Budhwani Henna, Sharma Vinita, Long Dustin, Simpson Tina
Department of Health Policy and Organization, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, United States.
Department of Epidemiology, College of Public Health and Health Professions and College of Medicine, University of Florida, Gainesville, FL, United States.
JMIR Res Protoc. 2022 Apr 8;11(4):e33982. doi: 10.2196/33982.
African American youth in rural Alabama are clinically underserved and have limited knowledge about the human papillomavirus and the novel coronavirus 2019 (COVID-19) vaccines, including knowledge about the risk for developing cervical or oropharyngeal cancers or COVID-19.
In this 30-month study, we propose to develop an in-clinic, youth-tailored, vaccine-promoting intervention for vaccine hesitancy reduction that can be seamlessly integrated into the existing environments of pediatric and family practice settings in rural Alabama.
This exploratory, sequential mixed methods study will be conducted in 3 phases. In the first phase, we will assess stakeholders' knowledge, sentiments, and beliefs related to vaccination in general, COVID-19 vaccination, and human papillomavirus vaccination. We will also assess stakeholders' perceptions of barriers to vaccination that exist in rural Alabama. This will be followed by a second phase wherein we will use the data collected in the first phase to inform the development and finalization of a noninvasive, modular, synchronous counseling intervention that targets the behaviors of 15- to 26-year-old adolescents. In the third phase, we will conduct a pilot hybrid type 1 effectiveness-implementation cluster-randomized controlled trial to assess intervention acceptability and feasibility (clinics: N=4; African American youth: N=120) while assessing a "clinical signal" of effectiveness. We will document implementation contexts to provide real-world insight and support dissemination and scale-up.
The study was funded at the end of December 2020. Approval from the University of Alabama at Birmingham Institutional Review Board was obtained in May 2021, and the qualitative data collection process outlined in the first phase of this project concluded in November 2021. The entire study is expected to be complete at the end of December 2023.
The results of the trial will provide much needed information on vaccine hesitancy in rural Alabama, and if found efficacious, the intervention could notably increase rates of vaccinations in one of the most underserved parts of the United States. The results from the trial will provide information that is valuable to public health practitioners and providers in rural settings to inform their efforts in increasing vaccination rates among 15- to 26-year-old African American youth in rural southern United States.
ClinicalTrials.gov NCT04604743; https://clinicaltrials.gov/ct2/show/NCT04604743.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/33982.
阿拉巴马州农村地区的非裔美国青年在临床医疗服务方面存在不足，对人乳头瘤病毒和2019年新型冠状病毒（COVID-19）疫苗的了解有限，包括对患宫颈癌或口咽癌风险以及COVID-19的了解。
在这项为期30个月的研究中，我们提议开发一种针对诊所的、适合青年的、促进疫苗接种的干预措施，以减少疫苗犹豫现象，该措施可无缝融入阿拉巴马州农村地区儿科和家庭医疗诊所的现有环境。
这项探索性的序贯混合方法研究将分三个阶段进行。在第一阶段，我们将评估利益相关者对一般疫苗接种、COVID-19疫苗接种和人乳头瘤病毒疫苗接种的知识、看法和信念。我们还将评估利益相关者对阿拉巴马州农村地区存在的疫苗接种障碍的认知。接下来是第二阶段，我们将利用第一阶段收集的数据，为针对15至26岁青少年行为的非侵入性、模块化、同步咨询干预措施的开发和完善提供信息。在第三阶段，我们将进行一项试点混合1型有效性-实施整群随机对照试验，以评估干预措施的可接受性和可行性（诊所：N = 4；非裔美国青年：N = 120），同时评估有效性的“临床信号”。我们将记录实施情况，以提供实际见解，并支持传播和扩大规模。
该研究于2020年12月底获得资助。2021年5月获得了阿拉巴马大学伯明翰分校机构审查委员会的批准，该项目第一阶段概述的定性数据收集过程于2021年11月结束。整个研究预计于2023年12月底完成。
该试验的结果将提供阿拉巴马州农村地区急需的关于疫苗犹豫的信息，如果发现有效，该干预措施可能会显著提高美国服务最不足地区之一的疫苗接种率。该试验的结果将为农村地区的公共卫生从业者和提供者提供有价值的信息，以指导他们提高美国南部农村地区15至26岁非裔美国青年疫苗接种率的努力。
ClinicalTrials.gov NCT04604743；https://clinicaltrials.gov/ct2/show/NCT04604743。
国际注册报告识别码（IRRID）：DERR1-10.2196/33982。
