PrEP Provider Toolkit

Site: Pacific AIDS Education & Training Center
Course: PrEP Provider Toolkit
Book: PrEP Provider Toolkit
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Date: Sunday, December 4, 2022, 4:38 PM

WELCOME

Welcome

Thank you for your interest in the Pacific AIDS Education and Training Center PrEP toolkit for providers.

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Welcome to the Pacific AIDS Education and Training Center’s provider toolkit for pre-exposure prophylaxis (PrEP). You are about to begin an educational session that will significantly improve the quality of care you provide and help contribute to the global efforts to eradicate the Human Immunodeficiency Virus (HIV).

Since its discovery in the 1980s, HIV has been a major public health issue that continues to affect millions worldwide. Fortunately, incredible medical advancements have been made in this field that not only significantly improve the lives of those living with HIV, but can also effectively prevent the occurrence of new infections.

PrEP is one of modern medicine’s most powerful tools in disease prevention as it is highly efficacious, well-tolerated, and cost-effective. However, despite its existence for the past decade (since 2012), utilization has been fairly limited due to provider knowledge, comfort, and deliverability barriers.

This site is specifically designed to improve your understanding and confidence in providing this essential tool. You will be guided through the most relevant and practical aspects of PrEP care and be provided with various resources to help you streamline PrEP into your everyday practice.

This toolkit primarily utilizes information from the Center for Disease Control and Prevention’s (CDC) PrEP Clinical Guidelines, updated in December 2021. Minor modifications of these guidelines will be suggested to reduce any confusion that may deter providers from utilizing PrEP while allowing for more comprehensive care that doesn’t jeopardize safety.

The information presented here will be directed towards clinicians and, at times, may get a bit technical. But rest assured that if you need further support and guidance, there is a free hotline available to help you address any and all aspects of PrEP care.

National Clinicians Consultation Center
855-HIV-PrEP (855-448-7737) Monday – Friday, 9am – 8pm Eastern Time
Voice mails can be left at any time.

Lastly, PrEP delivery and management are not meant to fall solely onto the shoulders of providers. Like all the other conditions you manage, the prevention of HIV with PrEP is best performed with a team approach, utilizing everyone in your practice setting from the front desk to the back office. However, if you decide that PrEP is not something you want to provide, patients can be directed to resources to learn more about PrEP and find a PrEP provider.


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What is the Pacific AETC?

 The Pacific AIDS Education and Training Center (Pacific AETC) is a member of a national AIDS Education and Training Center network of eight regional and three national centers, covering all 50 states, as well as US Territories and Jurisdictions. Funding is provided by the Health Resources and Services Administration (HRSA) HIV/AIDS Bureau through the Ryan White Program, Part F.

Pacific AETC works to expand the number and ability of healthcare professionals and organizations in the Pacific region to provide high-quality HIV-related services to increase access to healthcare and decrease health inequities. We work with health care providers, clinics, health jurisdictions, and policymakers in Arizona, California, Hawai`i, Nevada, and the US Affiliated Pacific Island Jurisdictions.

A network of eight Local Partners (LPs) provides services on local and regional levels. Five LPs are located throughout California, with state-wide programs in Arizona, Nevada, and Hawai’i. The Hawai’i LP also covers the six U.S. Pacific Jurisdictions (Guam, American Samoa, Federated States of Micronesia, Marshall Islands, North Mariana Islands, and Palau).

Each LP has its roster of qualified faculty, programs, and activities designed to meet their local region’s or state’s needs. LPs are based at academic medical centers, with access to highly qualified HIV specialists and community expertise. Contact your local AETC for details about training and capacity-building opportunities. Continuing education credit is available for many activities.

Target Audience

 Pacific AETC offers education, training, and capacity-building programs specifically designed to improve HIV/AIDS care, treatment, and prevention services for ALL interdisciplinary team members. This includes but is not limited to:

  • Mental Health Providers
  • Social Workers
  • Case Managers
  • Physicians
  • Nurses
  • Advance Practice Nurses
  • Physician Assistants
  • Dentists
  • Pharmacists
  • Community Health Workers

Local Partners & State Office of AIDS

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A network of eight Local Partners (LPs) provides services on local and regional levels. Five LPs are located throughout California, with one each in Arizona, Nevada, and Hawai’i. The Hawai’i LP also covers the six U.S. Pacific Jurisdictions (Guam, American Samoa, Federated States of Micronesia, Marshall Islands, North Mariana Islands, and Palau).

Each LP has its roster of qualified faculty, programs, and activities designed to meet their local region’s or state’s needs. LPs are based at academic medical centers, with access to highly qualified HIV specialists. Contact your regional AETC for details about training and capacity building opportunities. Continuing education credit is available for many activities.

Basics of HIV

Section 1Understanding the disease in which we are trying to prevent is important to truly value the power and potential of PrEP. In this section, we will be covering how HIV is transmitted, how we test for HIV, how new HIV infections present, and important public health statistics about HIV. Laying down this foundational understanding will help make sense of the information provided in the following sections.

Transmission risk factors

To truly understand and appreciate the potential of PrEP, it is worthwhile to briefly review the disease it prevents. HIV is a retroviral infection that specifically attacks the CD4 cells in the immune system.

Transmission of HIV typically occurs through contact with blood or fluids from the rectum, penis, or vagina. Additionally, HIV can be transmitted from a mother to her child perinatally or through breastfeeding. Exposure of HIV to damaged mucosal tissue or directly into the bloodstream is required for transmission. Exposure to HIV on intact skin does not pose a risk, nor do acts such as hugging, kissing, or sharing utensils.

Figure 1 depicts the estimated likelihood of acquiring HIV from an infected source based on the type of exposure. Note that the second highest risk factor occurs among people who inject drugs (PWIDs), which is a population of rising concern. For further information about HIV transmission: https://www.cdc.gov/hiv/basics/transmission.html

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Figure 1

Figure 1. - Estimated Probability of Acquiring HIV from an Infected Source by Exposure Type

   Factors contributing to HIV transmission are fundamentally important to understand as it helps discern which patients are at the highest risk and how to protect them best.

Anal sex or sex under the influence of drugs and alcohol has a higher likelihood of damaging the protective mucosal layer, which facilitates HIV transmission. Local inflammation caused by sexually transmitted infections (STI) also decreases the integrity of the mucosal lining. This partly explains why groups such as men who have sex with men (MSM) have higher rates of HIV transmission (Figure 2).

The CDC has a helpful tool that estimates the risk of sexually transmitted HIV based on various factors. It provides a powerful graphic that can be used with patients during visits to improve their self-perceived risk: https://hivrisk.cdc.gov/risk-estimator-tool/#-mb|iai

Figure 2

Figure 2. - New HIV Diagnoses in the US by Transmission Category, 2020

HIV Testing

The recommended tests for HIV can vary based on the clinical scenario and the type of PrEP medication being utilized. Let’s briefly review this to build a foundational understanding of HIV testing options, their indications, and their limitations.

HIV-RNA

  • Sometimes called nucleic acid test (NAT) or “viral load”
  • Measures the amount of circulating HIV genetic material
  • Becomes detectable ~10 days after HIV acquisition

p24 antigen (Ag)

  • A structural protein found in the HIV capsid
  • The antigen component of combined HIV-Ag/Ab testing.
  • Becomes detectable ~18 days after HIV acquisition

HIV antibody (Ab)

  • Antibodies against HIV; starts with IgM which gets replaced over time with IgG
  • The antibody component of combined HIV-Ag/Ab testing
  • Becomes detectable ~24 days after HIV acquisition

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Figure 3

Figure 3. - Timing of HIV Test Positivity After Acquisition

Newly acquired HIV infections take some time to make substantial copies of its genome. During this eclipse period, which typically lasts 10-12 days, we are unable to detect an HIV infection with any type of test. This eclipse period also happens to be the window period for HIV-RNA tests.

   The window period is the time between HIV acquisition and lab test positivity.

Each successive generation of HIV-Ag/Ab testing has worked to shorten the window period to allow for earlier diagnosis. The currently recommended and most commonly used HIV-Ag/Ab 4th-generation test checks for the p24 Ag, HIV-IgM, and HIV-IgG. The testing algorithm is presented in Figure 4. This test can be performed in the laboratory or as a point-of-care (POC). The only POC HIV-Ag/Ab test recommended in the context of PrEP is the Abbott Determine HIV-1/2 Ag/Ab Combo, a fingerstick test that generates results in 20 minutes. (1)

Figure 4

Figure 4 - HIV-Ag/Ab testing algorithm

The window period for a laboratory based 4th-generation HIV-Ag/Ab test is between 18-45 days; the point-of-care (POC) version has a slightly longer window period of 18-90 days. After the window period, these tests will detect 99% of all newly acquired HIV infections.

Although HIV-RNA tests have the shortest window period, we do not routinely rely on this test for screening as it is costly and places a high burden on laboratories.

HIV-RNA is typically only used in the following scenarios:

  1. Monitoring disease activity in someone with a known HIV infection
  2. Checking for HIV acquisition during the inter-test reactivity interval

   The inter-test reactivity interval (ITRI) is the time between HIV-RNA test positivity and HIV-Ag/Ab test positivity.

As highlighted in purple boxes in Figure 3, this ITRI can be as short as a week to as long as 80 days. Thankfully, it has been determined that the ITRI of current Ag/Ab tests to capture 95% of new infections is just one week. (2)  In other words, the current HIV-Ag/Ab tests that we use can reliably detect new infections just a week after HIV-RNA tests can.

