HIV Prevention in Primary Care Practice

Faculty Gregory S. Felzien, MD, AAHIVS Medical Advisor Division of Health Protection/IDI-HIV Georgia Department of Public Health Atlanta, Georgia

Dr. Gregory Felzien is the medical advisor within the Georgia Department of Public Health’s Division of Health Protection/IDI-HIV in Atlanta, Georgia. He received his medical degree from the University of Colorado School of Medicine in Aurora, Colorado, then completed an internship/residency at Vanderbilt University in Nashville, Tennessee, and a fellowship in infectious diseases at the Medical University of South Carolina in Charleston, South Carolina. Dr. Felzien holds board certification in internal medicine and infectious diseases and is certified as an American Academy of HIV (human immunodeficiency virus) Specialist (AAHIVS).

Andrea R. Jefferson-Saboor, FNP-C Family Nurse Practitioner Faebris Medical and Community Education Atlanta, Georgia

Ms. Andrea Jefferson-Saboor is a family nurse practitioner specializing in HIV/acquired immunodeficiency syndrome (AIDS) care, currently with Faebris Medical and Community Education in Atlanta, Georgia, where she is responsible for managing the care of individuals presenting for preexposure prophylaxis (PrEP), sexually transmitted infection (STI) screening and treatment, and HIV primary care. She completed her undergraduate studies at Florida A&M University in Tallahassee, Florida. She earned her Adult Nurse Practitioner Certificate at Florida International University in Miami, Florida, and her Master of Science in Nursing/Family Nurse Practitioner at Kennesaw State University in Kennesaw, Georgia. Ms. Jefferson-Saboor is board certified with the American Nurses Credentialing Center (ANCC).

Preamble Program Overview PrEP is a broad set of clinical tools that can be used to reduce the chances of acquiring HIV. Although it is highly effective, many people who could benefit from PrEP lack access or are not familiar with it. However, primary care providers can remedy this situation and truly make a difference in the lives of their patients who may be at risk of acquiring HIV. This eHealth Source™ educational activity comprises 5 chapters, covering an overview of HIV epidemiology, practical approaches to sexual history-taking and assessing patient risk of HIV acquisition, initiation and monitoring of PrEP medication, and overcoming the bias and stigma surrounding HIV and PrEP. Throughout the program, our expert faculty will provide their unique insights surrounding sexual health, HIV prevention, and PrEP, and how these may be incorporated into primary care practice.

References 1.

Hess KL, Hu X, Lansky A, Mermin J, Hall HI. Lifetime risk of a diagnosis of HIV infection in the United States. Ann Epidemiol. 2017;27(4):238-243.

2.

Siegler AJ, Mouhanna F, Giler RM, et al. The prevalence of pre-exposure prophylaxis use and the pre-exposure prophylaxis-to-need ratio in the fourth quarter of 2017, United States. Ann Epidemiol.

2018;28(12):841-849.

3.

Stewart J, Stekler JD. How to incorporate HIV PrEP into your practice. J Fam Pract.

2019;68(5):254-261.

Target Audience This activity is intended for primary care physicians, nurse practitioners, physician assistants, and other clinicians involved in the care of patients at risk of HIV.

Educational Objectives After completing this activity, the participant should be better able to: • Determine patient risk of HIV infection and eligibility for PrEP by initiating a patientprovider dialogue regarding sexual health and behavior • Utilize evidence-based HIV-prevention guidelines and safety and efficacy data to initiate and monitor PrEP therapy in eligible patients • Discuss strategies to reduce stigma related to sexual health, PrEP use, and HIV

Joint Accreditation Statement In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine (PIM) and Integritas Communications. PIM is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the health care team.

Physician Continuing Medical Education PIM designates this live activity for a maximum of 1.25 AMA PRA Category 1 Credits™.

Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Continuing Nursing Education The maximum number of hours awarded for this Continuing Nursing Education activity is 1.25 contact hours. Pharmacotherapy contact hours for Advanced Practice Registered Nurses is 0.5 APNP credits.

Disclosure of Conflicts of Interest PIM requires instructors, planners, managers, and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflicts of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality activities and related materials that promote improvements or quality in health care and not a specific proprietary business interest of a commercial interest.

Gregory S. Felzien, MD, AAHIVS Nothing to disclose Andrea R. Jefferson-Saboor, MSN, FNP-C Nothing to disclose Planners and Managers: The PIM planners and managers have nothing to disclose. The Integritas Communications planners and managers have nothing to disclose.

Disclosure of Unlabeled Use This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the US Food and Drug Administration. The planners of this activity do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient's conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer's product information, and comparison with recommendations of other authorities.

Fee Information & Refund/Cancellation Policy There is no fee for this educational activity.

CPE Questions – PIM Contact Information For information about the accreditation of this program, please contact PIM via email at inquiries@pimed.com or at http://www.pimed.com/.

Integritas Contact Information For all other questions regarding this activity, please contact Integritas via email at info@exchangecme.com.

Introduction Andrea Jefferson-Saboor, FNP-C

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exual health, including the physical, mental, and behavioral aspects of sexual health, is an important clinical area in caring for the whole person in a primary care practice.

Some topics of sexual health that are frequently addressed in primary care include birth control, erectile dysfunction, and sexual dysfunction. However, many aspects of sexual health, including HIV infection, are sometimes overlooked in primary care.

Those who do not communicate with their health care providers (HCPs) about sexual health issues are at a higher risk of sexually transmitted infections (STIs), including HIV infection. On the other hand, people who routinely communicate with their primary care providers (PCPs) about sexual health are more likely to enjoy better sexual health and less likely to become infected with an STI.1

Video 1: Introduction

Preexposure prophylaxis (PrEP) is a broad Andrea Jefferson-Saboor, FNP-C set of clinical tools that can be used to reduce the chances of acquiring HIV infection. These tools include behavioral assessment, preventive medication, condoms, HIV screening for the individual and partner(s), and ongoing counseling about safer sex practices and prevention. PrEP is highly effective at preventing HIV infection, but many people who could benefit do not receive it, often for reasons that are within the power of PCPs to remedy. At the individual provider level, acquiring knowledge about how and when to prescribe PrEP is a crucial step. Another important step is overcoming personal bias and discomfort in discussing sexual behaviors.

