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As trials were assessing the safety and efficacy of daily oral antiretroviral preexposure prophylaxis (PrEP) for the prevention of HIV infection, there was a clear need to understand the evolution of knowledge of, and attitudes toward, PrEP among primary care clinicians. Physicians and nurse practitioners were surveyed in 2009 (n = 1500), 2010 (n = 1504), 2012 (n = 1503), 2013 (n = 1507), 2014 (n = 1508) and 2015 (n = 1501) to assess their awareness of PrEP, willingness to prescribe PrEP, and whether they support use of public funds to pay for PrEP. Pharmacists (n = 251) were surveyed about PrEP in 2012 only. Descriptive statistics were computed for physician demographics and PrEP-related questions. Prevalence ratios for willingness to prescribe PrEP were computed using Poisson regression analysis. Awareness of PrEP was low among clinicians (2009: 24%, 2010: 29%) but increased after trials reported effectiveness (2012: 49%, 2013: 51%, 2014: 61%, 2015: 66%). Following a description of PrEP with an estimated effectiveness of 75%, across 6 of the study years 91% of clinicians indicated a willingness to prescribe PrEP to at least one group at high risk of HIV acquisition. A smaller majority of clinicians indicated support for public funding of PrEP in 2009: 59%, 2010: 53%, and 2013: 63%. In surveys conducted before and after the release of PrEP trial results, primary care clinicians were largely unaware of PrEP. They indicated high levels of willingness to prescribe it for patients at high risk of HIV acquisition and expressed interest in education about how to deliver this new clinical HIV prevention method. It will be important to continue monitoring clinician knowledge, attitudes, and practices as the use of PrEP increases in the US.

In this study, 1219 HIV-uninfected, heterosexual adults in Botswana were randomly assigned to tenofovir–emtricitabine (TDF–FTC) or placebo. The TDF–FTC group had a lower incidence of HIV infection but increased rates of side effects, including a significant loss of bone density. Biomedical strategies to prevent sexual transmission of human immunodeficiency virus (HIV) remain limited. 1 In animal models, preexposure prophylaxis with tenofovir disoproxil fumarate (TDF) or with the combination of TDF and emtricitabine (TDF–FTC) can prevent infections with HIV or hybrid simian–human immunodeficiency virus after vaginal or rectal challenge. 2 , 3 In humans, daily preexposure prophylaxis with TDF–FTC has been shown to reduce transmission of HIV by 44% among men who have sex with men 4 ; however, the findings from studies in heterosexual populations have been mixed. 5 – 8 Botswana has the world's second highest prevalence of HIV infection, estimated in 2008 to be . . .

The COVID-19 pandemic has disrupted HIV prevention, care, and transmission opportunities. This likely varies by geography, given differences in COVID-19 burden and mandates over time, and by age, given different likelihoods of severe COVID-19 consequences. We consider changes in sexual behavior, HIV testing, pre-exposure prophylaxis (PrEP) use and antiretroviral therapy (ART) use among men who have sex with men (MSM) over the first year of the COVID-19 epidemic, comparing the Atlanta metropolitan area and New York City (NYC). We use two continuous time-series datasets and one panel dataset, assessing changes over time within city and comparing across cities, and disaggregate major findings by age. For clinical results, ART use showed by far the smallest reductions, and testing the largest. Disruptions occurred concurrently between cities, despite the major wave of COVID-19, and government mandates, occurring later in Atlanta. Test positivity increased in NYC only. In both cities, younger MSM saw the greatest reductions in testing and PrEP use, but the smallest in sexual behavior. Reduced clinical service usage would be unconcerning if stemming solely from reductions in exposure; however, the patterns for young MSM suggest that the COVID-19 epidemic likely generated new conditions for increased HIV transmission, especially in this cohort.

The \"Ending the HIV Epidemic\" (EHE) initiative seeks to reduce new HIV infections in the U.S. by prioritizing federal resources towards highly impacted populations. Antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) are essential for reaching EHE goals. Adolescents are often at increased risk for HIV because they may lack agency in negotiating their sexual partnerships and may not have the same access to treatment and prevention as adults. This study estimates the potential contribution of expanded PrEP coverage among adolescents ages 15-17 to achieving the EHE goals in the South. An HIV-transmission model was built to simulate the HIV epidemic in the South. Increased ART and PrEP uptake were systematically varied with and without PrEP eligibility including individuals age<18. Prioritizing PrEP for adolescents had a negligible impact on incidence. At 50% uptake among eligible adolescents and 90% ART coverage, including adolescents only improved the percentage of infections averted from 80.1% to 80.3%. In 10 of 15 scenarios explored, there was no reduction in new infections when PrEP eligibility was expanded to include adolescents age<18. At 95% ART coverage at the population-level incidence among adolescents declined by over 80%, but PrEP uptake among adolescents did not contribute to additional declines in incidence among adolescents. Prioritizing PrEP for adolescents did not significantly contribute to reaching EHE incidence reductions goal. Focusing resources to specific adolescent populations at risk, such sexual minority males in high incidence settings, will remain an important public health goal outside the context of EHE.

