Vaccine HesitancyMIVacunaNCT06062056
Motivational Interviewing for Vaccine Uptake in Latinx Adults
A study testing EHR alert, Motivational Interviewing and Warm hand off to nurse in people with Vaccine Hesitancy, run by Boston College at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccine Hesitancy
- What is being tested?
- EHR alert, Motivational Interviewing and Warm hand off to nurse
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,698 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Oct 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
South End Community Health Center
Boston, Massachusetts, 02118
East Boston Neighborhood Health Center
Boston, Massachusetts, 02128
About this study
Official title: 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.
Read the 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.
- Conditions
- Vaccine Hesitancy
- Being tested
- EHR alert, Motivational Interviewing, Warm hand off to nurse
- Keywords
- COVID-19, Influenza, Latinx, Behavioral health, Motivational interviewing
- Medical subject headings
- Vaccination Hesitancy, COVID-19, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EHR alertOther
An EHR alert will be fired if a behavioral health patient is missing a COVID-19 or influenza vaccine.
Motivational InterviewingBehavioural
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 nurseBehavioural
For patients interested in vaccination following motivational interviewing, the behavioral health clinician will do a warm hand off to a nurse for vaccination
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Behavioral health clinicians will use motivational interviewing with eligible patients to address vaccine hesitancy Receives: Other: EHR alert; Behavioral: Motivational Interviewing; Behavioral: Warm hand off to nurse |
| Control | No intervention | Control sites will adhere to standard practice in behavioral health sessions (i.e., no discussions about vaccination) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Received COVID-19 vaccine/booster following an eligible behavioral health visit
Binary indicator extracted from EHR
Measured: Within 6 weeks of an eligible behavioral health visit
Received influenza vaccine following an eligible behavioral health visit
Binary indicator extracted from EHR
Measured: Within 6 weeks of an eligible behavioral health visit
Secondary outcomes (3)
Survey measure of vaccine hesitancy
Survey items measuring the 3Cs (complacency, confidence, convenience) of vaccine hesitancy
Measured: Completed within one week of an eligible behavioral health visit
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.
Measured: 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.
Measured: Completed within one week of an eligible behavioral health visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start2 Oct 2023
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Why it stopped: It's focus on vaccine hesitancy did not align with the administration's philosophy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaccine HesitancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A pragmatic multiple-period, cluster-randomized crossover design will be used.
- Masking
- None (open label)
- Enrolment
- 3,698 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston College
- Sponsor type
- University, hospital or other
- Collaborators
- East Boston Neighborhood Health Center, Harvard School of Public Health (HSPH), Boston Children's Hospital, National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Kirsten Davison, PhD, Principal investigator, Boston College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062056
- Sponsor's protocol ID
- 23.049.01
- Other IDs
- 5R01NR020482
- Acronym
- MIVacuna
- Status last verified
- Sep 2025
- First submitted
- 3 Aug 2023
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We submitted our application for review prior to the implementation of the new data sharing guidelines (January 25, 2023)
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.
PubMed 40523466
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Community-based Behavioral Health to Increase Vaccine Uptake in Latinx Adults With Mental Illness
- ClinicalTrials.gov ID
- NCT06062056
- Acronym / sponsor ID
- MIVacuna / 23.049.01
- Conditions
- Vaccine Hesitancy
- Keywords
- COVID-19, Influenza, Latinx, Behavioral health, Motivational interviewing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It's focus on vaccine hesitancy did not align with the administration's philosophy
- Enrolment
- 3,698 participants (actual)
- Lead sponsor
- Boston CollegeUniversity, hospital or other
- Collaborators
- East Boston Neighborhood Health Center, Harvard School of Public Health (HSPH), Boston Children's Hospital, National Institute of Nursing Research (NINR)
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A pragmatic multiple-period, cluster-randomized crossover design will be used.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: EHR alert, Behavioral: Motivational Interviewing, Behavioral: Warm hand off to nurseBehavioral health clinicians will use motivational interviewing with eligible patients to address vaccine hesitancy |
| Control | No intervention | –Control sites will adhere to standard practice in behavioral health sessions (i.e., no discussions about vaccination) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EHR alertAn EHR alert will be fired if a behavioral health patient is missing a COVID-19 or influenza vaccine. | Other | Intervention |
| Motivational InterviewingIn 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). | Behavioural | Intervention |
| Warm hand off to nurseFor patients interested in vaccination following motivational interviewing, the behavioral health clinician will do a warm hand off to a nurse for vaccination | Behavioural | Intervention |
Primary outcome
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
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
3 secondary outcomes
Survey measure of vaccine hesitancy
Time frame: Completed within one week of an eligible behavioral health visit
Survey measure of provider trust
Time frame: Completed within one week of an eligible behavioral health visit
Survey measure of vaccination intention
Time frame: Completed within one week of an eligible behavioral health visit
Results and safety
The study was stopped early (reason given: It's focus on vaccine hesitancy did not align with the administration's philosophy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Background: PubMed 40523466Scrivano 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.
- Research team websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. We submitted our application for review prior to the implementation of the new data sharing guidelines (January 25, 2023)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Davison, PhD principal investigator
Boston College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EHR alert, Motivational Interviewing and Warm hand off to nurse in people with Vaccine Hesitancy, run by Boston College at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: It's focus on vaccine hesitancy did not align with the administration's philosophy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Received COVID-19 vaccine/booster following an eligible behavioral health visit (time frame: Within 6 weeks of an eligible behavioral health visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06062056, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.