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Clinical Trials/NCT06062056
NCT06062056TerminatedNot Applicable

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

Boston College4 sites in 1 country3,698 target enrollmentStarted: October 2, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
3,698
Locations
4
Primary Endpoint
Received influenza vaccine following an eligible behavioral health visit

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Received influenza vaccine following an eligible behavioral health visit

Time Frame: Within 6 weeks of an eligible behavioral health visit

Binary indicator extracted from EHR

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

Time Frame: Within 6 weeks of an eligible behavioral health visit

Binary indicator extracted from EHR

Secondary Outcomes

  • Survey measure of vaccine hesitancy(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)
  • Survey measure of provider trust(Completed within one week of an eligible behavioral health visit)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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