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Background: Pre-exposure prophylaxis (PrEP) is a potent biomedica tool for HIV prevention; however, PrEP is underutilized among African American (AA) women in the Deep South of the United States, despite [...]

As HIV prevalence climbs globally, including more than 50 000 new infections per year in the United States, we need more effective HIV prevention strategies. The use of antiretrovirals for preexposure prophylaxis (PrEP) among high-risk persons without HIV is emerging as one such strategy. Randomized, controlled trials have demonstrated that once-daily oral PrEP decreased HIV incidence among at-risk men who have sex with men and African heterosexuals, including serodiscordant couples. An additional randomized, controlled trial of a topical pericoital antiretroviral microbicide gel decreased HIV incidence among at-risk heterosexual South African women. Two other studies in African women did not demonstrate the efficacy of oral or topical PrEP, raising concerns about adherence patterns and efficacy in this population. The U.S. Food and Drug Administration (FDA) Antiviral Drugs Advisory Committee reviewed these studies and additional data in May 2012 and voted to advise the approval of oral tenofovir-emtricitabine for PrEP in high-risk populations. On 16 July 2012, the FDA recommended that this combination medication be approved for use as PrEP in high-risk persons without HIV. Patients may seek PrEP from their primary care providers, and those receiving PrEP require monitoring. Thus, primary care providers should become familiar with PrEP. This review outlines current knowledge about PrEP as it pertains to primary care, including identifying persons likely to benefit from PrEP; counseling to maximize adherence and reduce potential increases in risky behavior; and monitoring for potential drug toxicities, HIV acquisition, and antiretroviral drug resistance. Issues related to cost and insurance coverage are also discussed. Recent data suggest that PrEP, combined with other prevention strategies, holds promise in helping to curtail the HIV epidemic. [ABSTRACT FROM AUTHOR]

Charlene A Flash,1 Sannisha K Dale,2–4 Douglas S Krakower3,5,6 1Section of Infectious Diseases, Department of Medicine, Baylor College of Medicine, Houston, TX, 2Massachusetts General Hospital, 3Department of Psychiatry, Harvard Medical School, Boston, MA, 4Department of Psychology, University of Miami, Coral Gables, FL, 5Division of Infectious Diseases, Beth Israel Deaconess Medical Center, 6The Fenway Institute, Boston, MA, USA Abstract: There are ~900,000 new HIV infections among women every year, representing nearly half of all new HIV infections globally. In the US, nearly one-fifth of all new HIV infections occur among women, and women from racial and ethnic minority communities experience disproportionately high rates of new HIV infections. Thus, there is a need to develop and implement effective HIV prevention strategies for women in the US and internationally, with a specific need to advance strategies in minority communities. Previous studies have demonstrated that oral HIV pre-exposure prophylaxis (PrEP), the use of antiretroviral medications by HIV-uninfected persons to prevent HIV acquisition, can reduce HIV incidence among women who are adherent to PrEP. However, to date, awareness and uptake of PrEP among women have been very limited, suggesting a need for innovative strategies to increase the knowledge of and access to PrEP among women in diverse settings. This narrative review summarizes the efficacy and safety data of PrEP in women, discusses considerations related to medication adherence for women who use PrEP, and highlights behavioral, social, and structural barriers to maximize the effectiveness of PrEP in women. It also reviews novel modalities for PrEP in women which are being developed and tested, including topical formulations and long-acting injectable agents that may offer advantages as compared to oral PrEP and proposes a community-oriented, social networking framework to increase awareness of PrEP among women. If women are provided with access to PrEP and support to overcome social and structural barriers to adhere to PrEP, this prevention strategy holds great promise to impact the HIV epidemic among women in the US and globally. Keywords: HIV, prevention, pre-exposure prophylaxis PrEP, narrative review

Background: Although some experts recommend anal cancer screening for disproportionally affected populations including people living with HIV (PWH), condyloma acuminata, human papillomavirus-associated gynecologic dysplasia and cancers, and solid organ transplants, actual screening practices remain understudied. Our objective was to characterize anal cancer screening practices among higher-risk populations in an academic medical system with access to high-resolution anoscopy., Methods: We extracted outpatient clinical data for the aforementioned populations from January 1, 2015, to August 1, 2022, at 3 sites of an academic medical system. Data included patients' demographics, medical comorbidities, and anal cytology and human papillomavirus testing results. We used χ2 tests and logistic regression to assess for associations between patient characteristics and anal cancer screening., Results: Of 7654 patients, 6.3% received anal cytology screening at least once including 21.7% of PWH, 13.8% of people with condyloma acuminata, 1.1% of people with gynecologic cancers, and 0.5% of people with solid organ transplants. In multivariable analysis, Black patients were 46% less likely to receive screening than White patients (95% confidence interval [CI], 0.40-0.71), and cisgender women were 73% less likely to receive screening than cisgender men (95% confidence interval, 0.20-0.38). Of 485 individuals who received anal cytology screening, 37.5% were only screened once and 70.5% had abnormal cytology on one or more screenings., Conclusion: Only one-fifth of PWH received anal cancer screening, and other higher-risk populations had even lower screening rates. Black patients and women were also less likely to be screened. Strategies to improve equitable screening practices for anal cancer are needed., Competing Interests: Conflict of Interest and Sources of Funding: The manuscript's first author (D.G.) received a Small Project Assistance grant from the American Sexually Transmitted Diseases Association to help fund research discussed in this manuscript. There are otherwise no conflicts of interest to report for the remaining authors., (Copyright © 2024 American Sexually Transmitted Diseases Association. All rights reserved.)

