HIV pre-exposure prophylaxis provision by U.S. health centers in 2021.

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.

Survey assessment of HIV pre-exposure prophylaxis availability in student health services in New England colleges and universities.

Objective: To determine HIV pre-exposure prophylaxis (PrEP) availability at student health services (SHS) in New England. Methods: We conducted an electronic survey of medical directors of SHS at New England colleges and universities. We measured the availability and volume of PrEP prescribing, barriers and facilitators to prescribing and provider knowledge. Results: Of 143 institutions surveyed, 39% completed questionnaires; 75% were private and 93% were 4 years. Thirty-six percent of institutions did not offer PrEP. Those offering PrEP started a mean of 2.0 per 1000 students/year. PrEP was available at more schools with higher vs. lower endowments (100 vs. 38%, p = 0.002), 4- vs. 2-year programs (68 vs. 0%, p = 0.042), and private vs. public schools (73 vs. 38%, p = 0.043). Conclusions: PrEP was not available at one in three New England SHS and prescribing rates at institutions that offered PrEP were low. Interventions are needed to improve PrEP access.

Low Awareness of and Access to Pre-exposure Prophylaxis But High Interest Among Heterosexual Women in Cleveland, Ohio.

Women received <5% of all US pre-exposure prophylaxis (PrEP) prescriptions in 2016. Among 351 heterosexual women surveyed in Cleveland, Ohio, 14.5% were aware of PrEP, 20.5% knew where to access PrEP, 75.9% were willing to try PrEP, and 50.9% expressed interest in more information.

Sexual Stereotypes Ascribed to Black Men Who Have Sex with Men: An Intersectional Analysis.

Sexual stereotypes may adversely affect the health of Black men who have sex with men (MSM). Greater understanding of the nature and nuances of these stereotypes is needed. This online, survey-based study used an inductive, intersectional approach to characterize the sexual stereotypes ascribed to Black MSM by the U.S. general public, their distinctiveness from those ascribed to Black men and MSM in general, and their relative prototypicality as compared to dominant subgroups. Members of the public, recruited in 2014-2015, were randomly assigned to survey conditions that varied systematically by race (Black, White, or unspecified) and sexual orientation (gay, heterosexual, or unspecified) of a designated social group. Participants (n = 285) reported stereotypes of their assigned group that they perceived to exist in U.S. culture in an open-response format. Cross-condition comparisons revealed that, overall, Black gay male stereotypes were non-prototypical of Black men or gay men. Rather, stereotypes of Black men were more similar to Black heterosexual men and stereotypes of gay men were more similar to White gay men. Nonetheless, 11 of the 15 most frequently reported Black gay male stereotypes overlapped with stereotypes of Black men (e.g., large penis), gay men (e.g., deviant), or both (e.g., promiscuous). Four stereotypes were unique relative to both Black men and gay men: down low, diseased, loud, and dirty. Findings suggest that Black MSM face multiple derogatory sexual stereotypes, several of which are group-specific. These stereotypes are consistent with cultural (mis)representations of Black MSM and suggest a need for more accurate portrayals of existing sexual diversity within this group.

Evolving Models and Ongoing Challenges for HIV Preexposure Prophylaxis Implementation in the United States.

BACKGROUND: The use of preexposure prophylaxis (PrEP) for HIV prevention was approved by the Food and Drug Administration in 2012, but delivery to at-risk persons has lagged. This critical review analyzes the current state of PrEP implementation in the United States, by reviewing barriers and innovative solutions to enhance PrEP access and uptake. SETTING: Clinical care settings, public health programs, and community-based organizations (CBOs). METHODS: Critical review of recent peer-reviewed literature. RESULTS: More than 100 papers were reviewed. PrEP is currently provided in diverse settings. Care models include sexually transmitted disease clinics, community health centers, CBOs, pharmacies, and private primary care providers (PCPs). Sexually transmitted disease clinics have staff trained in sexual health counseling and are linked to public health programs (eg, partner notification services), whereas PCPs and community health centers may be less comfortable counseling and feel time-constrained in managing PrEP. However, PCPs may be ideal PrEP providers, given their long-term relationships with patients, integrating PrEP into routine care. Collaborations with CBOs can expand PrEP care through adherence support and insurance navigation. Pharmacies can deliver PrEP, given their experience with medication dispensing and counseling, and may be more accessible for some patients, but to address other health concerns, liaisons with PCPs may be needed. CONCLUSIONS: PrEP implementation in the United States is moving forward with the development of diverse models of delivery. Optimal scale-up will require learning about the best features of each model and providing choices to consumers that enhance engagement and uptake.

