Establishing Novel Antiretroviral Imaging for Hair to Elucidate Nonadherence: Protocol for a Single-Arm Cross-sectional Study.

BACKGROUND: Adherence to antiretroviral (ARV) therapy is critical for achieving HIV RNA suppression in people living with HIV and for preventing HIV infection in uninfected individuals using preexposure prophylaxis. However, a high level of adherence can be challenging to achieve for people living with HIV on lifelong ARVs and for HIV-negative individuals using daily preexposure prophylaxis who are not at daily risk for HIV infection. Current biological measures of adherence are invasive and use bioanalytical methods that do not allow for real-time feedback during a clinic visit. This study was designed to test the feasibility and acceptability of using MedViewer, a novel, minimally invasive, hair-based assay that measures longitudinal ARV drug adherence in real time and provides an output for provider-patient discussion. OBJECTIVE: The primary objectives were to investigate the feasibility of delivering the MedViewer results as planned, the acceptability of participation in a discussion of the MedViewer results, and the appropriateness of using MedViewer for adherence counseling. The secondary objectives were to investigate additional dimensions of feasibility, acceptability, and appropriateness of using the MedViewer test during a routine clinic visit for people with HIV. METHODS: The proposed study was a single-arm cross-sectional study among patients receiving HIV care and providers of HIV care in a southeastern infectious disease clinic. The study originally planned to implement the MedViewer test with 50 eligible patients who were living with HIV across 2 viral load strata (undetectable or detectable plasma HIV RNA over the previous 2 years), administer brief visit-specific questionnaires to all patient and provider participants, and conduct qualitative in-depth interviews and quantitative end-line questionnaires with a subsample of patient participants (n=30) and all provider participants. RESULTS: The Establishing Novel Antiretroviral Imaging for Hair to Elucidate Nonadherence study was funded by the National Institute of Allergy and Infectious Diseases and approved by the local institutional review board on November 4, 2019. Provider participant enrollment began on January 17, 2020, and patient participant enrollment began on January 22, 2020. Participant enrollment was halted on March 16, 2020, because of the COVID-19 pandemic (16 providers and 10 patients on study). Study activities resumed on February 2, 2021, with COVID-19 modifications approved by the local institutional review board. Participant enrollment closed on October 8, 2021, and data collection closed on November 15, 2021. In total, 36 unique patient participants, representing 37 samples, and 20 provider participants were enrolled. Data analysis and manuscript writing will take place throughout 2023. CONCLUSIONS: We anticipate that the data collected through this study will provide important insights regarding the feasibility, acceptability, and appropriateness of incorporating new real-time longitudinal, minimally invasive adherence tests into routine clinical care and identify potential barriers to medication adherence among patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT04232540; https://clinicaltrials.gov/ct2/show/NCT04232540. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/41188.

Barriers to and Facilitators of COVID-19 Prevention Behaviors Among North Carolina Residents.

COVID-19 was the third leading cause of death in the United States in 2020. Prior to the wide dissemination of SARS-CoV-2 vaccines, individual prevention behaviors, such as wearing face masks, have been the primary non-pharmaceutical interventions to reduce infections. We surveyed 404 North Carolina residents recruited through Amazon MTurk in July 2020 to assess adherence to key prevention behaviors (6-foot distancing, mask wearing, and gathering limits) and barriers to and facilitators of adherence. Participants reported past 7-day prevention behaviors and behavioral barriers and facilitators informed by the Integrated Behavior Model and the Health Belief Model (perceived risk, perceived severity, behavioral attitudes, injunctive and descriptive norms, and personal agency). Reported adherence to each behavior in the past 7 days was generally high, with lower adherence to 6-foot distancing and mask wearing in the work context. The most commonly endorsed barriers to 6-foot distancing included physical impediments, forgetting, and unfavorable descriptive norms. For mask wearing, ability to keep a distance, discomfort/inconvenience, and forgetting were most commonly endorsed. In logistic regression models, injunctive social norms followed by perceived personal agency were the strongest independent correlates of 6-foot distancing. Behavioral attitudes and injunctive social norms were independently associated with mask wearing. For gathering size limit adherence, perceived personal agency was the strongest independent predictor followed by perceived severity of COVID-19. Messaging campaigns targeting these barriers and facilitators should be tested. Interventions improving the convenience and salience of physical distancing and mask wearing in high-density public places and places of work may also promote prevention behaviors.

