Real-World Implementation Challenges Associated with a Digital Pill System to Measure Adherence to HIV Pre-Exposure Prophylaxis from Two Studies of Men Who Have Sex With Men.

Once-daily oral pre-exposure prophylaxis (PrEP) is highly effective for HIV prevention, but its efficacy is dependent on adherence, which can be challenging for men who have sex with men (MSM) with substance use. Digital pill systems (DPS) represent a novel tool for directly measuring adherence through ingestible radiofrequency sensors that confirm ingestions in real-time. We examined operational challenges across two studies involving DPS to measure PrEP adherence. While most participants successfully operated the system, a number of technological and sociobehavioral challenges requiring intervention were identified across both studies. Technological issues were both system- and participant-related, and were primarily addressed with technical updates and participant re-education, while sociobehavioral issues, including health and housing changes and issues with technology access, warranted innovative solutions. Future research leveraging DPS technology should develop robust supportive infrastructure and mitigation procedures to promptly identify and resolve operational issues to optimize the potential benefits of DPS use.

Refinement of an Emergency Department-Based, Advance Care Planning Intervention for Patients With Cognitive Impairment and Their Caregivers.

BACKGROUND AND OBJECTIVES: Advance care planning (ACP) conversations are important to provide goal-concordant care (i.e., the care that matches the patient's previously stated goals) near end of life. While 31% of older adults presenting to the emergency department (ED) have dementia, only 39% have previously had ACP conversations. We refined and piloted an ED-based, motivational interview designed to stimulate ACP conversations (ED GOAL) for patients living with cognitive impairment and their caregivers. RESEARCH DESIGN AND METHODS: We systematically refined ED GOAL and then conducted an acceptability study in an urban, academic medical center. We prospectively enrolled adults aged 50+ with cognitive impairment and their caregivers. Trained clinicians conducted the intervention. We measured acceptability after the intervention and participants' ACP engagement at baseline and 1-month follow-up. RESULTS: Specific statements to address both the patient and caregiver were added to the ED GOAL script. Of 60 eligible patient/caregiver dyads approached, 26 participated, and 20 (77%) completed follow-up assessments. Patient mean age was 79 years (SD 8.5); 65% were female, 92.3% were White, 96.2% were non-Hispanic, and 69% had moderate dementia. Most patients/caregivers reported feeling completely heard and understood by the study clinician about their future medical care preferences (58%, 15/26). They also reported that the study clinician was very respectful (96%, 25/26) when eliciting those preferences. DISCUSSION AND IMPLICATIONS: Patients living with cognitive impairment and their caregivers found our refined ED GOAL acceptable and respectful. Future studies need to examine the effect of ED GOAL on ACP engagement among these dyads in the ED.

Impact of opioid law on prescriptions and satisfaction of pediatric burn and orthopedic patients: An epidemiologic study.

OBJECTIVES: The objective of this study was to determine the reduction in prescribed opioid pain dosage units to pediatric patients experiencing acute pain and to assess patient satisfaction with pain control 90-day post discharge following the 2017 Ohio opioid prescribing cap law. METHODS: The retrospective chart review included 960 pediatric (age 0-18 years) burn injury and knee arthroscopy patients treated between August 1, 2015-August 31, 2019. Prospectively, legal guardians completed a survey for a convenience sample of 50 patients. Opioid medications (days and morphine milligram equivalents (MMEs)/kg) prescribed at discharge before and after the Ohio law implementation were collected. Guardians reported experience and satisfaction with their child's opioid prescription at 90-days post discharge. RESULTS: From pre-law to post-law, there was a significant decrease (p<0.001) within the burn and knee cohorts in the median days (1.7 to 1.0 and 5.0 to 3.8, respectively) and median total MMEs prescribed (15.0 to 2.5 and 150.0 to 90.0, respectively). An interrupted time series analysis revealed a statistically significant decrease in MMEs/kg and days prescribed at discharge when the 2017 Ohio opioid prescription law went into effect, with an abrupt level change. Prospectively, more than half of participants were satisfied (72% burn and 68% knee) with their pain control and felt they received the right amount of medication (84% burn and 56% knee). Inpatient opioid use was not changed pre- and post-law. CONCLUSIONS: Discharge opioids prescribed for pediatric burn and knee arthroscopy procedures has decreased from 2015-2019. Caregivers varied greatly in their satisfaction with pain control and the amount of opioid prescribed.

