Improving Research Dissemination to Black Sexual Minority Men: Development of a Community-Led and Theory-Based Dissemination Plan.

Background. Although research dissemination to participants and community stakeholders is a fundamental component of translational research, it rarely occurs. The objective of this study was to create a community-led, theory-based dissemination plan to engage local Black sexual minority men in an active dissemination process throughout a sexual health research study. Method. Seven focus groups (N = 38) were conducted with Black, cisgender sexual minority men aged 18 to 45 years. Findings were analyzed through thematic content analysis guided by McGuire's persuasive communication theory. Findings were used to draft a dissemination plan, which was then reviewed and edited by the study's community advisory board (CAB). The plan continues to be updated in response to community needs through CAB discussions. Results. Participants preferred messages concerning syphilis and other health concerns as well as information on local resources. Preferred sources included researchers working with trusted community organizations and leaders. Preferred channels included community events and social media, implemented with consistency. CAB feedback included expanding the target audience of dissemination efforts as well as the development of ideas for channels (i.e., events) and sources (i.e., community organizations and leaders). Additional revisions occurred in response to the COVID-19 pandemic. Conclusion. Given the continued lack of research dissemination to participant and community stakeholders, the process of developing a community-led, theory-based dissemination plan may benefit and help guide researchers to adopt this practice. It is critical that participant and community stakeholder dissemination become more highly prioritized as we strive for public health improvements and the elimination of health disparities.

Population pharmacokinetics and pharmacodynamics of the neutralizing antibodies bamlanivimab and etesevimab in patients with mild to moderate COVID-19 infection

Abstract Bamlanivimab and etesevimab are neutralizing antibodies indicated for treatment of COVID-19 in patients with early mild or moderate disease. We present the use of pharmacokinetic-pharmacodynamic (PK/PD) modeling that characterizes the timecourse of viral load obtained from 2970 patients from two phase 2 clinical trials. The model was used for identification of optimal doses that would result in at least 90% of patients achieving serum drug concentrations that results in 90% of maximum drug effect (IC90) for at least 28 days. The serum IC90 (95% confidence interval) was estimated to be 4.2 (3.2, 4.3) µg/mL for bamlanivimab and 12.6 (9.7, 12.8) µg/mL for etesevimab. Observed clinical trial data confirmed PK and PK/PD model predictions that doses of 700 mg bamlanivimab and 1400 mg etesevimab would result in maximum reduction in viral load, with no additional effect seen at higher doses. No dose adjustment is recommended as age, sex, race, baseline viral load and hepatic impairment did not have a significant impact on the PK of the antibodies. Earlier drug administration resulted in greater reductions in viral load, demonstrating the importance of receiving treatment as soon as possible. Relative to placebo, typical reduction in viral load over a 7 day period was estimated to be 80 or 93% (drug administered 4 days or 1 days after the onset of symptoms, respectively), p<0.0001. PK/PD modeling and simulation was pivotal throughout the drug development and emergency use authorization process.