JMIR Res Protoc. 2022 Feb 22. doi: 10.2196/33982. Online ahead of print.

ABSTRACT

BACKGROUND: African American adolescents in rural Alabama are clinically underserved and have limited knowledge about the human papillomavirus HPV and coronavirus disease 2019 (COVID-19) vaccines, including risk for developing cervical or oropharyngeal cancers or the novel coronavirus.

OBJECTIVE: In this 30-month study, we propose to develop an in-clinic, youth-tailored vaccine promoting intervention, targeting vaccine hesitancy reduction, that can be seamlessly integrated into the existing environment of pediatric and family practice settings in rural Alabama.

METHODS: This exploratory sequential mixed-methods study will be conducted in three phases. In the first phase, we will assess stakeholders’ knowledge, sentiments, and beliefs related to vaccination in general, COVID-19 vaccination, and HPV 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 non-invasive, modular synchronous counseling intervention targeting behaviors of 15-17 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 (N=4 clinics; N=120 African American adolescents), while assessing a “clinical signal” of effectiveness. We will document implementation contexts to provide real-world insight to support dissemination and scale up.

RESULTS: This 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 outlined in the first phase of this project concluded in November 2021. The entire study is expected to complete at the end of December 2023.

CONCLUSIONS: The results of this trial will provide much needed information on vaccine hesitancy in rural Alabama, and if found efficacious, this intervention could notably increase rates of vaccinations in one of the most underserved parts of the United States. Results from the trial will provide information that is valuable to public health practitioners and providers in rural settings to inform their efforts designed to increase vaccination among 15-17 year old African American adolescents in the rural southern United States.

CLINICALTRIAL: ClinicalTrials.gov Identifier: NCT04604743.

INTERNATIONAL REGISTERED REPORT: DERR1-10.2196/33982.

PMID:35212640 | DOI:10.2196/33982