Patient motivators to use opioids for acute pain after emergency care.

Introduction: Patients are stakeholders in their own pain management. Factors motivating individuals to seek or use opioids therapeutically for treatment of acute pain are not well characterized but could be targeted to reduce incident iatrogenic opioid use disorder (OUD). Emergency departments (EDs) commonly encounter patients in acute pain for whom decisions regarding opioid therapy are required. Decision-making is necessarily challenged in episodic, unscheduled care settings given time pressure, limited information, and lack of pre-existing patient provider relationship. Patients may decline to take prescribed opioids or conversely seek opioids from other providers or non-medical sources. Methods: Using a framework analysis approach, we qualitatively analyzed transcripts from 29 patients after discharge from an ED visit for acute pain at a large, urban, academic hospital in the midwestern United States to describe motivating factors influencing patient decisions regarding opioid use for acute pain. A semi-structured interview guide framed participant discussion in either a focus group or interview transcribed and analyzed with conventional content analysis. Results: Four major themes emerged from our analysis including a) pain management literacy, b) control preferences, c) risk tolerance, and d) cues to action. Discussion: Our findings suggest targets for future intervention development and a framework to guide the engagement of patients as stakeholders in their own acute pain management.

Emergency department patient and physician survey accuracy compared to chart abstraction in patients with acute respiratory illness.

BACKGROUND: High-quality research studies in older adults are needed. Unfortunately, the accuracy of chart review data in older adult patients has been called into question by previous studies. Little is known on this topic in patients with suspected pneumonia, a disease with 500,000 annual older adult U.S. emergency department (ED) visits that presents a diagnostic challenge to ED physicians. The study objective was to compare direct interview and chart abstraction as data sources. METHODS: We present a preplanned secondary analysis of a prospective, observational cohort of ED patients ≥65 years of age with suspected pneumonia in two Midwest EDs. We describe the agreement between chart review and a criterion standard of prospective direct patient survey (symptoms) or direct physician survey (examination findings). Data were collected by chart review and from the patient and treating physician by survey. RESULTS: The larger study enrolled 135 older adults; 134 with complete symptom data and 129 with complete examination data were included in this analysis. Pneumonia symptoms (confusion, malaise, rapid breathing, any cough, new/worse cough, any sputum production, change to sputum) had agreement between patient/legally authorized representative survey and chart review ranging from 47.8% (malaise) to 80.6% (confusion). All examination findings (rales, rhonchi, wheeze) had percent agreement between physician survey and chart review of ≥80%. However, all kappas except wheezing were less than 0.60, indicating weak agreement. CONCLUSIONS: Both patient symptoms and examination findings demonstrated discrepancies between chart review and direct survey with larger discrepancies in symptoms reported. Researchers should consider these potential discrepancies during study design and data interpretation.

MyTPill: study protocol for a cross-over randomised controlled trial comparing novel strategies to monitor antiretroviral adherence among HIV+ prescription opioid users.

INTRODUCTION: Adherence to HIV antiretroviral therapy (ART) remains the cornerstone of HIV treatment. For individuals with suboptimal adherence, electronic adherence monitoring (EAM) technologies have become an important component of multimodal adherence support strategies. Most EAM technologies detect pillbox opening, and therefore, assume but cannot verify actual ingestion of oral medication. In contrast, a digital pill system (ID-capsule manufactured by etectRX, here named My/Treatment/Pill) measures directly ingestion of medications. Identifying the superior method to measure ART adherence would improve virological suppression by enabling the delivery of real-time interventions to support ART adherence, particularly in high-risk populations. METHODS AND ANALYSIS: Cross-over, randomised trial with 1:1 variable block size randomisation comparing two EAM systems in prescription opioid-using HIV+patient on once daily oral bictegravir, emtricitabine and tenofovir alafenamide regimens and detectable viral load >200 copies/mL within 30 days of screening (n=80). The primary outcome is once daily ART adherence measurement efficacy as assessed by comparing the accuracy of each EAM system as measured by concordance of the respective EAM systems to dried blood spot ART concentrations. Secondary outcomes are the identification of multilevel factors that are prevalent in the target population most closely linked to ART non-adherence and EAM non-adherence. ETHICS AND DISSEMINATION: This protocol was approved by the institutional review boards of participating sites (The Ohio State University, The Fenway Institute and the University of Miami). Data will be presented at scientific conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03978793.

