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Aim: The purpose of the present study was to compare the clinical efficacy of GC Gold Label IX, GC Gold Label IX Extra, and GC Gold Label Hybrid in occlusal surface cavities in primary molars prepared by hand instrumentation technique. Materials and methods: Ninety primary molars were selected from the children according to the inclusion and exclusion criteria. The selected teeth were randomly allocated into the following three groups, with 30 teeth in each group, according to the restorative material used: group I: GC Gold Label IX, group II: GC Gold Label IX Extra, and group III: GC Gold Label Hybrid. Occlusal cavities were prepared using hand instruments. Caries removal efficacy was verified using caries detector dye. The restorative materials were mixed and condensed into the prepared cavities. The restorations were assessed using modified United States Public Health Service (USPHS) evaluation criteria at 1, 3, and 6 months. Results: The results were tabulated and statistically analyzed using the Chi-squared test. No significant difference was found in terms of color match, marginal discoloration, marginal integrity, surface roughness, and secondary caries, but a significant difference was observed in terms of retention and anatomic form between group I and group III. Conclusion: GC Gold Label Hybrid exhibited better clinical performance with respect to GC Gold Label IX and comparable clinical performance with respect to GC Gold Label IX Extra. Clinical significance: GC Gold Label Hybrid is a newly developed glass ionomer cement (GIC), and its clinical performance needs to be studied. How to cite this article: Mittal M, Bajaj N, Bhola M, et al. Comparative Evaluation of GC Gold Label IX with GC Gold Label IX Extra and GC Gold Label Hybrid in Cavitated Lesions Prepared by Hand Instrumentation Technique in Primary Molars: An In Vivo Study. Int J Clin Pediatr Dent 2024;17(5):570-575.

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INTRODUCTION: Revision hip and knee total joint arthroplasty (TJA) is associated with higher healthcare costs and work burden than primary TJAs. However, previous studies demonstrated a decrease in the value of reimbursements for revision TJA, causing concerns for hospitals and surgeons regarding the financial sustainability of these resource-expensive procedures. This study aimed to investigate the Medicare billing trends of hospitals and surgeons for revision TJA between 2017 and 2022. METHODS: Medicare claims and payments for revision TJA were identified from the Centers for Medicare and Medicaid Services Part A and B databases. Hospital claims for revision TJA were identified through Diagnostic-Related Groups (467, 468). Surgeon claims were identified using Current Procedural Terminology codes for revision hip (27134, 27137, 27138) and knee (27486, 27487) TJA. Yearly charges, reimbursements, and markup ratios (MR = charge/reimbursement) were analyzed. All monetary values were adjusted to the 2022 U.S. dollars. RESULTS: A total of 43,125 surgeons and 152,974 hospital claims were included in this study. From 2017 to 2022, the total volume of revision TJA decreased by 19.4%. Hospital reimbursements remained relatively unchanged, with a decrease of 1.4%, while hospital charges increased by 11.8%, resulting in a 13.3% increase in the markup ratio. For surgeons, reimbursements decreased by 13.8%, and charges decreased by 11.0%, leading to a 3.3% increase in the markup ratio. The proportion of surgeon reimbursement to hospital reimbursement decreased from 8.5 to 7.5%. CONCLUSION: The comparison of the billing trends of hospitals and surgeons showed the relatively stable value of hospital reimbursement while the value of surgeon reimbursement continued to decline, implying the decreasing fiscal value of physicians' work. The study suggests the need for sustainable financial incentives for surgeons performing revision TJA and strategies to control hospital charges to alleviate financial burdens and improve patient access to revision TJA.

