Addressing COVID-19 vaccine hesitancy in rural community pharmacies: a protocol for a stepped wedge randomized clinical trial.

BACKGROUND: Uptake of COVID-19 vaccines remains problematically low in the USA, especially in rural areas. COVID-19 vaccine hesitancy is associated with lower uptake, which translates to higher susceptibility to SARS-CoV-2 variants in communities where vaccination coverage is low. Because community pharmacists are among the most accessible and trusted health professionals in rural areas, this randomized clinical trial will examine implementation strategies to support rural pharmacists in delivering an adapted evidence-based intervention to reduce COVID-19 vaccine hesitancy. METHODS: We will use an incomplete stepped wedge trial design in which we will randomize 30 rural pharmacies (unit of analysis) to determine the effectiveness and incremental cost-effectiveness of a standard implementation approach (consisting of online training that describes the vaccine hesitancy intervention, live webinar, and resource website) compared to adding on a virtual facilitation approach (provided by a trained facilitator in support of the delivery of the vaccine hesitancy counseling intervention by pharmacists). The intervention (ASORT) has been adapted from an evidence-based vaccine communication intervention for HPV vaccines through a partnership with rural pharmacies in a practice-based research network in seven southern US states. ASORT teaches pharmacists how to identify persons eligible for COVID-19 vaccination (including a booster), solicit and address vaccine concerns in a non-confrontational way, recommend the vaccine, and repeat the steps later if needed. The primary trial outcome is fidelity to the ASORT intervention, which will be determined through ratings of recordings of pharmacists delivering the intervention. The secondary outcome is the effectiveness of the intervention, determined by rates of patients who agree to be vaccinated after receiving the intervention. Other secondary outcomes include feasibility, acceptability, adoption, reach, and cost. Cost-effectiveness and budget impact analyses will be conducted to maximize the potential for future dissemination and sustainability. Mixed methods will provide triangulation, expansion, and explanation of quantitative findings. DISCUSSION: This trial contributes to a growing evidence base on vaccine hesitancy interventions and virtual-only facilitation of evidenced-based practices in community health settings. The trial will provide the first estimate of the relative value of different implementation strategies in pharmacy settings. TRIAL REGISTRATION: NCT05926544 (clinicaltrials.gov); 07/03/2023.

Race, Nativity, and Sex Disparities in Human Papillomavirus Vaccination Among Young Adults in the USA.

Research has demonstrated that the human papillomavirus (HPV) vaccine is a safe and effective way to decrease HPV-related cervical cancers; however, the vaccination rate in the USA is suboptimal. The current study examined racial and ethnic disparities in HPV vaccination among a nationally representative sample, including Native Hawaiian and Pacific Islanders (NHPI). This study also investigated the associations between nativity and vaccination, and sex differences between race/ethnicity and vaccination and nativity and vaccination. A cross-sectional study was conducted with a sample of adults aged 18-26 years drawn from the 2014 NHPI National Health Interview Survey (n = 2590) and the general 2014 National Health Interview Survey (n = 36,697). Log-binomial models were fitted to examine differences in vaccination. There was a statistically significant racial/ethnic difference in HPV vaccination (p = 0.003). More women than men were vaccinated (41.8% vs. 10.1%) (p < 0.001). There was a significant difference in HPV vaccination based on nativity: 27.4% of adults aged 18 to 26 years who were born in the USA and 27.7% born in a US territory received the HPV vaccine compared with 14.3% among those not born in the USA or a US territory (p < 0.001). The association of HPV vaccination with nativity and race/ethnicity differed by sex and showed several nuanced differences. Overall, the prevalence of HPV vaccination was low. The study's findings demonstrate the need for public health strategies to increase vaccination rates among all populations, with the critical need to identify strategies that are effective for men, racial/ethnic minorities, and immigrant women born outside the USA.

Development of Community Pharmacy Characteristics Questionnaire: Application of Cognitive Interviewing.

BACKGROUND: A questionnaire specific to community pharmacy characteristics, such as staffing models for clinical activities and business operations, does not exist. As community pharmacy practice expands, it is important to characterize how pharmacies are changing for outcomes research. The aim of this study was to conduct cognitive interviewing with community pharmacists to gain feedback on the formatting, readability, and content of items measuring community pharmacy characteristics to develop such a questionnaire. METHODS: National surveys and previously developed survey work were reviewed to identify the following question categories: business operations, human resource management, division of clinical responsibilities, technology, and enhanced services. Questions for each domain were drafted and assessed for applicability across different states and level of importance by researchers in 3 different states. Using the "think aloud" method of cognitive interviewing to evaluate clarity in instructions, question items and response entry, an iterative process was established that included 3 rounds of interviews with discussion and modifications made by the research team between each round. RESULTS: A total of thirteen cognitive interviews across 3 rounds were conducted via telephone and lasted between 30 and 60 minutes. Time for participant pharmacists to complete the questionnaire ranged from 12 minutes to 30 minutes. The interviews revealed areas of ambiguity, and missing response options for the variety of business structures. The question categories with the most problematic items were business operations, human resource management, and division of clinical responsibilities. CONCLUSION: Using cognitive interviewing, a community pharmacy questionnaire focusing on operational characteristics was developed. Future research is warranted to test the organizational characteristics defined in this paper with a larger sample size representing multiple states.