Chapter 1: Updates on HIV Demographics and Epidemiology Gregory S. Felzien, MD, AAHIVS US demographics, burden, and epidemiology of HIV

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pproximately 1.2 million people in the United States are living with HIV, and nearly 1 in 7 (about 14%) of them are not aware of their HIV-positive status. In 2018, 37,968 people received an HIV diagnosis in the United States and 6 territories.2 Annual infections in the United States have been reduced by more than two thirds since the height of the epidemic in the mid-1980s, but according to data from the Centers for Disease Video 2: Sexual Health Plan Control and Prevention (CDC), that Gregory S. Felzien, MD, AAHIVS progress has slowed in recent years. In addition, while there was an overall 7% decrease in new infections between 2014 and 2018, not all populations benefited equally from the improvement—the rates of infection actually increased for some demographics (Figure 1).3

Although the rate of infection in the transgender population is difficult to determine, the number of transgender men and women who received a diagnosis of HIV increased from 2014 through 2018 (Figure 2).4

Youth aged 13 to 24 years accounted for 21% of new HIV diagnoses in 2018.5 The total number of HIV infections in 2018, compared with 2014, decreased 14.5% in that age group, and 14% among those 35 to 54 years of age. In that same time period, HIV infections increased 6% for those 25 to 34 years of age and remained stable for those 55 years and older.4 In adolescents and young adults, as in the overall population, Blacks are greatly overrepresented among those who have been diagnosed with HIV, with 34.8 per 100,000 in the 15 to 19 year age group compared with 2.1 per 100,000 among Whites in this age group.4 By far, most of the new HIV diagnoses in young people are from male-tomale sexual contact. In contrast, among females in this age group who received new diagnoses of HIV, heterosexual contact was the most frequent mode of transmission.5 In an analysis of mortality, US census and HIV surveillance data for 2010 to 2014 were applied to a hypothetical cohort of 10 million live births to estimate lifetime risk if no preventive efforts were taken (Table 1). In this analysis, the lifetime risk of HIV infection was 1 in 68 for all males compared with 1 in 253 for all females. Among all men, lifetime risk was highest for Black men (1 in 22), men who are injection drug users (1 in 42), and Hispanic/Latino men (1 in 51). Among women, risk was highest among injection drug users (1 in 26) and Black women (1 in 54). Yet, the risk of HIV is greatest among Black men who have sex with men (MSM), where it is 1 in 2, and 1 in 5 among Hispanic/Latino MSM.6

HIV diagnoses are not evenly distributed across US states or regions (Figure 3).4 The highest rates of new diagnoses continue to occur in the South. Although the region has just 38% of the country’s population, the South accounts for 51% of all HIV diagnoses and 50% of all diagnoses of HIV infection among MSM.4

The South also has the highest death rate due to HIV. Many factors contribute to the disproportionate burden of HIV in the South, including:7

• Widespread poverty and unemployment • Poorer health outcomes • Lack of HIV testing and education • Reduced access to health care, health insurance, and expanded Medicaid coverage • Persistent stigma surrounding sexual orientation • Limited uptake of PrEP The “Ending the HIV Epidemic: A Plan for America” is a national approach proposed by the US Department of Health and Human Services in 2019 to eliminate new HIV infections in the United States.8 The 4 main strategies are: • Diagnosing all individuals with HIV as early as possible • Treating people with HIV rapidly and effectively to achieve sustained viral suppression • Preventing new HIV transmissions by using proven interventions, including PrEP and syringe services programs • Responding quickly to potential HIV outbreaks to get prevention and treatment services to people who need them The proposed initiative is designed to rapidly increase use of these strategies in 50 local areas that account for more than half of new HIV diagnoses (48 counties; San Juan, Puerto Rico; and Washington, DC) and 7 states with substantial HIV burden in rural areas. The goal is to reduce new HIV infections by 75% in 5 years and by 90% in 10 years.8

Disparities in HIV prevention HIV prevention has largely focused on increasing access to PrEP and implementing educational campaigns to address the observed differences of HIV disease burden among populations. These interventions may be undermined by more systemic problems, such as unstable housing, stigma, unaffordable medical care, homophobia, and difficulties traveling to medical care, that affect not only the likelihood of seeking medical care but also the likelihood of adhering to PrEP enough for it to be optimally effective.9,10 It is estimated that less than 10% of people behaviorally indicated for PrEP by the CDC are receiving PrEP protection.11 This is despite a greatly increased knowledge of PrEP among potential patients, with over 80% of MSM aware of PrEP in 2017.12 This low overall PrEP uptake rate disguises large disparities among subgroups in access to PrEP. Available data suggest that women, individuals ≤24 years old, and residents of the South have lower levels of PrEP use relative to the epidemic need. Although uptake of PrEP has been increasing overall, Black and Latinx populations and those who live in rural areas, the Midwest, and the South significantly lag in this trend. Even though 42% of new HIV infections occur in Blacks, this group makes up just 11% of PrEP users. The Latinx community is also disproportionally impacted by HIV; while 27% of all HIV infections occur in that population, they made up only 13% of PrEP users in 2016.4,13 This disparity is also seen in MSM. In a study of MSM according to race, a significantly lower percentage of Black and Latino men than White men had discussed PrEP with a PCP (43%, 44% vs 58%, respectively) or had used PrEP (26%, 30% vs 42%, respectively) within the past year.14 Transgender women are a distinct population with social and structural factors that distinguish them from MSM in terms of access to PrEP. In an analysis of 2 populationbased studies, one of transgender women and the other of MSM, transgender women

were more likely than MSM to have health insurance (96% vs 90% ), but less likely than MSM to have heard of PrEP (79% vs 97%), talked with a provider about PrEP (36% vs 55%), or used PrEP in the past 6 months (15% vs 40%).15 HIV disproportionately affects people in the southeast United States.7 Yet an online survey in Atlanta, Baltimore, Baton Rouge, Miami, New Orleans, and Washington, DC, conducted from April to August 2017, showed that a minority of PCPs located in these regions engage in HIV prevention and treatment. For example, 31% reported ever prescribing nonoccupational postexposure prophylaxis (nPEP), 18% reported prescribing PrEP, and 27% reported prescribing antiretroviral therapy.16 Additionally, though initiatives like Ready, Set, PrEP have put measures in place to remove financial barriers to access to PrEP (eg, provision of PrEP medication to those without prescription drug coverage) for patients without adequate health insurance coverage, the costs of PrEP and associated medical care can be prohibitive.8 Although PrEP medication can be acquired through patient assistance plans or co-pay cards, there are other costs.

During a usual year on PrEP, a person should be seen by a PCP every 3 months for provider counseling about safer sex and adherence to PrEP medications, laboratory testing, and prescription refills.17 Black and Latino gay and bisexual men and transgender women, who are at the highest risk of HIV and who have the most to gain from PrEP, are also more likely than White and cisgender populations to be uninsured or underinsured. In many geographic areas, the Affordable Care Act (ACA) reduced these disparities, but in the South, where many state legislatures have not adopted the ACA Medicaid expansion, disparities in insurance coverage have increased.18 By screening, testing, and prescribing PrEP medications when appropriate, PCPs can make a real difference and be an important part of ending the HIV epidemic.