Diagnosis of cancer in the Emergency Department: A scoping review.

BACKGROUND: The Emergency Department (ED) plays a key role in the identification and care of acute medical conditions, including cancer. In this scoping review, we aimed to determine the role of the ED in the acute diagnosis of cancer. METHODS: We conducted a scoping review of articles according to Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) using PubMed and Google Scholar. We screened studies of adults with a new diagnosis of cancer in the ED. We included randomized control trials, prospective, retrospective, and cross-sectional observational studies, and case reports published in English since 2000. We grouped the articles into categories based on their objectives and findings. RESULTS: Of the 4459 articles, we included 47 in the review. The identified studies fell into three major categories: (1) studies describing the incidental diagnosis of cancer in the ED (n = 11, 23%), (2) studies characterizing the acute initial presentation of cancer in the ED (n = 19, 41%), and (3) studies describing the ED as a pathway to cancer diagnosis in the healthcare system (n = 17, 36%). Across the studies, cancer diagnoses in the ED were more likely in patients with higher comorbidities, occurred at later stages, and resulted in worse survival rates. CONCLUSIONS: The ED plays a prominent role in the initial diagnosis of cancer. Efforts must be made to integrate the ED within the cancer care continuum.

Perceptions on wearable sensor-based interventions for monitoring of opioid therapy: A qualitative study.

Prescription opioid use is a risk factor for the development of opioid use disorder. Digital solutions, including wearable sensors, represent a promising opportunity for health monitoring, risk stratification and harm reduction in this treatment space. However, data on their usability and acceptability in individuals using opioids is limited. To address this gap, factors that impact usability and acceptability of wearable sensor-based opioid detection were qualitatively studied in participants enrolled in a wearable sensor-based opioid monitoring research study. At the conclusion of the monitoring period, participants were invited to take part in semi-structured interviews developed based on the technology acceptance model. Thematic analysis was conducted first using deductive, then inductive coding strategies. Forty-four participants completed the interview; approximately half were female. Major emergent themes include sensor usability, change in behavior and thought process related to sensor use, perceived usefulness in sensor-based monitoring, and willingness to have opioid use patterns monitored. Overall acceptance for sensor-based monitoring was high. Aesthetics, simplicity, and seamless functioning were all reported as key to usability. Perceived behavior changes related to monitoring were infrequent while perceived usefulness in monitoring was frequently projected onto others, requiring careful consideration regarding intervention development and targeting. Specifically, care must be taken to avoid stigma associated with opioid use and implied misuse. The design of sensor systems targeted for opioid use must also consider the physical, social, and cognitive alterations inherent in the respective disease processes compared to routine daily life.

Ingestible Electronic Sensors for Monitoring Real-time Adherence to HIV Pre-exposure Prophylaxis and Antiretroviral Therapy.

PURPOSE OF REVIEW: This review summarizes the recent advancements and future directions of digital pill systems (DPS) - which utilize ingestible sensors to directly measure medication ingestion events in real-time - in the context of HIV prevention and treatment. RECENT FINDINGS: Two DPS are cleared by the US Food and Drug Administration. The bioequivalence and stability of digitized pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART) have been established, and pilot studies have demonstrated the feasibility and acceptability of using DPS for PrEP and ART adherence measurement. Important bioethical and implementation considerations have been identified for future clinical trials. Continued technological advancement may reduce barriers to use, and integration of DPS into behavioral interventions may facilitate adherence improvement efforts. DPS represent an innovative tool for PrEP and ART adherence measurement. Future work will optimize the technology to reduce operational barriers. DPS have significant potential for expansion across a diverse array of diseases, though key bioethical considerations must be examined prior to large-scale implementation.

