Clinical trial NCT06062056: Motivational Interviewing for Vaccine Uptake in Latinx Adults
Official title: Leveraging Community-based Behavioral Health to Increase Vaccine Uptake in Latinx Adults With Mental Illness
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Vaccine Hesitancy
Keywords: COVID-19
Influenza
Latinx
Behavioral health
Motivational interviewing
Lead sponsor: Boston College
Sponsor class: OTHER
Collaborators: name: East Boston Neighborhood Health Center
name: Harvard School of Public Health (HSPH)
name: Boston Children's Hospital
name: National Institute of Nursing Research (NINR)
First posted: 2023-10-02
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A pragmatic multiple-period, cluster-randomized crossover design will be used.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Received COVID-19 vaccine/booster following an eligible behavioral health visit
timeFrame: Within 6 weeks of an eligible behavioral health visit
measure: Received influenza vaccine following an eligible behavioral health visit
timeFrame: Within 6 weeks of an eligible behavioral health visit
Secondary outcomes:
measure: Survey measure of vaccine hesitancy
timeFrame: Completed within one week of an eligible behavioral health visit
measure: Survey measure of provider trust
timeFrame: Completed within one week of an eligible behavioral health visit
measure: Survey measure of vaccination intention
timeFrame: Completed within one week of an eligible behavioral health visit
Other outcomes:
measure: COVID-19 vaccine series initiation (at least one dose of the vaccine)
timeFrame: 12 month intervals over a total of 48 months
measure: Up to date with COVID-19 vaccination (consistent with CDC guidelines)
timeFrame: 12 month intervals over a total of 48 months
measure: Up to date with influenza vaccine; received vaccine for current season (consistent with CDC guidelines)
timeFrame: 12 month intervals over a total of 48 months
Locations:
city: Boston
country: United States
facility: South End Community Health Center
state: Massachusetts
city: Boston
country: United States
facility: East Boston Neighborhood Health Center
state: Massachusetts
Study officials:
affiliation: Boston College
name: Kirsten Davison, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.