Long-acting injectables (LAIs) for HIV prevention and treatment could dramatically improve health outcomes and health equity for people with HIV and those who could benefit from pre-exposure prophylaxis. Despite widespread acceptability and demand by providers and potential users of LAIs, implementation has been extremely limited since the introduction of cabotegravir/rilpivirine, the first LAI for HIV treatment, in January 2021, and long-acting cabotegravir, the first LAI for HIV prevention, in December 2021. We report results of a provider survey, conducted by the HIV Medicine Association, which identified LAI implementation barriers related to health insurance processes, staffing and administrative support, drug costs and acquisition, and access for individuals who are uninsured. We provide policy recommendations to address those barriers and facilitate broad and equitable access to LAIs for HIV prevention and treatment, which will be necessary to achieve the goals of the US Ending the HIV Epidemic initiative., Competing Interests: Potential conflicts of interest . J. L. M., T. L. D., and S. E. D. have received research funding from the National Institutes of Health (NIH) paid to their institutions. A. W. serves on the Women's Research Initiative on HIV/AIDS (WRI) Advisory Group, and lodging and food for annual meetings is paid for by the WRI. C. F. K. has received research funding to her institution from Gilead Sciences, ViiV Healthcare, Moderna, Novavax, and Humanigen. A. A. has received research funding from the National Institute of Mental Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development paid to her institution, conducted research on HIV prevention in a multicenter study and an investigator-initiated study with grants from Gilead Sciences paid to her institution, and has received consulting fees from Gilead Sciences and ViiV Healthcare. S. M. has received research funding from ViiV Healthcare paid to her institution. D. K. has conducted research on HIV prevention with grants from Gilead Sciences and Merck to his institution, has received consulting fees from the University of Alabama at Birmingham and the University of North Texas Health Science Center, personal funds from Medscape and UpToDate to develop medical education content, and has had travel funded by PrEP4All to their meeting on a national PrEP program. M. C. M. has received research funding from NIH paid to her institution and has served on an advisory board for Gilead Sciences. J. A. C. has received research funding from NIH paid to his institution and consulting fees from Prime Education and Integritas Communications. K. A. C. has received research funding paid to her institution from NIH and has been a workshop participant for Janssen and an advisory board participant for Gilead Sciences. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2025. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Background: Over the past several years, there have been several changes affecting the available options for oral HIV preexposure prophylaxis, including approvals for tenofovir alafenamide with emtricitabine in 2019 and a generic formulation of tenofovir disoproxil fumarate with emtricitabine in 2020., Methods: In order to better understand providers' decision-making processes when deciding between these two drugs for pre-exposure prophylaxis, we conducted semi-structured in-depth interviews with resident, fellow and attending physicians in internal medicine and infectious diseases between May 2020 and March 2021. These interviews were analyzed to identify emergent codes, which were utilized in an inductive thematic analysis to identify major themes pertinent to pre-exposure prophylaxis decision-making., Results: Of 21 participants, 18 expressed a general preference for prescribing tenofovir disoproxil fumarate with emtricitabine, 2 preferred tenofovir alafenamide with emtricitabine and 1 had no specific preference. Providers perceived similar efficacy of the two formulations, and their clinical decisions were influenced primarily by whether HIV pre-exposure prophylaxis users belonged to a population with an indication for each of the two drugs (e.g. gender-related restrictions for tenofovir alafenamide), the medications' differing side effect profiles, cost and insurance considerations, prior personal and collective experience with each of these medications, and personal preferences. Respondents also noted that both providers and HIV pre-exposure prophylaxis users were influenced by external factors, including institutional prescribing guidance, advertising, and social influences, including from peers and colleagues., Conclusions: Our findings suggest that unbiased educational campaigns for both prescribers and users of HIV pre-exposure prophylaxis will be important to support evidence-based prescribing practices and cost-effective decisions among oral pre-exposure prophylaxis options., Competing Interests: The authors have read the journal’s policy and have the following competing interests: Fenway Health served as a recruitment site for this study. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2024 Merchant et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objective: Sexually transmitted infections (STIs), including HIV, are a key contributor to psychological and physical morbidity across the United States (US). African American (AA) women are disproportionately impacted by STIs, particularly in the Deep South of the US. Strong patient-provider communication can help to increase client understanding of STI prevention and treatment options. This study aimed to explore factors influencing effective patient-provider relationships and communication around STIs (including HIV) and sexual health broadly, which will ultimately inform the refinement of a patient-provider communication tool for discussing PrEP as an HIV prevention method., Methods: As part of a larger study focused on PrEP implementation, in-depth, semi-structured qualitative interviews were conducted among cisgender AA women who are PrEP-eligible, both with and without PrEP experience, as well as providers from three federally qualified health centers (FQHCs) and HIV service agencies in Alabama. Data were analyzed using content analysis., Results: A total of 41 participants enrolled, including 21 clients (n = 6 PrEP experienced; n = 15 PrEP naïve) and 20 providers. Qualitative data were organized across the following domains: meaning of health and sexual health, factors influencing the client-provider relationship, and factors influencing sexual health discussions among clients and providers. Key factors influencing client-provider relationships were organized at client, provider, and clinic levels. Factors impacting sexual health discussions between clients and providers were organized at client, provider, and structural levels., Conclusion: These interviews identified key determinants of effective client-provider communication pertaining to sexual health among cisgender AA women in the US South who were receiving care at FQHCs and HIV service organizations. Individual, provider, and clinic-level factors were identified that have implications for designing sexual health interventions for cisgender AA women., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Fifty-five of 62 women who inject drugs (WWID) selected long-acting cabotegravir (CAB-LA) over oral PrEP, and 51/55 received a first injection. More recent injection drug use and number of sexual partners were associated with selecting CAB-LA (P < .05). Findings provide preliminary evidence of a strong preference for longer-acting products among WWID., Competing Interests: Potential conflicts of interest. D. K. has conducted research on HIV prevention funded by grants from Gilead and Merck to his institution and has received personal fees for developing medical education content for Medscape, Virology Education, and UpToDate, Inc, and travel support from PrEP4All. T. S. B. has received funding to conduct research on HIV prevention funded by Gilead and has received personal consulting fees from ViiV Healthcare. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Pre-exposure prophylaxis (PrEP) is effective in preventing HIV transmission, but uptake and adherence among young men who have sex with men (YMSM) remains suboptimal. New PrEP formulations may enhance PrEP use, but little is known about their acceptability. We enrolled 39 cis- and transgender YMSM (age 18-34) from Boston, MA; Jackson, MS; Birmingham, AL; and New Orleans, LA, who participated in video-based focus groups (n = 30) or in-depth interviews (n = 9) to examine how new PrEP products (e.g., injections, monthly pills, implants) are perceived and might be improved for YMSM. Focus groups were transcribed, coded, and analyzed using grounded theory and content analysis. Nearly half (46%) of participants were Black; 11% identified as Hispanic. Seventy-nine percent were PrEP experienced. Product preference was driven by the desire for flexible, safe, effective, and affordable PrEP options. A majority of participants preferred subcutaneous injections every 6 months or monthly pills dispersed in 3 or 4 doses. Subcutaneous injections and batched monthly pills were favored by those with demanding schedules and those who desired fewer provider visits; monthly pills were more appealing for those who feared needles. Despite broad preferences for longer-acting products for convenience, participants raised concerns regarding side effects and waning protection after missed doses. Participants felt that more education about safety and efficacy profiles of new products could influence their attitudes. These findings suggest that it is important to prioritize YMSM's dynamic lifestyles during product development, and that product safety and efficacy information should be accessible in youth-friendly language., (© 2024. Merck & Co., Inc., Rahway, NJ, USA and its affiliates & Jonathan HillRorie, Katie Biello, Meg Quint, Bernadette Johnson, Latesha Elopre, Kendra Johnson, Rebecca Lillis, Kaylee Burgan, Douglas Krakower, Kenneth H. Mayer.)

