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Background: Cabotegravir long-acting injectable HIV pre-exposure prophylaxis (LAI-PrEP) is shown to be safe and efficacious. Understanding variations in potential user preferences for LAI-PrEP may be useful to inform segmented implementation [...]

Background: Long-acting injectable HIV pre-exposure prophylaxis (LAI-PrEP) is efficacious and may overcome some challenges of daily oral PrEP. LAI-PrEP has great potential to reduce HIV incidence in high-risk populations, including [...]

This paper reports on a study which comprised the first comprehensive evaluation of the Kids Kare Line telephone triage service in which experienced registered nurses respond to parents' requests for health-care advice for their child. This service is located in an acute care hospital in regional New South Wales, Australia. One hundred and one parents who telephoned the Kids Kare Line responded to a telephone-administered survey designed to determine the service's efficiency and effectiveness. Responses demonstrated that parents sought advice about a range of issues, of which the management of fever was the most frequent. All but five parents considered their call to have been answered promptly, all parents understood the advice provided to them and 96% of parents were satisfied with this advice. Fifty parents identified that they had not used another service or health practitioner for the same issue subsequent to their Kids Kare Line telephone call. [ABSTRACT FROM AUTHOR]

The increasing use of forged Al-alloy components in automotive vehicles has generated a large quantity of data which shows that a retained forged surface can have a significantly detrimental effect on fatigue performance. Extensive SEM studies of the fatigue crack initiation sites on four point bend S-N samples and the as-forged surface appearance of these and actual components have been undertaken. The results from these studies have shown common features across all the samples examined. These features, rather than the surface roughness, can be associated with multiple fatigue crack initiation sites and explain the observed reduction in fatigue properties.

Introduction: Cabotegravir long-acting injectable HIV pre-exposure prophylaxis (LA-PrEP) was shown to be safe and effective in multiple clinical trials. Increasing uptake and persistence among populations with elevated risk for HIV acquisition, especially among men who have sex with men (MSM), is critical to HIV prevention., Objective: This analysis aims to understand potential users' preferences for LA-PrEP, with audience segmentation., Design: Willingness to use and preferences for LA-PrEP were measured in HIV-negative, sexually active MSM in the 2020 American Men's Internet Survey. Respondents answered a discrete choice experiment with paired profiles of hypothetical LA-PrEP characteristics with an opt-out option (no LA-PrEP). Conditional and mixed logit models were run; the final model was a dummy-coded mixed logit that interacted with the opt-out., Setting: US national online sample., Results: Among 2506 MSM respondents, most (75%) indicated a willingness to use LA-PrEP versus daily oral PrEP versus no PrEP. Respondents were averse to side effects and increasing costs and preferred increasing levels of protection. Respondents preferred a 2-hour time to obtain LA-PrEP vs 1 hour, with a strong aversion to 3 hours. Overall, there was an aversion to opting out of LA-PrEP, with variations: those with only one partner, no/other insurance or who were Black, Indigenous or People of Colour were significantly less likely to prefer LA-PrEP, while those who were Hispanic/Latino, college educated and <40 years significantly preferred LA-PrEP., Conclusions: A large proportion of MSM expressed a preference for LA-PrEP over daily oral pills. Most respondents chose LA-PrEP regardless of cost, clinic time, side effects or protection level; however, preferences varied by sociodemographics. These varied groups likely require tailored intervention strategies to achieve maximum LA-PrEP uptake and persistence., Competing Interests: Competing interests: JG and Johns Hopkins University and THS and PSS and Emory University receive grant funding from ViiV Healthcare to conduct pre-exposure prophylaxis-related research. JFPB holds an Innovation in Regulatory Science Award from the Burroughs Wellcome Fund., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Cabotegravir long-acting injectable HIV pre-exposure prophylaxis (LA PrEP) is efficacious, with a good safety profile, and was approved by the US Food and Drug Administration in December 2021. Understanding variations in potential user preferences for LA PrEP may inform implementation and subsequently improve uptake and community-level effectiveness. HIV-negative, sexually active men who have sex with men (MSM) aged ≥15 years were recruited online for the 2019 American Men's Internet Survey, before LA PrEP approval. Respondents completed a discrete-choice experiment (DCE) with hypothetical LA PrEP attributes (out-of-pocket cost, perceived side effects, injection frequency, perceived stigma, service location). Latent class analysis segmented respondents into groups based on their preferences for the attributes presented, and relative importance of preference weights and willingness-to-pay were calculated. While the majority had never used daily oral PrEP, 73% of the 2489 respondents were very or somewhat likely to use LA PrEP. Three latent classes were identified from 2241 respondents in the DCE. The "side effects-averse" class was the largest group (64% of respondents) and placed 61% relative importance on side effects. The "ambivalent" class (20% of respondents) placed higher importance on stigma (17% of relative importance) than other classes. The "cost-conscious" class (16% of respondents) placed higher relative importance (62%) on cost compared with other attributes and classes. Perceived side effects were an important hypothetical barrier for LA PrEP uptake among a large proportion of potential MSM users. Minimizing out-of-pocket costs is likely to increase uptake and may be important to equitable access. Tailored communication strategies are recommended for the different groups of potential LA PrEP users.

