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Motivational Interviewing for Vaccine Uptake in Latinx Adults

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06062056
Acronym
MIVacuna
Enrollment
3698
Registered
2023-10-02
Start date
2023-10-02
Completion date
2025-04-30
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaccine Hesitancy

Keywords

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

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.

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.

Interventions

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

BEHAVIORALMotivational 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).

BEHAVIORALWarm 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

Sponsors

East Boston Neighborhood Health Center
CollaboratorUNKNOWN
Harvard School of Public Health (HSPH)
CollaboratorOTHER
Boston Children's Hospital
CollaboratorOTHER
National Institute of Nursing Research (NINR)
CollaboratorNIH
Boston College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Received COVID-19 vaccine/booster following an eligible behavioral health visitWithin 6 weeks of an eligible behavioral health visitBinary indicator extracted from EHR
Received influenza vaccine following an eligible behavioral health visitWithin 6 weeks of an eligible behavioral health visitBinary indicator extracted from EHR

Secondary

MeasureTime frameDescription
Survey measure of provider trustCompleted within one week of an eligible behavioral health visitSurvey item assessing if patients trust that their counselor will give them accurate vaccine (COVID-19 or influenza) information. Developed by research team.
Survey measure of vaccine hesitancyCompleted within one week of an eligible behavioral health visitSurvey items measuring the 3Cs (complacency, confidence, convenience) of vaccine hesitancy
Survey measure of vaccination intentionCompleted within one week of an eligible behavioral health visitSurvey items assessing whether patient intends to get a vaccine (COVID-19 or influenza). Developed by the research team.

Other

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026