Purpose: Pediatric primary care clinicians are often uncertain about patients' HIV infection risk and pre-exposure prophylaxis (PrEP) prescribing guidelines. This study was conducted to help identify ways to design and deliver useful electronic health record (EHR)-based alerts for PrEP to help mitigate this issue., Methods: Individual interviews and focus groups with pediatricians explored provider preferences for clinical decision support around PrEP in the EHR. Key themes were identified via the immersion-crystallization qualitative analytic technique., Results: Clinicians described ideal decision support tools as succinct, helpful in identifying patients at risk of acquiring HIV, providing automated follow-up, and linking to evidence-based prescribing guidelines. Concerns emerged about alert fatigue., Discussion: This study summarizes clinicians' preferences for EHR tool development to support PrEP provision among pediatricians with limited comfort and experience with prescribing PrEP. These findings can inform the development of PrEP decision support by implementing provider-centered feedback., (Copyright © 2024 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: African American (AA) women in the U.S. South experience significant HIV incidence, and efforts to support antiretroviral pre-exposure prophylaxis (PrEP) uptake and maintenance among this group have been insufficient. This study aimed to explore perceptions, attitudes, and implementation preferences surrounding PrEP use for AA women in the U.S. South., Methods and Measures: The study team conducted qualitative interviews with AA cisgender women clients ( n  = 21) and their providers ( n  = 20) in Federally Qualified Health Centers and HIV clinics in Alabama. The research team employed directed qualitative content analysis to analyze interview data., Results: Five themes emerged: a) inconsistent access to PrEP and PrEP knowledge, b) need for improving low PrEP awareness, c) managing hesitancy to prescribe or use PrEP, d) perceived HIV vulnerability and inherent stigma, and e) normalizing PrEP as part of routine sexual healthcare to increase uptake and maintenance. Interviews revealed an openness towards PrEP as an HIV prevention strategy for AA, cisgender women in Alabama., Conclusion: Improving PrEP uptake and maintenance among AA women in the U.S. South must go beyond increasing awareness to improving PrEP access and trust through visibility of AA women's PrEP use and incorporating PrEP education and services into routine sexual healthcare.

Objectives: The aim of this study was to assess HIV preexposure prophylaxis (PrEP) provision in U.S. health centers., Design: The U.S. Ending the HIV Epidemic (EHE) initiative designated health centers as the main healthcare system through which PrEP scale-up occurs. Health centers offer primary care to over 30 million disproportionately uninsured, racially or ethnically minoritized, and low-income patients. This study is the first to assess PrEP provision across health centers, including characteristics of clinics, patient populations, and policies associated with PrEP prescribing., Methods: The Health Resources and Services Administration's Uniform Data System contained aggregate data on PrEP prescriptions and patient sociodemographics at health centers from January 1 through December 31, 2021, in 50 U.S. states, the District of Columbia, and eight U.S. territories. We compared patient demographics and availability of Medicaid expansion and PrEP assistance programs at health centers that prescribed vs. those that did not prescribe PrEP., Results: Across 1375 health centers serving 30 193 278 patients, 79 163 patients were prescribed PrEP. Health centers that prescribed any PrEP had higher proportions of sexual, gender, racial, and ethnic minority patient populations compared with health centers that prescribed no PrEP. Compared with health centers that prescribed no PrEP, a higher proportion of health centers that prescribed PrEP were located in designated high-priority jurisdictions of the EHE initiative or states with Medicaid expansion or public PrEP assistance programs., Conclusion: Health centers are critical for scaling up PrEP in minoritized populations disproportionately affected by HIV, facilitated through federal and state-level policies. These findings highlight service gaps and inform future interventions to optimize PrEP implementation and support EHE initiative goals., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Objectives: For adults with a complaint of diarrhea presenting to United States emergency departments (EDs) from 2016 to 2021, we examined the: (1) occurrence and temporal trends in these ED visits, (2) frequency with which services were provided (laboratory testing, radiologic imaging, and intravenous fluids (IV fluids) administration) and patients were admitted; and (3) factors associated with service provision and admission., Methods: Data from the National Hospital Ambulatory Medical Care Survey (2016-2021) were analyzed. Multivariable logistic regression modeling was employed to examine factors associated with service provision and admission, according to patient demographic characteristics, healthcare insurance status, and associated clinical symptoms; ED geographic location; and type of ED medical staff who evaluated the patient., Results: From 2016 to 2017, there were 3.3-3.7 million ED visits/year by adults with a complaint of diarrhea (3.1% [95% CI 2.9-3.3] of all adult US ED visits). Services were provided and patients were admitted per these frequencies: complete blood count (80%; 95% CI 76-83); blood culture (8%; 95% CI 6-9); metabolic panel (94%; 95% CI 86-97); ultrasound (8%; 95% CI 7-10); abdominal/pelvic CT (33%; 95% CI 29-35); IV fluids (63%; 95% CI 50-66); and admission (16%; 95% CI 14-18). Factors associated with receipt of these services and admission included other presenting symptoms (abdominal pain, vomiting, and nausea), ED geographic location, ED medical staff member evaluating the patient, race, Hispanic ethnicity, and type of health insurance., Conclusion: For adult patients presenting to US EDs with a complaint of diarrhea, US EDs highly utilized selected laboratory tests and radiologic imaging. Differences in utilization raise concerns about equitable healthcare delivery and call for further investigation into the underlying reasons, as well as the development and adoption of standardized care pathways., Competing Interests: The authors declare no conflicts of interest., (© 2024 The Authors. Journal of the American College of Emergency Physicians Open published by Wiley Periodicals LLC on behalf of American College of Emergency Physicians.)

Background: Incarcerated women experience high rates of HIV and sexually transmitted infections (STIs); few are offered HIV preexposure prophylaxis (PrEP). We aimed to examine HIV/STI screening rates in this population and identify PrEP eligibility., Methods: Results of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) urine and HIV/syphilis screening in cisgender women in the Dallas County Jail were compiled from January to October 2020. An electronic health record review was conducted for a subgroup in March 2020 to identify PrEP eligibility., Results: Overall, 4398 of 13,292 women were screened for CT and 4389 of 13,292 for GC, and among them, 479 (11%) screened for HIV and 562 (13%) for syphilis. Furthermore, 462 of 4398 (11%) were positive for CT, 323 of 4389 (7%) were positive for GC, 10 of 479 (2%) had positive HIV test results, of whom 6 (1.3%) were new diagnoses and 75 (13%) had a reactive rapid plasma reagin test. In March 2020, of 541 women screened, 90 tested positive for CT or GC. Of these 90, 70 (78%) did not receive HIV or syphilis screening, including women with these risk factors: 10 (14%) were homeless, 11 (16%) reported heroin use, and 10 (14%) reported methamphetamine use. Based on the presence of an acute bacterial STI, 17% (96 of 541) were PrEP eligible., Conclusions: Incarcerated women had high STI rates and other risk factors for HIV acquisition, although only 1 in 5 with acute STIs (11% overall) was also screened for HIV or syphilis. HIV prevention efforts should include comprehensive STI/HIV screening, linkage to treatment, and identification of PrEP candidates., Competing Interests: Conflict of Interest and Sources of Funding: A.E.N receives research funding from Gilead Sciences. D.K. conducts research on preexposure prophylaxis funded by grants from Merck and Gilead Sciences to Fenway Health; has received funding to develop educational content on preexposure prophylaxis from Virology Education and UpToDate, Inc.; and has been a consultant to Loma Linda U., UAB, and the University of North Texas Health Sciences Center., (Copyright © 2023 American Sexually Transmitted Diseases Association. All rights reserved.)

