Motivational Interviewing for Vaccine Uptake in Latinx Adults (MIVacuna)

Leveraging Community-based Behavioral Health to Increase Vaccine Uptake in Latinx Adults With Mental Illness

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.

Study Overview

• Status: Terminated
• Conditions: Vaccine Hesitancy
• Intervention / Treatment: Other: EHR alert; Behavioral: Motivational Interviewing; Behavioral: Warm hand off to nurse

Detailed Description

Prior to the Coronavirus disease (COVID-19) pandemic, the World Health Organization declared vaccine hesitancy, defined as a delay in the acceptance or refusal of vaccination despite availability of vaccination services, as one of the top 10 threats to global health. Today, despite massive recent and ongoing global efforts, vaccine hesitancy remains a major threat, particularly in populations that experience health disparities rooted in structural racism. One such population is Hispanic/Latinx adults (Latinxs). Prior to the national COVID-19 vaccine campaign, Latinxs had twice the rate of COVID-19 infection, 2.8 times the rate of hospitalization and 2.3 times the death rate of non-Latinx whites. Despite being at higher risk of COVID-19 related morbidity and mortality, Latinxs have been particularly hesitant to get vaccinated. In the early stages of vaccine rollout, vaccine uptake rates among Latinxs lagged at least 10% percentage points behind non-Latinxs and, as of Feb 2022, only 37% of Latinxs compared to 56% of non-Latinx whites had received a booster shot.

Adults with mental illness are also at high risk for COVID-19 infection, with more severe complications and higher mortality Yet there are no strategies for addressing vaccine hesitancy in this population. This gap is particularly important for Latinxs, who have disproportionately borne the mental health burden of the pandemic. There is, therefore, an urgent need for innovative, practical, and sustainable strategies to address vaccine hesitancy among the priority population of Latinx adults with mental illness.

The investigators will address this gap with a novel intervention that integrates evidence-based motivational interviewing (MI) into behavioral health (BH) services, coupled with electronic prompting, and vaccination access at the point of care. Key to the intervention is that the proposed MI protocol explicitly acknowledges cultural values that are central to the Latinx population and impact their interactions with health care providers. Additionally, the intervention has been specifically designed to: (i) be feasible and readily implemented in an integrated care setting, such as that offered by federally qualified health centers (FQHC); (ii) be sustainable in the long-term regardless of how the rapidly-changing COVID-19 vaccination landscape evolves; and, (iii) provide additional potential benefits in the form of increasing influenza vaccination which is generally low in the Latinx population.

• Study Type: Interventional
• Enrollment (Actual): 3698
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02128
      • East Boston Neighborhood Health Center
    • Boston, Massachusetts, United States, 02118
      • South End Community Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Patient Inclusion Criteria:

• 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)

Patient Exclusion Criteria:

- NA

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Behavioral health clinicians will use motivational interviewing with eligible patients to address vaccine hesitancy	Other: EHR alert; An EHR alert will be fired if a behavioral health patient is missing a COVID-19 or influenza vaccine.; Behavioral: Motivational Interviewing; 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).; Behavioral: Warm hand off to nurse; For patients interested in vaccination following motivational interviewing, the behavioral health clinician will do a warm hand off to a nurse for vaccination
No Intervention: Control; Control sites will adhere to standard practice in behavioral health sessions (i.e., no discussions about vaccination)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survey measure of provider trust	Survey item assessing if patients trust that their counselor will give them accurate vaccine (COVID-19 or influenza) information. Developed by research team.	Completed within one week of an eligible behavioral health visit
Survey measure of vaccination intention	Survey items assessing whether patient intends to get a vaccine (COVID-19 or influenza). Developed by the research team.	Completed within one week of an eligible behavioral health visit
Survey measure of vaccine hesitancy	Survey items measuring the 3Cs (complacency, confidence, convenience) of vaccine hesitancy	Completed within one week of an eligible behavioral health visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
COVID-19 vaccine series initiation (at least one dose of the vaccine)	Binary indicator extracted from EHR assessed longitudinally	12 month intervals over a total of 48 months
Up to date with COVID-19 vaccination (consistent with CDC guidelines)	Binary indicator extracted from EHR assessed longitudinally	12 month intervals over a total of 48 months
Up to date with influenza vaccine; received vaccine for current season (consistent with CDC guidelines)	Binary indicator extracted from EHR assessed longitudinally	12 month intervals over a total of 48 months

Collaborators and Investigators

• Sponsor: Boston College
• Collaborators: National Institute of Nursing Research (NINR); Boston Children's Hospital; Harvard School of Public Health (HSPH); East Boston Neighborhood Health Center
• Investigators: Principal Investigator: Kirsten Davison, PhD, Boston College

Publications and helpful links

General Publications

• 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.

Helpful Links

• Research team website

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: August 3, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Motivational interviewing; Influenza; COVID-19; Latinx; Behavioral health
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Behavior; Treatment Adherence and Compliance; Health Behavior; Treatment Refusal; Vaccination Refusal; COVID-19; Influenza, Human; Vaccination Hesitancy; Health Services; Health Care Facilities Workforce and Services; Behavioral Disciplines and Activities; Directive Counseling; Counseling; Mental Health Services; Motivational Interviewing
• Other Study ID Numbers: 23.049.01; 5R01NR020482 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We submitted our application for review prior to the implementation of the new data sharing guidelines (January 25, 2023)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No