Association of COVID-19 With Achieving Time-to-Surgery Benchmarks in Patients With Musculoskeletal Trauma.

Importance: In response to the COVID-19 pandemic, many hospital systems were forced to reduce operating room capacity and reallocate resources. The outcomes of these policies on the care of injured patients and the maintenance of emergency services have not been adequately reported. Objective: To evaluate whether the COVID-19 pandemic was associated with delays in urgent fracture surgery beyond national time-to-surgery benchmarks. Design Setting and Participants: This retrospective cohort study used data collected in the Program of Randomized Trials to Evaluate Preoperative Antiseptic Skin Solutions in Orthopaedic Trauma among at 20 sites throughout the US and Canada and included patients who sustained open fractures or closed femur or hip fractures. Exposure: COVID-19-era operating room restrictions were compared with pre-COVID-19 data. Main Outcomes and Measures: Surgery within 24 hours after injury. Results: A total of 3589 patients (mean [SD] age, 55 [25.4] years; 1913 [53.3%] male) were included in this study, 2175 pre-COVID-19 and 1414 during COVID-19. A total of 54 patients (3.1%) in the open fracture cohort and 407 patients (21.8%) in the closed hip/femur fracture cohort did not meet 24-hour time-to-surgery benchmarks. We were unable to detect any association between time to operating room and COVID-19 era in either open fracture (odds ratio [OR], 1.40; 95% CI, 0.77-2.55; P = .28) or closed femur/hip fracture (OR, 1.01; 95% CI, 0.74-1.37; P = .97) cohorts. In the closed femur/hip fracture cohort, there was no association between time to operating room and regional COVID-19 prevalence (OR, 1.07; 95% CI, 0.70-1.64; P = .76). Conclusions and Relevance: In this cohort study, there was no association between meeting time-to-surgery benchmarks in either open fracture or closed femur/hip fracture during the COVID-19 pandemic compared with before the pandemic. This is counter to concerns that the unprecedented challenges associated with managing the COVID-19 pandemic would be associated with clinically significant delays in acute management of urgent surgical cases and suggests that many hospital systems within the US were able to effectively implement policies consistent with time-to-surgery standards for orthopedic trauma in the context of COVID-19-related resource constraints.

Development and Application of an Interdisciplinary Rapid Message Testing Model for COVID-19 in North Carolina.

INTRODUCTION: From the onset of the COVID-19 pandemic, public health officials have sought to develop evidence-based messages to reduce COVID-19 transmission by communicating key information to media outlets and the public. We describe the development of an interdisciplinary rapid message testing model to quickly create, test, and share messages with public health officials for use in health campaigns and policy briefings. METHODS: An interdisciplinary research team from the University of North Carolina at Chapel Hill assembled in March 2020 to assist the state health department in developing evidence-based messages to influence social distancing behaviors in the state. We developed and iteratively executed a rapid message testing model; the components of the 4-step model were message creation, survey development, survey administration, and analysis and presentation to health department officials. The model was executed 4 times, each during a 7-day period in April and May, and each subsequent survey included new phrasing and/or messaging informed by the previous week's survey. A total of 917 adults from North Carolina participated in the 4 surveys. RESULTS: Survey participants rated messages focused on protecting oneself and others higher than messages focused on norms and fear-based approaches. Pairing behaviors with motivations increased participants' desire to social distance across all themes and subgroups. For example, adding "Protect your grandmother, your neighbor with cancer, and your best friend with asthma," to messaging received a 0.9-point higher score than the base message, "Stay 6 feet apart from others when out in public." PRACTICE IMPLICATIONS: Our model to promote social distancing in North Carolina during the COVID-19 pandemic can be used for rapid, iterative message testing during public health emergencies.