Introduction: African American women (AA), particularly those living in the Southeastern USA, experience disproportionately high rates of HIV infection. Pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention tool that may circumvent barriers to traditional HIV prevention tools, such as condom use; however, very little is known about how to improve PrEP access and uptake among AA women who may benefit from PrEP use. This project aims to understand how to increase PrEP access among AA women in the rural Southern USA, which may ultimately affect HIV incidence in this population., Methods and Analysis: The goal of the current study is to systematically adapt a patient-provider communication tool to increase PrEP uptake among AA women receiving care at a federally qualified health centre in Alabama. We will use an iterative implementation process, by assessing the feasibility, acceptability and preliminary impact of the tool on PrEP uptake, using a pilot preintervention/postintervention design (N=125). We will evaluate women's reasons for declining a referral to a PrEP provider, reasons for incomplete referrals, reasons for not initiating PrEP after a successful referral and ongoing PrEP use at 3 and 12 months after PrEP initiation among our sample. The proposed work will significantly contribute to our understanding of factors impacting PrEP uptake and use among AA women, particularly in underserved areas in the Deep South that are heavily impacted by the HIV epidemic and experience worse HIV-related health outcomes relative to other areas in the USA., Ethics and Dissemination: This protocol has been approved by the Institutional Review Board (IRB) at University of Alabama at Birmingham (Birmingham, AL; protocol 300004276). All participants will review a detailed informed consent form approved by the IRB and will provide written or verbal informed consent prior to enrolment. Results will be disseminated through peer-reviewed manuscripts, reports, and local, national and international presentations., Trial Registration Number: NCT04373551., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Pre-exposure prophylaxis (PrEP) is a highly effective biomedical prevention intervention and a major strategy for reducing the HIV burden in the United States. However, PrEP provision and uptake remain lower than estimated needs, and in ways that may exacerbate HIV disparities among Black adolescent girls and young women in the southern United States. Data suggest that gaps in provider knowledge of HIV epidemiology and PrEP and skills assessing sexual health practices are important barriers to provision and uptake, with limited evidence-based interventions to address these gaps., Objective: This paper describes the "PrEP-Pro" intervention, a multicomponent intervention to train and support family medicine (FM) trainees to promote PrEP for adolescent girls and young women in Alabama., Methods: The PrEP-Pro intervention comprises 3 main components guided by the Capability-Opportunity-Motivation-Behavior (COM-B) model for behavioral change and the Consolidated Framework for Implementation Research (CFIR): (1) provider HIV epidemiology and PrEP education, (2) sexual history taking, and (3) PrEP Champions. In phase 1, we will work with community advisory boards (providers and clients) and then conduct focus groups with FM trainees to adapt content to train FM residents on HIV epidemiology and PrEP and develop implementation strategies, including provider-facing tools and client-facing educational materials. In phase 2, we will pretest and then pilot-test the initially adapted PrEP-Pro intervention with FM trainees. FM trainees will complete baseline, 3-, and 6-month questionnaires post PrEP-Pro intervention. We will also conduct in-depth interviews (IDIs) with FM pilot participants, adolescent girls and young women who accessed care after the PrEP-Pro pilot, and key stakeholders. The primary outcomes are PrEP-Pro acceptability and feasibility, which would be assessed using validated instruments at months 3 (among pretest participants) and 6 (among pilot participants). Secondary outcomes will also be assessed, including PrEP knowledge, sexual history-taking attitudes and practices, PrEP prescriptions among adolescent girls and young women encounters, and sexually transmitted infections (STIs) and HIV testing among adolescent girls and young women encounters in 6 months., Results: Study results will be disseminated to practices, state health officials, and other key stakeholders to solicit feedback on implementation opportunities and challenges to inform a hybrid effectiveness implementation trial. Our results will also be presented at local and national conferences and submitted to peer-reviewed journals., Conclusions: As PrEP grows, there is a pressing need to train FM providers and develop appropriate, contextually relevant tools to support PrEP implementation. The PrEP-Pro intervention is a multicomponent intervention to train FM residents across Alabama on sexual history-taking, PrEP provision for adolescent girls and young women, and supporting practice-based PrEP Champions. The PrEP-Pro intervention is anticipated to increase PrEP prescriptions for adolescent girls and young women and expand comprehensive sexual and reproductive health care for adolescent girls and young women in rural and urban Alabama., International Registered Report Identifier (irrid): PRR1-10.2196/44908., (©Oluwaseyi O Isehunwa, Samantha V Hill, Alex Tobias Menninger, Brook Hubner, Douglas Krakower, Dustin M Long, Madeline C Pratt, Meredith E Clement, Nicholas Van Wagoner, Robin Gaines Lanzi, Tina Simpson, Latesha Elopre, Lynn T Matthews. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 21.03.2023.)

Background: Human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) is underutilized in the southern United States. Rapid identification of individuals vulnerable to diagnosis of HIV using electronic health record (EHR)-based tools may augment PrEP uptake in the region., Methods: Using machine learning, we developed EHR-based models to predict incident HIV diagnosis as a surrogate for PrEP candidacy. We included patients from a southern medical system with encounters between October 2014 and August 2016, training the model to predict incident HIV diagnosis between September 2016 and August 2018. We obtained 74 EHR variables as potential predictors. We compared Extreme Gradient Boosting (XGBoost) versus least absolute shrinkage selection operator (LASSO) logistic regression models, and assessed performance, overall and among women, using area under the receiver operating characteristic curve (AUROC) and area under precision recall curve (AUPRC)., Results: Of 998 787 eligible patients, 162 had an incident HIV diagnosis, of whom 49 were women. The XGBoost model outperformed the LASSO model for the total cohort, achieving an AUROC of 0.89 and AUPRC of 0.01. The female-only cohort XGBoost model resulted in an AUROC of 0.78 and AUPRC of 0.00025. The most predictive variables for the overall cohort were race, sex, and male partner. The strongest positive predictors for the female-only cohort were history of pelvic inflammatory disease, drug use, and tobacco use., Conclusions: Our machine-learning models were able to effectively predict incident HIV diagnoses including among women. This study establishes feasibility of using these models to identify persons most suitable for PrEP in the South., (© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Gender inequities in academic advancement persist in many specialties, including Infectious Diseases (ID). Prior studies of advancement disparities have been predominantly quantitative, utilizing large physician databases or surveys. We used qualitative methods to explore ID physicians' experiences and beliefs about causes and ways to mitigate gender inequities in advancement., Methods: We conducted semistructured focus group discussions with academic ID physicians in the United States at IDWeek 2019 to explore perceived barriers and facilitators to academic advancement. Participants were assigned to focus groups based on their academic rank and gender. We analyzed focus group transcripts using content analysis to summarize emergent themes., Results: We convened 3 women-only focus groups (1 for instructors/assistant professors, 1 for associate professors, and 1 for full professors) and 1 men-only focus group of full professors (total N = 50). Our analyses identified several major themes on barriers to equitable academic advancement, including (1) interpersonal and institutional gender bias, (2) difficulty balancing the demands of family life with work life, and (3) gender differences in negotiation strategies., Conclusions: Barriers to gender equity in academic advancement are myriad and enduring and span the professional and personal lives of ID physicians. In addition to swift enactment of policy changes directed at critical issues such as ending workplace harassment and ensuring adequate parental leaves for birth and nonbirth parents, leaders in academic medicine must shine a bright light on biases within the system at large and within themselves to correct these disparities with the urgency required., Competing Interests: Potential conflicts of interest. All authors have reported no conflicts of interest relevant to this manuscript., (© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Background: The impact of gender on outcomes in patients suffering from coronavirus disease 2019 (COVID-19) is frequently debated. However, the synchronous influence of additional risk factors is seldom mentioned. With increasing emphasis on identifying patients who are at risk of complications from COVID-19, we decided to conduct a retrospective review to assess the influence of age and body mass index (BMI) on gender-based differences in outcomes. Materials and Methods: A retrospective review of 1288 patients was conducted at a tertiary care hospital. Binary logistic regression was used to assess differences in risk factors and outcomes between genders. The associations between predictors and outcomes were described using odds ratios in tables, forest plots, and regression curves plotted using Sigma Plot. Results: Majority of patients were women (53.6% vs. 46.4%). Median BMI in men was higher than women ( p  = 0.003). Key predictors for all-cause morbidity/mortality in men were diabetes, chronic kidney disease, and regular use of angiotensin-converting enzyme inhibitors. In women, age >65 and regular use of inhaled steroid were additional risk factors. Men had a higher risk of acute respiratory distress syndrome (2.83 [1.70-4.70]), acute renal failure (1.96 [1.20-3.20]), and had a longer length of stay (0.11 [1.52]). Obesity has a stronger bearing on outcomes in women, and age has a more pronounced effect on outcomes in men. Conclusion: Extremes of BMI and older age are associated with worse outcomes in both men and women. Obesity has a stronger bearing on outcomes of COVID-19 infection in women, while the effect of older age on outcomes is more pronounced in men.

