informed vaccine decisions. ^{1 2 3 4 5}

Is motivational interviewing safe for humans?

Motivational interviewing is a communication technique used by healthcare professionals to help people make informed decisions, and there is no evidence suggesting it is unsafe for humans. ^{1 2 4 6 7}

How is Motivational Interviewing different from other treatments for vaccine hesitancy?

Motivational Interviewing is unique because it focuses on enhancing a person's internal motivation to change their attitude towards vaccines by exploring and resolving their mixed feelings, rather than using traditional methods that may not be effective or could increase hesitancy. It involves a collaborative communication style between healthcare providers and patients, creating a safe and trusting environment to support informed decision-making. ^{1 2 6 8 9}

Research Team

Kirsten Davison, PhD

Principal Investigator

Boston College

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Using motivational interviewing techniques to inform decision-making for COVID-19 vaccination. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Preparing student-pharmacists to utilize motivational interviewing techniques to address COVID-19 vaccine hesitancy in underrepresented racial/ethnic patient populations. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Assessment of training of general practice interns in motivational interviews about vaccination. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Development of PIVOT with MI: A motivational Interviewing-Based vaccine communication training for pediatric clinicians. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Motivating Behavioral Change. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Development of motivational interviewing skills in immunization (MISI): a questionnaire to assess MI learning, knowledge and skills for vaccination promotion. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Motivational interviewing and vaccine acceptance in children: The MOTIVE study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Motivational Interviewing Strategies for Addressing COVID-19 Vaccine Hesitancy. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

The use of motivational interviewing to overcome COVID-19 vaccine hesitancy in primary care settings. [2023]