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Background: Cardiovascular diseases (CVDs) are not only the primary cause of mortality in China but also represent a significant financial burden. The World Health Organization highlight that as China undergoes rapid socioeconomic development, its disease spectrum is gradually shifting towards that of developed countries, with increasing prevalence of lifestyle-related diseases such as ischemic heart disease and stroke. We reviewed the rates and trends of CVDs incidence, mortality and disability-adjusted life years (DALYs) burden in China and compared them with those in the United States (US) and Japan for formulating CVDs control policies. Methods: Data on CVDs incidence, death and DALYs in China, the US and Japan were obtained from the GBD 2019 database. The Joinpoint regression model was used to analyze the trends in CVDs incidence and mortality in China, the US and Japan, calculate the annual percentage change and determine the best-fitting inflection points. Results: In 2019, there were approximately 12,341,074 new diagnosed cases of CVDs in China, with 4,584,273 CVDs related deaths, causing 91,933,122 DALYs. The CVDs age-standardized incidence rate (ASIR) in China (538.10/100,000) was lower than that in the US and globally, while age-standardized death rate (ASDR) (276.9/100,000) and age-standardized DALY rate (6,463.47/100,000) were higher than those in the two regions. Compared with the US and Japan, from 1990 to 2019, the CVDs incidence rate in China showed an increasing trend, with a lower annual decrease in ASDR and a younger age structure of disease burden. Furthermore, the disease spectrum in China changed minimally, with stroke, ischemic heart disease, and hypertensive heart disease being the top three leading CVDs diseases in terms of incidence and disease burden, also being the major causes of CVDs in the US and Japan. Conclusion: The prevention and control of CVDs is a global issue. The aging population and increasing unhealthy lifestyles will continue to increase the burden in China. Therefore, relevant departments in China should reference the established practices for CVDs control in developed countries while considering the diversity of CVDs in different regions when adjusting national CVDs control programs.

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Oropouche virus has recently caused outbreaks in South America and the Caribbean, expanding into areas to which the virus was previously not endemic. This geographic range expansion, in conjunction with the identification of vertical transmission and reports of deaths, has raised concerns about the broader threat this virus represents to the Americas. We review information on Oropouche virus, factors influencing its spread, transmission risk in the United States, and current status of public health response tools. On the basis of available data, the risk for sustained local transmission in the continental United States is considered low because of differences in vector ecology and in human-vector interactions when compared with Oropouche virus-endemic areas. However, more information is needed about the drivers for the current outbreak to clarify the risk for further expansion of this virus. Timely detection and control of this emerging pathogen should be prioritized to mitigate disease burden and stop its spread.

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Foodborne disease burden estimates inform public health priorities and can help the public understand disease impact. This article provides new estimates of the cost of U.S. foodborne illness. Our research updated disease modeling underlying these cost estimates with a focus on enhancing chronic sequelae modeling and enhancing uncertainty modeling. Our cost estimates were based on U.S. Centers for Disease Control and Prevention estimates of the numbers of foodborne illnesses, hospitalizations, and deaths caused by 31 known foodborne pathogens and unspecified foodborne agents. We augmented these estimates of illnesses, hospitalizations, and deaths with more detailed modeling of health outcomes, including chronic sequelae. For health outcomes, we relied on U.S. data and research where possible, supplemented by the use of non-U.S. research where necessary and scientifically appropriate. Cost estimates were developed from large insurance or hospital charge databases, public data sources, and existing literature and were adjusted to 2023 dollars. We estimated the cost of foodborne illness in the United States circa 2023 to be $75 billion. Deaths accounted for 56% and chronic outcomes for 31% of the mean cost. The costliest pathogen was nontyphoidal Salmonella at $17.1 billion followed by Campylobacter at $11.3 billion. Toxoplasma ($5.7 billion) and Listeria ($4 billion) followed due primarily to deaths and chronic outcomes from pregnancy-associated cases. Per-case cost ranged from $196 for Bacillus cereus to $4.6 million for Vibrio vulnificus. Unspecified agents accounted for 38% of the total cost of foodborne illness, but these illnesses were generally mild (per-case cost $781). These cost estimates can help inform food safety priorities. Our pathogen-specific per-case cost estimates can also help inform benefit-cost analysis required for new federal food safety regulations.