Pre-exposure prophylaxis (PrEP) is underused in the southern United States (US), a region with high HIV incidence. Clinical decision support (CDS) tools could increase PrEP prescriptions. We explored barriers to PrEP delivery and views of CDS tools to identify refinements for implementation strategies for PrEP prescribing and PrEP CDS tools. We conducted focus groups with health care providers from two federally qualified health centers in Alabama and analyzed the results using rapid qualitative methods. Barriers to PrEP included providers' lack of training in PrEP, competing priorities and time constraints during clinical visits, concerns about side effects, and intensive workload. We identified refinements to the planned implementation strategies to address the barriers, including training all clinic staff in PrEP and having CDS PrEP alerts in electronic health records sent to all staff. Development and deployment of CDS tools in collaboration with providers has potential to increase PrEP prescribing in high-priority jurisdictions.

Human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) protects high risk patients from becoming infected with HIV. Clinicians need help to identify candidates for PrEP based on information routinely collected in electronic health records (EHRs). The greatest statistical challenge in developing a risk prediction model is that acquisition is extremely rare., Methods: Data consisted of 180 covariates (demographic, diagnoses, treatments, prescriptions) extracted from records on 399 385 patient (150 cases) seen at Atrius Health (2007-2015), a clinical network in Massachusetts. Super learner is an ensemble machine learning algorithm that uses k-fold cross validation to evaluate and combine predictions from a collection of algorithms. We trained 42 variants of sophisticated algorithms, using different sampling schemes that more evenly balanced the ratio of cases to controls. We compared super learner's cross validated area under the receiver operating curve (cv-AUC) with that of each individual algorithm., Results: The least absolute shrinkage and selection operator (lasso) using a 1:20 class ratio outperformed the super learner (cv-AUC = 0.86 vs 0.84). A traditional logistic regression model restricted to 23 clinician-selected main terms was slightly inferior (cv-AUC = 0.81)., Conclusion: Machine learning was successful at developing a model to predict 1-year risk of acquiring HIV based on a physician-curated set of predictors extracted from EHRs., (© 2020 John Wiley & Sons, Ltd.)

Background: The drivers of the gap in advancement between men and women faculty in academic Infectious Diseases (ID) remain poorly understood. This study sought to identify key barriers to academic advancement among faculty in ID and offer policy suggestions to narrow this gap., Methods: During the 2019 IDWeek, we conducted focus groups with women faculty members at all ranks and men Full Professors, then we administered a brief survey regarding work-related barriers to advancement to the Infectious Disease Society of America (IDSA) membership. We report themes from the 4 focus group discussions that are most closely linked to policy changes and descriptive analyses of the complementary survey domains., Results: Policy change suggestions fell into 3 major categories: (1) Policy changes for IDSA to implement; (2) Future IDWeek Program Recommendations; and (3) Policy Changes for IDSA to Endorse as Best Practices for ID Divisions. Among 790 faculty respondents, fewer women reported that their institutional promotion process was transparent and women Full Professors were significantly more likely to have been sponsored., Conclusions: Sponsorship and informed advising about institutional promotions tracks may help to narrow the advancement gap. The Infectious Disease Society of America should consider ambitious policy changes within the society and setting expectations for best practices among ID divisions across the United States., (© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

Background: In the United States, sexually transmitted infections, particularly HIV, occur at disproportionally high rates among young men who have sex with men (YMSM). Oral pre-exposure prophylaxis (PrEP) is a highly effective in reducing HIV acquisition. Reduction of condom use has been noted among adult populations of MSM using PrEP. However, less is known about PrEP and condom use among YMSM., Purpose: Our objective was to understand condom attitudes/beliefs and behaviors among YMSM in the context of PrEP use and nonuse., Methodological Orientation: We conducted qualitative interviews between May and November, 2017 in Boston, MA. All YMSM were HIV-negative by self-report. We purposively sampled youth who used PrEP and those who did not use PrEP. Data were analyzed using content analysis., Sample: The sample consisted of 31 YMSM aged 17-24 years (mean = 21.5 years)., Conclusions: Young men who have sex with men provided rich descriptions of their condom-use philosophies and behaviors. Three themes emerged: 1) Different condom philosophies between youth who used PrEP and youth who do not, 2) Inconsistent or absent condom use by PrEP users, and 3) Similar condom behaviors regardless of PrEP use with certain partner types, if low self-efficacy was reported, and when sex occurred during periods of substance use and/or intoxication., Implications for Practice: This study provides understanding of YMSM condom decision-making process in the context of PrEP use or nonuse. Findings are useful to inform development and testing of individually tailored interventions for YMSM based on their personal condom-use philosophies and behaviors to improve risk reduction decision making, use of condoms, and PrEP., Competing Interests: Competing interests: The authors report no conflicts of interest., (Copyright © 2020 American Association of Nurse Practitioners.)

Among 146 urban heterosexuals screening negative for human immunodeficiency virus, one third anticipated increased sexual risk taking with human immunodeficiency virus preexposure prophylaxis. Men (vs. women) and black (vs. white) participants had increased odds for anticipating decreased condom use. Men and persons reporting transactional sex expected to increase sexual partnerships. Risk compensation could affect reproductive health and disease control.