However, this indicates that clinical scenarios still exist where HIV-RNA testing is needed before starting PrEP. We will be covering this in detail in the coming sections. Admittedly, this is the most challenging portion of PrEP care though it does not need to be applied in the vast majority of cases, so do not be deterred.

The recommended tests for HIV can vary based on the clinical scenario and the type of PrEP medication being utilized. Let’s briefly review this to build a foundational understanding of HIV testing options, their indications, and their limitations.

Acute HIV infections

The early stages of an HIV infection present many challenges in clinical decision making. In the previous section, we covered how objective measures can vary based on the timing of infection. Using subjective measures in the clinical setting is even more challenging, if not impossible, to accurately diagnose acute retroviral syndrome (ARS).

Only half of new HIV infections are estimated to cause symptoms between 2-4 weeks after acquisition. Among those who reported symptoms, only fever and fatigue occurred in most cases. Other less commonly reported symptoms include myalgia, rash, headache, sore throat, cervical adenopathy, joint aches, night sweats, and diarrhea. (3)  This leads to a very broad differential diagnosis. Taken altogether, symptoms of ARS are both unreliable and extremely nonspecific; and thus, should not be used in isolation to make clinical decisions.

Furthermore, after this short period of time when symptoms occur, patients can go on for years without any new complaints. In fact, despite collective efforts to perform more routine testing, it is estimated that about 13% of people living with HIV/AIDS (PLWHA) are unaware of their diagnosis and account for over a third of new infections. (4)

How, then, can we improve our clinical gestalt for a condition that presents so ambiguously and has such an enormous impact on the lives of individuals and communities?

The answer to this question is complex, but it relies on several key points.

  • An environment and approach that fosters patient comfort and trust is necessary to start relevant conversations
  • Thorough and accurate sexual and substance use histories must be obtained
  • A firm understanding of HIV tests must be developed and they should be utilized judiciously.

We will cover techniques and frameworks to help you improve these skills in the coming sections.

Important HIV Epidemiology

Prevalence captures the proportion of a population that currently lives with a condition. Incidence captures the proportion of a population that is newly infected with a condition.

Medical advancements such as antiretroviral therapy (ART) contribute to longer life expectancies among people living with HIV/AIDS (PLWHA) and, thus, rising prevalence rates. When it comes to PrEP, we are more concerned with incidence rates as it is a preventive tool to avoid new infections from occurring.

Figure 5 shows that the incidence of HIV in the United States has been steadily declining over the years. Despite this seemingly reassuring trend, when viewed with a closer lens, concerning disparities are revealed across racial groups, age groups, and geographic regions. HIV disproportionately affects Black/African Americans between the ages of 20-34, and a startling majority of all new HIV cases occur in Southern states alone (Figures 6-8). (5)

It is also worth pointing out that the major reductions in HIV incidence occurred before PrEP was introduced. Improved testing and treatment of those living with HIV account for these early changes in incidence rates. This highlights the rather limited impact PrEP has had on this crucial statistic.

Since its availability, PrEP has predominantly benefited white gay and bisexual men. HIV incidence is worsening among groups of growing concern, such as Latino men and women and people who inject drugs (PWIDs) (Figure 9).

Most of the graphics shown below have been adopted from the National HIV Curriculum, a free resource created by the University of Washington and funded by the Health Resources and Services Administration (HRSA). It includes easy to follow, self-guided modules that provide an in-depth understanding of HIV: https://www.hiv.uw.edu/

They also make resources to improve your understanding of STIs, Hepatitis B, and Hepatitis C. Both CME and CNE credits can be earned by completing these self-study modules.

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Figure 5

Figure 5 - Incidence Rates in the United States, 2008-2019

Figure 6

Figure 6 - Incidence Rates in the United States in 2019, by Race/Ethnicit

Figure 7

Figure 7 - HIV Incidence in the United States in 2019, by Age Group

Figure 8

Figure 8 - New HIV Diagnosis in the United States in 2019, by Region of Residence

Figure 9

Figure 9 - New HIV Diagnosis in the United States in by Race and Transmission Group, 2014-2018

Patient-centered approach

Section 2Discussing PrEP naturally requires very sensitive information to be shared. A mindful and patient-centered approach is necessary to instill the comfort and build proper rapport. In this section, we will review gender-related terminology and how to effectively obtain a sexual and substance use history. Tailoring your approach will continuously involve trial and error but over time, you will find what works best for you and your patients.

Review of gender-related terminology

Currently, there are different indications of which PrEP medication to use depending on the sex of the patient. Sex is not the same as gender, nor is it equivalent to, or indicative of, someone’s current anatomy, sexual orientation, or sexual practices. It is easy to confuse these terms which can affect internal biases, patient rapport, and overall quality of care. Therefore, it is worthwhile at this point to review gender-related terminology.

The term sex is used to refer to the designation that is given at birth based on biological factors such as sex chromosomes and genitalia present at birth. Typically, a person is assigned male at birth (AMAB) or female at birth (AFAB). A person may also be assigned intersex when there are conditions that make this determination ambiguous (e.g., congenital adrenal hyperplasia, androgen insensitivity syndrome, etc.).

There exist social constructs that are tied to a person’s sex which are sometimes called gender norms. These norms encompass things such as roles and expressions. For example, men have to be in positions of power or only women can wear makeup and dresses. An individual may not always identify or agree with these norms or their bimodality.

Gender identity refers to an individual's internal perception of where in the spectrum of gender norms they fit in most. Relatedly, gender expression is the external presentation of this concept - how a person chooses to look.
Someone whose gender identity is congruent with their sex is termed cisgender.
Someone whose gender identity is different from their sex is termed transgender.
A person whose sex is assigned male at birth (AMAB) but identifies as a female is termed a transgender woman (TGW), sometimes referred to as male-to-female (MtF).
Conversely, there are also female-to-male (FtM) transgender persons.
Sometimes, a person may choose to undergo medical therapies and interventions to affirm their gender identity. This may be referred to as transsexual - a subset of the transgender umbrella term. It is never appropriate to assume a patient’s existing anatomy based on their sex or gender.

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Figure 10

Figure 10 - Gender Identity and Expressions

Sexual orientation refers to the physical, romantic, and/or emotional attraction one feels towards another gender(s).
Heterosexuality is the attraction between those of the opposite sex (i.e. straight)
Homosexuality is the attraction between those of the same sex (i.e. lesbian, gay)
A term often used in medicine is men who have sex with men (MSM).
Bisexuality refers to the attraction to those of both sexes. Asexuality is the lack of attraction to both sexes.

Lastly, sexual practices specifically discuss the sexual acts a person engages in.
Some examples include receptive anal intercourse (RAI), insertive anal intercourse (IAI), receptive vaginal intercourse (RVI), insertive vaginal intercourse (IVI), oral sex, masturbation, etc. Similarly, it is never safe to assume the sexual practices of a patient based on sex, gender, or orientation. We will soon discuss how to take a proper sexual (and substance use) history.

For the purposes of PrEP, an important patient population has been defined based on sex and sexual orientation: men who have sex with men and transgender women who have sex with men (MSM/TGWSM). This will be utilized throughout the toolkit, so please dedicate the time needed to understand these definitions.

This is by no means a comprehensive overview of this topic. This section aims to lay a foundation for understanding some of the nuances of PrEP care that will soon be addressed. For a more comprehensive overview of gender-related terminology and definitions: https://transcare.ucsf.edu/guidelines/terminology.

Sexual and substance use history

The CDC created a helpful framework for taking a sexual history termed “The 5 P’s”. (6)  The National Coalition for Sexual Health expanded this to “The 6 P’s” which includes a “Plus” category that encompasses topics such as pleasure, problems, and pride. (7).  This coalition also created a helpful video series to improve your approach when taking a sexual history. (8)

The 6 P’s of a Sexual History

  1. Partners
  2. Practices
  3. Past History of STIs
  4. Protection
  5. Pregnancy
  6. Plus: Pleasure, Problems, & Pride

Given the rising incidence rate of HIV among people who inject drugs (PWIDs), it is important to expand on the second “P” in this framework: Practices.
Although this approach raises the question of drug and alcohol use in the context of sex, a simple follow-up question to further assess these habits could be…

“Have you ever used injection drugs that were not prescribed by a doctor such as heroin, cocaine, meth, or others?”

If the patient answers “yes,” ask further about the frequency of use and most recent use. Most importantly, ask if they ever share drug injecting equipment of any sort. This includes needles, syringes, cookers, filters, etc. A common misconception is that the patient is not at risk for acquiring transmissible infections as long as different injection needles are used. Ask carefully and provide risk reduction strategies when applicable.

Relatedly, bloodborne infections such as HIV, Hepatitis B, and Hepatitis C can also be transmitted through needles used for tattoos, particularly in correctional facilities. (42)  Inquire about any tattoos the patient has or plans on getting to tailor your care and patient education.

It may not always be feasible to ask every question mentioned in this section; the point of this framework is to help you progressively improve your history-taking skills. Remember that it may take several conversations about PrEP before a patient decides that it is right for them. Even if typical risk factors are not made apparent, it is always worthwhile to at least ask your patients if they have heard of PrEP. A patient will never take something into consideration if they don’t have an awareness of it at all.

Uplifting BIPOC for PrEP Uptake

Providing PrEP to BIPOC

The BIPOC acronym stands for Black, Indigenous and People of Color. The term BIPOC is used to highlight the unique relationship to whiteness that Indigenous and Black people have that shapes the experiences of and relationship to white supremacy for all people of color within a U.S. context. Using the term BIPOC is people-first and allows us to shift away from terms like “marginalized” and “minority.”