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The study objective was to investigate the factors associated with physical and psychological wellness of United States (US) adults with asthma. This cross-sectional analysis used a sample of 2329 US adults with asthma in the 2021 Medical Expenditure Panel Survey data. A logistic regression model investigated the association of the following factors and the dependent variables (physical wellness and psychological wellness): age, sex, race, ethnicity, education, employment, healthcare provision, marriage, income, regular physical activity, current smoker, pain, and limitations. Nationally representative estimates were produced through a weighted analysis. The data structure was maintained using cluster and strata variables. The alpha limit was 0.05. Factors associated with higher odds of reporting good physical wellness included: private (versus no) healthcare provision (odds ratio [OR] = 2.63, 95% confidence interval [CI] = 1.10-6.26), good (versus poor) psychological wellness (OR = 6.83, 95% CI = 4.35-10.72), regular (versus no regular) physical activity (OR = 2.18, 95% CI = 1.42-3.34), little/moderate (versus quite a bit/extreme) pain (OR = 3.51, 95% CI = 2.38-5.15) and no (versus any) limitation (OR = 3.73, 95% CI = 2.30-6.06). In the psychological wellness model, those aged ≥70 (OR = 6.18, 95% CI = 2.72-14.07), 60-69 (OR = 4.64, 95% CI = 2.13-10.10), and 50-59 (OR = 4.96, 95% CI = 2.24-11.02) versus those aged 18-29, and good (versus poor) physical wellness (OR = 6.89, 95% CI = 4.34-10.94) were associated with higher odds of reporting good versus poor psychological wellness. In conclusion, these results may be helpful at targeting resources to optimize the wellness of US adults with asthma. Additional studies are needed to determine any temporal associations between these findings.

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Background: Advanced pulmonary tuberculosis (APT) may reflect delays in tuberculosis (TB) diagnosis and contribute to ongoing disease transmission and poor outcomes. We characterized trends and factors associated with APT over ten years in a high TB-burden county within the United States. Methods: We evaluated microbiologically and clinically confirmed TB cases reported to the Alameda County Public Health Department during 2010-2019. APT was defined as the presence of cavitation on chest imaging and positive acid-fast bacilli sputum smear. Over the ten-year period, we determined overall incidence and annual trends, and conducted multivariable logistic regression to identify sociodemographic and clinical factors associated with APT. Results: We included 997 cases with pulmonary TB, of which 128 (12.8 %) had APT. The 10-year incidence of APT was 8.8 cases per 100,000, with no significant change in proportion over time. The median age of cases with APT were 50 years (IQR 32-61), 68 % were male, and 78.9 % were non-US-born. On multivariable assessment, APT cases were more likely than non-APT cases to use drugs in the past year (aOR 2.43, 95 % CI 1.10-35.09), to have diabetes (aOR 2.51, 95 % CI: 1.59-3.96), and be HIV negative (aOR 9.32 versus HIV positive, 95 % CI 1.87-169.77). While US nativity was not significantly associated with APT, it was an effect modifier. In stratified analysis, APT was more likely among those with drug-use in the last year among US-born, while diabetes was associated with APT among non-US-born individuals. Conclusions: APT remains a substantial proportion of TB cases. Efforts to increase awareness and access to care are needed for key risk groups including those with recent drug use or diabetes, with consideration of cultural and linguistic factors given differences by US nativity.

