Motivational Interviewing for Vaccine Uptake in Latinx Adults

NCT06062056 | Terminated DMC

• 2 other identifiers: 23.049.015R01NR020482
• Study Type: interventional
• Target: 3,698
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Vaccine Hesitancy

Keywords

COVID-19; Influenza; Latinx; Behavioral health; Motivational interviewing

Outcome Measures

Primary Outcomes (2)

• Received COVID-19 vaccine/booster following an eligible behavioral health visit

  Binary indicator extracted from EHR

  Within 6 weeks of an eligible behavioral health visit

• Received influenza vaccine following an eligible behavioral health visit

  Binary indicator extracted from EHR

  Within 6 weeks of an eligible behavioral health visit

Secondary Outcomes (3)

• Survey measure of vaccine hesitancy

  Completed within one week of an eligible behavioral health visit

• Survey measure of provider trust

  Completed within one week of an eligible behavioral health visit

• Survey measure of vaccination intention

  Completed within one week of an eligible behavioral health visit

Other Outcomes (3)

• COVID-19 vaccine series initiation (at least one dose of the vaccine)

  12 month intervals over a total of 48 months

• Up to date with COVID-19 vaccination (consistent with CDC guidelines)

  12 month intervals over a total of 48 months

• Up to date with influenza vaccine; received vaccine for current season (consistent with CDC guidelines)

  12 month intervals over a total of 48 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: EHR alert; Behavioral: Motivational Interviewing; Behavioral: Warm hand off to nurse

Control

NO INTERVENTION

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

Interventions

EHR alert OTHER

An EHR alert will be fired if a behavioral health patient is missing a COVID-19 or influenza vaccine.

Intervention

Motivational Interviewing BEHAVIORAL

In response to the alert and using support tools in the EHR, the behavioral health clinician will integrate motivational interviewing into the counseling session to discuss vaccine hesitancy (if it is deemed appropriate based on patient needs and clinical judgment).

Intervention

Warm hand off to nurse BEHAVIORAL

For patients interested in vaccination following motivational interviewing, the behavioral health clinician will do a warm hand off to a nurse for vaccination

Intervention

Eligibility Criteria

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

You may qualify if:

• Aged 18 years and older
• Identifies as Latinx or speaks Spanish
• Completed an eligible behavioral health (BH) visit between the start and end dates of the intervention period.
• Patient is missing a COVID-19 vaccine/booster or the influenza vaccine at the beginning of their behavioral health visit (i.e., they are not fully up to date with their COVID-19 and influenza vaccines)

You may not qualify if:

• \- NA

Sponsors & Collaborators

• Boston College: lead
• East Boston Neighborhood Health Center: collaborator
• Harvard School of Public Health (HSPH): collaborator
• Boston Children's Hospital: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (2)

South End Community Health Center

Boston, Massachusetts, 02118, United States

Location

East Boston Neighborhood Health Center

Boston, Massachusetts, 02128, United States

Location

Related Publications (1)

• Scrivano RM, van de Water BJ, Rueras N, Alfonso J, McManama O'Brien KH, Soto X, Caumeran VJS, Campos BM, Mancusi M, Diehl B, Southwick E, Moreno E, Bora C, Armbruster S, Abuelezam NN, Calvo R, Haneuse S, Davison KK. Motivational Interviewing for Vaccine Uptake in Latinx Adults (MI Vacuna): Study protocol for a pragmatic multiple-period cluster-randomized crossover trial. Contemp Clin Trials. 2025 Aug;155:107987. doi: 10.1016/j.cct.2025.107987. Epub 2025 Jun 14.

  PMID: 40523466 BACKGROUND

Related Links

• Research team website

MeSH Terms

Conditions

Vaccination Hesitancy; COVID-19; Influenza, Human

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kirsten Davison, PhD

  Boston College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pragmatic multiple-period, cluster-randomized crossover design will be used.

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: October 2, 2023
• Study Start: October 2, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)