   Structural and political determinants of health drive inequities, HIV infection and the use of PrEP among BIPOC. In 2018, at the Conference on Retroviruses and Opportunistic Infections (CROI) new data about PrEP use showed that PrEP medication is not reaching most Americans who could benefit, especially people of color. Out of 500,000 African Americans and nearly 300,000 Latinos across the nation that could benefit from PrEP only 7,000 prescriptions were filled by these communities. This data shows a stark unmet need for HIV prevention medication.

The substansial disparity of HIV in BIPOC communities is driven by experiences of discrimation and stigma, lack of access to healthcare services, lack of education and employment opportunities, and unstable housing.

Longstanding social and economic inequities elevate health risks and vulnerabilities for BIPOC, and HIV continues to disproportionately impact these communities, specifically sexual minority men and transgender women in the United States. Disparities are most prominent for Black and Hispanic/Latino groups. At the current rate of infection, estimates suggest that 1 in 2 Black men who have sex with men (MSM) and 1 in 5 Hispanic/Latino MSM will be diagnosed with HIV in their lifetime; these racial and ethnic disparities in HIV prevalence also extend to Black and Hispanic/Latina transgender women. These communities carry a higher burden of HIV compared to white transgender women. In the U.S., an estimated 44% of Black and 26% of Latino/Hispanic transgender women are living with HIV compared to 7% of white transgender women. The substantial disparity of HIV in these communities is driven by experiences of discrimination and stigma, lack of access to healthcare services, lack of education and employment opportunities, and unstable housing.

HIV pre-exposure prophylaxis (PrEP) inequities in the US – both in terms of race and geographical location – have not only persisted in the last decade, but have increased, according to research presented to the 24th International AIDS Conference (AIDS 2022) by Dr Patrick Sullivan from Emory University.

While HIV prevention methods, such as PrEP, are highly effective and necessary in ending the HIV epidemic, serious racial/ethnic disparities, structural inequities, and systemic racism block progress for Black and Hispanic/Latino cis-gender sexual minority men and transgender women in accessing this effective HIV prevention medication. In 2018, at the Conference on Retroviruses and Opportunistic Infections (CROI), new data about PrEP use showed that PrEP medication is not reaching most Americans who could benefit, especially people of color. PrEP uptake has been persistently low among US women, particularly Black cisgender women, who account for 61% of new HIV diagnoses among cis women. Preliminary 2020 CDC data show only 9% (42,372) of the nearly 469,000 Black people who could benefit from PrEP received a prescription in 2020, and only 16% (48,838) of the nearly 313,000 Hispanic/Latino people who could benefit from PrEP received a prescription. Meanwhile, 66% of their White counterparts are utilizing PrEP. This emphasizes the continued unmet need for HIV prevention medication, especially among BIPOC.

Percentage of PrEP Uptake Among Americans Who Would Benefit from a Prescription While 25% of people eligible for PREP were prescibed it in 2020, coverage is not equal

Barriers to PrEP Faced by Communities Disproportionately Impacted by HIV

While African Americans only make up 13% of the U.S. population, they accounted for 42% of the 37,832 new HIV diagnoses in 2018, the highest rate among all racial and ethnic groups. Black women accounted for 57% of the new HIV diagnoses among women. Most new HIV diagnoses among women are attributed to heterosexual contact (84%) followed by injection drug use (16%). Black/African American cisgender women continue to be disproportionately affected by HIV. Challenges to successful PrEP implementation among ciswomen include lack of awareness, access to healthcare, insurance and out-of-pocket costs and low perceived risk.

Cisgender BIPOC women experience low PrEP uptake due to lack of awareness of the medication, access to healthcare, and low perceived risk yet this community makes up 42% of new HIV incidence.
An estimated 44% of Black transgender women and 26% of Hispanic/Latina transgender women are living with HIV compared of White transgender women. BIPOC transgender women face individual, interpersonal and structural-level barriers to successfull PrEP implementaton.

Transgender women—those who were assigned male at birth and who identity as female—are disproportionately affected by the HIV epidemic in the U.S. Between 2009 and 2014, an estimated 1,974 transgender women were diagnosed with HIV in the U.S., representing 84% of transgender people diagnosed. Racial and ethnic minority transgender women bear a higher burden of HIV compared to White transgender women. In the U.S., an estimated 44% of Black transgender women and 26% of Hispanic/Latina transgender women are living with HIV compared to 7% of White transgender women. Barriers to PrEP uptake among transgender women fall along multiple socio-ecological levels. Individual-level barriers may include low PrEP awareness and knowledge, past experiences of violence, uncertainty about health insurance coverage and associated health costs, concerns about side effects, possible hormone interactions, past negative healthcare experiences, and self-perception of being at low risk for HIV infection.

Some examples of interpersonal-level barriers include lack of support of cisgender male partners for PrEP, and medical mistrust due to experiences of transphobia. Structural-level barriers include lack of trans-inclusive PrEP marketing, lack of integration of PrEP services into feminizing hormone therapy (FHT) and gender affirming care, and social marginalization (lack of adequate employment and stable housing). Experiences of social marginalization because of gender, class, race, sexual identity, poverty, and the intersection of these identities and experiences may contribute to increased vulnerability to HIV infection among Black and Hispanic/Latina transgender women. Although several studies have investigated barriers and facilitators to PrEP uptake among transgender women, there is a dearth of research on multilevel barriers to PrEP uptake and adherence specifically among Black and Hispanic/Latinx transgender women.

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Barriers to PrEP Uptake in Trangender BiPOC Women
BMSM are the most affected by HIV and are diagnosed at a rate of 6 times higer than white MSM. Awareness and uptake of PrEP are the lowest in this commnity. Latino MSM is another group that is critically affected by HIV and accounts for 85% of all new HIV diagnoses amond Latino males

In the United States, Black men who have sex with men (BMSM) are the most affected by HIV and are diagnosed at a rate of 6.0 times higher than white MSM. Awareness and uptake of PrEP are lowest among this community. Latino MSM are another group that is critically affected by HIV and account for 85% of all new HIV diagnoses among Latino males. Like BMSM, barriers like cost and lack of insurance, concerns about side effects, societal or contextual factors such as racism and homophobia and HIV/AIDS conspiracy beliefs are barriers preventing Latino MSM from accessing PrEP.

Youth continue to be a population impacted by higher rates of HIV. In 2019, 21% of new HIV diagnoses were among young people aged 13-24, and most of these cases are among Black and Latino youth. PrEP uptake among racial and ethnic minority adolescents has been slow due to lack of awareness of PrEP, behavioral factors, and legal and financial barriers to adolescents seeking sexual and reproductive health care.

HIV incidence is increasing anound BIPOC youth due to lack of awareness around PrEP, behavioral factors, and legal financial barriers to adolescents seeking sexual and reproductive health care
American Indian and Alaska Native Communities are being left behind in many ways including having access to HIV prevention.

Indian/Alaska Native adults and adolescents increased. Access to PrEP and PEP in American Indian and Alaska Native (AI/AN) communities can be limited and there are cultural and historical considerations that impact Tribal communities’ ability to adopt PrEP, and social and systematic considerations that also present challenges.

According to the CDC, Asian Americans who make up only 6 percent of the U.S. population, make up 2 percent of all HIV infections. The CDC suggests this disparity is so great due to cultural factors, such as language barriers and immigration issues that create barriers to accessing healthcare (though this only addresses access to care for Asian immigrants, not Asian Americans who have lived in the U.S. for generations.) Low PrEP utilization rates among the Asian/Pacific Islander communities could be because of lack of awareness about the medication, misconceptions regarding its affordability, misinformation about its effects and fear of community stigma about sex.

Low PrEP uptake rates among Asian/Pacific Islander communities can be due to many factors including stigma, lack of awarenes and msconceptions
Among communities who use substances and experience homelessness, HIV incidence is high yet PrEP is largely underutilized. This population experiences competing health and survival needs and is vulnerable to many overlapping instersectionalities including lack of affordable housing, socioeconomic marginalization, and the opoid epidemic

HIV incidence is high among people who use drugs and are unhoused across the U.S. This is fueled by the opioid epidemic, lack of affordable housing, socioeconomic marginalization, and other complex factors. Despite this, PrEP is largely under-utilized among this vulnerable population.

Some of the low PrEP uptake can be attributed to practical barriers, such as competing health and survival needs, and medications being lost or stolen due to being unhoused and without a safe place to store medications. However, there is also a pervasive belief among clinicians that people who use drugs who are unhoused are not good candidates for PrEP. This idea is likely due to overlapping stigmas and isn’t supported by data.

According to California Department of Public Health Office of AIDS, Substance Use Community engagement efforts have linked methamphetamine use to increased risk for HIV infection and falling out of medical care. County-specific data on methamphetamine use is not easily accessible. This CDPH report on Ending the HIV Epidemic utilizes county-specific data on 1) amphetamine-related Emergency Department (ED) visits and 2) amphetamine-related deaths 2011-2018; all data obtained from the California Opioid Overdose Surveillance Dashboard. From 2011-2013, there was an overall increase of ED visits attributable to amphetamine use in Alameda County, from 5.01 visits/100,000 population in 2011, to 5.81/100,000 in 2013. Since 2013, ED visits steadily declined to a low of 1.7/100,000 in 2018. Deaths, on the other hand, fluctuated more widely, from a low of 1.18/100,000 in 2011 to a high of 4/100,000 in 2013.

However, in 2018, deaths attributable to amphetamine use spiked dramatically to a high of 8.26/100,000. This spike, coming as ED visits continued to decline, may reflect persons not seeking medical care for amphetamine overdose rather than decreased use. Not seeking medical care for amphetamine overdose could be secondary to a lack of access to medical care, fear of legal ramifications, or to unwitnessed overdose— the reasons are unclear from this data.