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BACKGROUND: Prevalence estimates of atrial fibrillation (AF) from large populations have not been updated for >2 decades. Using data from 1996 to 1997, a previous study projected that there would be 3.3 million adults with AF in the United States in 2020. OBJECTIVES: The purpose of this study was to determine the contemporary age-, sex-, and race-standardized prevalence and the number of adults with diagnosed AF in the United States. METHODS: We merged California's state-wide health care databases to assemble a cohort of adults aged ≥20 years who received hospital-based care in California from 2005 to 2019. International Classification of Diseases codes were used to identify AF and other comorbidities. After accounting for deaths, we utilized the U.S. Census to calculate the national age-, sex-, and race-standardized estimates of diagnosed AF. RESULTS: Of 29,250,310 patients (mean age 50.6 ± 19.8 years, 53.8% women, 50.1% White), 2,003,867 (6.8%) had an AF diagnosis. The proportion of patients with diagnosed AF increased from 4.49% in 2005 to 2009 to 6.82% in 2015 to 2019. Over time, AF patients became relatively younger, were less likely to be female or White, and were more likely to have hypertension and diabetes. Standardizing based on age-, sex-, race-, and ethnicity-based proportions to the U.S. population, we estimate that the current national prevalence of diagnosed AF is at least 10.55 million (95% CI: 10.48-10.62 million), comprising 4.48% (95% CI: 4.47%-4.49%) of the adult population. CONCLUSIONS: The prevalence of diagnosed AF in the United States is higher than previously estimated. More efficient prevention and treatment strategies are needed to curb the burden of AF in the United States.

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Access to postpartum care (PPC) varies in the US and little data exists about whether patient factors may influence receipt of care. Our study aimed to assess the effect of provider-patient racial concordance on Black patients' receipt of PPC. We conducted a cross-sectional study analyzing over 24,000 electronic health records of childbirth hospitalizations at a large academic medical center in Alabama from January 2014 to March 2020. The primary outcome variable was whether a Black patient with a childbirth hospitalization had any type of PPC visit within 12 weeks after childbirth. We used a generalized estimating equation (GEE) logistic regression model to assess the relationship between provider-patient racial concordance and receipt of PPC. Black patients with Black main providers of prenatal or childbirth care had significantly higher adjusted odds of receiving PPC (adj. OR 2.26, 95% CI 1.65-3.09, p < .001) compared to Black patients with non-Black providers. White patients who had White providers did not have statistically significantly different odds of receiving PPC compared to those with non-White providers after adjustment (adj. OR 0.88, 95% CI 0.68-1.14). Although these results should be interpreted with caution given the low number of Black providers in this sample, our findings suggest that in one hospital system in Alabama, Black birthing people with a racially concordant main prenatal and delivery care provider may have an increased likelihood of getting critical PPC follow-up.

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BACKGROUND: Despite high vaccine-effectiveness, wild-type measles can occur in previously vaccinated persons. We compared the clinical presentation and disease severity of measles by vaccination status and age in the post-elimination era in the United States. METHODS: We included U.S. measles cases reported from 2001-2022. Breakthrough measles was defined as cases with ≥1 documented dose of measles-containing vaccine, classic measles as the presence of rash, fever, and ≥1 symptoms (cough, coryza, or conjunctivitis), and severe disease as the presence of pneumonia, encephalitis, hospitalization, or death. Vaccinated cases with low and high avidity IgG were classified as primary (PVF) and secondary (SVF) vaccine failures, respectively. RESULTS: Among 4,056 confirmed measles cases, 2,799 (69%) were unvaccinated, 475 (12%) were breakthrough infections, and 782 (19%) had unknown vaccination; 1,526 (38%), 1,174 (29%), and 1,355 (33%) were aged <5, 5-19, and ≥20 years, respectively. We observed a general decline in classic presentation and severe disease with an increase in the number of doses, and less complications among children aged 5-19 years compared to other age-groups. Among 93 breakthrough cases with avidity results, 11 (12%) and 76 (82%) were classified as PVF and SVF, respectively, with a higher proportion of PVFs having a classic measles presentation and severe disease than SVFs. DISCUSSION: Breakthrough measles cases tended to have milder disease with less complications. A small proportion of breakthrough infections were due to PVF than SVF. It is critical to maintain high MMR vaccination coverage in the United States to prevent serious measles illnesses.