Chapter 2: Risk Assessment and HIV Testing Gregory S. Felzien, MD, AAHIVS Taking a sexual history

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exual health has been defined as a state of physical, emotional, mental, and social well-being in relation to sexuality. Sexual health requires a positive and respectful approach to sexuality and sexual relationships, as well as the possibility of having pleasurable and safe sexual experiences, free of coercion, discrimination, and violence.19 Many patients have sexual health questions and would welcome guidance from their PCPs. The patient should not wait for the PCP to ask about sexual health and the PCP should not wait for the patient to ask. Otherwise, the discussion may not happen since each party is waiting for the other to start the conversation. Many medical students never receive sexuality education, or health care education for lesbian, gay, Video 3: Discussing Sexual Health bisexual, trans, and queer (LGBTQ) Gregory S. Felzien, MD, AAHIVS populations.20 A good practice is to ask a few routine questions of all adult and adolescent patients.21 Doing so begins to remove the stigma around discussing sex and can help normalize these discussions by letting people know that asking about sexual health is as routine as asking about physical and mental health.

Just as individuals are routinely screened for factors that could pose a risk to their vital systems and organs, such as surveillance to detect cancer, PCPs should provide routine screening to detect any risks to the sexual health of the populations in their care. Sexual behavior assessments can serve as tools to promote provider-patient communication about PrEP, as well as to identify PrEP candidates by standardizing conversations about sexual behaviors and drug use practices.10 Health care providers can improve their proficiency in communicating with patients about sexual health by practicing some proven strategies.9 One of the first steps is for providers to evaluate personal comfort level and identify any biases they may have. In the clinic, it is important to help the patient feel comfortable by establishing rapport before asking sexual health questions (Figure 4).9

The CDC suggests a “5 P’s” approach to taking a sexual history: Partners, Practices, Past history of STIs, Protection, and Pregnancy prevention/reproductive life plan. This framework provides a guide to choosing which questions to ask as part of the essential care of adult and adolescent patients (Figure 5).22 It is also important to recognize a sixth P: Pleasure. Clinicians should recognize there is a reason most people are sexual beings and conduct their counseling with that in mind.

HIV testing The CDC recommends that people between the ages of 13 and 64 years be tested for HIV at least once as part of routine health care and that those with an increased risk of HIV acquisition, such as MSM, be tested more frequently, depending on sexual behaviors and community HIV prevalence.23 A general rule is that people with risk factors should be tested at least annually. Clinicians should not determine need for HIV testing solely on patient age, but should consider HIV exposure in all individuals, regardless of age.

Numerous organizations including the CDC, American College of Obstetricians/ Gynecologists (ACOG), American Academy of Pediatrics, and American Academy of Family Physicians recommend routine screening for HIV infection in all pregnant women using an opt-out approach (meaning that patients will be screened unless they object) and rapid screening for women who present in labor whose HIV status is unknown. For pregnant women at greater risk of HIV acquisition, or who had a negative HIV test early in pregnancy, the CDC and ACOG recommend that a repeat HIV test be done in the third trimester.23 There are 3 types of HIV tests available: nucleic acid tests (NAT), antigen/antibody tests, and antibody tests (Figure 6).24

Unfortunately, many people with HIV are not diagnosed until they have advanced HIV or AIDS (acquired immunodeficiency syndrome). According to a recently published analysis of health care visits by people aged 13 to 64 years between 2009 and 2017, HIV testing occurred at <1% of visits to physician offices and <3% of visits to community health centers.25 Although HIV testing increased in community health centers, it is still quite low in this setting, which serves populations with some of the highest rates of undiagnosed HIV infection.

HIV is a serious health disorder that can be detected by a reliable, inexpensive screening test before symptoms develop. What previously was considered a life expectancy gap between those with and those without HIV, no longer exists if antiretroviral treatment is started early when CD4 counts are at least 500 cells/ÂľL.26 Furthermore, testing costs are negligible in relation to expected benefits. Yet data indicate that only about one third of community PCPs incorporate routine HIV testing into their practices.27

Developing/modifying and uniformly implementing policies and procedures for routine HIV screening are key to increasing the use of HIV testing in community practices.21 As part of these policies and procedures, routine screening should be implemented using an â&#x20AC;&#x153;optoutâ&#x20AC;? approach, meaning patients should be informed (eg, through a patient brochure, practice literature/form, or discussion) that an HIV test is included in standard preventive screening, but they may decline the test.28 Routine opt-out screening has proven highly effective at identifying people with HIV at earlier stages, which in turn reduces the risk of transmission. Opt-out testing removes the stigma associated with HIV testing.23,28 Additionally, a universal, opt-out approach (permitted in all states but Nebraska) is preferred to risk-based screening for many reasons. A risk-based approach may fail to identify people with HIV who are under 20 years of age, women, members of some races or ethnicities, nonurban dwellers in low-incidence areas, and heterosexual men who are unaware of their risk of HIV.29 HIV prevention counseling should not be a requirement for HIV testing. The decision to decline testing should be noted in the patientâ&#x20AC;&#x2122;s medical record. Providing patients with accessible information about why they should be tested can promote better patientprovider interactions and enable people to make good decisions about their health care.

Educational needs differ across populations, and to be most effective, information should be specific to its audience.21

Chapter 3: Effective Approaches to HIV Prevention Andrea Jefferson-Saboor, FNP-C Safer sex counseling and harm reduction

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cceptance and maintenance of safer behaviors with regard to sexual practices, injection practices, and substance use are essential for long-term prevention of HIV infection, so they are a critical aspect of PrEP.17 Sexual risk-reduction counseling should include basic information about STIs and their transmission and a discussion of ways to lower risk, such as using condoms, improving communication about safer sex, problem solving, and goal setting.9 The CDC also recommends reducing the number of sexual partners, and mutual monogamy as effective strategies for lowering the likelihood of acquiring STIs. However, when talking with patients it is important to recognize that judgments and assumptions made by clinicians can be major barriers to effective communication. For example, in 1 study, half of MSMs felt stigmatized after disclosing inconsistent condom use, sexual practices, or multiple partners.30 One participant in this study reported that when his doctor said limiting his number of sexual partners could reduce his risk, “It comes across as judgment. I’ve not encountered anyone who was so overtly scornful of my behavioral choices as self-sabotaging. Just extremely judgmental, extremely unhelpful; basically, made recommendations to stop doing that.” Another participant said that when his doctor told him he should use condoms even when using PrEP, “The way he said it felt as if there were an assumption that I wasn’t going to use protection.”

Reduction or elimination of risky injection practices can be achieved by providing access to drug treatment and relapse prevention services for persons who are ready to take part in treatment. For persons unable to engage in drug treatment (eg, on a waiting list or lacking insurance or not motivated to do so), providing access to unused injection equipment through syringe service programs, prescriptions for syringes, or purchase from pharmacies without a prescription (where legal) can reduce HIV exposure. In addition, providing cognitive or behavioral counseling and any indicated mental health or social services, or referring the patient to these services, may help reduce risky injection practices.17 Overall, knowledge of PrEP is low among people who inject drugs (PWID).31 However, there is some evidence that needle exchange programs and substance abuse treatment programs may have the potential to increase knowledge of PrEP in this population.31,32 Discussing PrEP with individuals who are likely to benefit is an important part of HIV risk reduction. However, many providers are not offering their patients this highly effective preventive measure. In an analysis of data collected from a 2018 cross-sectional survey in Atlanta, Georgia, 85% of PrEP-naïve MSM reported visiting a PCP in the past year, but only 31% recalled having any provider discuss PrEP.33 The 2 most frequently cited reasons for

not using PrEP medications were not knowing enough about PrEP (35%) and perception of low personal risk of acquiring HIV (37%).