Background: The prevalence of diabetes remains high, with traditional lifestyle interventions demonstrating limited success in improving diabetes-related outcomes, particularly among individuals with diabetes-related mental health comorbidities. Digital health interventions provide the ability to ease the sustained and rigorous self-management needs associated with diabetes care and treatment. Current interventions though, are plagued by small sample sizes, underpowered pilot studies, and immense heterogeneity in program intervention, duration, and measured outcomes., Objective: Therefore, this work aimed to evaluate the effectiveness of a mobile health diabetes management program on measures of glycemic control in a high-risk population with type 2 diabetes (hemoglobin A1c [HbA1c] ≥8.0%), utilizing a sample of 1128 participants who provided baseline and follow-up data. The sustainability of this change in glycemic control was examined in a subset of participants (n=455) at 6 months and 1 year following program enrollment. A secondary analysis examined changes in glycemic control among a subset of participants with self-reported mild-to-moderate depression at baseline., Methods: This study utilized a single-arm, retrospective design. Participants were enrolled in the Vida Health Diabetes Management Program. This app-based intervention utilized one-on-one remote sessions with a health coach, registered dietitian nutritionist, and/or a certified diabetes care and education specialist and structured lessons and tools related to diabetes management and self-care. Participants provided baseline (-365 to 21 days of program enrollment) as well as follow-up (at least 90 days following program enrollment) HbA1c values. Paired t tests were used to evaluate changes in HbA1c between baseline and follow-up time points. The 8-item Patient Health Questionnaire and the 7-item Generalized Anxiety Disorder Scale were utilized to assess self-reported depressive and anxiety symptoms, respectively. Paired t tests and linear regression modeling accounting for pertinent covariates were used to evaluate changes in mental health symptom acuity and their relationship with changes in glycemic control., Results: We observed a significant decrease in HbA1c of -1.35 points between baseline (mean 9.84, SD 1.64) and follow-up (mean 8.48, SD 1.77; t=22.56, P<.001) among this large, high-risk sample. This decrease was sustained up to 1 year following program enrollment. Additionally, a significant relationship between improvements in depressive symptom acuity and improvements in HbA1c was observed (β=-0.74, P=.03)., Conclusions: This study demonstrates clinically meaningful improvements in glycemic control among participants enrolled in the Vida Health Diabetes Management Program. Additionally, this work presents one of the largest studied samples of participants enrolled in a digital health diabetes management program to date., (©Aarathi Venkatesan, Gretchen Zimmermann, Kelly Rawlings, Claudia Ryan, Louise Voelker, Caitlyn Edwards. Originally published in JMIR Formative Research (https://formative.jmir.org), 13.01.2023.)