Why Are We Doing So Poorly?

National HIV screening recommendations place healthcare providers at the helm in the fight against HIV. While the goal of healthcare providers should be to ensure high quality HIV prevention for patients, their stigmatizing attitudes, beliefs, and behaviors toward vulnerable populations impede progress in identifying patients who would benefit from PrEP. Some of the assumptions that clinicians make about patients seeking PrEP accompany and may exacerbate systemic factors affecting PrEP uptake, like patients’ distrust, lack of access to care, and lack of awareness of PrEP. One of the key reasons cited for clinicians not prescribing PrEP is their assumption that patients will not be adherent to PrEP followed by assumptions that patients taking PrEP will increase their frequency of condomless sex or number of sexual partners.

Strategies for Healthcare Providers to Increase PrEP Uptake among BIPOC Communities.

What is Medical Mistrust?

Medical Mistrust is “an absence of trust that health care providers and organizations genuinely care for patients’ interests, are honest, practice confidentiality, and have the competence to produce the best possible results.”

The Origins of Medical Mistrust

Research indicates that Medical Mistrust is rooted in the history of mistreatment, discrimination, and abuse perpetrated against Black and brown bodies, sexual and gender diverse people, and other marginalized groups by both the State and the medical establishment. In addition, contemporary experiences of discrimination in health such as inequities in access to medical insurance, health care facilities, and treatments along with institutional practices that make it difficult for marginalized communities to access quality health care also play a significant role in shaping Medical Mistrust particularly among Black and other patients of color. Studies that have explored healthcare experiences among different populations have identified a significant association between race and medical mistrust such that Black Americans are significantly more likely than White Americans to mistrust healthcare personnel and the medical system as a whole.

10 Strategies to Address Medical Mistrust

The Impact of Medical Mistrust

  • Trust in health care among Americans has declined in recent decades
  • Mistrust may prevent people from seeking care
  • Black Americans are more likely than whites to say they do not trust their medical provider
  • People who say they mistrust health care organizations are less likely to take medical advice, keep follow-up appointments, or fill prescriptions
  • People who say they mistrust health care systems are more likely to report being in poor health

Talking with Patients about Medical Mistrust – How to Have Those Conversations

In the U.S., trust in the health care system is extremely low. Reversing medical mistrust is integral to building and strengthening patient-provider relationships. Health care professionals should assume patient mistrust and take the appropriate steps to address it.

Effective ways to communicate with patients about Medical Mistrust

  1. Openly discuss mistrust with patients
  2. Talk with, not at patients
  3. Partner with patients in making decisions about their health care

Medical mistrust has been identified as a primary driver of racial and ethnic inequities in health outcomes in the U.S. Among Black individuals, medical mistrust stems from experiences with discrimination in healthcare and is the result of persistent social inequity and structural racism, both contemporary and historical. Regarding PrEP use, several studies have identified medical mistrust as a barrier to uptake among Black individuals. Studies that have explored healthcare experiences among different populations have identified a significant association between race and medical mistrust such that Black Americans are significantly more likely than White Americans to mistrust healthcare personnel and the medical system as a whole.

Medical mistrust is a major barrier to a strong patient-clinician relationship. Patient mistrust in health care clinicians and in the health care system generally, negatively influences patient behavior and health outcomes.

Furthermore, the staff of healthcare organizations do not reflect the face of the communities they serve. Numerous studies have shown that increased provider diversity is associated with improved healthcare quality. Concordant care, defined as a patient and provider sharing a common attribute such as race, ethnicity, or gender, has been associated with improved quality of care. According to the Association of American Medical Colleges, only about 36% of active physicians are female, and only about 5% of physicians identify as Black or African-American, despite this group making up 13% of the U.S. population. Fewer than 6% of physicians identify as Hispanic, despite Hispanics making up about 19% of the U.S. population. However, 28% of physicians and surgeons in the United States are immigrants, with doctors from India and China making up the largest groups. This speaks to issues of systemic oppression: People from minority groups that have been oppressed for generations in the United States are less represented as physicians than are immigrants of color. There is a long history related to how we have gotten here. Since Abraham Flexner’s review of the American medical education system in 1910, it was believed that there was a limited role for Black physicians in the medical community and that Black physicians possessed less potential and ability than their White counterparts. The result of this characterization led to the closure of five of seven African American medical schools. The impact is still felt today.

HIV incidence is increasing anound BIPOC youth due to lack of awareness around PrEP, behavioral factors, and legal financial barriers to adolescents seeking sexual and reproductive health care

Social determinants of health, the conditions in environments where people live, drive inequities, HIV acquisition and the use of PrEP among BIPOC. These social determinants include, among others, economic stability, access to quality education, and access to quality healthcare.

The uptake of PrEP has been shown to be impacted by unmet social determinants of health (SDOH) needs. These include basic needs (e.g., food, shelter, water), health/social service needs (e.g., healthcare), and economic needs (e.g., money for savings). Socioeconomic factors identified to affect PrEP uptake included lack of insurance, difficult access to transportation, and inflexible work situations. Individuals with more unmet SDOH needs may have other priorities that divert their focus from obtaining preventative health services.

There are multiple socioeconomic factors to consider when looking at the barriers to PrEP uptake among disproportionately impacted communities at both the individual-level and structural-level barriers. Individual-level barriers to PrEP uptake include low PrEP awareness and knowledge, past experiences of violence, uncertainty about health insurance coverage and associated health costs, concerns about side effects, possible hormone interactions, past negative healthcare experiences, and self-perception of being at low risk for HIV infection.

What providers can do to improve PrEP utilization among BIPOC people?

  1. Prior to meeting your patient:
    • Check your bias and personal story: what baggage do you bring to the table?
    • Look at their chart to get a sense of who they are
    • Beware of microaggressions
      1. Don’t speak in generalities
      2. Don’t assume race/ethnicity
      3. Don’t assume gender/sexual identity
      4. Don’t assume pop culture references
      5. Condescension while being questioned
  1. What to bring to the patient interaction?
    • Any member of the care team (e.g., PrEP Navigator, Case Manager) can learn about the familial context and/or patient’s culture and share what they learn with the provider and/or providers can build rapport by expressing an interest in learning about these aspects of the patient's life as they get to know each other
    • Questions around culture
    • Familial Context
      1. Learn about the familial responsibilities of the patient
      2. Learn about the patient’s biological/chosen support system
      3. Ask about personal & familial experience with health insurance
      4. Ensure prescriptions are affordable within the patient’s budget
      5. Discuss ease of getting to your clinic
      6. Discuss ease of physically accessing referral care and/or pharmacies
    • Words Matter
      1. Providers can utilize a mutually agreed-upon opening script within the clinic about how to frame these questions. An example could be: "I'm interested in learning about how we can support you now or in the future" or "it's important to me to know if there are any issues that are coming up even if I can't help right away"
      2. It is not “dumbing-down” to speak to patients in a culturally-responsive manner
      3. If you do not speak their vernacular, learn
      4. If you misspeak & offend, apologize
      5. Watch for “Why” questions: instead of asking “Why do you want to take PrEP?” or “why don’t you use condoms,” you can ask “Tell me about what makes you want to take PrEP” or “Tell me about how you make decisions about condoms”
      6. Do not ask: “Do you understand?”
      7. Ask: “Please tell me what you think I said. It is important that we are on the same page.”
    • Support Resilience
      1. It is important to “reframe the misconception to see [Black LGBTQ people] as “at risk” and instead see them as “at promise” for a future of good health and well-being anchored in their own resilience and supported by our abilities as staff, providers, and institutions to provide services to contribute to their resilience.”
        1. Consider exploring strengths and coping strategies by asking: What do you love about yourself? What has helped you to keep going even when times are hard? How can I best help you as you start PrEP?
    • Care to Treatment
      1. Take time to address fears about a particular drug, pharmaceutical company, or the healthcare industrial complex. Take care not to argue a point, but rather to hear their perspective/concerns, then ask for permission to share additional information or your experience as a clinician, if appropriate.
      2. Storytelling of other patients’ experiences with medication is key for trust
      3. Share personal experience when appropriate, this is critical when recommending preventative care
      4. Be transparent if you or your clinic have been involved with any clinical trials or are receiving funding from pharmaceutical companies
  1. Create a safe & welcoming clinic
    • Staff Diversity
      1. Actively engage clinic leadership to champion Diversity, Equity, Inclusion and Anti-Racism efforts.
      2. Hire and retain staff that reflect the patient population, especially clinicians
      3. Encourage clinic leadership (including Human Resources) to adopt workplace policies, procedures, and compensation rates that foster retention of a culturally concordant workforce.
      4. Speak with staff and conduct quarterly trainings on cultural responsiveness.
    • Have inclusive imagery and signs visible.
    • Have BIPOC-centric brochures & magazines in waiting areas
    • Post a Diversity & Inclusion statement in a conspicuous location
  1. Bringing them back to care
    • Before the patient leaves the visit:
      1. Confirm the best form of future contact
      2. If you have a portal, make sure that it is on their mobile phone
      3. Ask them to send you a Test Message
      4. Introduce them to the person(s) who may follow-up
    • Patients, clients, customers may come once, but maybe not again
    • Look at your client-level data and see if your BIPOC clients are coming back for their appointments
    • It’s probably not them … It may just be you (and/or your staff)
      1. Conduct an anonymous survey of patients
      2. Be committed to receiving feedback and change
      3. Reiterate that you are committed to their success
      4. Ask for a verbal report card before the patient leaves

Address Social Determinants of Health whenever possible. One of the findings in a PrEP navigation study highlights the benefit of offering clinical and non-clinical PrEP services to clients in one place which facilitates clients’ access to PrEP services. A co-located approach can ameliorate barriers such as time constraints, PrEP cost and lack of insurance, and low/limited income. This is particularly important when there is a low PrEP uptake among racial and gender minorities who are disproportionately affected by HIV.