Clearly, many people would benefit from sexual health and HIV counseling and education. A study of 377 US men indicated that those who had an increased perception of HIV susceptibility were significantly more likely to feel comfortable discussing PrEP with a PCP.34 Providers who believe they do not have the time to spend on counseling need to recognize that other clinic staff, such as case managers and nurse educators, may be able to provide this education.

Video 4: Sexually Transmitted Infections

Andrea Jefferson-Saboor, FNP-C Clinician and staff biases, as well as those of patients and their partners, friends, and family may also create a barrier to sexual health care and HIV prevention. In surveys and focus groups with MSM and transgender women about PrEP-related attitudes, some participants have indicated a belief that using PrEP medications makes patients more likely to engage in unsafe sexual practices and that people should pick their sexual partners more carefully instead of taking medications.35,36 Some randomized trials and cohort studies of PrEP have identified rises in STIs following initiation of PrEP, whereas other research has found no such increase. CDC guidelines require PrEP users to be monitored and tested for STIs and HIV every 3 months.17 Data adjusted for monitoring and screening shows no significant change in STI incidence from preenrollment in PrEP to postenrollment.37-39 Regardless of providersâ&#x20AC;&#x2122; personal beliefs on this topic, the recommended and appropriate course of action for those in their care is to provide PrEP along with counseling and frequent monitoring for STIs.17

HIV prevention in women Providers should not overlook the need for women to be evaluated and counseled about PrEP. Many women and their PCPs misperceive their risk of HIV infection and may be unaware of PrEP as an HIV prevention option.40 In a survey of women who had recently visited Planned Parenthood, just 23% of participants reported having heard of PrEP prior to the study.41 This was true even though the survey was conducted among women visiting clinics located in Connecticut cities in which the state health department had previously launched a PrEP public awareness campaign, which included advertisements targeting women. The researchers speculate that even fewer women may be aware of PrEP in neighboring regions.

In 2016, among 78,360 persons who filled prescriptions for PrEP in the United States, women accounted for only 4.7% of PrEP users.13 Similarly, 2016 survey data from women in several Southern cities (N=225), showed that only 10.7% of women had even heard of PrEP, including 6% of women who were eligible for PrEP (n=72).42 In a report on a focus group that included mostly Black women (91.7%), it was estimated that fewer than 10% of the 144 participants had even heard of PrEP prior to participating in the group.43 A retrospective analysis in the United States found that adolescents/adults younger than 24 years accounted for 15.4% of TDF/FTC use of PrEP and adolescents younger than 18 years accounted for only 1.5%. Among adolescents younger than 18 years of age, females accounted for 83.5% of use, whereas among young adults aged 18 to 24 years, TDF/FTC for PrEP was predominantly used by men (84.2%).44

However, women who receive education about PrEP find the option attractive.42,43 In a focus group that included 144 women, many expressed anger that they had not heard about PrEP prior to the study, and once they learned about PrEP, most expressed interest in it as an HIV-prevention option.43 Likewise, in the survey of HIV-negative women (N=225) in southern cities, only 11% of this mostly Black group (83.1%) had heard of PrEP. After a brief description of PrEP, 173 (76.9%) expressed willingness to consider using PrEP.42 Clearly, even the most basic education about PrEP could be an important factor in reducing the unmet need for PrEP in women. There are many potential reasons for low use of PrEP among women who could benefit from it: lack of perceived risk of HIV infection, depression, low self-esteem, mistrust of medical institutions, social stigma, housing insecurity, cost, and side effects.45 Fortunately, there is some evidence that the disparity is being reduced. In an analysis of linked pharmacy and claims data representing >90% of US prescriptions, rates of PrEP use by women increased from 2012 (68.57/100,000) to 2017 (783.98/100,000).46

Medications for PrEP Presently, there are 2 oral medications for PrEP approved by the US Food and Drug Administration (FDA). Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is recommended for use by all adults and adolescents at risk of HIV infection. Tenofovir alafenamide/emtricitabine (TAF/FTC) was approved by the FDA in 2019 for adults and adolescents, but it is not recommended for people at risk of HIV infection through receptive vaginal sex. Taken as prescribed, PrEP is very effective in reducing the risk of transmission of HIV.47,48 The difference between the 2 medications is in the form of tenofovir contained in each product.49 Tenofovir alafenamide is a prodrug of tenofovir that has been designed to enter HIV-infected cells more efficiently than TDF. It can therefore be given at a much lower dose (less than one tenth) than TDF. TAF appears to be associated with less kidney toxicity and less decrease in bone mineral density (BMD) compared with TDF. In addition, TDF/FTC appears to decrease high-density lipoprotein (HDL), low-density lipoprotein (LDL), and total cholesterol levels whereas TAF/TFC appears to increase triglyceride levels.48 Any licensed prescriber can prescribe PrEP; specialization in infectious diseases or HIV medicine is not required. In fact, PCPs who routinely see people at risk of HIV infection should consider offering PrEP to all eligible patients.

Evidence supporting PrEP It is well established that TDF/FTC is effective in reducing the risk of new HIV infection in all at-risk populations (Figure 7).50-52

The efficacy and safety data of PrEP was first established in the iPrEx trial, which compared TDF/FTC with placebo in 2499 HIV-seronegative men or transgender women who have sex with men. The patients received a comprehensive package of other HIV prevention services. Once-daily TDF/FTC was associated with a 44% reduction in the incidence of HIV, compared with placebo. For patients in the TDF/FTC group who had detectable drug levels, the odds of HIV infection were lower by a factor of 12.9 (P<0.001) compared with those without detectable drug levels, corresponding to a relative reduction in HIV risk of 92% (P<0.001).50 In the Partners PrEP trial in HIV-serodiscordant heterosexual couples, the HIV-seronegative partner in each couple was randomly assigned to 1 of 3 study regimens: once daily TDF, TDF/FTC, or matching placebo. All couples received standard HIV-1 treatment and prevention services. TDF/FTC was associated with a relative reduction of 75% in the incidence of HIV-1 infection when provided in conjunction with other HIV prevention services, and the protection was not statistically different in women and men. In the TDF/ FTC arm, detectable levels of TDF, compared with undetectable levels, were associated with an estimated 90% reduction in the relative risk of acquiring HIV.51 The efficacy of PrEP in preventing HIV infection in PWIDs was explored in a trial that enrolled volunteers from 17 drug treatment clinics in Bangkok, Thailand. Participants were eligible if they were 20 to 60 years old, were HIV-negative, and reported injecting drugs during the previous year. Once-daily TDF decreased the incidence of HIV infection by 49% when provided with other HIV prevention services. Compared with participants without detectable tenofovir diphosphate (TFV-DP) levels, participants with detectable concentrations of TDF had 70% lower odds of HIV infection (odds ratio (OR), 0.30; 95% CI, 0.09â&#x20AC;&#x201C;0.98; P=0.04).52 As demonstrated by these and other studies, TDF/FTC is highly effective among people who take it daily. PrEP has been shown to decrease the risk of acquiring HIV from sex by about 99% and may reduce the risk among those who inject drugs by at least 74%.17 More recently, data from the DISCOVER trial have shown that TAF/FTC is noninferior to TDF/FTC in terms of prevention of HIV acquisition in MSM and transgender women.48 In the trial, 5387 study participants were randomized in a 1:1 ratio to receive TAF/FTC or TDF/ FTC. The primary endpoint was incident HIV infection when 100% of participants had completed 48 weeks and at least 50% had completed 96 weeks. At the time of the primary

