Braun Ashlea, Corcoran Sarah, Tu Doan Khue, Jernigan Cameron, Moriasi Cate, Businelle Michael, Bui Thanh
Health Promotion Sciences, Hudson College of Public Health, University of Oklahoma Health Sciences, Tulsa, OK, United States.
Department of Nutritional Sciences, Oklahoma State University, Stillwater, OK, United States.
JMIR Res Protoc. 2025 Apr 28;14:e64010. doi: 10.2196/64010.
Despite documented effectiveness, the public health impact of vaccinations is severely limited by misperceptions, hesitancy, and poor acceptance. Messaging from health care providers has not yet been optimized to overcome these barriers and has not been tailored to groups that face health disparities, such as rural Americans. Because vaccines have become controversial, as illustrated by the public response to the SARS-CoV-2 vaccines, traditional approaches that use persuasive education or advice to change perspectives are unlikely to have long-term effects and may even be counterproductive. Alternatively, motivational interviewing (MI) is a conversational approach to address modifiable behavior and its empathic nature can be useful when navigating challenging topics. Although MI has been found to be efficacious in improving vaccination rates among children and adolescents, it is unknown whether MI can reduce vaccine hesitancy and health disparities among underserved rural adults. Further, the ideal mode of delivery for MI is unknown, especially "dose," "intensity," and integration with mobile health (mHealth). Therefore, it is essential to investigate the efficacy of MI in promoting vaccine uptake in rural populations to reduce health disparities.
This study aims to develop and evaluate the feasibility, acceptability, and preliminary efficacy of our mHealth-based MI intervention to diminish SARS-CoV-2 vaccine hesitancy (MOTIVACC).
This pilot study uses mixed methods. A 2-phase study will be conducted: convening a community advisory panel to understand barriers and facilitators to vaccination and mHealth uptake among adults (phase 1, n=16-20), and a pilot 3-group single-blind randomized controlled trial (RCT) for 8 weeks (phase 2, N=60). In the RCT, we recruit adults who have received no previous dose of the COVID-19 vaccine and randomize them into one of three arms: standard MI (SMI; n=20), intensive MI (IMI; n=20), or mHealth-based MOTIVACC (n=20). The primary RCT outcomes are positive change in vaccine hesitancy and intention to obtain the vaccines, measured on Likert scales. The secondary RCT outcome is the actual vaccine receipt.
Phase 1 of this study was approved by the ethics committees of both the University of Oklahoma and Oklahoma State University in July 2022, and was completed in June 2023. Phase 2 of this study was approved by the ethics committee at the University of Oklahoma in April 2024.
This randomized trial will evaluate the preliminary efficacy of MI for targeting SARS-CoV-2 vaccine hesitancy, as well as compare traditional MI versus mHealth-based MI. This will provide pivotal data on scalable strategies to assist in navigating vaccine hesitancy, including in rural populations.
ClinicalTrials.gov NCT05977192; https://clinicaltrials.gov/study/NCT05977192.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/64010.
尽管疫苗接种已被证明有效，但其对公共卫生的影响却因误解、犹豫和接受度低而受到严重限制。医疗保健提供者传递的信息尚未得到优化，无法克服这些障碍，也未针对面临健康差异的群体进行调整，比如美国农村地区的居民。由于疫苗已引发争议，如公众对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）疫苗的反应所示，采用说服性教育或建议来改变观念的传统方法不太可能产生长期效果，甚至可能适得其反。相比之下，动机性访谈（MI）是一种用于解决可改变行为的对话方式，其共情性质在处理具有挑战性的话题时可能会有所帮助。虽然已发现动机性访谈在提高儿童和青少年的疫苗接种率方面有效，但尚不清楚它是否能减少农村地区未得到充分服务的成年人的疫苗犹豫情绪和健康差异。此外，动机性访谈的理想实施方式尚不清楚，尤其是“剂量”“强度”以及与移动健康（mHealth）的整合。因此，研究动机性访谈在促进农村人口接种疫苗以减少健康差异方面的效果至关重要。
本研究旨在开发并评估基于移动健康的动机性访谈干预措施（MOTIVACC）以减少SARS-CoV-2疫苗犹豫情绪的可行性、可接受性和初步效果。
本试点研究采用混合方法。将进行一项两阶段研究：召集一个社区咨询小组，以了解成年人接种疫苗和采用移动健康的障碍与促进因素（第一阶段，n = 16 - 20），以及一项为期8周的试点三臂单盲随机对照试验（RCT）（第二阶段，N = 60）。在随机对照试验中，我们招募从未接种过2019冠状病毒病疫苗的成年人，并将他们随机分为三个组之一：标准动机性访谈组（SMI；n = 20）、强化动机性访谈组（IMI；n = 20）或基于移动健康的MOTIVACC组（n = 20）。随机对照试验的主要结局是用李克特量表衡量的疫苗犹豫情绪的积极变化以及接种疫苗的意愿。随机对照试验的次要结局是实际接种疫苗情况。
本研究的第一阶段于2022年7月获得俄克拉荷马大学和俄克拉荷马州立大学伦理委员会的批准，并于2023年6月完成。本研究的第二阶段于2024年4月获得俄克拉荷马大学伦理委员会的批准。
这项随机试验将评估动机性访谈针对SARS-CoV-2疫苗犹豫情绪的初步效果，并比较传统动机性访谈与基于移动健康的动机性访谈。这将为协助应对疫苗犹豫情绪（包括农村人口中的疫苗犹豫情绪）的可扩展策略提供关键数据。
ClinicalTrials.gov NCT05977192；https://clinicaltrials.gov/study/NCT05977192。
国际注册报告识别码（IRRID）：DERR1-10.2196/64010。