Background Research surrounding attitudes and intentions concerning pre-exposure prophylaxis (PrEP) among at-risk heterosexuals, women and ethnic and racial minorities is needed to inform programs to scale this effective HIV prevention intervention among these populations., Methods: The study sample includes 192 HIV-negative heterosexuals recruited from HIV testing sites operating in high HIV prevalence neighbourhoods in a mid-Atlantic city. Participants received brief educational sessions on PrEP and completed a self-administered survey assessing sociodemographic factors, HIV risk behaviours and theoretical determinants of PrEP uptake, based on the Theory of Planned Behaviour., Results: Participants were majority persons of colour (86%), with a median age of 43 years. Compared with Whites, a higher percentage of Black and Brown persons had more than five sex partners (75.0%), used condoms inconsistently (85.6%) and engaged in transactional sex (84.4%). Most expressed positive PrEP attitudes and indicated intention to adopt PrEP, especially if recommended by their doctor. In a multivariable model, willingness to take PrEP if suggested by a healthcare provider (aOR: 4.17; 95% CI: 1.42-12.24) and willingness to take PrEP even if it caused side-effects (aOR: 1.98; 95% CI: 1.01-3.90) were both associated with greater PrEP adoption intentions., Conclusions: A diverse at-risk population was identified through community-based HIV testing. Low perceived HIV risk, as well as PrEP-related attitudes, subjective norms and perceived behavioural control were associated with PrEP use intentions. These factors are potential targets for interventions to increase PrEP adoption among diverse heterosexual samples.

Introduction: Discontinuations of HIV preexposure prophylaxis (PrEP) by at-risk individuals could decrease the effectiveness of PrEP. Our objective was to characterize patterns of, reasons for, and clinical outcomes associated with PrEP discontinuations in primary care., Methods: We conducted medical chart reviews for patients prescribed PrEP during 2011 to 2014 at a Boston community health centre specializing in healthcare for sexual and gender minorities. Patients were followed through 2015. We characterized patients' sociodemographics, relationship status, behavioural health conditions, patterns of and reasons for PrEP discontinuations, and HIV seroconversions. Cox proportional hazards models were used to assess patient factors associated with PrEP discontinuations., Results: Of the 663 patients prescribed PrEP, the median age was 33 years, 96% were men who have sex with men (MSM) and 73% were non-Hispanic white; 40% were in committed relationships and 15% had HIV-infected partners. Patients either used PrEP continuously (60%), had 1 or more discontinuations (36%), or did not initiate PrEP (4%). Discontinuations were most often due to a decrease in HIV risk perception (33%), non-adherence to care plans (16%), or insurance barriers (12%). Of the 7 (1.1%) PrEP patients diagnosed with HIV, 1 was HIV-infected at baseline, 2 seroconverted while using PrEP, and 4 seroconverted after discontinuations. In a multivariable model adjusted for race/ethnicity, relationship status, substance use disorders, and insurance status, those who were less than 30 years old (aHR 2.0, 95% CI 1.4 to 2.9 for ages 18 to 24, aHR 2.2, 95% CI 1.6 to 3.1 for ages 25 to 29, vs. ages 30 to 39 years), who identified as transgender women (aHR 2.0, 95% CI 1.2 to 3.4, vs. cisgender men), and who had mental health disorders (aHR 1.2, 95% CI 1.1 to 1.4 for each additional disorder) were more likely to have discontinuations., Conclusions: Discontinuations of PrEP use among this American sample of predominately MSM were common, particularly among patients who were younger, identified as transgender women, or had behavioural health issues. As HIV seroconversions occurred after discontinuations of PrEP, strategies to prevent inappropriate discontinuations are needed., (© 2019 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

The Health Belief Model has been useful for studying uptake of HIV prevention behaviors and has had limited application to understanding utilization of pre-exposure prophylaxis (PrEP), a biomedical strategy to reduce HIV acquisition. We recruited 90 persons undergoing HIV screening and educated them about PrEP. We followed up with 35 participants approximately 3 weeks later and quantitatively assessed PrEP uptake. No participant had initiated PrEP. We conducted in-depth interviews with 15 participants to explore situational factors impacting this decision. In this paper we provide an overview of PrEP-related engagement using qualitative data to contextualize (in)action. While participants perceived PrEP as beneficial, perceived benefits did not outweigh real- and perceived barriers, such as financial and time-related constraints. In order to promote PrEP uptake, cues to action that increase the benefits of PrEP during seasons of risk, and interventions that reduce real and perceived barriers are needed.

Background: Access to hepatitis B virus (HBV) and hepatitis C virus (HCV) diagnostics remains a key bottleneck in scale-up of access to HBV and HCV treatment, particularly in low- and middle-income countries (LMICs) that lack laboratory resources and skilled personnel. To inform the development of World Health Organization (WHO) testing guidelines on who to test and how to test, we performed a "values and preferences" survey of end users and implementers of hepatitis testing in LMICs on current hepatitis B and C testing practices and acceptability of diagnostic approaches, as well as preferences for the future., Methods: The survey consisted of a four-part, 28 question online survey tool using SurveyMonkey software. The invitation to participate was sent via email to a network of contacts in hepatitis clinical care, research, advocacy and industry., Results: The survey collected responses on current testing practices from 48 respondents in 23 LMICs. Only a small proportion of hepatitis testing is currently funded through government-supported programmes. Most limit their testing programmes to blood donor screening and although testing is recommended in several populations, this is not well implemented. Also, there is still very limited access to virological testing., Conclusions: The survey showed that HBV and HCV testing programmes in LMICs are inadequate and/or scarce. Lack of affordable diagnostic tests; lack of funding, public education and awareness; absence of national policies and guidelines; and a dearth of skilled health professionals are the most important barriers to scaling up HBV and HCV diagnosis and treatment.

Background: The current low access to virological testing to confirm chronic viraemic HCV infection in low- and middle-income countries (LMIC) is limiting the rollout of hepatitis C (HCV) care. Existing tests are complex, costly and require sophisticated laboratory infrastructure. Diagnostic manufacturers need guidance on the optimal characteristics a virological test needs to have to ensure the greatest impact on HCV diagnosis and treatment in LMIC. Our objective was to develop a target product profile (TPP) for diagnosis of HCV viraemia using a global stakeholder consensus-based approach., Methods: Based on the standardised process established to develop consensus-based TPPs, we followed five key steps. (i) Identifying key potential global stakeholders for consultation and input into the TPP development process. (ii) Informal priority-setting exercise with key experts to identify the needs that should be the highest priority for the TPP development; (iii) Defining the key TPP domains (scope, performance and operational characteristics and price). (iv) Delphi-like process with larger group of key stakeholder to facilitate feedback on the key TPP criteria and consensus building based on pre-defined consensus criteria. (v) A final consensus-gathering meeting for discussions around disputed criteria. A complementary values and preferences survey helped to assess trade-offs between different key characteristics., Results: The following key attributes for the TPP for a test to confirm HCV viraemic infection were identified: The scope defined is for both HCV detection as well as confirmation of cure. The timeline of development for tests envisioned in the TPP is 5 years. The test should be developed for use by health-care workers or laboratory technicians with limited training in countries with a medium to high prevalence of HCV (1.5-3.5% and >3.5%) and in high-risk populations in low prevalence settings (<1.5%). A clinical sensitivity at a minimum of 90% is considered sufficient (analytical sensitivity of the equivalent of 3000 IU/ml), particularly if the test increases access to testing through an affordable price, increase ease-of-use and feasibility on capillary blood. Polyvalency would be optimal (i.e. ability to test for HIV and others). The only characteristic that full agreement could not be achieved on was the price for a virological test. Discussants felt that to reach the optimal target price substantial trade-offs had to be made (e.g. in regards to sensitivity and integration)., Conclusion: The TPP and V&P survey results define the need for an easy-to-use, low cost test to increase access to diagnosis and linkage to care in LMIC.