efficacy analysis TAF/FTC was noninferior to TDF/FTC for HIV prevention, as the upper limit of the 95% CI of the incidence rate ratio (IRR) was less than the prespecified noninferiority margin of 1.62 (IRR, 0.47 [95% CI, 0.19â&#x20AC;&#x201C;1.15]).53 As a primary endpoint analysis, the IRR of TAF/FTC to TDF/FTC was evaluated when 100% of participants had completed 96 weeks.54 Among the 2670 participants who received TAF/FTC over 96 weeks, 8 acquired HIV (incidence rate, 0.16/100 person-years [PY]).

Among the 2665 participants who received TDF/FTC, 15 acquired HIV (incidence rate, 0.30/100 PY). These results confirm the noninferiority of TAF/FTC versus TDF/FTC (IRR, 0.54; 95% CI, 0.23â&#x2C6;&#x2019;1.26) (Figure 8).54

Across studies, PrEP efficacy is consistently tied to patient adherence. Overall, DISCOVER participants had very high adherence rates. Tenofovir diphosphate levels in red blood cells were significantly lower in participants with low adherence than in better-adhering participants.55 In fact, the most important risk factor for acquisition of HIV on study was low adherence to PrEP.55 In DISCOVER, Black MSM were more likely to be lost to follow-up and 2.4 times more likely to be nonadherent than non-Black participants.56 Participants in the TAF/FTC group in the DISCOVER trial had stable BMD at the hip and increased spine BMD at 48 weeks.53 In contrast, participants in the TDF/FTC group lost about 1% of their BMD over 48 weeks. The 96-week analysis of DISCOVER also indicated that patients using TAF/FTC had significantly improved BMD and better renal safety biomarkers than those using TDF/FTC.57 However, treatment with TDF/FTC was associated with lower HDL, LDL, and total cholesterol levels whereas TAF/TFC was associated with increased triglyceride levels.48

Chapter 4: Initiation and Monitoring of PrEP Andrea Jefferson-Saboor, FNP-C

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rEP is for individuals without HIV who are at risk of acquiring HIV from sexual activity or injection drug use. Those with a greater likelihood of HIV acquisition, who should be assessed for PrEP include (Table 2)17,58:

• Sexually active gay and bisexual men without HIV • Sexually active heterosexual men and women without HIV • Sexually active transgender individuals without HIV • Individuals without HIV who inject drugs • Individuals who have been prescribed nPEP and report continued sexual or drug-use behaviors that may increase their risk of acquiring HIV, or who have used multiple courses of postexposure prophylaxis (PEP)

Determining PrEP eligibility Clinical eligibility for people considering PrEP includes several required components17: • Conduct a comprehensive behavioral risk assessment (sexual; injection drug use) to identify appropriate PrEP candidates • Confirm HIV-negative status within the previous week: select preferred HIV tests and/or accurately interpret HIV test results

• Perform laboratory assessment for PrEP-associated risks and correlate clinically (include other baseline labs required for PrEP initiation) - Hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV) screening serology - Serum creatinine - 3-site STI testing (oropharynx, urine, and rectal swabs) for syphilis, gonorrhea, and chlamydia - Pregnancy testing for women of childbearing potential It is vital to confirm individuals as HIV-negative before initiating PrEP. Otherwise, there is a risk that they could develop drug-resistant HIV. Although TDF/FTC and TAF/FTC are appropriate components of an antiretroviral regimen to treat HIV, they must be combined with additional antiretroviral agents to provide effective treatment for HIV-positive individuals.58 Although fourth-generation combined antigen/antibody tests are preferred, at a minimum, clinicians should document a negative antibody test result within the week before initiating (or reinitiating) PrEP medications. The required HIV testing can be done by drawing blood and sending the specimen to a laboratory for testing or by performing a rapid, point-ofcare FDA-approved fingerstick blood test. When testing for PrEP eligibility, oral rapid tests should not be used to screen for HIV infection because they can be less sensitive than blood tests.58 When interpreting HIV-test results, PCPs should keep in mind that there is an approximate 18-day period during which even fourth-generation combined antigen/antibody tests may fail to detect early HIV infection.24 Therefore, all patients should be questioned regarding specific signs and symptoms suggestive of or consistent with early/acute HIV (Table 3).

Only with both negative HIV testing and negative screening for these signs and symptoms should there be further consideration of PrEP prescribing.17

If a patient has had signs/symptoms of acute HIV infection within the previous 4 weeks, the following options are suggested58: • Test patient with a combination antibody/antigen assay, ideally with a laboratory-based method. If the test is negative, PrEP can be initiated.

• Test patient with a viral load (VL) assay. If the patient has a measurable VL <3000 copies/mL, infection is unlikely, but PrEP should be deferred while testing is repeated. If the VL is below the level of detection of the assay, and the patient has no signs/ symptoms on that day, PrEP can be initiated.

• Defer PrEP and retest patient for HIV antibody in 1 month.

Anyone who tests positive for HIV infection should be referred for immediate assessment and initiation of antiretroviral treatment.

Infection with HBV is not a contraindication to PrEP, but all patients considered for PrEP with TDF/FTC or TAF/FTC must be screened for HBV. Both TAF/FTC and TDF/FTC are

treatment options for HBV, and discontinuation of these agents in an individual with chronic active HBV can result in rebound hepatitis. If patients with HBV start PrEP, when they stop the medication their liver function should be closely monitored for reactivation of HBV replication that could result in hepatic damage.47,48,58 In addition, providers should confirm that the patient’s estimated creatinine clearance (eCrCl) is ≥60 mL/min (using the Cockcroft-Gault formula) before initiating TDF/FTC as PrEP, or ≥30 mL/min before initiating TAF/FTC.58 TDF/FTC is a safe and effective HIV-prevention strategy for women who are at risk of HIV acquisition, including during conception, pregnancy, and postpartum. TAF/FTC is not approved in those having receptive vaginal sex. Continuing TDF/FTC during breastfeeding may be beneficial for some women, however, long-term safety of infant exposure to TDF/ FTC has not been determined. TDF/FTC does not reduce the effectiveness of oral contraceptives.58

Initiating PrEP If a patient is determined to be clinically eligible for PrEP, an appropriate medication should be prescribed. In addition, PrEP should be considered as part of a comprehensive HIV prevention plan, which includes a discussion and education about the medications and the regimen to maximize their safe use, condom use, STI prevention, support for medication adherence, and other sexual/behavioral counseling to decrease the likelihood of acquiring HIV infection. Prevention services or service referrals to help patients minimize their exposure to HIV should be offered when indicated. As well, clinicians should provide effective contraception to women who are taking PrEP and who do not wish to become pregnant.17,58 TDF/FTC is recommended for use by all adults and adolescents at risk of HIV infection.

