Developing a Clinic-Based, Vaccine-Promoting Intervention for African American Youth in Rural Alabama: Protocol for a Pilot Cluster-Randomized Controlled Implementation Science Trial

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT04604743; https://clinicaltrials.gov/ct2/show/NCT04604743 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/33982