Motivational Interviewing for Vaccine Uptake in Latinx Adults

Vaccine Hesitancy Clinical Trial

— MIVacuna  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06062056
• Other study ID #: 23.049.01
• Secondary ID: 5R01NR020482
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: August 31, 2027

Study information

• Verified date: October 2023
• Source: Boston College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 6000
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Patient Inclusion Criteria:

• Aged 18 years and older

• Identifies as Latinx

• 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

Related Conditions & MeSH terms

• Vaccine Hesitancy

Intervention

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).
• 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

Locations

Country	Name	City	State
United States	East Boston Neighborhood Health Center	Boston	Massachusetts
United States	South End Community Health Center	Boston	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Boston College	Boston Children's Hospital, East Boston Neighborhood Health Center, Harvard School of Public Health (HSPH), National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Quinn SC, Jamison AM, An J, Hancock GR, Freimuth VS. Measuring vaccine hesitancy, confidence, trust and flu vaccine uptake: Results of a national survey of White and African American adults. Vaccine. 2019 Feb 21;37(9):1168-1173. doi: 10.1016/j.vaccine.2019.01.033. Epub 2019 Jan 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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
Primary	Received influenza vaccine following an eligible behavioral health visit	Binary indicator extracted from EHR	Within 6 weeks of an eligible behavioral health visit
Secondary	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
Secondary	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
Secondary	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