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

Abstract

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.