The recommended dosage for HIV-1 uninfected adults and adolescents weighing at least 35 kg is 1 tablet (containing 300 mg of TDF and 200 mg of FTC) once daily, taken orally with or without food. TDF/FTC is not indicated for persons whose eCrCl is below 60 mL/ min. In addition, creatinine should be closely monitored. Avoid administering TDF/FTC to patients who are concurrently taking or who have recently taken nephrotoxic drugs. The most common adverse reactions (reported by >2% of participants in the TDF/FTC cohorts and more frequently than by those receiving placebo) were headache, abdominal pain, and weight loss.17,47 TAF/FTC was FDA-approved in 2019 for PrEP for adults and adolescents, but it is not recommended for people at risk of HIV infection through receptive vaginal sex. One tablet containing 200 mg of FTC and 25 mg of TAF is taken once daily with or without food in individuals with body weight at least 35 kg. TAF/FTC is not recommended for individuals with eCrCL <30 mL/min unless the eCrCL is below 15 mL/min per minute and they are receiving chronic hemodialysis. The most common adverse reaction (incidence ≥5%, all grades) was diarrhea.48,58 Time to maximum HIV prevention varies with mode of HIV exposure. The approximate time to maximum protection for those engaging in receptive anal sex is 7 days and for receptive vaginal sex is 21 days. It is also 21 days for those who may be exposed due to injection drug use. The time to maximum prevention for insertive anal or insertive vaginal sex is unknown. Patients should be advised that condom use is critical while tissue concentrations remain low, and that ongoing, consistent use of condoms is necessary for the prevention of both HIV and other STIs.58

Comprehensive guidelines for prescribing PrEP have been published by the CDC in a clinical practice guideline (https://clinicalinfo.hiv.gov/themes/custom/aidsinfo/documents/ cdc-hiv-prep-guidelines-2017.pdf) and supplement (https://www.cdc.gov/hiv/pdf/risk/prep/ cdc-hiv-prep-provider-supplement-2017.pdf). Both can be found on the CDC website.17,59 The clinical Providersâ&#x20AC;&#x2122; Supplement contains tools such as a patient/provider checklist, patient information sheets, provider information sheets, a risk incidence assessment, supplemental counseling information, billing codes, and practice quality measures.59 These supplemental tools can help with implementation of PrEP. If questions arise or if prescribing advice is needed, clinicians should call the National Clinician Consultation Center PrEP Line at 1-855-448-7737.

Video 5: TelePrEP Andrea Jefferson-Saboor, FNP-C

Monitoring people who are receiving PrEP PrEP medications should be prescribed as part of a comprehensive, ongoing, HIV prevention plan. Table 4 shows the laboratory testing and monitoring that should be provided for people on PrEP.17 At least every 3 months, repeat HIV testing and assess for signs or symptoms of acute infection to document that patients are still HIV-negative. Also repeat pregnancy testing for patients of childbearing potential. Assess for side effects, adherence, and behaviors that may increase the likelihood of HIV acquisition. Provide support for medication adherence and risk-reduction behaviors. Furthermore, the CDC recommends comprehensive STI screening every 3 months for MSM using PrEP. As this recommendation is often neglected in clinical practice, it is important for systems to be put into place to ensure appropriate monitoring.60

Supporting adherence To be effective, PrEP requires high levels of treatment continuance and adherence.17 A study of the pharmacokinetics of directly observed TDF dosing in MSM found that the active form of TDF in iPrEx participants, corresponded to an HIV risk reduction efficacy of 99% for 7 doses per week, 96% for 4 doses per week, and 76% for 2 doses per week.

Although there is some leeway for a missed dose, the level of efficacy is directly tied to adherence. Guidelines refer to a missed dose as 1 dose and protection will decrease over 7-10 days after ceasing daily PrEP use. Since some patients have acquired HIV infection soon after stopping PrEP it is important to encourage continuance and not suggest that a person just restart PrEP if missed for several days. A laboratory study examining vaginal and colorectal tissue levels of active metabolites of TDF and FTC found that drug levels associated with significant protection against HIV infection required 6-7 doses per week (~85% adherence) for lower vaginal tract tissues but only 2 doses per week (28% adherence) for colorectal tissues. These results show that that there appears to be less leeway for missed doses among women than among MSM.17 Should a patient report missing a dose, instruct the patient to take a single missed dose as soon as it is remembered. If, however, it is nearly time for the next dose, the patient should proceed with the regular dosing schedule.58 The CDC recommends providing a 90-day supply of PrEP medication (rather than a 30day supply with 2 refills) as a way to facilitate adherence and decrease trips to the pharmacy.58 Evidence from antiretroviral treatment adherence studies over the past 15 years and data from the completed PrEP trials provide guidance about how to support adherence. These approaches are listed in Figure 9.17

An adherence plan should also include strategies for travel or weekends away from home (when routines will be disrupted), identification of family and friends who can support the patientâ&#x20AC;&#x2122;s intentions to adhere, and discussion of how to overcome barriers to adherence due to lack of disclosure/privacy at home.17 Several studies have shown that adherence to PrEP is a particular problem for women.45 Lack of perceived risk of HIV infection is a top reason, but acceptance also depends on patient experiences, perceptions of product attributes (including side effects), and product use requirements.45 Transgender women are less likely than MSM to report being adherent to PrEP.15 PCPs may want to suggest use of keychain pill boxes or mobile phone apps.61

The current COVID-19 pandemic The CDC has developed guidance for providing PrEP when facility-based services and inperson patientâ&#x20AC;&#x201C;clinician contact is limited.58 In this guidance, the CDC urges providers to continue to ensure the availability of PrEP for patients newly initiating PrEP and patients continuing PrEP. Quarterly HIV testing should be continued for patient safety. Lab-only visits for assessment of HIV infection and other indicated tests for provision of PrEP are preferred. When these are not available or feasible, the CDC recommends considering laboratories that have validated protocols for testing home-collected samples. If a PrEP clinic is closing or suspending services temporarily, PCPs should establish referral relationships with other clinics, telemedicine services, or pharmacies so that clients may remain engaged in PrEP care.

The Adolescent and Young Adult Medicine Clinic at the University of California, San Francisco reports that over the course of several weeks in March 2020, it was able to rapidly replace most in-person visits with telemedicine visits.62 Telemedicine visits increased from zero to 97% of patient encounters in 1 month. The number of visits per month was comparable with that during the previous year.

