NCT05977192

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

11 months

First QC Date

July 30, 2023

Last Update Submit

March 17, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Changes in vaccine hesitancy and confidence

    Baseline and follow-up (8 weeks)

  • Changes in intention to receive the vaccine

    Baseline and follow-up (8 weeks)

Secondary Outcomes (5)

  • Changes in expectations related to vaccines

    Baseline and follow-up (8 weeks)

  • Changes in self-efficacy

    Baseline and follow-up (8 weeks)

  • Changes in ambivalence

    Baseline and follow-up (8 weeks)

  • Changes in value-behavior discrepancy

    Baseline and follow-up (8 weeks)

  • Number of participants who receive the COVID-19 vaccine

    Follow-up (8 weeks)

Other Outcomes (1)

  • Percentage of total of ecological momentary assessment messages opened/viewed

    8 weeks (from baseline to follow up)

Study Arms (3)

Standard MI

EXPERIMENTAL
Behavioral: Standard MIBehavioral: Ecological momentary assessment (EMA) messages

Intensive MI

EXPERIMENTAL
Behavioral: Intensive MIBehavioral: Ecological momentary assessment (EMA) messages

MOTIVACC

EXPERIMENTAL
Behavioral: MOTIVACCBehavioral: Ecological momentary assessment (EMA) messages

Interventions

Standard MIBEHAVIORAL

One phone-based MI session

Standard MI
Intensive MIBEHAVIORAL

Four phone-based MI sessions

Intensive MI
MOTIVACCBEHAVIORAL

mHealth-based MI

MOTIVACC

EMA messages focused on vaccinations and health

Intensive MIMOTIVACCStandard MI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years
  • Reside in a rural area
  • No previous dose of a SARS-CoV-2 vaccine
  • Speak English
  • Able to provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Oklahoma State University

Stillwater, Oklahoma, 74078, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Vaccination Hesitancy

Interventions

Ecological Momentary Assessment

Condition Hierarchy (Ancestors)

Vaccination RefusalTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 30, 2023

First Posted

August 4, 2023

Study Start

April 1, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

March 21, 2025

Record last verified: 2025-03

Locations