Purpose of Review: The review describes the evidence for HIV preexposure prophylaxis (PrEP) with daily combined tenofovir disoproxil fumarate and emtricitabine for adolescents and young adults. Current recommendations are described, as are the unique medical, socioeconomic, and legal considerations regarding the use of PrEP for youth., Recent Findings: PrEP with daily oral tenofovir disoproxil fumarate-emtricitabine has been shown to help prevent new HIV infection among adults at substantial risk. Evidence suggests a protective benefit of PrEP for youth at risk for HIV, although low adherence is emerging as a barrier to effective use., Summary: Effective use of antiretrovirals for PrEP represents a seminal development in HIV prevention efforts. Improving access and adherence to PrEP for youth has the potential to substantially reduce the incidence of HIV in this population.

Since FDA approval of HIV pre-exposure prophylaxis (PrEP) for HIV prevention, attention has been focused on PrEP implementation. The CDC estimates that 1.2 million U.S. adults might benefit from PrEP, but only a minority are using PrEP, so there is a significant unmet need to increase access for those at risk for HIV. Given the large numbers of individuals who have indications for PrEP, there are not enough practicing specialists to meet the growing need for providers trained in providing PrEP. Moreover, since PrEP is a preventive intervention for otherwise healthy individuals, primary care providers (PCPs) should be primary prescribers of PrEP. There are important clinical considerations that providers should take into account when planning to prescribe PrEP, which are highlighted in the clinical case discussed. A growing body of research also suggests that some providers may be cautious about prescribing PrEP because of concerns regarding its "real-world" effectiveness, anticipated unintended consequences associated with its use, and ambiguity as to who should prescribe it. This review summarizes findings from studies that have assessed prescriber behavior regarding provision of PrEP, and offers recommendations on how to optimize PrEP implementation in primary care settings. Development and dissemination of educational interventions for PCPs and potential PrEP users are needed, including improved methods to assist clinicians in identifying appropriate PrEP candidates, and programs to promote medication adherence and access to social and behavioral health services. PCPs are well-positioned to prescribe PrEP and coordinate health-related services to improve the sexual health of their patients, but tailored educational programs are needed., Competing Interests: Dr. Mayer and Dr. Krakower have received unrestricted research grants from Gilead Sciences, and Dr. Mayer has received an unrestricted research grant from ViiV Health Care. Mr. Silapaswan reports no conflicts of interest.

Introduction: Pre-exposure prophylaxis (PrEP), taken as a single daily coformulated pill containing tenofovir -emtricitabine, is a promising intervention to reduce the likelihood of HIV acquisition in at-risk individuals, including men who have sex with men. Little is known about the acceptability of less than daily, intermittent PrEP regimens., Methods: We conducted an online survey of North American men who have sex with men to characterize their sexual frequency and planning behaviors and correlate these with PrEP dosing preferences., Results: Of the 3217 respondents who completed the survey, 46% reported engaging in unplanned condomless anal intercourse (CAI) at least once in previous 3 months and 8% reported engaging in CAI more than once per week. In multivariable analysis, reporting unplanned CAI was associated with lower educational level, identifying as homosexual/gay as compared with bisexual, being in a monogamous relationship, having a higher self-perceived risk of HIV acquisition, reporting higher income, engaging in CAI more than five times in the last 3 months, and not having visited a health care provider in the previous year. Frequent CAI (>1 time per week) was associated with being younger, identifying as homosexual/gay as compared with bisexual, being in a monogamous relationship, and having a higher self-perceived risk of HIV. Having only planned sex over the last 3 months was associated with a preference for event-based PrEP, whereas having frequent or unplanned CAI was associated with a preference for daily or time-driven PrEP regimens, respectively., Conclusion: Our findings suggest that preferences for different PrEP regimens are associated with the sexual frequency and planning behaviors of potential users.

Introduction: After the initial approval of the use of tenofovir disoproxil fumarate-emtricitabine (TDF/FTC) by the US Food and Drug Administration in 2012 for anti-HIV pre-exposure prophylaxis (PrEP), uptake was initially limited, but more recent community surveys and expert opinion suggest wider acceptance in some key populations., Discussion: Demonstration projects are underway to determine the best practices in the United States to identify at-risk individuals in primary care and sexually transmitted disease clinics who could benefit from PrEP. Studies of PrEP in combination with behavioural interventions are being evaluated. Studies to evaluate the use of PrEP by HIV-uninfected women in HIV-discordant couples interested in safe conception are also getting underway. The optimal deployment of PrEP as part of a comprehensive national HIV/AIDS strategy in the United States has been limited by lack of knowledge among some at-risk people and by some medical providers indicating that they do not feel sufficiently knowledgeable and comfortable in prescribing PrEP. Studies are underway to determine how to assist busy clinicians to determine which of their patients could benefit from PrEP. Although most federal health insurance programmes will cover most of the costs associated with PrEP, underinsured patients in states that have not enacted health reform face additional challenges in paying for PrEP medication and appropriate clinical monitoring., Conclusions: PrEP implementation in the United States is a work in progress, with increasing awareness and uptake among some individuals in key populations.

The FDA approval of emtricitabine/tenofovir disoproxil fumarate for pre-exposure prophylaxis (PrEP) in 2012 has raised questions about the delivery of PrEP in a real-world setting. iPad-based questionnaires were given to providers at conferences in California and New York to assess knowledge, experience and attitudes regarding PrEP in HIV and non-HIV providers. HIV provider status was defined either by self-identification or by having greater than 5 years of HIV care experience. Knowledge scores were the sum of correct answers from five PrEP knowledge questions. Univariate analyses used t-test to compare knowledge scores and Fisher's exact test for past or future PrEP prescription between HIV and non-HIV providers. Multivariable linear or logistic regression models were used to assess factors associated with the outcomes. Of 233 respondents, the mean age was 40 years, 59 % were White, 59 % were physicians and 52 % were HIV providers. In univariate analysis, mean PrEP knowledge scores (max 5) were significantly higher for HIV providers (2.8 versus 2.2; p < 0.001), age > 41 (mean 2.8 versus 2.3; p = 0.004), White race (2.7 versus 2.2; p = 0.026) and participants in the New York region (3.0 versus 2.3; p < 0.001). In a multivariable model of knowledge scores, all but age remained significant. Among 201 potential prescribers, the rate of prior PrEP prescription was higher among HIV providers than non-HIV providers (34 versus 9 %; p < 0.001) and by knowledge score, but the association with provider status was no longer significant in multivariable analysis that controlled for knowledge. Intent to prescribe PrEP in the future was high for all provider types (64 %) and was associated with knowledge scores in multivariable analysis. The most common concerns about PrEP (>40 % of providers) were drug toxicities, development of resistance and patient adherence to follow-up; 32 % identified risk compensation as a concern. HIV providers had significantly greater PrEP knowledge than non-HIV providers, but differences by provider type in past PrEP prescription were largely dependent on knowledge. Future PrEP prescription was also associated with knowledge, though all providers expressed greater future use. Education of potential PrEP providers will be a key component of successful PrEP implementation.