As mentioned before, the CDC advises that when prescribing PrEP, clinicians should consider providing a prescription for a 90-day supply of PrEP medication (rather than a 30-day supply with 2 refills) to minimize trips to the pharmacy and to facilitate PrEP adherence.58

PrEP on demand The International Antiviral Society−USA panel has stated that pericoital TDF/FTC is effective for HIV prevention among MSM and an alternative to daily PrEP for MSM with infrequent sexual exposures. This approach is sometimes called on-demand PrEP, eventdriven PrEP, or 2-1-1. The person takes 2 pills, 2 to 24 hours before sex, 1 pill 24 hours later, and 1 more pill 24 hours after that. If the individual has sex more than 24 hours after taking the first dose, or engages in sex over multiple days, that person should continue taking 1 pill every day until he has taken 2 doses, 24 hours apart, following the last time the individual had anal sex. This approach can be used as HIV prevention before planned sexual activity, with the medication taken only when needed. On-demand PrEP is not appropriate for heterosexual men and women, transgender men and women, and PWIDs.63 Although not currently part of CDC guidelines, evidence suggests that on-demand PrEP is highly effective at preventing HIV infection among high-risk MSM. The ANRS IPERGAY trial enrolled high-risk MSM in France and Canada to assess on-demand PrEP with TDF/FTC.64 Men who used PrEP had an 86% relative reduction of HIV incidence compared with those randomly assigned to placebo. An open-label extension study confirmed the efficacy of on-demand PrEP in this population.65

Nonoccupational postexposure prophylaxis (nPEP) PCPs sometimes care for people who need PEP against HIV infection due to potential immediate exposure through sexual behavior, injection drug use, or sexual assault; this is known as nPEP. Those who may have been exposed through health care work may require occupational PEP (oPEP). Treatment involves taking a 28-day course of antiretroviral medication. PEP is a medical emergency and should be initiated as early as possible for all individuals with an exposure that has the potential for HIV transmission; it is not recommended 72 hours after exposure. If started soon after exposure, PEP can reduce the risk of HIV infection by over 80%. Adherence to a full 28-day course of antiretroviral medication is critical to the effectiveness of the intervention.66 PEP normally consists of 3 anti-HIV drugs from 2 different classes. To optimize adherence, consideration should be given to minimizing side effects and number of doses per day and/or pills per dose. The following regimens are preferred66: • TDF 300 mg with FTC 200 mg once daily plus raltegravir 400 mg twice daily ─ OR ─ • TDF 300 mg with FTC 200 mg once daily plus dolutegravir 50 mg once daily Attention to a patient’s childbearing status or potential is crucial. Dolutegravir should be avoided in nonpregnant women of childbearing potential who are sexually active or have been sexually assaulted and who are not using an effective birth control method; dolutegravir should also be avoided in pregnant women early in pregnancy since there is risk of an unborn infant developing a neural tube defect during the first 28 days.67 People receiving PEP can be transitioned to PrEP as long as HIV-negative status is confirmed and there are no signs or symptoms of acute infection. Complete any PrEP baseline laboratory testing not already performed as part of PEP testing and provide counseling about medication adherence and risk reduction.66

Chapter 5: Exploring Bias and Stigma Around HIV and Sexual Health Issues Gregory S. Felzien, MD, AAHIVS

S

tigma continues to be a major factor in HIV prevention and treatment because many populations that are disproportionately affected by HIV are also marginalized and/or stigmatized by the health care system and society.21 For example, interviews with Latino MSM who were using PrEP documented that they had experienced multiple forms of stigma, including disapproving judgment, negative labels and attitudes, rejection, and the discrediting of individuals who use PrEP.68 These occurrences of stigma arose across various settings and came from several different sources, including friends, family, sex partners, and medical providers.

Provider bias surrounding HIV, PrEP, and STIs can be a major barrier to optimal clinical care.21,69 Therefore, providers should be aware that many people in their care face bias not only from the larger culture in which they live but also from their own friends and family, employers and colleagues, and faith-based organizations. It is wise to be humble about the ability to understand the Video 6: Bias and Stigma circumstances from which patients come.

A compassionate true interest in the Gregory S. Felzien, MD, AAHIVS unique situation of each individual can go a long way toward providing an appropriate therapeutic atmosphere. Be aware of the impact of the physical positioning.

For example, if a PCP stands or sits in a chair that towers over the patient, it can set an intimidating tone.

In addition to this individual attention, the atmosphere of the office or clinic must also be considered. If the posters on the wall and the variety of educational material in the waiting area send a supportive, nonjudgmental message, that can set the tone for the interactions with providers.21 Designing patient services with cultural humility can increase the effectiveness of engagement efforts, more efficiently build trust between the health center and individuals with a greater likelihood of HIV acquisition, promote patient advocacy and engagement in care, and ultimately support successful progression along the HIV care continuum. The diversity of individuals seeking care from health centers spans race, ethnicity, gender, sexual orientation, nationality, and primary language. Effective engagement and service provision require an understanding of the specific needs and challenges facing various populations, as well as the implementation of concrete actions to support appropriate patient interactions.21

For example, recommendations to create health care with cultural humility for LGBTQ+ individuals include70: • Educating staff on specific health disparities experienced by the LGBTQ+ communities and how to collect sexual and social history • Using gender-neutral language on forms and in communications • Asking patients what pronoun and name they prefer to be called • Refraining from making assumptions about a person’s sexual orientation or gender identity by asking directly about identity and sexual behavior • Displaying LGBTQ+-friendly symbols • Registering with the Gay and Lesbian Medical Association’s online directory For many PCPs, examining strongly held beliefs and biases may be a necessary first step to creating a welcoming environment for LGBTQ+ patients.70 Patients report that positive health encounters are important; negative experiences may result in clinically significant behavior changes that may impact a patient’s health.71

Summary PrEP is highly effective at preventing HIV infection. There are 2 proven options that can be prescribed and monitored in primary care or community health care settings. However, many people who could benefit do not receive PrEP. A major shift in perspective, language and tone, and programs may be required in many practices to address stigma about PrEP. However, this effort is absolutely necessary to ensure broader reach of PrEP as a prevention strategy and improve its utilization by the individuals who need it most.

Many of the barriers to increased PrEP uptake can be removed by PCPs who are committed to being a part of addressing the HIV epidemic and providing appropriate treatment to people already in their care. It bears repeating that by screening, testing, and prescribing PrEP medications when appropriate, PCPs can make a real difference and be an important part of ending the HIV epidemic.

Clinical Resource Center Clinical Practice Guidelines Guidance and resources during disruption of STD clinical services; update on STD treatment options.

Centers for Disease Control and Prevention; May 2020. https://www.cdc.gov/std/dstdp/dcl-clarification-may2020.pdf

2015 sexually transmitted diseases treatment guidelines.