  • Hire a PrEP Navigator or train community health workers in PrEP Navigation
  • Partner with eligibility workers to optimize insurance coverage
  • Support with transportation benefits
  • Connect to food and housing resources
  • Connect to benefits/social services providers
  • Follow up on any issues related to medication or care related costs or delays

Make PrEP easier to talk about:

  • Talk about PrEP with everyone.
  • Mention PrEP with every HIV test order/result universally.
  • Make PrEP easier for patients to get:
    • Stock generic PrEP and use it as first line agent (cost-effective).
    • Offer tele-prep follow-up as an option.
    • Do not withhold next prescriptions due to missed appointment (as long as the HIV test is complete and negative).

Offer options:

  • Consider offering a 1-month follow-up if the patient is ambivalent or unsure about adherence (before extending to every 3 month visits).
  • Honor choice: Continue to offer all tools in the HIV prevention toolkit even if it’s not the provider’s preference.
  • If patient is not ready for sexual history discussion on first visit, that’s ok. Revisit this discussion at next appointment or when rapport is built.

Barriers to PrEP Faced by Communities Disproportionately Impacted by HIV

While African Americans only make up 13% of the U.S. population, they accounted for 42% of the 37,832 new HIV diagnoses in 2018, the highest rate among all racial and ethnic groups. Black women accounted for 57% of the new HIV diagnoses among women. Most new HIV diagnoses among women are attributed to heterosexual contact (84%) followed by injection drug use (16%). Black/African American cisgender women continue to be disproportionately affected by HIV. Challenges to successful PrEP implementation among ciswomen include lack of awareness, access to healthcare, insurance and out-of-pocket costs and low perceived risk.

Cisgender BIPOC women experience low PrEP uptake due to lack of awareness of the medication, access to healthcare, and low perceived risk yet this community makes up 42% of new HIV incidence.
An estimated 44% of Black transgender women and 26% of Hispanic/Latina transgender women are living with HIV compared of White transgender women. BIPOC transgender women face individual, interpersonal and structural-level barriers to successfull PrEP implementaton.

Transgender women—those who were assigned male at birth and who identity as female—are disproportionately affected by the HIV epidemic in the U.S. Between 2009 and 2014, an estimated 1,974 transgender women were diagnosed with HIV in the U.S., representing 84% of transgender people diagnosed. Racial and ethnic minority transgender women bear a higher burden of HIV compared to White transgender women. In the U.S., an estimated 44% of Black transgender women and 26% of Hispanic/Latina transgender women are living with HIV compared to 7% of White transgender women. Barriers to PrEP uptake among transgender women fall along multiple socio-ecological levels. Individual-level barriers may include low PrEP awareness and knowledge, past experiences of violence, uncertainty about health insurance coverage and associated health costs, concerns about side effects, possible hormone interactions, past negative healthcare experiences, and self-perception of being at low risk for HIV infection.

Some examples of interpersonal-level barriers include lack of support of cisgender male partners for PrEP, and medical mistrust due to experiences of transphobia. Structural-level barriers include lack of trans-inclusive PrEP marketing, lack of integration of PrEP services into feminizing hormone therapy (FHT) and gender affirming care, and social marginalization (lack of adequate employment and stable housing). Experiences of social marginalization because of gender, class, race, sexual identity, poverty, and the intersection of these identities and experiences may contribute to increased vulnerability to HIV infection among Black and Hispanic/Latina transgender women. Although several studies have investigated barriers and facilitators to PrEP uptake among transgender women, there is a dearth of research on multilevel barriers to PrEP uptake and adherence specifically among Black and Hispanic/Latinx transgender women.

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Barriers to PrEP Uptake in Trangender BiPOC Women
BMSM are the most affected by HIV and are diagnosed at a rate of 6 times higer than white MSM. Awareness and uptake of PrEP are the lowest in this commnity. Latino MSM is another group that is critically affected by HIV and accounts for 85% of all new HIV diagnoses amond Latino males

In the United States, Black men who have sex with men (BMSM) are the most affected by HIV and are diagnosed at a rate of 6.0 times higher than white MSM. Awareness and uptake of PrEP are lowest among this community. Latino MSM are another group that is critically affected by HIV and account for 85% of all new HIV diagnoses among Latino males. Like BMSM, barriers like cost and lack of insurance, concerns about side effects, societal or contextual factors such as racism and homophobia and HIV/AIDS conspiracy beliefs are barriers preventing Latino MSM from accessing PrEP.

Youth continue to be a population impacted by higher rates of HIV. In 2019, 21% of new HIV diagnoses were among young people aged 13-24, and most of these cases are among Black and Latino youth. PrEP uptake among racial and ethnic minority adolescents has been slow due to lack of awareness of PrEP, behavioral factors, and legal and financial barriers to adolescents seeking sexual and reproductive health care.

HIV incidence is increasing anound BIPOC youth due to lack of awareness around PrEP, behavioral factors, and legal financial barriers to adolescents seeking sexual and reproductive health care
American Indian and Alaska Native Communities are being left behind in many ways including having access to HIV prevention.

Indian/Alaska Native adults and adolescents increased. Access to PrEP and PEP in American Indian and Alaska Native (AI/AN) communities can be limited and there are cultural and historical considerations that impact Tribal communities’ ability to adopt PrEP, and social and systematic considerations that also present challenges.

According to the CDC, Asian Americans who make up only 6 percent of the U.S. population, make up 2 percent of all HIV infections. The CDC suggests this disparity is so great due to cultural factors, such as language barriers and immigration issues that create barriers to accessing healthcare (though this only addresses access to care for Asian immigrants, not Asian Americans who have lived in the U.S. for generations.) Low PrEP utilization rates among the Asian/Pacific Islander communities could be because of lack of awareness about the medication, misconceptions regarding its affordability, misinformation about its effects and fear of community stigma about sex.

Low PrEP uptake rates among Asian/Pacific Islander communities can be due to many factors including stigma, lack of awarenes and msconceptions
Among communities who use substances and experience homelessness, HIV incidence is high yet PrEP is largely underutilized. This population experiences competing health and survival needs and is vulnerable to many overlapping instersectionalities including lack of affordable housing, socioeconomic marginalization, and the opoid epidemic

HIV incidence is high among people who use drugs and are unhoused across the U.S. This is fueled by the opioid epidemic, lack of affordable housing, socioeconomic marginalization, and other complex factors. Despite this, PrEP is largely under-utilized among this vulnerable population.

Some of the low PrEP uptake can be attributed to practical barriers, such as competing health and survival needs, and medications being lost or stolen due to being unhoused and without a safe place to store medications. However, there is also a pervasive belief among clinicians that people who use drugs who are unhoused are not good candidates for PrEP. This idea is likely due to overlapping stigmas and isn’t supported by data.

According to California Department of Public Health Office of AIDS, Substance Use Community engagement efforts have linked methamphetamine use to increased risk for HIV infection and falling out of medical care. County-specific data on methamphetamine use is not easily accessible. This CDPH report on Ending the HIV Epidemic utilizes county-specific data on 1) amphetamine-related Emergency Department (ED) visits and 2) amphetamine-related deaths 2011-2018; all data obtained from the California Opioid Overdose Surveillance Dashboard. From 2011-2013, there was an overall increase of ED visits attributable to amphetamine use in Alameda County, from 5.01 visits/100,000 population in 2011, to 5.81/100,000 in 2013. Since 2013, ED visits steadily declined to a low of 1.7/100,000 in 2018. Deaths, on the other hand, fluctuated more widely, from a low of 1.18/100,000 in 2011 to a high of 4/100,000 in 2013.

However, in 2018, deaths attributable to amphetamine use spiked dramatically to a high of 8.26/100,000. This spike, coming as ED visits continued to decline, may reflect persons not seeking medical care for amphetamine overdose rather than decreased use. Not seeking medical care for amphetamine overdose could be secondary to a lack of access to medical care, fear of legal ramifications, or to unwitnessed overdose— the reasons are unclear from this data.

Why Are We Doing So Poorly?

National HIV screening recommendations place healthcare providers at the helm in the fight against HIV. While the goal of healthcare providers should be to ensure high quality HIV prevention for patients, their stigmatizing attitudes, beliefs, and behaviors toward vulnerable populations impede progress in identifying patients who would benefit from PrEP. Some of the assumptions that clinicians make about patients seeking PrEP accompany and may exacerbate systemic factors affecting PrEP uptake, like patients’ distrust, lack of access to care, and lack of awareness of PrEP. One of the key reasons cited for clinicians not prescribing PrEP is their assumption that patients will not be adherent to PrEP followed by assumptions that patients taking PrEP will increase their frequency of condomless sex or number of sexual partners.

Strategies for Healthcare Providers to Increase PrEP Uptake among BIPOC Communities.

What is Medical Mistrust?

Medical Mistrust is “an absence of trust that health care providers and organizations genuinely care for patients’ interests, are honest, practice confidentiality, and have the competence to produce the best possible results.”

