Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naïve (AMBER) and virologically suppressed (EMERALD) participants with neurological and/or psychiatric comorbidities: Week 96 subgroup analysis.

OBJECTIVE: Our objective was to evaluate the prevalence of pre-existing neurological and/or psychiatric comorbidities (NPCs) and efficacy/safety outcomes for participants with versus without baseline NPCs in AMBER and EMERALD. METHODS: AMBER (treatment-naïve population) and EMERALD (virologically suppressed population) were phase III randomized studies of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg. The primary objective of this post hoc analysis was to assess virological response (HIV-1 RNA <50 copies/mL) at week 48 by intent-to-treat US Food and Drug Administration snapshot analysis comparing participants with and without baseline NPCs. RESULTS: Among participants in AMBER, 88/362 (24%) in the D/C/F/TAF arm and 99/363 (27%) in the control arm had baseline NPCs; in EMERALD, 294/763 (39%; D/C/F/TAF) and 166/378 (44%; control) participants had baseline NPCs. At baseline, psychiatric NPCs were more common than neurological NPCs in both studies; the most common of each type were depression and headache, respectively. High virological response rates were achieved with D/C/F/TAF across studies regardless of baseline NPCs at weeks 48 (range 86%-95%) and 96 (range 80%-91%). No participants in either study with a baseline NPC prematurely discontinued because of a study drug-related neurological or psychiatric adverse event. CONCLUSION: D/C/F/TAF may be a suitable treatment option for individuals with HIV-1 and NPCs.

Development and implementation of an online community as a strategy for mixed methods research during a pandemic.

Conducting mixed methods research is critical for healthcare researchers to understand attitudes, behaviors, and experiences on health-related topics, such as vaccine acceptance. As the COVID-19 pandemic has made it difficult to employ traditional, face-to-face qualitative methodologies, this paper describes the use of a virtual platform to conduct person-centered research. To overcome these challenges and better understand the attitudes and behaviors of vaccine-eligible individuals in the United States, an online health community called the Virtual Engagement Research Community (VERC) was designed and implemented. Using the Health Belief Model as a framework, the VERC employed a mixed methods approach to elicit insights, which included discussion topics, rapid polls, and surveys. Throughout the initial enrollment period of April-October 2021, continuous improvement efforts were made to bolster recruitment and member engagement. This agile research strategy was successful in utilizing mixed methods to capture community sentiments regarding vaccines. While this community focused on vaccination, the methodology holds promise for other areas of health research such as obesity, HIV, mental health disorders, and diabetes.

The COVID-19 pandemic has made it difficult to conduct research in person, but qualitative and quantitative data remain critical for developing research design. To gather and understand vaccine perceptions, opinions, and behaviors in a real time manner, The Virtual Engagement Research Community (VERC) was launched. As of October 2021, the VERC had 72 members who had the opportunity to participate in research events such as surveys, polls, discussion topics, and moderated chats in a private, invitation-only virtual community. The online format offered researchers the opportunity to adapt the types and frequency of engagements, fine-tune the research questions based on community responses and current events, and adjust the analysis and reporting methodology as needed to increase participation and maximize the value of the VERC. The success of the VERC and the lessons learned support the use of online communities to enhance mixed methods research as a valuable strategy for other health researchers.

Impact of Two Different Antimicrobial Stewardship Methods on Frequency of Streamlining Antimicrobial Agents in Patients with Bacteremia.

OBJECTIVE To assess the likelihood of antimicrobial streamlining between 2 antimicrobial stewardship methods. DESIGN Retrospective cohort study. SETTING Large academic medical center. METHODS Frequency and time to antimicrobial streamlining were compared during a prior authorization and a prospective audit period. Streamlining was defined as an antimicrobial change to a narrower agent if available or to a broader agent if the isolate was resistant to empiric therapy. Patients included were ≥18 years old with monomicrobial bacteremia with S. aureus, Enterococcus spp., or any aerobic Gram-negative organism. RESULTS A total of 665 cases of bacteremia met inclusion criteria. Frequency of streamlining was similar between periods for all cases of bacteremia (audit vs restriction: 60.7% vs 53.2%; P=.12), S. aureus bacteremia (73.2% vs 76.9%; P=.671), and Enterococcus bacteremia (81.6% vs 71.9%; P=.335). Compared to restriction, the audit period was associated with an increased frequency of streamlining for cases of Gram-negative bacteremia (51.4% vs 35.6%; odds ratio [OR], 1.85; 95% confidence interval [CI], 1.06-3.25), those on the medical service (67.9% vs 53.1%; OR, 1.86; 95% CI, 1.09-3.16), and those admitted through the emergency department (71.6% vs 51.4%; OR, 2.32; 95% CI, 1.24-4.34). Characteristics associated with increased streamlining included: absence of ß-lactam allergy (P<.001), Gram-negative bacteremia (P<.001), admission through the emergency department (P=.001), and admission to a medical service (P=.011). CONCLUSIONS Compared with prior authorization, prospective audit increased antimicrobial streamlining for cases of Gram-negative bacteremia, those admitted through the emergency department, and those admitted to a medical but not surgical service. Infect Control Hosp Epidemiol 2016:1-7.