Centers for Disease Control and Prevention, 2015; last reviewed December 2019. https://www.cdc.gov/std/tg2015/default.htm

Updated guidelines for antiretroviral postexposure prophylaxis after sexual, injection drug use, or other nonoccupational exposure to HIVâ&#x20AC;&#x201D; United States, 2016.

CDC Stacks. Centers for Disease Control and Prevention; last updated May 2018. https://stacks.cdc.gov/view/cdc/38856

Standards of Care for the Health of Transsexual, Transgender, and Gender Nonconforming People.

Coleman E, et al. 7th ed. East Dundee, Illinois: World Professional Association for Transgender Health; 2012. https://www.wpath.org/publications/soc

Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2020 recommendations of the International Antiviral Societyâ&#x20AC;&#x201C;USA panel.

Saag M, Gandhi R, Hoy J, et al. JAMA. 2020. [Epub ahead of print]. https://jamanetwork.com/journals/jama/fullarticle/2771873

Guidelines for prevention and treatment of opportunistic infections in adults and adolescents with HIV. US Department of Health and Human Services; revised May 2020. https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-opportunistic-infection/ whats-new-guidelines

Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. US Department of Health and Human Services; last updated December 2019. https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/whats-new-guidelines

Preexposure prophylaxis for the prevention of HIV infection in the United Statesâ&#x20AC;&#x201D;2017 update. A clinical practice guideline.

US Public Health Service. Centers for Disease Control and Prevention; 2018. https://clinicalinfo.hiv.gov/themes/custom/aidsinfo/documents/cdc-hiv-prepguidelines-2017.pdf

Professional Resources American Academy of HIV Medicine; supporting the HIV care provider and the profession. https://aahivm.org/

Basic statistics.

Centers for Disease Control and Prevention; July 2020. https://www.cdc.gov/hiv/basics/statistics.html

HIV testing.

Centers for Disease Control and Prevention; 2020. https://www.cdc.gov/hiv/testing/index.html

HIV in the United States by region.

Centers for Disease Control and Prevention; July 2020. https://www.cdc.gov/hiv/statistics/overview/geographicdistribution.html

HIV and youth.

Centers for Disease Control and Prevention; May 2020. www.cdc.gov/hiv/group/age/youth/index.html

Pre-exposure prophylaxis (PrEP).

Centers for Disease Control and Prevention; May 2020. https://www.cdc.gov/hiv/clinicians/prevention/prep.html

Taking a sexual history.

Centers for Disease Control and Prevention; April 2020. https://www.cdc.gov/hiv/clinicians/transforming-health/health-care-providers/sexualhistory.html

PrEP to prevent HIV and promote sexual health.

New York State Department of Health AIDS Institute, Clinical Guidelines Program; July 2020. https://www.hivguidelines.org/prep-for-prevention/

Sexual History Taking Toolkit; July 2020.

TargetHIV. https://targethiv.org/library/sexual-history-taking-toolkit

Ending the HIV epidemic: Ready, Set, PrEP. US Department of Health and Human Services. https://www.getyourprep.com/

Center of Excellence for Transgender Health.

Prevention Science, Department of Medicine; University of California, San Francisco. https://prevention.ucsf.edu/transhealth

National Clinician Consultation Center.

University of California, San Francisco; 2020. https://nccc.ucsf.edu/

HIV drug interactions.

University of Liverpool (website); September 2020. http://www.hiv-druginteractions.org/checker

Patient Resources HIV basics.

Centers for Disease Control and Prevention; June 2020. https://www.cdc.gov/hiv/basics/index.html

Prevention for women. Resources on HIV prevention for U.S. women.

HIVE online; 2019. https://www.hiveonline.org/prep4women/

Get HIV care HRSA Ryan White HIV/AIDS Program https://hab.hrsa.gov/get-care

HIV resources.

National Institutes of Health. https://www.oar.nih.gov/hiv-resources/public

Positively Aware.

Positively Aware, created by TPAN (Test Positive Aware Network), is a source of HIV-treatment news for consumers, as well as an educational tool for HIV caregivers. The site features PrEP resources, including videos for men who have sex with men and transgender people. https://www.positivelyaware.com/

UCSF transgender care.

University of California, San Francisco https://transcare.ucsf.edu/

Suggested Reading Emtricitabine/tenofovir alafenamide; January 2020.

AIDS Info. US Department of Health and Human Services. https://clinicalinfo.hiv.gov/en/drugs/emtricitabine-tenofovir-alafenamide/tablet-film-coated

Emtricitabine/tenofovir disoproxil fumarate; July 2020.

HIV Info. US Department of Health and Human Services. https://clinicalinfo.hiv.gov/en/drugs/emtricitabine-tenofovir-disoproxil-fumarate/patient

Antiretroviral prophylaxis for HIV prevention in heterosexual men and women.

Baeten JM, et al. N Engl J Med. 2012;367(5):399-410. http://www.nejm.org/doi/full/10.1056/NEJMoa1108524#t=article

Stigma, medical mistrust, and perceived racism may affect PrEP awareness and uptake in black compared to white gay and bisexual men in Jackson, Mississippi and Boston, Massachusetts.

Cahill S, et al. AIDS Care. 2017;29(11):1351-1358. https://pubmed.ncbi.nlm.nih.gov/28286983/

Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, doubleblind, placebo-controlled phase 3 trial.

Choopanya K, et al. Lancet. 2013;381(9883):2083-2090. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)61127-7/abstract

Being PrEPared â&#x20AC;&#x201C; preexposure prophylaxis and HIV disparities.

Goldstein RH, et al. N Engl J Med. 2018;379(14):1293-1295. https://www.nejm.org/doi/full/10.1056/NEJMp1804306

Preexposure chemoprophylaxis for HIV prevention in men who have sex with men.

Grant RM, et al. N Engl J Med. 2010;363(27):2587-2599. http://www.nejm.org/doi/full/10.1056/NEJMoa1011205#t=article

The phase 3 DISCOVER study: daily F/TAF or F/TDF for HIV preexposure prophylaxis.

Hare CB, et al. 26th CROI 2019; March 4-7, 2019; Seattle, WA. Abstract 104. https://www.croiconference.org/abstract/phase-3-discover-study-daily-ftaf-or-ftdf-hivpreexposure-prophylaxis/

Lifetime risk of a diagnosis of HIV infection in the United States.

Hess KL, et al. Ann Epidemiol. 2017;27(4):238-243. https://www.sciencedirect.com/science/article/abs/pii/S1047279717301539?via%3Dihub

Phase 3 randomized, controlled DISCOVER study of daily F/TAF or F/TDF for HIV pre-exposure prophylaxis: week 96 results.

Ruane P, et al. 17th European AIDS Conference (EACS); November 6-9, 2019; Basel, Switzerland. Poster PE3/16. https://www.natap.org/2019/EACS/EACS_50.htm

How to incorporate HIV PrEP into your practice.

Stewart J, Stekler JD. J Fam Pract. 2019;68(5):254-261. https://www.mdedge.com/familymedicine/article/202573/infectious-diseases/howincorporate-hiv-prep-your-practice

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