The Origins of Medical Mistrust

Research indicates that Medical Mistrust is rooted in the history of mistreatment, discrimination, and abuse perpetrated against Black and brown bodies, sexual and gender diverse people, and other marginalized groups by both the State and the medical establishment. In addition, contemporary experiences of discrimination in health such as inequities in access to medical insurance, health care facilities, and treatments along with institutional practices that make it difficult for marginalized communities to access quality health care also play a significant role in shaping Medical Mistrust particularly among Black and other patients of color. Studies that have explored healthcare experiences among different populations have identified a significant association between race and medical mistrust such that Black Americans are significantly more likely than White Americans to mistrust healthcare personnel and the medical system as a whole.

10 Strategies to Address Medical Mistrust

The Impact of Medical Mistrust

  • Trust in health care among Americans has declined in recent decades
  • Mistrust may prevent people from seeking care
  • Black Americans are more likely than whites to say they do not trust their medical provider
  • People who say they mistrust health care organizations are less likely to take medical advice, keep follow-up appointments, or fill prescriptions
  • People who say they mistrust health care systems are more likely to report being in poor health

Talking with Patients about Medical Mistrust – How to Have Those Conversations

In the U.S., trust in the health care system is extremely low. Reversing medical mistrust is integral to building and strengthening patient-provider relationships. Health care professionals should assume patient mistrust and take the appropriate steps to address it.

Effective ways to communicate with patients about Medical Mistrust

  1. Openly discuss mistrust with patients
  2. Talk with, not at patients
  3. Partner with patients in making decisions about their health care

Medical mistrust has been identified as a primary driver of racial and ethnic inequities in health outcomes in the U.S. Among Black individuals, medical mistrust stems from experiences with discrimination in healthcare and is the result of persistent social inequity and structural racism, both contemporary and historical. Regarding PrEP use, several studies have identified medical mistrust as a barrier to uptake among Black individuals. Studies that have explored healthcare experiences among different populations have identified a significant association between race and medical mistrust such that Black Americans are significantly more likely than White Americans to mistrust healthcare personnel and the medical system as a whole.

Medical mistrust is a major barrier to a strong patient-clinician relationship. Patient mistrust in health care clinicians and in the health care system generally, negatively influences patient behavior and health outcomes.

Furthermore, the staff of healthcare organizations do not reflect the face of the communities they serve. Numerous studies have shown that increased provider diversity is associated with improved healthcare quality. Concordant care, defined as a patient and provider sharing a common attribute such as race, ethnicity, or gender, has been associated with improved quality of care. According to the Association of American Medical Colleges, only about 36% of active physicians are female, and only about 5% of physicians identify as Black or African-American, despite this group making up 13% of the U.S. population. Fewer than 6% of physicians identify as Hispanic, despite Hispanics making up about 19% of the U.S. population. However, 28% of physicians and surgeons in the United States are immigrants, with doctors from India and China making up the largest groups. This speaks to issues of systemic oppression: People from minority groups that have been oppressed for generations in the United States are less represented as physicians than are immigrants of color. There is a long history related to how we have gotten here. Since Abraham Flexner’s review of the American medical education system in 1910, it was believed that there was a limited role for Black physicians in the medical community and that Black physicians possessed less potential and ability than their White counterparts. The result of this characterization led to the closure of five of seven African American medical schools. The impact is still felt today.

HIV incidence is increasing anound BIPOC youth due to lack of awareness around PrEP, behavioral factors, and legal financial barriers to adolescents seeking sexual and reproductive health care

Social determinants of health, the conditions in environments where people live, drive inequities, HIV acquisition and the use of PrEP among BIPOC. These social determinants include, among others, economic stability, access to quality education, and access to quality healthcare.

The uptake of PrEP has been shown to be impacted by unmet social determinants of health (SDOH) needs. These include basic needs (e.g., food, shelter, water), health/social service needs (e.g., healthcare), and economic needs (e.g., money for savings). Socioeconomic factors identified to affect PrEP uptake included lack of insurance, difficult access to transportation, and inflexible work situations. Individuals with more unmet SDOH needs may have other priorities that divert their focus from obtaining preventative health services.

There are multiple socioeconomic factors to consider when looking at the barriers to PrEP uptake among disproportionately impacted communities at both the individual-level and structural-level barriers. Individual-level barriers to PrEP uptake include low PrEP awareness and knowledge, past experiences of violence, uncertainty about health insurance coverage and associated health costs, concerns about side effects, possible hormone interactions, past negative healthcare experiences, and self-perception of being at low risk for HIV infection.

What Providers Can Do To Improve PrEP Utilization Among BIPOC People?

  1. Prior to meeting your patient:
    • Check your bias and personal story: what baggage do you bring to the table?
    • Look at their chart to get a sense of who they are
    • Beware of microaggressions
      1. Don’t speak in generalities
      2. Don’t assume race/ethnicity
      3. Don’t assume gender/sexual identity
      4. Don’t assume pop culture references
      5. Condescension while being questioned
  1. What to bring to the patient interaction?
    • Any member of the care team (e.g., PrEP Navigator, Case Manager) can learn about the familial context and/or patient’s culture and share what they learn with the provider and/or providers can build rapport by expressing an interest in learning about these aspects of the patient's life as they get to know each other
    • Questions around culture
    • Familial Context
      1. Learn about the familial responsibilities of the patient
      2. Learn about the patient’s biological/chosen support system
      3. Ask about personal & familial experience with health insurance
      4. Ensure prescriptions are affordable within the patient’s budget
      5. Discuss ease of getting to your clinic
      6. Discuss ease of physically accessing referral care and/or pharmacies
    • Words Matter
      1. Providers can utilize a mutually agreed-upon opening script within the clinic about how to frame these questions. An example could be: "I'm interested in learning about how we can support you now or in the future" or "it's important to me to know if there are any issues that are coming up even if I can't help right away"
      2. It is not “dumbing-down” to speak to patients in a culturally-responsive manner
      3. If you do not speak their vernacular, learn
      4. If you misspeak & offend, apologize
      5. Watch for “Why” questions: instead of asking “Why do you want to take PrEP?” or “why don’t you use condoms,” you can ask “Tell me about what makes you want to take PrEP” or “Tell me about how you make decisions about condoms”
      6. Do not ask: “Do you understand?”
      7. Ask: “Please tell me what you think I said. It is important that we are on the same page.”
    • Support Resilience
      1. It is important to “reframe the misconception to see [Black LGBTQ people] as “at risk” and instead see them as “at promise” for a future of good health and well-being anchored in their own resilience and supported by our abilities as staff, providers, and institutions to provide services to contribute to their resilience.”
        1. Consider exploring strengths and coping strategies by asking: What do you love about yourself? What has helped you to keep going even when times are hard? How can I best help you as you start PrEP?
    • Care to Treatment
      1. Take time to address fears about a particular drug, pharmaceutical company, or the healthcare industrial complex. Take care not to argue a point, but rather to hear their perspective/concerns, then ask for permission to share additional information or your experience as a clinician, if appropriate.
      2. Storytelling of other patients’ experiences with medication is key for trust
      3. Share personal experience when appropriate, this is critical when recommending preventative care
      4. Be transparent if you or your clinic have been involved with any clinical trials or are receiving funding from pharmaceutical companies
  1. Create a safe & welcoming clinic
    • Staff Diversity
      1. Actively engage clinic leadership to champion Diversity, Equity, Inclusion and Anti-Racism efforts.
      2. Hire and retain staff that reflect the patient population, especially clinicians
      3. Encourage clinic leadership (including Human Resources) to adopt workplace policies, procedures, and compensation rates that foster retention of a culturally concordant workforce.
      4. Speak with staff and conduct quarterly trainings on cultural responsiveness.
    • Have inclusive imagery and signs visible.
    • Have BIPOC-centric brochures & magazines in waiting areas
    • Post a Diversity & Inclusion statement in a conspicuous location
  1. Bringing them back to care
    • Before the patient leaves the visit:
      1. Confirm the best form of future contact
      2. If you have a portal, make sure that it is on their mobile phone
      3. Ask them to send you a Test Message
      4. Introduce them to the person(s) who may follow-up
    • Patients, clients, customers may come once, but maybe not again
    • Look at your client-level data and see if your BIPOC clients are coming back for their appointments
    • It’s probably not them … It may just be you (and/or your staff)
      1. Conduct an anonymous survey of patients
      2. Be committed to receiving feedback and change
      3. Reiterate that you are committed to their success
      4. Ask for a verbal report card before the patient leaves

Address Social Determinants of Health whenever possible. One of the findings in a PrEP navigation study highlights the benefit of offering clinical and non-clinical PrEP services to clients in one place which facilitates clients’ access to PrEP services. A co-located approach can ameliorate barriers such as time constraints, PrEP cost and lack of insurance, and low/limited income. This is particularly important when there is a low PrEP uptake among racial and gender minorities who are disproportionately affected by HIV.

  • Hire a PrEP Navigator or train community health workers in PrEP Navigation
  • Partner with eligibility workers to optimize insurance coverage
  • Support with transportation benefits
  • Connect to food and housing resources
  • Connect to benefits/social services providers
  • Follow up on any issues related to medication or care related costs or delays

Make PrEP easier to talk about:

  • Talk about PrEP with everyone.
  • Mention PrEP with every HIV test order/result universally.
  • Make PrEP easier for patients to get:
    • Stock generic PrEP and use it as first line agent (cost-effective).
    • Offer tele-prep follow-up as an option.
    • Do not withhold next prescriptions due to missed appointment (as long as the HIV test is complete and negative).

Offer options:

  • Consider offering a 1-month follow-up if the patient is ambivalent or unsure about adherence (before extending to every 3 month visits).
  • Honor choice: Continue to offer all tools in the HIV prevention toolkit even if it’s not the provider’s preference.
  • If patient is not ready for sexual history discussion on first visit, that’s ok. Revisit this discussion at next appointment or when rapport is built.