Impact of individual and treatment characteristics on wearable sensor-based digital biomarkers of opioid use.

Opioid use disorder is one of the most pressing public health problems of our time. Mobile health tools, including wearable sensors, have great potential in this space, but have been underutilized. Of specific interest are digital biomarkers, or end-user generated physiologic or behavioral measurements that correlate with health or pathology. The current manuscript describes a longitudinal, observational study of adult patients receiving opioid analgesics for acute painful conditions. Participants in the study are monitored with a wrist-worn E4 sensor, during which time physiologic parameters (heart rate/variability, electrodermal activity, skin temperature, and accelerometry) are collected continuously. Opioid use events are recorded via electronic medical record and self-report. Three-hundred thirty-nine discreet dose opioid events from 36 participant are analyzed among 2070 h of sensor data. Fifty-one features are extracted from the data and initially compared pre- and post-opioid administration, and subsequently are used to generate machine learning models. Model performance is compared based on individual and treatment characteristics. The best performing machine learning model to detect opioid administration is a Channel-Temporal Attention-Temporal Convolutional Network (CTA-TCN) model using raw data from the wearable sensor. History of intravenous drug use is associated with better model performance, while middle age, and co-administration of non-narcotic analgesia or sedative drugs are associated with worse model performance. These characteristics may be candidate input features for future opioid detection model iterations. Once mature, this technology could provide clinicians with actionable data on opioid use patterns in real-world settings, and predictive analytics for early identification of opioid use disorder risk.

Mobile Robotic Platform for Contactless Vital Sign Monitoring.

The COVID-19 pandemic has accelerated methods to facilitate contactless evaluation of patients in hospital settings. By minimizing in-person contact with individuals who may have COVID-19, healthcare workers can prevent disease transmission and conserve personal protective equipment. Obtaining vital signs is a ubiquitous task that is commonly done in person by healthcare workers. To eliminate the need for in-person contact for vital sign measurement in the hospital setting, we developed Dr. Spot, a mobile quadruped robotic system. The system includes IR and RGB cameras for vital sign monitoring and a tablet computer for face-to-face medical interviewing. Dr. Spot is teleoperated by trained clinical staff to simultaneously measure the skin temperature, respiratory rate, and heart rate while maintaining social distancing from patients and without removing their mask. To enable accurate, contactless measurements on a mobile system without a static black body as reference, we propose novel methods for skin temperature compensation and respiratory rate measurement at various distances between the subject and the cameras, up to 5 m. Without compensation, the skin temperature MAE is 1.3°C. Using the proposed compensation method, the skin temperature MAE is reduced to 0.3°C. The respiratory rate method can provide continuous monitoring with a MAE of 1.6 BPM in 30 s or rapid screening with a MAE of 2.1 BPM in 10 s. For the heart rate estimation, our system is able to achieve a MAE less than 8 BPM in 10 s measured in arbitrary indoor light conditions at any distance below 2 m.

Opioid-related overdose and chronic use following an initial prescription of hydrocodone versus oxycodone.