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Background: Despite its efficacy in reducing lung cancer (LC)-specific mortality by 20%, screening with low-dose computed tomography (LDCT) in eligible groups remains low (5-16%). Black individuals are more commonly affected by LC than other racial/ethnic groups in the United States (U.S.) but less likely to undergo LC screening (LCS). Our study aimed to explore the knowledge and beliefs of Black individuals at high risk regarding LCS. Methods: Black individuals (n=17) who met the 2021 United States Preventive Services Task Force (USPSTF) LCS eligibility criteria were recruited in upstate New York. In-depth semi-structured interviews were conducted, audio recorded, and transcribed to explore knowledge and beliefs that could influence the uptake of LCS. A qualitative thematic analysis method was used to identify and analyze themes within the data. Results: We identified principal themes about LC and LCS. Although most participants reported that smoking was the major risk factor for LC, some participants placed more emphasis on other factors as the major risk factors for LC and de-emphasized the role of smoking. Most participants were not aware that screening for LC existed. Several barriers and facilitators for LCS were identified. Conclusions: Awareness about LCS among Black individuals is low. Addressing barriers may help increase LCS rates among Black individuals, ultimately reducing their LC mortality. The findings from our study have important implications in designing more effective interventions involving community health workers and healthcare clinicians to increase LCS uptake among Black individuals at high risk.

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PURPOSE: The United States Medical Licensing Examination (USMLE) is an examination series required for allopathic physician licensure in the United States (US). USMLE content is created and maintained by the National Board of Medical Examinations (NBME). The specialty composition of the USMLE and NBME taskforce members involved in the creation of examination content is currently unknown. METHODS: Using the 2021 USMLE and 2021 NBME Committees and Task Forces documents, we determined each member's board-certified primary specialty and involvement in test material development committees who we dubbed "test writers". Total active physicians by primary specialty were recorded from the 2020 Physician Specialty Data Report published by the Association of American Medical Colleges (AAMC). Descriptive statistics and chi-square analysis were used to analyze the cohorts. RESULTS: The USMLE and NBME test writer primary specialty composition was found to be significantly different compared to the US active physician population (USMLE χ2[32] = 172, p < .001 and NBME χ2[32] = 200, p < .001). Only nineteen specialties were represented within USMLE test writers, with three specialties being proportionally represented. Two specialties were represented within NBME test writers. Obstetrics and Gynecology physicians were proportionally represented in USMLE but not within NBME test writers. Internal Medicine (IM) accounts for the largest percentage of all USMLE test writers (60/197, 30%) with an excess representation of 31 individuals. CONCLUSIONS: There is an imbalance in the specialty representation of USMLE and NBME test writers compared to the US active physician population. These findings may have implications for the unbiased and accurate portrayal of topics in such national examinations; thus, future investigation is warranted.

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Japanese encephalitis virus (JEV) is associated with encephalitis in humans and reproductive and neurological illness in pigs. JEV has expanded beyond its native distribution in southeast Asia, with identifications in Europe (2010) and Africa (2016), and most recently, its spread into mainland Australia (2021-2022). The introduction of JEV into the United States (US) is a public health risk, and could also impact animal health and the food supply. To efficiently and cost-effectively manage risk, a better understanding of how and where diseases will be introduced, transmitted, and spread is required. To achieve this objective, we updated our group's previous qualitative risk assessment using an established semi-quantitative risk assessment tool (MINTRISK) to compare the overall rate of introduction and risk, including impacts, of JEV in seven US regions. The rate of introduction from the current region of distribution was considered negligible for the Northeast, Midwest, Rocky Mountain, West, Alaska, and Hawaii regions. The South region was the only region with a pathway that had a non-negligible rate of introduction; infected mosquito eggs and larvae introduced via imported used tires (very low; 95% uncertainty interval (UI) = negligible to high). The overall risk estimate for the South was very high (95% UI = very low to very high). Based on this risk assessment, the South region should be prioritized for surveillance activities to ensure the early detection of JEV. The assumptions used in this risk assessment, due to the lack of information about the global movement of mosquitoes, number of feral pigs in the US, the role of non-ardeid wild birds in transmission, and the magnitude of the basic reproduction ratio of JEV in a novel region, need to be fully considered as these impact the estimated probability of establishment.