PrEP Background

Section 3We will begin reviewing PrEP by introducing the different medications that are available and covering their effectiveness. Echoing some of the trends that were mentioned under HIV epidemiology, this section will also work to highlight the inequities in PrEP delivery and how we can work to improve them.


Medications Available

PrEP encompasses a group of medications meant to be taken by someone who is HIV negative to prevent acquiring an HIV infection.

PRE = Before

EXPOSURE = Coming into potential contact with HIV

PROPHYLAXIS = Treatment to prevent an infection

There are three different medications available for PrEP. Brand names are provided in bold.

  1. Emtricitabine 200mg & tenofovir disoproxil fumarate 300mg (F/TDF). Truvada
    • - Oral tablet approved for PrEP use in July 2012
  2. Emtricitabine 200mg & tenofovir alafenamide 25mg (F/TAF). Descovy
    • - Oral tablet approved for PrEP use in October 2019
  3. Cabotegravir 600mg in 3mL (CAB). Apretude
    • - Intramuscular injection approved for PrEP use in December 2021
    • - Cabotegravir 30mg is also available in an oral form called Vocabria. There is an optional oral lead-in for 30 days before starting the injectable form.

Effectiveness

The majority of existing PrEP studies have focused on the use of oral F/TDF (Truvada) to prevent sexual transmission of HIV in both assigned sexes (AMAB & AFAB), regardless of sexual orientation. (9)

To date, only one study has specifically investigated the efficacy of tenofovir disoproxil fumarate among people who inject drugs (PWIDs). (10)  Like all medications, it was determined early on that the effectiveness of PrEP varies greatly with adherence.

These initial landmark trials established that with daily adherence…

 F/TDF (Truvada) reduces the risk of acquiring HIV through sex by 99% and through IVDU by 74%.

The DISCOVER trial compared F/TDF (Truvada) directly to F/TAF (Descovy). This study only included MSM/TGWSM. It was concluded that F/TAF (Descovy) is non-inferior to F/TDF (Truvada) in preventing sexual transmission among this select patient population. (11)

The HIV Prevention Trials Network (HPTN) 083 and 084 were then performed in similar fashion and concluded that cabotegravir (Apretude) is superior to F/TDF (Truvada) in MSM/TGWSM and cisgender women, respectively. (12)

It is worth mentioning that the superiority of cabotegravir is primarily derived from improved patient adherence as it does not rely on the need for daily ingestion. Subset analysis does show that effectiveness was similar when F/TDF (Truvada) levels indicated proper adherence. Biochemically, they are essentially equivalent.

There has also been mounting interest and investigation of event-driven PrEP (ED-PrEP), also known as on-demand, non-daily, intermittent, or 2-1-1 PrEP. Rather than daily ingestion, ED-PrEP is a method where PrEP is taken shortly before sex and then the following two days.

ED-PrEP has only been studied using F/TDF (Truvada) to prevent the sexual acquisition of HIV among men who have sex with men (MSM). Existing studies have found that ED-PrEP is non-inferior to daily intake. (13)  This type of use is not currently FDA approved in the U.S. though according to the latest CDC Guidelines, it may be considered in select patients. (14)

  Take Home Points


There are many nuances to what was just discussed, which will be further detailed in the coming sections. For now, the key take-home point is that ALL forms of PrEP are highly effective in preventing HIV infections and should, at the very least, be mentioned to your patients.

Important PrEP Epidemiology

As alluded to in the initial section on HIV epidemiology, reductions in HIV incidence have not been favorable among the most critical patient populations.

Black and Latino patients make up the lionshare of new HIV cases every year yet, account for a small proportion of PrEP use (Figure 11).

Females account for nearly a fifth of new HIV infections but make up a meager 8% of all PrEP prescriptions (Figure 12).

By region, the South accounts for the majority of new HIV infections every year but PrEP use is limited to 39% of all active prescriptions (Figure 13).

Taken altogether, we now understand that PrEP is highly efficacious though its impact on public health measures has been rather restricted. It is no coincidence that the inequalities we see in PrEP care reflect the same patterns we see in so many other aspects of society.

Now, more than ever before, we must work together to improve these injustices to allow the potential of PrEP to take hold. Whether you are a general provider with no prior experience or a seasoned veteran in infectious diseases, the following sections will work to improve your comfort and delivery of PrEP care, especially to those who need it most.

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Click the title of the figure to view source.

Figure 11

Figure 11 - Percentage of PrEP use in 2021 and HIV incidence in 2020 by Race

Figure 12

Figure 12 - Percentage of PrEP use by sex, 2021.

Click for full size view

Figure 13

Figure 13 - PrEP Use in the Southern Region of the U.S., 2021.

Patient Eligibility

section 4This section will cover who is eligible for PrEP by reviewing the indications and contraindications. There are also several situations and important considerations that must be discussed in order to safely provide PrEP. Although this section will introduce some technical topics that can create further confusion, do not be deterred as they occur infrequently and useful resources exist to help guide you through them.

Indications

The CDC published the latest national guideline for PrEP in December 2021. It includes several tables that detail all of the patient indications for PrEP use which can be found here.

The following table summarizes this information with minor modifications to improve simplicity and includes certain details that were omitted.

Indications for Pre-Exposure Prophylaxis

PrEP is indicated if ALL of the following applies:

  • Is ≥12 years old
  • Weighs ≥35kg (77 lbs)
  • Has had a negative HIV test within the last week1
  • And ONE of the following risk factors in the past 6 months

Risk Factors:

  • High-risk sex2 with a partner(s) of unknown HIV status
  • Sex with an HIV+ partner
  • Diagnosed and/or treated for a STI4
  • Share injection drug equipment with partner(s) of unknown HIV status5
  • Requested and/or utilized non-occupational post-exposure prophylaxis (nPEP)
  • Requesting PrEP without disclosing further details

Indications for Specific Therapies:

  • F/TDF (Truvada) - eCrCl ≥ 60ml/min6
  • F/TAF (Descovy) - MSM/TGWSM only, eCrCl ≥ 30ml/min
  • CAB (Apretude) - no eCrCl cutoff

Footnotes

  1. Lab-based 4th-gen HIV Ab/Ag test OR a POC HIV Ag/Ab test (Abbott Determine).
    Oral fluid tests or HIV-Ab only POC tests are not recommended. Additional HIV-RNA testing is recommended if the patient has been on oral PrEP/PEP in the past 3 months or injectable PrEP in the past year.
  2. High risk sex: inconsistent condom use, anal sex, transactional sex, or sex+substance abuse with partner(s) of unknown HIV status.
  3. HIV+ partners with viral loads consistently <200 copies/mL for ≥6 consecutive months pose a negligible risk of sexually transmitting HIV. U=U: (15) undetectable = untransmittable
  4. Chlamydia, gonorrhea, syphilis, genital herpes (16), bacterial vaginosis (17),  trichomoniasis. (18).
  5. U=U has not been proven in HIV transmission that occurs through IV drug use
  6. eCrCl: estimated creatinine clearance. Calculated using the Cockcroft-Gault Equation
Table 1. Indications to utilize PrEP

Contraindications

Contraindications for Pre-Exposure Prophylaxis

PrEP is not indicated if ANY of the following applies:

  • Is <12 years old
  • Weighs <35 kg (77 lbs)
  • Does not meet the required eCrCl cutoffs1
  • Takes severely contraindicated drugs2
  • Has an indication for HIV post-exposure prophylaxis (PEP)3
  • HIV+ or HIV unknown4
  • High clinical suspicion for acute HIV infection5
  • Injectable CAB (Apretude) cannot be used in those with buttock implants or fillers

Footnotes

  1. F/TDF (Truvada): eCrCl must be ≥ 60ml/min
    F/TAF (Descovy): eCrCl must be ≥ 30ml/min
  2. F/TDF (Truvada): adefovir
    F/TAF (Descovy): St. John’s Wort, rifampin, rifabutin, rifapentine
    CAB (Apretude): rifampicin, rifapentine, carbamazepine, oxcarbazepine, phenytoin, phenobarbital
  3. Substantial risk of HIV acquisition in the past 72 hours
  4. Requires a negative lab-based 4th-gen HIV Ag/Ab test OR POC HIV Ag/Ab test (Abbott Determine).
    If the patient has been on oral PrEP/PEP in the past 3 months or injectable PrEP in the past year, also needs a negative HIV-RNA test in the past week.
    Oral fluid tests or HIV-Ab only POC tests are not recommended.
  5. Substantial HIV-exposure event AND symptoms of ARS unexplained by a more likely diagnosis in the past 4 weeks
Table 2. Contraindications to utilize PrEP

Careful Considerations

Non-occupational postexposure prophylaxis (nPEP)

Postexposure prophylaxis (PEP) refers to the use of antiretroviral medications (ARVs) to prevent HIV acquisition when there was potential exposure in the past 72 hours.

There are two forms of PEP based on the setting where the exposure event occurred. It is termed occupational PEP (oPEP) if the exposure occurred among healthcare personnel in a healthcare setting and non-occupational PEP (nPEP) for all other scenarios.

The following algorithm adopted from the National HIV Curriculum website was created using the 2016 CDC guidelines for nPEP (Figure 14). (19)

The first determination that needs to be made is the level of risk for HIV acquisition. Substantial risk is defined as direct exposure of mucosal sites or the bloodstream (non-intact skin or percutaneous) with specific bodily fluids (blood, genital fluids, or breastmilk) when the source patient is HIV+.

This is a good start though it requires you to know the HIV-status of the source patient, a detail typically unknown in cases that occur outside of medical settings. It also disregards the latest evidence of U=U. (15) The risk may be negligible if the event was sexual contact with an HIV+ source who has had undetectable viral levels for more than six consecutive months.