BACKGROUND: Hydrocodone and oxycodone are prescribed commonly to treat pain. However, differences in risk of opioid-related adverse outcomes after an initial prescription are unknown. This study aims to determine the risk of opioid-related adverse events, defined as either chronic use or opioid overdose, following a first prescription of hydrocodone or oxycodone to opioid naïve patients. METHODS: A retrospective analysis of multiple linked public health datasets in the state of Oregon. Adult patients ages 18 and older who a) received an initial prescription for oxycodone or hydrocodone between 2015-2017 and b) had no opioid prescriptions or opioid-related hospitalizations or emergency department visits in the year preceding the prescription were followed through the end of 2018. First-year chronic opioid use was defined as ≥6 opioid prescriptions (including index) and average ≤30 days uncovered between prescriptions. Fatal or non-fatal opioid overdose was indicated from insurance claims, hospital discharge data or vital records. RESULTS: After index prescription, 2.8% (n = 14,458) of individuals developed chronic use and 0.3% (n = 1,480) experienced overdose. After adjustment for patient and index prescription characteristics, patients receiving oxycodone had lower odds of developing chronic use relative to patients receiving hydrocodone (adjusted odds ratio = 0.95, 95% confidence interval (CI) 0.91-1.00) but a higher risk of overdose (adjusted hazard ratio (aHR) = 1.65, 95% CI 1.45-1.87). Oxycodone monotherapy appears to greatly increase the hazard of opioid overdose (aHR 2.18, 95% CI 1.86-2.57) compared with hydrocodone with acetaminophen. Oxycodone combined with acetaminophen also shows a significant increase (aHR 1.26, 95% CI 1.06-1.50), but not to the same extent. CONCLUSIONS: Among previously opioid-naïve patients, the risk of developing chronic use was slightly higher with hydrocodone, whereas the risk of overdose was higher after oxycodone, in combination with acetaminophen or monotherapy. With a goal of reducing overdose-related deaths, hydrocodone may be the favorable agent.

Ingestible electronic sensors to measure instantaneous medication adherence: A narrative review.

OBJECTIVE: Medication nonadherence contributes to significant morbidity and mortality worldwide. While many techniques to measure adherence exist, digital pill systems represent a novel, direct method of measuring adherence and a means of providing instantaneous adherence supports. In this narrative review, we discuss digital pill system research based on clinical trials and qualitative investigations conducted to date and potential future applications of digital pill system in medication adherence measurement. METHODS: We conducted a literature search in PubMed of English language peer-reviewed articles describing the use of digital pill system for medication adherence measurement between 2000 and 2021. We included all articles that described the deployment of ingestible sensors and those involving qualitative investigations of digital pill system with human subjects. RESULTS: A total of 95 articles were found on initial search; 75 were removed based on exclusion criteria. Included articles were categorized as investigations that deployed an ingestible sensor in human populations (n = 18), or those that conducted qualitative work (n = 3). For pilot studies, the mean accuracy of the sensor to successfully detect a medication ingestion event ranged from 68% to 100%. When digital pill systems were deployed in real-world clinical settings, accuracy ranged from 68% to 90% with lower accuracy due to nonadherence to digital pill system technology. Qualitative studies demonstrated that providers and patients perceive the digital pill system as a facilitator for improving adherence and as a potential platform for delivering adherence interventions. Additionally, ingestion data from digital pill system was viewed as useful in facilitating adherence discussions between clinicians and patients. CONCLUSIONS: This narrative review demonstrates that the use of digital pill system is broadly feasible across multiple disease states including human immunodeficiency virus, hepatitis C infection, solid organ transplants, tuberculosis, schizophrenia, cardiovascular disease, and acute fractures, where adherence is closely linked to significant morbidity and mortality. It also highlights key areas of research that are still needed prior to broad-scale clinical deployment of such systems.

The Effect of Noise-Masking Earbuds (SleepBuds) on Reported Sleep Quality and Tension in Health Care Shift Workers: Prospective Single-Subject Design Study.

