Development of a core outcome set for studies investigating safety, efficacy, and implementation of COVID-19 vaccines: A collaboration with African American/Black communities in Baltimore City, Maryland

Background: Since it was declared a global pandemic in March 2020, Coronavirus Disease 2019 (COVID-19) has claimed over one million lives in the United States. Since COVID-19 vaccine rollout efforts began in Baltimore City, Maryland in December 2020, approximately 63.4% of all residents have been fully vaccinated (i.e., received their first and second doses in a two-dose series or received a single-dose vaccine). Despite efforts to implement equitable vaccine distribution in Baltimore City, prominent disparities in COVID-19 vaccine uptake persist, with poorer, predominantly Black neighborhoods frequently reporting lower levels of vaccine uptake than affluent, predominantly White neighborhoods. Guided by key principles of community-based participatory research, this dissertation explores community experiences with COVID-19 vaccines and develops a core outcome set (COS), inclusive of community-important outcomes, for use in studies evaluating the safety, efficacy, and implementation of COVID-19 vaccines. Methods: In March 2022, semi-structured interviews were held with vaccinated and unvaccinated Black residents of a community in Baltimore City reporting 40% vaccination uptake. Data were analyzed using inductive thematic analysis with subsequent subgroup analyses and thematic network analyses. To assess the extent to which outcomes measured in COVID-19 vaccine studies published between December 2019 and March 2022 aligned with factors of vaccine hesitancy, a systematic literature review (SLR) was conducted. Results from the qualitative analyses and the SLR informed the development of a candidate list of outcomes used in the first round of a Delphi study held in June 2020. After two rounds of Delphi survey distribution, a face-to-face consensus meeting was held with community members and community health workers to prioritize outcomes of interest to all relevant stakeholders and finalize the COS. Results: Thematic analysis yielded four emergent themes relating to COVID-19 vaccine uptake decision making: (I) Safety and efficacy of vaccines, (II) Perceived importance of COVID-19 vaccines in relation to pre-existing community needs, divided into two subthemes, a) Environmental injustice and (b) Personal health concerns, (III) Access to trustworthy, understandable information, and (IV) Physical access to vaccines. Participants acknowledged that physical access to COVID-19 vaccines was not a major barrier to uptake, however finding trustworthy and understandable information about the safety and efficacy of the vaccines were common areas of concern. Of all primary outcomes (N=20) identified in the 56 articles included in the SLR, 85% (n=17) corresponded with factors of vaccine hesitancy. The final COS included 19 outcomes across four "domains:" "Is the vaccine safe?";"Does the vaccine work in my body?";"Does the vaccine work in the community?";and "Outcomes identified during consensus meeting." Conclusion: The findings from this dissertation suggest that although community-important outcomes related to safety and efficacy of vaccines are often addressed in clinical studies, outcomes measuring institutional trust, economic and health impacts, community acceptance of the vaccines, and trustworthiness of vaccine information are underutilized in studies of vaccine implementation. As these social factors function as barriers to vaccine uptake, particularly among underserved communities, they should be regarded as indicators of equitable access to COVID-19 vaccines. The findings from this dissertation provide a framework with which public health researchers can begin to rethink measures of equity in vaccine rollout efforts. (PsycInfo Database Record (c) 2023 APA, all rights reserved)

Factors associated with COVID-19 vaccination during June-October 2021: A multi-site prospective study.

INTRODUCTION: Vaccine hesitancy presents a challenge to COVID-19 control efforts. To identify beliefs associated with delayed vaccine uptake, we developed and implemented a vaccine hesitancy survey for the COVID-19 Community Research Partnership. METHODS: In June 2021, we assessed attitudes and beliefs associated with COVID-19 vaccination using an online survey. Self-reported vaccination data were requested daily through October 2021. We compared responses between vaccinated and unvaccinated respondents using absolute standardized mean differences (ASMD). We assessed validity and reliability using exploratory factor analysis and identified latent factors associated with a subset of survey items. Cox proportional hazards models and mediation analyses assessed predictors of subsequent vaccination among those initially unvaccinated. RESULTS: In June 2021, 29,522 vaccinated and 1,272 unvaccinated participants completed surveys. Among those unvaccinated in June 2021, 559 (43.9 %) became vaccinated by October 31, 2021. In June, unvaccinated participants were less likely to feel "very concerned" about getting COVID-19 than vaccinated participants (10.6 % vs. 43.3 %, ASMD 0.792). Among those initially unvaccinated, greater intent to become vaccinated was associated with getting vaccinated and shorter time to vaccination. However, even among participants who reported no intention to become vaccinated, 28.5 % reported vaccination before study end. Two latent factors predicted subsequent vaccination-being 'more receptive' was derived from motivation to protect one's own or others' health and resume usual activities; being 'less receptive' was derived from concerns about COVID-19 vaccines. In a Cox model, both factors were partially mediated by vaccination intention. CONCLUSION: This study characterizes vaccine hesitant individuals and identifies predictors of eventual COVID-19 vaccination through October 31, 2021. Even individuals with no intention to be vaccinated can shift to vaccine uptake. Our data suggest factors of perceived severity of COVID-19 disease, vaccine safety, and trust in the vaccine development process are predictive of vaccination and may be important opportunities for ongoing interventions.

Factors associated with COVID-19 vaccination during June–October, 2021: a multi-site prospective study

Introduction Vaccine hesitancy presents a challenge to COVID-19 control efforts. To identify beliefs associated with delayed vaccine uptake, we developed and implemented a vaccine hesitancy survey for the COVID-19 Community Research Partnership. Methods In June 2021, we assessed attitudes and beliefs associated with COVID-19 vaccination using an online survey. Self-reported vaccination data were requested daily through October 2021. We compared responses between vaccinated and unvaccinated respondents using absolute standardized mean differences (ASMD). We assessed validity and reliability using exploratory factor analysis and identified latent factors associated with a subset of survey items. Cox proportional hazards models and mediation analyses assessed predictors of subsequent vaccination among those initially unvaccinated. Results In June 2021, 29,522 vaccinated and 1,272 unvaccinated participants completed surveys. Among those unvaccinated in June 2021, 559 (43.9%) became vaccinated by October 31, 2021. In June, unvaccinated participants were less likely to feel "very concerned” about getting COVID-19 than vaccinated participants (10.6% vs. 43.3%, ASMD 0.792). Among those initially unvaccinated, greater intent to become vaccinated was associated with getting vaccinated and shorter time to vaccination. However, even among participants who reported no intention to become vaccinated, 28.5% reported vaccination before study end. Two latent factors predicted subsequent vaccination—being ‘more receptive' was derived from motivation to protect one's own or others' health and resume usual activities;being ‘less receptive' was derived from concerns about COVID-19 vaccines. In a Cox model, both factors were partially mediated by vaccination intention. Conclusion This study characterizes vaccine hesitant individuals and identifies predictors of eventual COVID-19 vaccination through October 31, 2021. Even individuals with no intention to be vaccinated can shift to vaccine uptake. Our data suggest factors of perceived severity of COVID-19 disease, vaccine safety, and trust in the vaccine development process are predictive of vaccination and may be important opportunities for ongoing interventions.