The study subjects were followed for 3324 person-years (median, 1.2 years; maximum, 2.8 years). Of these subjects, 10 were found to have been infected with HIV at en rollment, and 100 became infected during follow-up (36 in the FTC–TDF group and 64 in the placebo group), indicating a 44% reduction in the incidence of HIV (95% confidence interval, 15 to 63; P = 0.005). In the FTC–TDF group, the study drug was detected in 22 of 43 of seronegative subjects (51%) and in 3 of 34 HIV-infected subjects (9%) (P<0.001). Nausea was reported more frequently during the first 4 weeks in the FTC–TDF group than in the placebo group (P<0.001). The two groups had similar rates of serious adverse events (P = 0.57). Conclusions Oral FTC–TDF provided protection against the acquisition of HIV infection among the subjects. Detectable blood levels strongly correlated with the prophylactic effect. (Funded by the National Institutes of Health and the Bill and Melinda Gates Foun dation; ClinicalTrials.gov number, NCT00458393.)

/pdf/preexposure-chemoprophylaxis-for-hiv-prevention-in-men-who-2umcnj2j8w.pdf

Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men

The prevalence of pre-exposure prophylaxis use and the pre-exposure prophylaxis-to-need ratio in the fourth quarter of 2017, United States.

This study examined potential facilitators and barriers to pre-exposure prophylaxis (PrEP) use and their association with PrEP acceptability and motivations for adherence among 184 MSM and transgender women living in New York City. Participants were presented with educational information about PrEP and completed a computerized survey. Overall, 55.4% of participants reported willingness to take PrEP. The most highly endorsed barriers to PrEP use were health concerns, including both long-term impacts and short-term side effects, questions about PrEP's impact on future drug resistance, and concerns that PrEP does not provide complete protection against HIV. The most highly endorsed facilitator was free access to PrEP, followed by access to support services such as regular HIV testing, sexual health care/monitoring, and access to one-on-one counseling. Participants of color rated both barriers and facilitators as more important than their White counterparts. In multivariate models, barrier and facilitator scores significantly predicted not only PrEP acceptability, but also motivation for PrEP adherence among those who were likely to use PrEP. PrEP implementation programs should consider addressing these barriers and facilitators in protocol and policy development. Findings underscore the importance of support services, such as sexual health counseling, to the success of PrEP as a prevention strategy.

From Efficacy to Effectiveness: Facilitators and Barriers to PrEP Acceptability and Motivations for Adherence Among MSM and Transgender Women in New York City

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.

/pdf/hiv-providers-perceived-barriers-and-facilitators-to-3e7zm55rcb.pdf

HIV Providers’ Perceived Barriers and Facilitators to Implementing Pre-exposure Prophylaxis in Care Settings: A Qualitative Study

The HIV care continuum is a framework that models the dynamic stages of HIV care. The continuum consists of five main steps, which, at the population level, are depicted cross-sectionally as the HIV treatment cascade. These steps include diagnosis, linkage to care (LTC), retention in care (RiC), adherence to antiretroviral therapy (ART), and viral suppression. Although the HIV treatment cascade is represented as a linear, unidirectional framework, persons living with HIV (PLWH) often experience the care continuum in a less streamlined fashion, skip steps altogether, or even exit the continuum for a period of time and regress to an earlier stage. The proportion of PLWH decreases at each successive step of the cascade, beginning with an estimated 86% who are diagnosed and dropping dramatically to approximately 30% of PLWH who are virally suppressed in the United States (US). In this current issues review, we describe each step in the cascade, discuss targeted interventions that address weak points in the continuum, review domestic and international policies that help shape and direct HIV care strategies, and conclude with recommendations and future directions for HIV providers and policymakers. While we primarily examine issues related to domestic HIV care in the US, we also discuss international applications of the continuum in order to provide broader context.

https://link.springer.com/content/pdf/10.1186%2Fs12981-016-0120-0.pdf

The HIV treatment cascade and care continuum: updates, goals, and recommendations for the future.

Background
An international randomized clinical trial (RCT) on pre-exposure prophylaxis (PrEP) as an human immunodeficiency virus (HIV)-prevention intervention found that taken on a daily basis, PrEP was safe and effective among men who have sex with men (MSM) and male-to-female transgender women. Within the context of the HIV epidemic in the United States (US), MSM and transgender women are the most appropriate groups to target for PrEP implementation at the population level; however, their perspectives on evidenced-based biomedical research and the results of this large trial remain virtually unknown. In this study, we examined the acceptability of individual daily use of PrEP and assessed potential barriers to community uptake.

/pdf/community-member-perspectives-from-transgender-women-and-men-1x6yvtmghu.pdf

Community Member Perspectives from Transgender Women and Men Who Have Sex with Men on Pre-Exposure Prophylaxis as an HIV Prevention Strategy: Implications for Implementation

Background 
A recent clinical trial demonstrated that a daily dose tenofovir disoproxil fumarate and emtricitabrine (TDF-FTC) can reduce HIV acquisition among men who have sex with men (MSM) and transgender (TG) women by 44%, and up to 90% if taken daily. We explored how medical and service providers understand research results and plan to develop clinical protocols to prescribe, support and monitor adherence for patients on PrEP in the United States.


Methods 
Using referrals from our community collaborators and snowball sampling, we recruited 22 healthcare providers in San Francisco, Oakland, and Los Angeles for in-depth interviews from May-December 2011. The providers included primary care physicians seeing high numbers of MSM and TG women, HIV specialists, community health clinic providers, and public health officials. We analyzed interviews thematically to produce recommendations for setting policy around implementing PrEP. Interview topics included: assessing clinician impressions of PrEP and CDC guidance, considerations of cost, office capacity, dosing schedules, and following patients over time.


Results 
Little or no demand for PrEP from patients was reported at the time of the interviews. Providers did not agree on the most appropriate patients for PrEP and believed that current models of care, which do not involve routine frequent office visits, were not well suited for prescribing PrEP. Providers detailed the need to build capacity and were concerned about monitoring side effects and adherence. PrEP was seen as potentially having impact on the epidemic but providers also noted that community education campaigns needed to be tailored to effectively reach specific vulnerable populations.


Conclusions 
While PrEP may be a novel and clinically compelling prevention intervention for MSM and TG women, it raises a number of important implementation challenges that would need to be addressed. Nonetheless, most providers expressed optimism that they eventually could prescribe and monitor PrEP in their practice.

/pdf/a-qualitative-study-of-provider-thoughts-on-implementing-pre-40n1t8gv45.pdf

A qualitative study of provider thoughts on implementing pre-exposure prophylaxis (PrEP) in clinical settings to prevent HIV infection

Background: In preparation for full Affordable Care Act implementation, California has instituted two healthcare initiatives that provide comprehensive coverage for previously uninsured or underinsured individuals. For many people living with HIV, this has

/pdf/california-s-bridge-to-reform-identifying-challenges-and-305d07nad1.pdf

California's “Bridge to Reform”: Identifying Challenges and Defining Strategies for Providers and Policymakers Implementing the Affordable Care Act in Low-Income HIV/AIDS Care and Treatment Settings

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Community Member Perspectives from Transgender Women and Men Who Have Sex with Men on Pre-Exposure Prophylaxis as an HIV Prevention Strategy: Implications for Implementation

A qualitative study of provider thoughts on implementing pre-exposure prophylaxis (PrEP) in clinical settings to prevent HIV infection

California's “Bridge to Reform”: Identifying Challenges and Defining Strategies for Providers and Policymakers Implementing the Affordable Care Act in Low-Income HIV/AIDS Care and Treatment Settings