BACKGROUND: Shift work is associated with sleep disorders, which impair alertness and increase risk of chronic physical and mental health disease. In health care workers, shift work and its associated sleep loss decrease provider wellness and can compromise patient care. Pharmacological sleep aids or substances such as alcohol are often used to improve sleep with variable effects on health and well-being. OBJECTIVE: We tested whether use of noise-masking earbuds can improve reported sleep quality, sleepiness, and stress level in health care shift workers, and increase alertness and reaction time post night shift. METHODS: Emergency medicine resident physicians were recruited for a prospective, single-subject design study. Entrance surveys on current sleep habits were completed. For 14 days, participants completed daily surveys reporting sleep aid use and self-rated perceived sleepiness, tension level, and last nights' sleep quality using an 8-point Likert scale. After overnight shifts, 3-minute psychomotor vigilance tests (PVT) measuring reaction time were completed. At the end of 14 days, participants were provided noise-masking earbuds, which they used in addition to their baseline sleep regimens as they were needed for sleep for the remainder of the study period. Daily sleep surveys, post-overnight shift PVT, and earbud use data were collected for an additional 14 days. A linear mixed effects regression model was used to assess changes in the pre- and postintervention outcomes with participants serving as their own controls. RESULTS: In total, 36 residents were recruited, of whom 26 participants who completed daily sleep surveys and used earbuds at least once during the study period were included in the final analysis. The median number of days of earbud use was 5 (IQR 2-9) days of the available 14 days. On days when residents reported earbud use, previous nights' sleep quality increased by 0.5 points (P<.001, 95% CI 0.23-0.80), daily sleepiness decreased by 0.6 points (P<.001, 95% CI -0.90 to -0.34), and total daily tension decreased by 0.6 points (P<.001, 95% CI -0.81 to -0.32). These effects were more pronounced in participants who reported worse-than-average preintervention sleep scores. CONCLUSIONS: Nonpharmacological noise-masking interventions such as earbuds may improve daily sleepiness, tension, and perceived sleep quality in health care shift workers. Larger-scale studies are needed to determine this interventions' effect on other populations of shift workers' post-night shift alertness, users' long-term physical and mental health, and patient outcomes.

"I'd feel like someone was watchin' me watching for a good reason": perceptions of data privacy, access, and sharing in the context of real-time PrEP adherence monitoring among HIV-negative MSM with substance use.

Once-daily oral tenofovir/emtricitabine is highly effective as pre-exposure prophylaxis (PrEP) against HIV but is dependent on adherence, which may be challenging for men who have sex with men (MSM) and use substances. Digital pill systems (DPS) permit the direct, real-time measurement of adherence, though user perceptions of data privacy in this context are unknown. Thirty prospective DPS users - HIV-negative MSM with non-alcohol substance use - completed in-depth qualitative interviews exploring preferences around privacy, access, and sharing of DPS adherence data. Participants discussed some concerns about the impact of DPS use on personal privacy, and emphasized the need for robust data protections in the technology. Participants were interested in having on-demand access to their adherence data, and were most willing to share data with primary care providers and long-term relationship partners. Future investigations exploring bioethical frameworks around DPS use are warranted, and user preferences should inform best practices for protecting DPS data.

Factors Associated With Opioid Overdose After an Initial Opioid Prescription.

Importance: The opioid epidemic continues to be a public health crisis in the US. Objective: To assess the patient factors and early time-varying prescription-related factors associated with opioid-related fatal or nonfatal overdose. Design, Setting, and Participants: This cohort study evaluated opioid-naive adult patients in Oregon using data from the Oregon Comprehensive Opioid Risk Registry, which links all payer claims data to other health data sets in the state of Oregon. The observational, population-based sample filled a first (index) opioid prescription in 2015 and was followed up until December 31, 2018. Data analyses were performed from March 1, 2020, to June 15, 2021. Exposures: Overdose after the index opioid prescription. Main Outcomes and Measures: The outcome was an overdose event. The sample was followed up to identify fatal or nonfatal opioid overdoses. Patient and prescription characteristics were identified. Prescription characteristics in the first 6 months after the index prescription were modeled as cumulative, time-dependent measures that were updated monthly through the sixth month of follow-up. A time-dependent Cox proportional hazards regression model was used to assess patient and prescription characteristics that were associated with an increased risk for overdose events. Results: The cohort comprised 236 921 patients (133 839 women [56.5%]), of whom 667 (0.3%) experienced opioid overdose. Risk of overdose was highest among individuals 75 years or older (adjusted hazard ratio [aHR], 3.22; 95% CI, 1.94-5.36) compared with those aged 35 to 44 years; men (aHR, 1.29; 95% CI, 1.10-1.51); those who were dually eligible for Medicaid and Medicare Advantage (aHR, 4.37; 95% CI, 3.09-6.18), had Medicaid (aHR, 3.77; 95% CI, 2.97-4.80), or had Medicare Advantage (aHR, 2.18; 95% CI, 1.44-3.31) compared with those with commercial insurance; those with comorbid substance use disorder (aHR, 2.74; 95% CI, 2.15-3.50), with depression (aHR, 1.26; 95% CI, 1.03-1.55), or with 1 to 2 comorbidities (aHR, 1.32; 95% CI, 1.08-1.62) or 3 or more comorbidities (aHR, 1.90; 95% CI, 1.42-2.53) compared with none. Patients were at an increased overdose risk if they filled oxycodone (aHR, 1.70; 95% CI, 1.04-2.77) or tramadol (aHR, 2.80; 95% CI, 1.34-5.84) compared with codeine; used benzodiazepines (aHR, 1.06; 95% CI, 1.01-1.11); used concurrent opioids and benzodiazepines (aHR, 2.11; 95% CI, 1.70-2.62); or filled opioids from 3 or more pharmacies over 6 months (aHR, 1.38; 95% CI, 1.09-1.75). Conclusions and Relevance: This cohort study used a comprehensive data set to identify patient and prescription-related risk factors that were associated with opioid overdose. These findings may guide opioid counseling and monitoring, the development of clinical decision-making tools, and opioid prevention and treatment resources for individuals who are at greatest risk for opioid overdose.

