Real-world data to evaluate effects of a multi-level dissemination strategy on access, outcomes, and equity of monoclonal antibodies for COVID-19.

Introduction: Multi-level dissemination strategies are needed to increase equitable access to effective treatment for high-risk outpatients with COVID-19, particularly among patients from disproportionately affected communities. Yet assessing population-level impact of such strategies can be challenging. Methods: In collaboration with key contributors in Colorado, we conducted a retrospective cohort study to evaluate a multi-level dissemination strategy for neutralizing monoclonal antibody (mAb) treatment. Real-world data included county-level, de-identified output from a statewide mAb referral registry linked with publicly available epidemiological data. Outcomes included weekly number of mAb referrals, unique referring clinicians, and COVID-19 hospitalization rates. We assessed weekly changes in outcomes after dissemination strategies launched in July 2021. Results: Overall, mAb referrals increased from a weekly average of 3.0 to 15.5, with an increase of 1.3 to 42.1 additional referrals per county in each post-period week (p < .05). Number of referring clinicians increased from a weekly average of 2.2 to 9.7, with an additional 1.5 to 22.2 unique referring clinicians observed per county per week beginning 5 weeks post-launch (p < .001). Larger effects were observed in communities specifically prioritized by the dissemination strategies. There were no observed differences in COVID-19 hospitalization rates between counties with and without mAb treatment sites. Conclusion: Real-world data can be used to estimate population impact of multi-level dissemination strategies. The launch of these strategies corresponded with increases in mAb referrals, but no apparent population-level effects on hospitalization outcomes. Strengths of this analytic approach include pragmatism and efficiency, whereas limitations include inability to control for other contemporaneous trends.

"All of the things to everyone everywhere": A mixed methods analysis of community perspectives on equitable access to monoclonal antibody treatment for COVID-19.

BACKGROUND: Neutralizing monoclonal antibody (mAb) treatment for COVID-19 prevents hospitalization and death but is underused, especially in racial/ethnic minority and rural populations. Reasons for underuse and inequity may include community member lack of awareness or healthcare access barriers, among others. This study assessed mAbs community awareness and opportunities for improving equitable mAb access. METHODS: A concurrent mixed methods study including surveys and focus groups with adults with high-risk conditions or their proxy decision-makers. Surveys and focus group guides addressed diffusion of innovation theory factors. Descriptive statistics and Fisher's exact method was used to report and compare survey findings by race and ethnicity. Rapid qualitative methods were used for focus group analysis. RESULTS: Surveys from 515 individuals (460 English, 54 Spanish, 1 Amharic), and 8 focus groups (6 English, 2 Spanish) with 69 participants, completed June 2021 to January 2022. Most survey respondents (75%) had heard little or nothing about mAbs, but 95% would consider getting mAb treatment. Hispanic/Latino and Non-Hispanic People of Color (POC) reported less awareness, greater concern about intravenous infusions, and less trust in mAb safety and effectiveness than White, Non-Hispanic respondents. Focus group themes included little awareness but high interest in mAb treatment and concerns about cost and access barriers such as lacking established sources of care and travel from rural communities. Focus groups revealed preferences for broad-reaching but tailored messaging strategies using multiple media and trusted community leaders. CONCLUSIONS: Despite unfamiliarity with mAb treatment, most respondents were open to receiving mAbs or recommending mAbs to others. While mAb messaging should have broad reach "to everyone everywhere," racial and geographic disparities in awareness and trust about mAbs underscore need for tailored messaging to promote equitable access. Care processes should address patient-level barriers like transportation, insurance, or primary care access. COVID-19 treatment dissemination strategies should promote health equity.

Clinician Perspectives on Monoclonal Antibody Treatment for High-Risk Outpatients with COVID-19: Implications for Implementation and Equitable Access.

BACKGROUND: There is an urgent need to identify and address factors influencing uptake and equitable access to monoclonal antibody (mAb) treatment for high-risk outpatients with COVID-19. OBJECTIVE: To assess clinician knowledge, beliefs, and experiences regarding obtaining mAb treatment for eligible patients. DESIGN AND PARTICIPANTS: Survey of clinicians (N = 374) practicing in the state of Colorado who care for patients with COVID-19 in primary care, emergency medicine, and other clinical settings. MAIN MEASURE(S): Diffusion of innovation theory concepts including knowledge, perceived strength of evidence, barriers, and experience with, ease of use, preparedness, and feasibility, appropriateness, and acceptability of mAb referral systems and processes. KEY RESULTS: Most respondents indicated little to no knowledge about mAb therapies for COVID-19 (67%, 74%, 77%, for bamlanivimab, bamlanivimab+etesivimab, and casirivimab+imdevimab, respectively). About half reported little to no familiarity with eligibility criteria (50.9%) and did not know the strength of evidence (31%, 43%, 52%, for bamlanivimab, bamlanivimab+etesivimab, and casirivimab+imdevimab, respectively). Lack of knowledge or confidence in treatment was a top barrier to mAbs use; other barriers included complicated referral processes, patients not eligible when seen, and out-of-pocket costs concerns. Respondents rated four mAb referral steps as generally acceptable, appropriate, and feasible to complete in their primary outpatient clinical setting. Only 24% indicated their clinical setting was very prepared to facilitate referrals, 40% had ever referred a patient for mAbs, and 43% intended to refer a patient in the next month. CONCLUSIONS: Clinician education on strength of evidence and eligibility criteria for mAbs is needed. However, education alone is not sufficient. Given the urgent need to rapidly scale up access to treatment and reduce hospitalizations and death from COVID-19, more efficient, equitable systems and processes for referral and delivery of care, such as those coordinated by health systems, public health departments, or disaster management services, are warranted.