Introduction Antiretroviral medication coverage remains sub-optimal in much of the United States, particularly the Sothern region, and Non-Hispanic Black or African American persons (NHB) continue to be disproportionately impacted by the HIV epidemic. The “Ending the HIV Epidemic in the U.S.” (EHE) initiative seeks to reduce HIV incidence nationally by focusing resources towards the most highly impacted localities and populations. This study evaluates the impact of hypothetical improvements in ART and PrEP coverage to estimate the levels of coverage needed to achieve EHE goals in the South. Methods We developed a stochastic, agent-based network model of 500,000 individuals to simulate the HIV epidemic and hypothetical improvements in ART and PrEP coverage. Results New infections declined by 78.6% at 90%/40% ART/PrEP and 94.3% at 100%/50% ART/PrEP. Declines in annual incidence rates surpassed 75% by 2025 with 90%/40% ART/PrEP and 90% by 2030 with 100%/50% ART/PrEP coverage. Increased ART coverage among NHB MSM was associated with a linear decline in incidence among all MSM. Declines in incidence among Hispanic/Latino and White/Other MSM were similar regardless of which MSM race group increased their ART coverage, while the benefit to NHB MSM was greatest when their own ART coverage increased. The incidence rate among NHB women declined by over a third when either NHB heterosexual men or NHB MSM increased their ART use respectively. Increased use of PrEP was associated with a decline in incidence for the groups using PrEP. MSM experienced the largest absolute declines in incidence with increasing PrEP coverage, followed by NHB women. Conclusions Our analysis indicates that it is possible to reach EHE goals. The largest reductions in HIV incidence can be achieved by increasing ART coverage among MSM and all race groups benefit regardless of differences in ART initiation by race. Improving ART coverage to > 90% should be prioritized with a particular emphasis on reaching NHB MSM. Such a focus will reduce the largest number of incident cases, reduce racial HIV incidence disparities among both MSM and women, and reduce racial health disparities among persons with HIV. NHB women should also be prioritized for PrEP outreach.

Pre-exposure prophylaxis (PrEP) has demonstrated high efficacy to reduce HIV infections, however, racial/ethnic HIV disparities continue among black MSM. The purpose of this review was to assess available data to inform interventions to increase PrEP awareness, uptake, and adherence among black MSM. Of the 3024 studies retrieved, 36 met final inclusion criteria and were categorized into the PrEP care continuum: (1) awareness (n = 16), (2) uptake (n = 9), and (3) adherence (n = 12). Only 26 of the studies presented analytical findings by race/ethnicity. Key barrier themes included cost, HIV-related stigma, and fear of potential side effects. A key facilitator theme identified by black MSM included gaining PrEP awareness from social and sexual networks. There are significant gaps in research on black MSM and PrEP utilization, especially regarding PrEP uptake and adherence. These data are needed to inform interventions to address current inequities in PrEP services, to help improve care outcomes for black MSM.

The United States Public Health Service released clinical practice guidelines for daily oral preexposure prophylaxis (PrEP) in May 2014. Local health departments (LHDs) are expected to play a critical role in PrEP implementation. We surveyed LHDs to assess awareness of and interest in supporting PrEP implementation, what roles they were taking, or believed they should take, in supporting PrEP, and what resources would be required to do so. LHDs were surveyed in 2015 to assess their engagement in PrEP implementation (n = 500). The study employed a cross-sectional survey design with a randomly selected stratified sample. Among responding LHDs (n = 284), 109 (29%, weighted proportion) reported engagement in PrEP implementation. LHDs serving large jurisdictions (population 500,000+) and located in the West were more likely to be engaged in PrEP implementation. Making referrals for PrEP (74%) and conducting education and outreach to community members (51%) were the activities most frequently reported by LHDs engaged in PrEP implementation; 45% anticipated expanding their level of engagement. Among LHDs not engaged in PrEP implementation, 13% expected to become engaged over the next four years, 46% were undecided, and 41% reported it was unlikely. Information about PrEP for health care providers and information about PrEP for health department staff were the most frequently reported resource needs for LHDs engaged and not engaged in PrEP implementation, respectively. PrEP implementation by LHDs was limited in 2015, three years after Food and Drug Administration approval and one year after the U.S. Public Health Service issued clinical practice guidelines. PrEP is a recently available intervention that is requiring LHDs to adjust existing HIV prevention efforts and service delivery models. Additional resources and implementation research is needed to effectively support PrEP scale-up by LHDs. Efforts must also be undertaken to increase PrEP awareness, knowledge, and implementation capacity among LHDs.