Background: Several barriers to diabetes treatment and care exist, particularly in underserved medical communities., Objective: This study aimed to evaluate a novel, culturally adapted, Spanish-language mHealth diabetes program for glycemic control., Methods: Professional Spanish translators, linguists, and providers localized the entirety of the Vida Health Diabetes Management Program into a culturally relevant Spanish-language version. The Spanish-language Vida Health Diabetes Management Program was used by 182 (n=119 women) Spanish-speaking adults with diabetes. This app-based program provided access to culturally adapted educational content on diabetes self-management, one-on-one remote counseling and coaching sessions, and on-demand in-app messaging with bilingual (Spanish and English) certified health coaches, registered dietitian nutritionists, and certified diabetes care and education specialists. Hemoglobin A 1c (HbA 1c ) was the primary outcome measure, and a 2-tailed, paired t test was used to evaluate changes in HbA 1c before and after program use. To determine the relationship between program engagement and changes in glycemic control, a cluster-robust multiple regression analysis was employed., Results: We observed a significant decrease in HbA 1c of -1.23 points between baseline (mean 9.65%, SD 1.56%) and follow-up (mean 8.42%, SD 1.44%; P<.001). Additionally, we observed a greater decrease in HbA 1c among participants with high program engagement (high engagement: -1.59%, SD 1.97%; low engagement: -0.84%, SD 1.64%; P<.001)., Conclusions: This work highlights improvements in glycemic control that were clinically as well as statistically significant among Spanish-preferring adults enrolled in the Vida Health Spanish Diabetes Management Program. Greater improvements in glycemic control were observed among participants with higher program engagement. These results provide needed support for the use of digital health interventions to promote meaningful improvements in glycemic control in a medically underserved community., (©Caitlyn Edwards, Elisa Orellana, Kelly Rawlings, Mirta Rodriguez-Pla, Aarathi Venkatesan. Originally published in JMIR Formative Research (https://formative.jmir.org), 07.12.2022.)

Objectives: The challenges of improving the integration of care for older people with complex care needs are well recognised. Evidence suggests that solutions should be co-designed with older people to ensure they are contextually relevant and person-centred., Methods: As a first step in a co-design project to improve integrated care for older people, seven interviews and three workshops were held with older people and service providers. Data collected via recordings, notes and journey maps were inductively analysed., Results: Five themes were identified: relationships and roles, patient capacity and safety, information and systems, multiway communication, and transitions and flow. This created a more holistic and person-centred picture of integrated care than typically derived from published literature., Conclusions: Older people perceive integrated care from relational, organisational, informational and individual viewpoints. This reinforces the central importance of adopting a person-centred, as opposed to health system-focused, approach to designing and implementing integrated care solutions., (© 2021 AJA Inc.)

Preventing HIV transmission is a crucial step in ending the HIV epidemic. Safe and effective pre-exposure prophylaxis (PrEP) has been available in the United States since 2012. We set out to determine if persons at greatest risk for HIV acquisition were receiving HIV PrEP. HIV-negative individuals from the Observational Pharmaco-Epidemiology Research & Analysis (OPERA) cohort who were prescribed daily PrEP were contrasted with newly diagnosed HIV persons without PrEP use between July 16, 2012 and October 31, 2020 to determine if the PrEP prescriptions reached the populations who were seroconverting. Poisson regression was used to estimate incidence rates of seroconversion to HIV among PrEP initiators, as well as new diagnoses of sexually transmitted infections among both the PrEP group and the newly HIV+ group. Out of the 14,598 PrEP users and 3558 persons newly diagnosed with HIV in OPERA, demographics varied widely. Older individuals, those of non-Black race, men, nonintravenous (IV) drug users, and those with commercial insurance were proportionally overrepresented among those prescribed PrEP compared to persons newly diagnosed with HIV during the same time period. Over 82% of new HIV+ individuals received care in the southern United States compared to only 45% of PrEP users. Seroconversion to HIV among PrEP users was generally uncommon, although more frequent among those who identified as Black individuals, especially in the 13-25 years old age range. In conclusion, providers need innovative programs to better identify, educate, and link those at greatest risk of HIV acquisition, especially young people, women, Black individuals, and IV drug users, to PrEP.