Values, preferences and current hepatitis B and C testing practices in low- and middle-income countries: results of a survey of end users and implementers.

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.

Optimising diagnosis of viraemic hepatitis C infection: the development of a target product profile.

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.

Pre-exposure prophylaxis for MSM and transgender persons in early adopting countries.

: Pre-exposure prophylaxis (PrEP) is a potent and underutilized HIV prevention tool. In this paper we review the state of knowledge regarding PrEP implementation for men who have sex with men and transgender persons in early adopting countries. We focus on implementation of PrEP in demonstration projects and clinical care, and describe the status of PrEP availability and uptake. We report on approaches to identifying appropriate PrEP candidates in real-world settings and on best practices for clinical monitoring. This includes the exclusion of undiagnosed HIV infection prior to PrEP initiation and longitudinal measurement of renal function, in light of safety data. Since adherence is the primary factor moderating the effectiveness of PrEP, we discuss effective adherence support interventions. Additionally, we review the evidence for risk compensation with PrEP use and opportunities to provide PrEP as part of comprehensive and inclusive preventive health programs. We summarize cost-effectiveness studies, including their variable conclusions because of differing underlying assumptions, and discuss the importance of budgetary impact for public health programs and health care insurers. Further, we emphasize a need for greater engagement of health care providers in PrEP to increase access. We conclude with recommendations for ways to improve future efforts at implementing PrEP.

Culturally Competent Sexual Healthcare as a Prerequisite for Obtaining Preexposure Prophylaxis: Findings from a Qualitative Study.

PURPOSE: Men who have sex with men (MSM) experience stigma in healthcare settings, which impedes disclosure of sexual behavior, potentially limiting uptake of preexposure prophylaxis (PrEP). The purpose of this study was to describe the context of this limitation and explore geographical variability. METHODS: To understand how discomfort in healthcare settings affects PrEP utilization, we conducted two online focus groups with geographically diverse samples of MSM. RESULTS: Respondents identified primary care providers as preferred sources for PrEP, but potential uptake was limited by barriers to establishing nonjudgmental relationships with these providers. CONCLUSION: Improved patient-provider communication about sexual behaviors might increase PrEP use among MSM.

"Support Your Client at the Space That They're in": HIV Pre-Exposure Prophylaxis (PrEP) Prescribers' Perspectives on PrEP-Related Risk Compensation.

Despite the demonstrated effectiveness of HIV pre-exposure prophylaxis (PrEP) and evidence that most PrEP users do not engage in risk compensation (i.e., increased risk behavior due to a perceived decrease in HIV susceptibility), some healthcare providers report patient risk compensation to be a deterrent to prescribing PrEP. Overcoming this barrier is essential to supporting PrEP access and uptake among people at risk for HIV. To inform such efforts, this qualitative study explored PrEP-related risk compensation attitudes among providers with firsthand experience prescribing PrEP. US-based PrEP providers (n = 18), most of whom were HIV specialists, were recruited through direct outreach and referral from colleagues and other participants. Individual 90-min semistructured interviews were conducted by phone or in person from September 2014 through February 2015, transcribed, and thematically analyzed. Three attitudinal themes emerged: (1) providers' role is to support patients in making informed decisions, (2) risk behavior while taking PrEP does not fully offset PrEP's protective benefit (i.e., PrEP confers net protection, even with added behavioral risk), and (3) PrEP-related risk compensation is unduly stigmatized within and beyond the healthcare community. Participants were critical of other healthcare providers' negative judgment of patients and reluctance to prescribe PrEP due to anticipated risk compensation. Several providers also acknowledged an evolution in their thinking from initial ambivalence toward greater acceptance of PrEP and PrEP-related behavior change. PrEP providers' insights about risk compensation may help to address unsubstantiated concerns about PrEP-related risk compensation and challenge the acceptability of withholding PrEP on these grounds.

Pre-Exposure Prophylaxis: A Narrative Review of Provider Behavior and Interventions to Increase PrEP Implementation in Primary Care.

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.

Knowledge is Power! Increased Provider Knowledge Scores Regarding Pre-exposure Prophylaxis (PrEP) are Associated with Higher Rates of PrEP Prescription and Future Intent to Prescribe PrEP.

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.

HIV providers' perceived barriers and facilitators to implementing pre-exposure prophylaxis in care settings: a qualitative study.

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.

What primary care providers need to know about preexposure prophylaxis for HIV prevention: a narrative review.

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.