Vaccination HesitancyCOVID-19NCT05977192
Mobile Health-based Motivational Interviewing to Promote COVID-19 Vaccination
A study testing Standard MI, Intensive MI and MOTIVACC in people with Vaccination Hesitancy, run by Oklahoma State University at 2 sites in United States.
Trial summary
The objective of this study is to evaluate the preliminary efficacy and acceptability of an mobile Health-based motivational interviewing (MI) intervention to promote SARS-CoV-2 vaccination (MOTIVACC) compared to traditional phone-based MI. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccination Hesitancy
- What is being tested?
- Standard MI, Intensive MI and MOTIVACC
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2024to 1 Mar 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
Who may be able to join
- >18 years
- Reside in a rural area
- No previous dose of a SARS-CoV-2 vaccine
- Speak English
- Able to provide informed consent
Who cannot join
- A cognitive or other disability that inhibits smart phone use
- Inability to participate because of medical or psychiatric conditions diagnosed by a physician/clinician
- Enrollment in other COVID-19 research; pregnant or lactating
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Oklahoma State University
Stillwater, Oklahoma, 74078
About this study
Official title: Mobile Health-based Motivational Interviewing to Promote Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccination in Oklahomans
The objective of this study is to evaluate the preliminary efficacy and acceptability of an mobile Health-based motivational interviewing (MI) intervention to promote SARS-CoV-2 vaccination (MOTIVACC) compared to traditional phone-based MI.
- Conditions
- Vaccination Hesitancy
- Being tested
- Standard MI, Intensive MI, MOTIVACC, Ecological momentary assessment (EMA) messages
- Medical subject headings
- Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard MIBehavioural
One phone-based MI session
Intensive MIBehavioural
Four phone-based MI sessions
MOTIVACCBehavioural
mHealth-based MI
Ecological momentary assessment (EMA) messagesBehavioural
EMA messages focused on vaccinations and health
| Study group | Role | What they receive |
|---|---|---|
| Standard MI | Experimental | Not described Receives: Behavioral: Standard MI; Behavioral: Ecological momentary assessment (EMA) messages |
| Intensive MI | Experimental | Not described Receives: Behavioral: Intensive MI; Behavioral: Ecological momentary assessment (EMA) messages |
| MOTIVACC | Experimental | Not described Receives: Behavioral: MOTIVACC; Behavioral: Ecological momentary assessment (EMA) messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in vaccine hesitancy and confidence
Measured: Baseline and follow-up (8 weeks)
Changes in intention to receive the vaccine
Measured: Baseline and follow-up (8 weeks)
Secondary outcomes (5)
Changes in expectations related to vaccines
Measured: Baseline and follow-up (8 weeks)
Changes in self-efficacy
Measured: Baseline and follow-up (8 weeks)
Changes in ambivalence
Measured: Baseline and follow-up (8 weeks)
Changes in value-behavior discrepancy
Measured: Baseline and follow-up (8 weeks)
Number of participants who receive the COVID-19 vaccine
Measured: Follow-up (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Apr 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
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 Vaccination 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oklahoma
- Responsible party
- Principal investigator, Ashlea Braun, Oklahoma State University Center for Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977192
- Sponsor's protocol ID
- IRB-22-282-STW
- Acronym
- COVID-19
- Status last verified
- Mar 2025
- First submitted
- 30 Jul 2023
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Braun A, Corcoran S, Tu Doan K, Jernigan C, Moriasi C, Businelle M, Bui T. Mobile Health-Based Motivational Interviewing to Promote SARS-CoV-2 Vaccination in Rural Adults: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 28;14:e64010. doi: 10.2196/64010.
PubMed 40294409
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Health-based Motivational Interviewing to Promote Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccination in Oklahomans
- ClinicalTrials.gov ID
- NCT05977192
- Acronym / sponsor ID
- COVID-19 / IRB-22-282-STW
- Conditions
- Vaccination Hesitancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Oklahoma State UniversityUniversity, hospital or other
- Collaborators
- University of Oklahoma
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 4 Aug 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 objective of this study is to evaluate the preliminary efficacy and acceptability of an mobile Health-based motivational interviewing (MI) intervention to promote SARS-CoV-2 vaccination (MOTIVACC) compared to traditional phone-based MI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard MI | Experimental | Behavioral: Standard MI, Behavioral: Ecological momentary assessment (EMA) messages |
| Intensive MI | Experimental | Behavioral: Intensive MI, Behavioral: Ecological momentary assessment (EMA) messages |
| MOTIVACC | Experimental | Behavioral: MOTIVACC, Behavioral: Ecological momentary assessment (EMA) messages |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >18 years
- Reside in a rural area
- No previous dose of a SARS-CoV-2 vaccine
- Speak English
- Able to provide informed consent
Key exclusion criteria (3 listed)
- A cognitive or other disability that inhibits smart phone use
- Inability to participate because of medical or psychiatric conditions diagnosed by a physician/clinician
- Enrollment in other COVID-19 research; pregnant or lactating
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 |
|---|---|---|
| Standard MIOne phone-based MI session | Behavioural | Standard MI |
| Intensive MIFour phone-based MI sessions | Behavioural | Intensive MI |
| MOTIVACCmHealth-based MI | Behavioural | MOTIVACC |
| Ecological momentary assessment (EMA) messagesEMA messages focused on vaccinations and health | Behavioural | Intensive MI, MOTIVACC, Standard MI |
Primary outcome
Changes in vaccine hesitancy and confidence
Time frame: Baseline and follow-up (8 weeks)
Changes in intention to receive the vaccine
Time frame: Baseline and follow-up (8 weeks)
5 secondary outcomes
Changes in expectations related to vaccines
Time frame: Baseline and follow-up (8 weeks)
Changes in self-efficacy
Time frame: Baseline and follow-up (8 weeks)
Changes in ambivalence
Time frame: Baseline and follow-up (8 weeks)
Changes in value-behavior discrepancy
Time frame: Baseline and follow-up (8 weeks)
Number of participants who receive the COVID-19 vaccine
Time frame: Follow-up (8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Derived from this study: PubMed 40294409Braun A, Corcoran S, Tu Doan K, Jernigan C, Moriasi C, Businelle M, Bui T. Mobile Health-Based Motivational Interviewing to Promote SARS-CoV-2 Vaccination in Rural Adults: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 28;14:e64010. doi: 10.2196/64010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard MI, Intensive MI and MOTIVACC in people with Vaccination Hesitancy, run by Oklahoma State University 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?
The sponsor lists 5 inclusion and 3 exclusion criteria. 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: finished, as of the sponsor's last update on 21 Mar 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in vaccine hesitancy and confidence (time frame: Baseline and follow-up (8 weeks)). 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 NCT05977192, 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 21 Mar 2025.