Despite declining HIV infection rates, persistent racial and ethnic disparities remain. Appropriate calculations of diagnosis rates by HIV transmission category, race and ethnicity, and geography are needed to monitor progress towards reducing systematic disparities in health outcomes. We estimated the number of heterosexually active adults (HAAs) by sex and state to calculate appropriate HIV diagnosis rates and disparity measures within subnational regions. The analysis included all HIV diagnoses attributed to heterosexual transmission in 2018 in the United States, in 50 states and the District of Columbia. Logistic regression models estimated the probability of past-year heterosexual activity among adults in three national health surveys, by sex, age group, race and ethnicity, education category, and marital status. Model-based probabilities were applied to estimated counts of HAAs by state, which were synthesized through meta-analysis. HIV diagnoses were overlaid to calculate racial- and ethnic-specific rates, rate differences (RDs), and rate ratios (RRs) among HAAs by sex and state. Nationally, HAA women have a two-fold higher HIV diagnosis rate than HAA men (rate per 100,000 HAAs, women: 6.57; men: 3.09). Compared to White non-Hispanic HAAs, Black HAAs have a 20-fold higher HIV diagnosis rate (RR, men: 21.28, women: 19.55; RD, men: 15.40, women: 31.78) and Hispanic HAAs have a 4-fold higher HIV diagnosis rate (RR, men: 4.68, RD, women: 4.15; RD, men: 2.79, RD, women: 5.39). Disparities were ubiquitous across regions, with >75% of states in each region having Black-to-White RR ≥10. The racial and ethnic disparities across regions suggests a system-wide failure particularly with respect to preventing HIV among Black and Hispanic women. Pervasive disparities emphasize the role for coordinated federal responses such as the current Ending the HIV Epidemic (EHE) initiative.

Risk compensation (RC) could reduce or offset the biological prevention benefits of HIV preexposure prophylaxis (PrEP) among those at substantial risk of infection, including men who have sex with men (MSM). We investigated the potential extent and causal mechanisms through which RC could impact HIV transmission at the population and individual levels. Using a stochastic network-based mathematical model of HIV transmission dynamics among MSM in the United States, we simulated RC as a reduction in the probability of condom use after initiating PrEP, with heterogeneity by PrEP adherence profiles and partnership type in which RC occurred. Outcomes were changes to population-level HIV incidence and individual-level acquisition risk. When RC was limited to MSM highly/moderately adherent to PrEP, 100% RC (full replacement of condoms) resulted in a 2% relative decline in incidence compared to no RC, but an 8% relative increase in infection risk for MSM on PrEP. This resulted from confounding by indication: RC increased the number of MSM indicated for PrEP as a function of more condomless anal intercourse among men otherwise not indicated for PrEP; this led to an increased PrEP uptake and subsequent decline in incidence. RC is unlikely to decrease the prevention impact of PrEP, and in some cases RC may be counterintuitively beneficial at the population level. This depended on PrEP uptake scaling with behavioral indications. Due to the increased acquisition risk associated with RC, however, clinicians should continue to support PrEP as a supplement rather than replacement of condoms.

Tenofovir-emtricitabine (TDF-FTC) pre-exposure prophylaxis (PrEP) has been found to be effective for prevention of HIV infection in several clinical trials. Two studies of TDF PrEP among men who have sex with men showed slight bone mineral density (BMD) loss. We investigated the effect of TDF and the interaction of TDF and hormonal contraception on BMD among HIV-uninfected African men and women. We evaluated the effects on BMD of using daily oral TDF-FTC compared to placebo among heterosexual men and women aged 18-29 years enrolled in the Botswana TDF2 PrEP study. Participants had BMD measurements at baseline and thereafter at 6-month intervals with dual-energy X-ray absorptiometry (DXA) scans at the hip, spine, and forearm. A total of 220 participants (108 TDF-FTC, 112 placebo) had baseline DXA BMD measurements at three anatomic sites. Fifteen (6.8%) participants had low baseline BMD (z-score of <-2.0 at any anatomic site), including 3/114 women (2.6%) and 12/106 men (11.3%) (p = 0.02). Low baseline BMD was associated with being underweight (p = 0.02), having high blood urea nitrogen (p = 0.02) or high alkaline phosphatase (p = 0.03), and low creatinine clearance (p = 0.04). BMD losses of >3.0% at any anatomic site at any time after baseline were significantly greater for the TDF-FTC treatment group [34/68 (50.0%) TDF-FTC vs. 26/79 (32.9%) placebo; p = 0.04]. There was a small but significant difference in the mean percent change in BMD from baseline for TDF-FTC versus placebo at all three sites at month 30 [forearm -0.84% (p = 0.01), spine -1.62% (p = 0.0002), hip -1.51% (p = 0.003)]. Use of TDF-FTC was associated with a small but statistically significant decrease in BMD at the forearm, hip and lumbar spine. A high percentage (6.8%) of healthy Batswana young adults had abnormal baseline BMD Further evaluation is needed of the longer-term use of TDF in HIV-uninfected persons. ClinicalTrials.gov NCT00448669.