Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 1, 2021
Open Peer Review Period: Oct 1, 2021 - Nov 26, 2021
Date Accepted: Feb 22, 2022
Date Submitted to PubMed: Feb 25, 2022
(closed for review but you can still tweet)
Developing a clinic-based vaccine promoting intervention for African American adolescents in rural Alabama: protocol for a pilot cluster randomized controlled implementation science trial
ABSTRACT
Background:
Adolescents in rural Alabama are clinically underserved and have limited knowledge about the HPV and COVID-19 vaccines, including risk for developing cervical or oropharyngeal cancers or COVID-19.
Objective:
In this 30-month study, we propose to develop an in-clinic, culturally appropriate 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 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 15-17 year old adolescents. In the third phase, we will conduct a hybrid type 1 effectiveness-implementation cluster randomized control 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:
The study is expected to conclude by the end of 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 adolescents. Clinical Trial: ClinicalTrials.gov Identifier: NCT04604743
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