Background: Traditional lifestyle interventions have shown limited success in improving diabetes-related outcomes. Digital interventions with continuously available support and personalized educational content may offer unique advantages for self-management and glycemic control., Objective: In this study, we evaluated changes in glycemic control among participants with type 2 diabetes who enrolled in a digital diabetes management program., Methods: The study employed a single-arm, retrospective design. A total of 950 participants with a hemoglobin A 1c (HbA 1c ) baseline value of at least 7.0% enrolled in the Vida Health Diabetes Management Program. The intervention included one-to-one remote sessions with a Vida provider and structured lessons and tools related to diabetes management. HbA 1c was the primary outcome measure. Of the 950 participants, 258 (27.2%) had a follow-up HbA 1c completed at least 90 days from program start. Paired t tests were used to evaluate changes in HbA 1c between baseline and follow-up. Additionally, a cluster-robust multiple regression analysis was employed to evaluate the relationship between high and low program usage and HbA 1c change. A repeated measures analysis of variance was used to evaluate the difference in HbA 1c as a function of the measurement period (ie, pre-Vida enrollment, baseline, and postenrollment follow-up)., Results: We observed a significant reduction in HbA 1c of -0.81 points between baseline (mean 8.68, SD 1.7) and follow-up (mean 7.88, SD 1.46; t 257 =7.71; P<.001). Among participants considered high risk (baseline HbA 1c ≥8), there was an average reduction of -1.44 points between baseline (mean 9.73, SD 1.68) and follow-up (mean 8.29, SD 1.64; t 139 =9.14; P<.001). Additionally, average follow-up HbA 1c (mean 7.82, SD 1.41) was significantly lower than pre-enrollment HbA 1c (mean 8.12, SD 1.46; F 2, 210 =22.90; P<.001) There was also significant effect of program usage on HbA 1c change (β=-.60; P<.001) such that high usage was associated with a greater decrease in HbA 1c (mean -1.02, SD 1.60) compared to low usage (mean -.61, SD 1.72)., Conclusions: The present study revealed clinically meaningful improvements in glycemic control among participants enrolled in a digital diabetes management intervention. Higher program usage was associated with greater improvements in HbA 1c . The findings of the present study suggest that a digital health intervention may represent an accessible, scalable, and effective solution to diabetes management and improved HbA 1c . The study was limited by a nonrandomized, observational design and limited postenrollment follow-up data., (©Gretchen Zimmermann, Aarathi Venkatesan, Kelly Rawlings, Michael D Scahill. Originally published in JMIR Diabetes (https://diabetes.jmir.org), 02.06.2021.)