Background: Stigmatizing social environments (of which 'structural stigma' is one component) negatively affect health-related outcomes. However, few studies have examined structural stigma related to sexual minority status as a risk factor for HIV outcomes among MSM., Methods: In August 2013, members of a large MSM social and sexual networking site in the United States completed a survey about HIV-prevention practices. A previously validated composite index provided values for state-level structural stigma, including density of same-sex couples, proportion of public high schools with Gay-Straight Alliances, state laws protecting sexual minorities, and public opinion toward homosexuality. Multivariable logistic generalized estimating equations assessed the relationship between structural stigma and condomless anal intercourse, use and awareness of antiretroviral-based HIV-prevention strategies (i.e. pre and postexposure prophylaxis, or PEP and PrEP), and comfort discussing male-male sex with primary care providers., Results: Among the 4098 HIV-uninfected MSM, lower state-level structural stigma was associated with decreased odds of condomless anal intercourse [adjusted odds ratio (aOR) 0.97 per one unit increase in structural stigma score, 95% confidence interval (CI) 0.94-0.99], increased odds of awareness of PEP (aOR 1.06, 95% CI 1.02-1.09), and PrEP (aOR 1.06, 95% CI 1.02-1.10), having taken PEP (aOR 1.15, 95% CI 1.05-1.26) and PrEP (aOR 1.21, 95% CI 1.01-1.44), and comfort discussing male-male sex with providers (aOR 1.08, 95% CI 1.05-1.11), after adjusting for social and state-level confounders., Conclusion: MSM living in more stigmatizing environments had decreased use of antiretroviral-based HIV-prevention strategies compared to those in less stigmatizing environments. Legal reforms protecting sexual minorities should be evaluated as structural interventions that could reduce HIV risk among MSM.

Limited data exist regarding attitudes and acceptability of topical and oral HIV pre-exposure prophylaxis (PrEP) among US black women. This investigation explored interest in HIV chemoprophylaxis and modes of use. Five focus groups enrolled 26 black women recruited from an inner-city community health center and affiliated HIV testing sites. Thematic analysis utilized Atlas.ti. Most women expressed interest in PrEP, as many reported condom failure concerns. Most women preferred a pill formulation to intravaginal gel because of greater perceived privacy and concerns about vaginal side effects and gel leakage. Women who had taken pills previously advocated daily dosing and indicated adherence concerns about episodic or post-coital PrEP. Many women desired prophylactic strategies that included partner testing. Urban black women are interested in utilizing PrEP; however, misgivings exist about gel inconvenience and potential side effects for themselves and their partners. Most women preferred oral PrEP, dosed daily.

Oral pre-exposure prophylaxis (PrEP) can reduce HIV incidence among at-risk persons. However, for PrEP to have an impact in decreasing HIV incidence, clinicians will need to be willing to prescribe PrEP. HIV specialists are experienced in using antiretroviral medications, and could readily provide PrEP, but may not care for HIV-uninfected patients. Six focus groups with 39 Boston area HIV care providers were conducted (May-June 2012) to assess perceived barriers and facilitators to prescribing PrEP. Participants articulated logistical and theoretical barriers, such as concerns about PrEP effectiveness in real-world settings, potential unintended consequences (e.g., risk disinhibition and medication toxicity), and a belief that PrEP provision would be more feasible in primary care clinics. They identified several facilitators to prescribing PrEP, including patient motivation and normative guidelines. Overall, participants reported limited prescribing intentions. Without interventions to address HIV providers' concerns, implementation of PrEP in HIV clinics may be limited.

Purpose of Review: Recent randomized controlled trials have demonstrated that HIV pre-exposure prophylaxis (PrEP) can decrease HIV incidence among several at-risk populations, including men who have sex with men, serodiscordant couples, and heterosexual men and women. As PrEP is a biomedical intervention that requires clinical monitoring and a high level of medication adherence, maximizing the public health effectiveness of PrEP in real-world settings will require the training of a cadre of healthcare providers to prescribe PrEP. Therefore it is critical to understand provider knowledge, practices, and attitudes towards PrEP prescribing, and to develop strategies for engaging and training providers to provide PrEP., Recent Findings: Limited numbers of studies have focused on PrEP implementation by healthcare providers. These studies suggest that some providers are knowledgeable about PrEP, but many are not, or express misgivings. Although many clinicians report willingness to provide PrEP, few have prescribed PrEP in clinical practice. Provider comfort and skills in HIV risk assessment are suboptimal, which could limit identification of individuals who are most likely to benefit from PrEP use., Summary: Further studies to understand facilitators and barriers to HIV-risk assessment and PrEP prescribing by practicing clinicians are needed. Innovative training strategies and decision-support interventions for providers could optimize PrEP implementation and therefore merit additional research.

Intermittent dosing of pre-exposure prophylaxis (iPrEP) has potential to decrease costs, improve adherence, and minimize toxicity. Practical event-based dosing of iPrEP requires men who have sex with men (MSM) to be sexually active on fewer than 3 days each week and plan for sexual activity. MSM who may be most suitable for event-based dosing were older, more educated, more frequently used sexual networking websites, and more often reported that their last sexual encounter was not with a committed partner. A substantial proportion of these MSM endorse high-risk sexual activity, and event-based iPrEP may best target this population.

With an estimated 2.6 million new HIV infections diagnosed annually, the world needs new prevention strategies to partner with condom use, harm reduction approaches for injection drug users, and male circumcision. Antiretrovirals can reduce the risk of mother-to-child HIV transmission and limit HIV acquisition after occupational exposure. Macaque models and clinical trials demonstrate efficacy of oral or topical antiretrovirals used prior to HIV exposure to prevent HIV transmission, ie pre-exposure prophylaxis (PrEP). Early initiation of effective HIV treatment in serodiscordant couples results in a 96% decrease in HIV transmission. HIV testing to determine serostatus and identify undiagnosed persons is foundational to these approaches. The relative efficacy of different approaches, adherence, cost and long-term safety will affect uptake and impact of these strategies. Ongoing research will help characterize the role for oral and topical formulations and help quantify potential benefits in sub-populations at risk for HIV acquisition.