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This article highlights the effect of the COVID-19 pandemic on immigration. and immigrant wellbeing in the United States by focusing on all categories of migrants, documented and undocumented. We argue that in the wake of the pandemic, immigrants disproportionately experienced higher rates of unemployment, greater losses of income, more exposure occupational risks, and higher rates of food and housing insecurity, all of which exacerbated preexisting differentials in access to health and health care to generate higher rates of COVID infection, morbidity, and mortality among adults and stunted educational outcomes for their children. The prospects for a full post-pandemic recovery of immigrants' wellbeing are dampened by the severe nature of COVID's negative effects on immigrants; the unusually hostile context of reception immigrants face after the pandemic; the large number of immigrants lacking legal status or holding tenuous documentation; and the formidable deportation regime that prevails in the United States that puts a great strain on immigrant communities. Undocumented migration has surged to restart undocumented population growth, further clouding the future for immigrants in the country. It is unclear whether reforms proposed by the Biden Administration be enacted and successful in improving their prospects. In general, this article aims to contribute to the broader discussion about migration and health policies.

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AIM: Elevated body mass index (BMI) presents a significant public health challenge in the United States, contributing to considerable morbidity, mortality and economic burden. This study investigates the health burden of overweight and obesity in the United States from 1990 to 2021, leveraging the Global Burden of Disease data set to analyse trends, disparities and potential determinants of high BMI-related health outcomes. MATERIALS AND METHODS: Our study focused on the United States, analysing trends in disability-adjusted life years (DALY) and deaths attributable to high BMI, defined as a BMI of 25 kg/m2 or higher for adults. Statistical analyses included estimated annual percentage change (EAPC) in age-standardized DALY rates and age-standardized death rates. Pearson correlation was performed between EAPCs and the socio-demographic index (SDI), with significance set at p < 0.05. RESULTS: From 1990 to 2021, age-standardized DALY rates attributable to high BMI increased by 24.9%, whereas the age-standardized death rates increased by 5.2%. Age disparities showed DALYs peaking at 60-64 years for males and 65-69 years for females, with deaths peaking at 65-69 years for males and 90-94 years for females. A strong negative correlation was found between the EAPC in age-standardized DALY and death rates and the SDI. CONCLUSIONS: Overweight and obesity significantly impact public health in the United States, especially among older adults and lower socio-demographic regions. Comprehensive public health strategies integrating behavioural, technological and environmental interventions are crucial. Future research should focus on longitudinal studies, personalized interventions and policy-driven approaches to address the multifaceted influences on high BMI.

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BACKGROUND: There are little data on the relationship between physical activity and suicidal behavior in medical students. Therefore, this cross-sectional study aimed to investigate the association between physical activity and suicidal behavior and identify mediating factors involved in the association among medical students from the United States. METHODS: Data from the Healthy Minds Study (2007-2023) were used. Physical activity and suicidal behavior (i.e., suicidal ideation, suicide plans, and suicide attempts) were self-reported. Control variables included age, gender, ethnicity/race, relationship status, citizenship, current financial stress, and academic year. Mediating factors were flourishing, generalized anxiety disorder symptoms, depressive symptoms, eating disorder symptoms, binge drinking, smoking, and drug use. RESULTS: There were 6452 medical students included in the study (median [IQR] age 25.0 [3.0] years; 4032 [62.5 %] women). After adjusting for control variables, compared with <1 hour of physical activity per week, the odds of any suicidal behavior were significantly lower for 3-4 hours (OR = 0.57, 95 % CI = 0.41-0.79) and ≥5 hours of physical activity per week (OR = 0.52, 95 % CI = 0.39-0.70). The physical activity-any suicidal behavior relationship was partially explained by decreased depressive symptoms (39.4 %), increased flourishing (27.6 %), and decreased generalized anxiety disorder symptoms (18.7 %). LIMITATIONS: Data are of a cross-sectional nature. CONCLUSIONS: There was an inverse association between physical activity and suicidal behavior in medical students from the United States, while several variables were identified as mediating factors (i.e., depressive symptoms, flourishing, and general anxiety disorder symptoms). Further research is needed to corroborate these findings in other settings, while longitudinal data are urgently warranted.