Real-World User Experiences with a Digital Pill System to Measure PrEP Adherence: Perspectives from MSM with Substance Use.

Once-daily oral pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV transmission, but adherence can be challenging for men who have sex with men (MSM) who use substances. A novel method for directly measuring ingestion events is a digital pill system (DPS), which comprises an ingestible radiofrequency emitter that signals a wearable Reader device upon PrEP ingestion, relaying ingestion data to a wearable Reader device and then to a smartphone application. Qualitative interviews were conducted with 15 MSM with non-alcohol substance use following an open-label pilot demonstration trial involving use of the DPS to measure PrEP adherence for 90 days. The purpose of this qualitative investigation was to understand overall user experiences and potential barriers and facilitators to using the DPS to measure PrEP adherence among MSM. The DPS was largely perceived as acceptable, novel, and valuable, with most participants reporting that the system was easily integrated into their daily routines. Technological and design factors, especially related to the wearable Reader, impacted participants' interest in using the technology long-term; several suggested improvements were discussed.Trial Registration ClinicalTrials.gov: NCT03842436.

Development of a digital pill and respondent behavioral intervention (PrEPSteps) for HIV pre-exposure prophylaxis adherence among stimulant using men who have sex with men.

The efficacy of pre-exposure prophylaxis (PrEP) for HIV prevention in men who have sex with men (MSM) is contingent upon consistent adherence. Digital pill systems (DPS) provide real-time, objective measurement of ingestions and can inform behavioral adherence interventions. Qualitative feedback was solicited from MSM who use stimulants to optimize a cognitive behavioral therapy (CBT)-based intervention (LifeSteps), used in conjunction with a DPS, to promote PrEP adherence (PrEPSteps). Seven focus groups and one individual qualitative interview were conducted in Boston, MA with cisgender, HIV-negative MSM who reported stimulant use and current PrEP use or interest. Focus groups and interviews explored reactions to the DPS and PrEPSteps messaging components: contingent reinforcement (CR), corrective feedback (CF), LifeSteps, and substance use Screening, Brief Intervention, and Referral to Treatment (SBIRT). Quantitative assessments were administered. Qualitative data were analyzed using applied thematic analysis. Twenty MSM participated. Most were White (N = 12), identified as homosexual or gay (N = 15), and college-educated (N = 15). Ages ranged from 24 to 68 years (median 35.5). Participants were willing to engage with the DPS and viewed it as beneficial for promoting adherence. Confirmatory CR messages were deemed acceptable, and a neutral tone was preferred. CF messages were viewed as most helpful and as promoting individual responsibility. LifeSteps was perceived as useful for contextualizing nonadherence. However, SBIRT was a barrier to DPS use; concerns around potential substance use stigma were reported. MSM who use stimulants were accepting of the DPS and PrEPSteps intervention. CR, CF, and LifeSteps messages were viewed as helpful, with modifications pertaining to tone and content; SBIRT messages were not preferred.