Background: Inaccurate blood glucsoe monitoring systems (BGMSs) can lead to adverse health effects. The Diabetes Technology Society (DTS) Surveillance Program for cleared BGMSs is intended to protect people with diabetes from inaccurate, unreliable BGMS products that are currently on the market in the United States. The Surveillance Program will provide an independent assessment of the analytical performance of cleared BGMSs., Methods: The DTS BGMS Surveillance Program Steering Committee included experts in glucose monitoring, surveillance testing, and regulatory science. Over one year, the committee engaged in meetings and teleconferences aiming to describe how to conduct BGMS surveillance studies in a scientifically sound manner that is in compliance with good clinical practice and all relevant regulations., Results: A clinical surveillance protocol was created that contains performance targets and analytical accuracy-testing studies with marketed BGMS products conducted by qualified clinical and laboratory sites. This protocol entitled "Protocol for the Diabetes Technology Society Blood Glucose Monitor System Surveillance Program" is attached as supplementary material., Conclusion: This program is needed because currently once a BGMS product has been cleared for use by the FDA, no systematic postmarket Surveillance Program exists that can monitor analytical performance and detect potential problems. This protocol will allow identification of inaccurate and unreliable BGMSs currently available on the US market. The DTS Surveillance Program will provide BGMS manufacturers a benchmark to understand the postmarket analytical performance of their products. Furthermore, patients, health care professionals, payers, and regulatory agencies will be able to use the results of the study to make informed decisions to, respectively, select, prescribe, finance, and regulate BGMSs on the market., Competing Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: DCK has served on advisory panels for Insuline, Lifecare, Novartis, Roche, Sanofi, Tempramed and Voluntis, has received research support from Eli Lilly, Halozyme, Janssen, and Novo Nordisk, and owns stocks/shares in Tempramed. JLP is an independent consultant and president of Joan Lee Parkes Consulting Inc. She has consulted for Diabetes Technology Society and Lifescan in 2014 and 2015. BPK served as an advisor to Astra Zeneca, Becton, Dickinson, and Company and Sanofi-Aventis and has received research support from Animas Inc, BD, Dexcom, Insulet, Roche Diagnostics, Sanofi-Aventis, and Tandem Diabetes Care. Stock ownership: Inspark Technologies, Inc, and TypeZero Technologies. RAV was a consultant for Sanofi, Medtronic, and Bayer at the time of the development of this program. He received an Investigator Initiated Research Grant from Dexcom. Currently, he has no disclosures except that he is an employee of Medtronic. RDB is on the Board of Diabetes Technology Society. JN has received honoraria and travel expenses from IL, BioRad, Fujiribio, Radiometer and Becton Dickinson over the past year related to scientific presentations and professional consulting. SS is an employee of Abbott Diabetes Care. JJS attended an advisory board meeting for Bayer Diabetes Care on April 25, 2015. CL, SB, GAR, AK, RL, MP, KR, DS, ES, RS, and HWV have no relevant disclosures., (© 2015 Diabetes Technology Society.)

Introduction: Truvada® (TVD) was approved in July 2012 by the US FDA for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in high-risk adults. This study explores the characteristics of US PrEP users and their prescribers over the past two years., Materials and Methods: A previously described algorithm was used to identify TVD for PrEP by excluding use for HIV treatment, post-exposure prophylaxis, and off-label treatment of chronic hepatitis B. National electronic patient level data from ~55% of all US retail pharmacies that dispensed TVD between January 1, 2012 and March 31, 2014 was collected. De-identified patient-level data including prescription refill data, medical claims and patient demographics were analyzed via logistic regression to estimate the odds of change by year., Results: A total of 3253 unique individuals who started TVD for PrEP between January 1, 2012 and March 31, 2014 were included in this analysis. Women comprised 42.0% of PrEP users. Although mean age was 38.1+11.9 years, with males being significantly older (39.3+11.6) than females (36.4+12.3), 11.5% of individuals were under 25 years old. The proportion of males under 25 was 7.4% (95% CI 6.3-8.7); significantly lower than that of women, 17.2% (95% CI 15.3-19.3). New starts have increased from 293 in 2012 to 472 Q1 2014. During the 12-month period ending March 31, 2013 and March 31, 2014 the number of new starts among females dropped from 44.5% to 22.9%., Conclusions: The population of TVD for PrEP users in the US nationally appears to be shifting demographically. It continues to be initiated mostly by primary care providers. Over a two-year period new starts of Truvada for PrEP have increased considerably among males. While the overall proportion of female users decreased between Q1 2012 and Q1 2014, females that started on PrEP are younger than males. More community-level data on PrEP usage will be helpful in informing local efforts to integrate PrEP in HIV prevention messaging and services.