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The consumption of animal-source foods, and particularly red meat from ruminants, is a major contributor to greenhouse gas emissions, freshwater use, and loss of biodiversity. Reducing red meat consumption has been identified as a key strategy to mitigate climate change; however, little is known about how to effectively intervene to promote its reduction in the United States (US). This study aimed to examine meat (red, unprocessed, and poultry) and seafood consumption patterns, the factors influencing their consumption (including a reduction in their consumption over time), and how these differed based on socioeconomic variables. The study was conducted through an online survey with a representative sample of the US population (n = 1224) in 2021 using KnowledgePanel®. Overall, we found that most participants reported consuming red meat (78%), processed meat (74%), or poultry (79%) 1-4 times per week, with several differences in consumption patterns based on socio-demographic characteristics. A substantial proportion of the population reported reducing their red (70%) and processed meat (64%) consumption over the previous year, which was much higher than those that reported reducing poultry (34%) or seafood (26%). Key factors influencing red meat reduction were health and price, while environmental sustainability and animal welfare were less important, particularly among certain socio-demographic groups. These findings can help provide insight into how best to frame messaging campaigns aimed at shifting red meat consumption in the US to support climate change mitigation. Focusing on the factors that resonate more with consumers is more likely to lead to shifts in consumption patterns.

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BACKGROUND: HIV prevention is a public health priority. Despite progress in recent years, pre-exposure prophylaxis (PrEP) use remains suboptimal especially among groups disproportionately impacted by new HIV diagnoses such as gender and sexual minorities of color. Multiple barriers including a lack of PrEP providers and challenges with attending quarterly monitoring visits contribute to low PrEP uptake and retention. Home-based PrEP (HB-PrEP) services could reduce stigma, increase convenience, expand health system capacity for PrEP care, and improve PrEP retention. OBJECTIVE: Home Option Testing for PrEP (HOT4PrEP) is a hybrid randomized controlled trial (RCT) that aims to examine whether HB-PrEP care is acceptable to PrEP users, feasible to implement in a sexual health clinic setting, and impacts PrEP retention. METHODS: The RCT will recruit 458 persons currently taking or soon to initiate PrEP at a sexual health clinic in Seattle, Washington, and randomize them to continue the standard of care or have the option to use HB-PrEP for 2 of 3 triannual PrEP follow-up visits. Participants in the intervention arm will be sent home kits containing gonorrhea and chlamydia swabs and Tasso devices for blood self-collection. The primary outcome is PrEP retention between groups at 20 months; secondary outcomes include user satisfaction and acceptability, feasibility, self-reported PrEP adherence, and sexually transmitted infection (STI) incidence. Interviews with PrEP users and clinic staff will elucidate barriers and facilitators of implementation. RESULTS: The HOT4PrEP RCT began enrolling in March 2022, was on hold during the height of the US mpox epidemic, then resumed enrollment in December 2022. Of the first 100 enrollees, the median age is 34 years, and most are cisgender gay men (89/100, 89%) with at least some college education (91/100, 91%). Among the 49 participants randomized to the HB-PrEP option, 33 (67%) chose to self-collect samples at home at least once, of whom 27 (82%) successfully returned test kits for HIV and STI testing. Primary PrEP retention and qualitative analyses are ongoing. CONCLUSIONS: Implementation of HB-PrEP into a high-volume sexual health clinic seems to be feasible and acceptable to early RCT enrollees. This strategy has the potential to address individual and systemic barriers associated with initiating and persisting on PrEP, such as increasing sexual health agency and expanding clinical capacity to serve greater numbers of PrEP users. TRIAL REGISTRATION: ClinicalTrials.gov NCT05856942; https://clinicaltrials.gov/study/NCT05856942. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56587.

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