Click image for full size view

Click the title of the figure to view source.

Figure 14

Figure 14 - Algorithm for use of non-occupational post-exposure prophylaxis (nPEP)

Table 3 - Available Methods of Emergency Contraception

In most cases, the substantial risk is hard to determine; thus, we must rely on our knowledge of HIV transmission probability (Figure 1) and other related factors (risk calculator).

Patients placed on nPEP should be asked if they would like to transition to PrEP after completion of the 28-day course. HIV-RNA and HIV-Ag/Ab should be collected during the last week of nPEP, and if they are both negative, patients can be switched to PrEP.

This can be a daunting and confusing “gray” area, which is why the National Clinician Consultation Center also has a dedicated hotline for nPEP questions.

(888) 448-4911 9am-8pm. Eastern Time Monday – Friday,
11am – 8pm. Eastern Time on weekends & holidays.
For further information, refer to the National HIV Curriculum website and the AETC’s nPEP toolkit.

One final note. The timing of nPEP roughly coincides with the timing of emergency contraception (EC). This critical component of care should be incorporated into the discussion when applicable. ACOG Guidelines on EC.

Suspicion for HIV Acquisition During the Inter-test Reactivity Interval (ITRI)

As previously discussed, the early stages of HIV infection pose many challenges for our laboratory and clinical approaches. In particular, the ITRI, which is the narrow time period when HIV-RNA is positive, but the HIV-Ag/Ab test is negative.

Click the image to open table in new window

Table 4 - Deferring PrEP Initiation Due to Clinical Concern of Acute HIV Infection

Current guidelines suggest...

PrEP should be deferred until HIV-RNA test results are obtained if, in the past four weeks, the patient had potential exposure to HIV AND experienced symptoms of the acute retroviral syndrome (ARS). (20)

Now, there are some underlying subtleties to this approach. First, as we now know, “potential exposures” can range widely in their risk of HIV transmission. For example, penile-vaginal sex with a condom poses a much lower risk than unprotected receptive anal intercourse.

For PrEP, there is no consensus as to where the threshold falls for what is considered a substantial risk. However, some parallels can be drawn to nPEP.

Second, given that ARS symptoms are inconsistent and obscure, we must consider the likelihood of other conditions. Perhaps, the patient with fever and fatigue was recently diagnosed with COVID-19. Delaying PrEP initiation would not be appropriate in this setting. Similar to the Well’s criteria for DVT and PE that asks if an alternative diagnosis is more likely, we suggest using other contextual factors to help make this decision.

A slight revision using these points of clarification would be…

PrEP should be deferred until HIV-RNA test results are obtained if, in the past four weeks, the patient had potential exposure to HIV with substantial risk AND experienced symptoms of the acute retroviral syndrome (ARS), unexplained by a more probable cause.

If the patient meets this suggested criteria, HIV-RNA and HIV-Ab/Ag should be collected and results reviewed prior to starting PrEP.

Again, utilize the National Clinicians Consultation Center hotline if you are ever in need of support.

(888) 448-4911 9am-8pm. Eastern Time Monday – Friday,
11am – 8pm. Eastern Time on weekends & holidays.

For further information, refer to the National HIV Curriculum website and the AETC’s nPEP toolkit.

Delayed Seroconversion

All of the medications in all three formulations of PrEP have activity against the HIV virus. They each require a certain level of concentration to ensure adequate protection. Since PrEP is a medication that relies heavily on patient adherence, there have been a few documented HIV infections that occurred during PrEP use. When drug levels fall below this critical threshold, HIV can permanently establish itself as a new infection. The residual amounts of PrEP medication that were inadequate in preventing infection go on to suppress the virus partially.

This partial suppression can sometimes delay the body’s natural immune response of creating antibodies. This phenomenon, called delayed seroconversion, can prolong the window period of HIV-Ag/Ab tests and thus, the ITRI.

The average time of delayed seroconversion for oral PrEP (F/TDF and F/TAF) is about 30 days (range 7-68 days) and for injectable PrEP (CAB), 80 days (range 35-185). (21)   Because of this, there are minor changes for the lab recommendations when a patient was recently on PrEP.

Other Considerations

Although they are not strong contraindications, the following details warrant careful consideration before initiating PrEP. Please do not let the details of this section deter you from discussing and providing PrEP with your patients. These intricate aspects of PrEP are included to fine-tune your understanding and address some common questions that may arise.

Pregnancy and breastfeeding

There is an increased risk of acquiring HIV during periods of conception, pregnancy, and breastfeeding. (22). F/TDF (Truvada) is the recommended agent for this patient population; it does not cause any adverse pregnancy outcomes. The effects on infants exposed to F/TDF during lactation have not been well studied though existing studies suggest very limited drug exposure. (23)

Further investigation is needed for F/TAF (Descovy) and CAB (Apretude) in this patient population. Existing data among HIV+ women taking these agents for HIV treatment does show favorable safety profiles. Use of these agents as PrEP may be considered if there is a shared and informed decision that the risks outweigh the benefits.

Information should be anonymously submitted if any form of PrEP is used during pregnancy at http://www.apregistry.com/

Disorders that affect bone mineral density (BMD)

Both F/TDF (Truvada) and F/TAF are known to lower BMD. Although F/TDF (Truvada) is often cited as the more “toxic” agent on bone health when compared to F/TAF (Descovy), all existing studies have found only small and clinically insignificant impacts on BMD. Furthermore, the minor losses in BMD caused by F/TDF (Truvada) were fully recovered within 12-18 months of drug discontinuation. (24)

Nevertheless, preference towards F/TAF (Descovy) or CAB (Apretude) may be warranted in those with prior pathologic fracture and/or pre-existing conditions related to poor bone health such as: osteopenia/osteoporosis, type I diabetes, celiac disease (or other malabsorptive conditions), hyperthyroidism, hyperparathyroidism, osteogenesis imperfecta, multiple myeloma, chronic use of glucocorticosteroids or hormone blockers.

None of these conditions are hard contraindications to PrEP use and it should be discussed that BMD declines are much more significant and irreversible once HIV is contracted.

Drugs with potentially concerning interactions

Aside from the previously mentioned drugs that are absolutely contraindicated, other drugs may cause interactions that warrant careful monitoring for toxicities. Especially those that are nephrotoxic. Utilize https://hiv-druginteractions.org/checker to make informed decisions for your patients.

Hepatitis B virus (HBV) infection

The medications in oral formulations of PrEP (F/TDF and F/TAF) also have activity against HBV. Among patients with a positive hepatitis B surface antigen (HBsAg), abrupt discontinuation of oral PrEP can potentially cause hepatic flares.

More recent analyses have gone on to say that HBsAg+ individuals with normal or near normal transaminase levels have an extremely low risk of hepatic flare when stopping PrEP. The CDC guidelines specifically states that PrEP should not be withheld while waiting for HBV results. (25)

Nevertheless, the potential of causing hepatic flares is not to be taken lightly and due to this concept, ED-PrEP is not recommended for patients who are HBsAg+.

Patients ≥ 65 years old

No direct studies have been performed on this age group. Kidney function and bone mineral density naturally deteriorates with age so caution should be used with select PrEP agents.

Table 5. Careful considerations regarding PrEP Use

PrEP Initiation

Section 5Once you and the patient have agreed to start PrEP, there are important aspects of counseling and management that needs to be done. This section will review these topics to help you provide comprehensive care that extends a bit beyond HIV prevention. Keep in mind that these topics are meant to be addressed across multiple visits as you build longitudinal care with your patients.

Counseling on Use

   Building a good understanding of the underlying social context is a fundamental prerequisite to delivering effective and compassionate PrEP care.

Counseling on PrEP is naturally a sensitive topic as it broaches personal information and socially controversial issues. There are many ways to medically discuss the components of care with a patient. Similar to the subtleties mentioned in the section on how to take a sexual and substance use history, the counseling involved during PrEP initiation requires a mindful approach. Minor adjustments in our language may be critical in establishing a good rapport and ensuring proper patient understanding and follow-up care.

The inequities seen in PrEP make this point particularly important. The negative stigma that continues to be associated with HIV and issues related to medical mistrust are just some of the many reasons why PrEP is not being adequately delivered to those who need it most.

The style and approach in which you discuss PrEP is an ever-evolving process that will require trial and error. Continue refining your approach while including the following counseling points during your initial discussions of PrEP.

PrEP Initiation Patient Counseling Checklist

I have discussed ALL of the following points with the patient

  • Their risk of acquiring HIV and the benefits PrEP has to offer
  • When taken appropriately, PrEP offers more protection against HIV than condoms. 99% vs. 90% (25)
  • PrEP is an optional medication used to prevent a condition (HIV) that will require medication therapy
  • Information about the 3 medication options for PrEP
  • PrEP can be started and stopped at anytime based on the patient’s preference (minding the HBV status)
    • For injectable cabotegravir (Apretude), discontinuation will require oral PrEP and lab monitoring every 3 months for a year after the last injection
  • All formulations of PrEP are well tolerated with side effects including: headache, insomnia, nausea, vomiting, diarrhea, rash, fatigue. Side effects occur in <5% of all patients.
    • Side effects of injectable cabotegravir (Apretude) also include minor injection site reactions.
    • All of these side effects are non-life threatening and typically resolve within the first month.
  • PrEP takes time to reach adequate levels to provide protection
    • For daily F/TDF (Truvada)
      • 1 week of consecutive use to protect penile tissue and rectal tissue
      • 3 weeks of consecutive use to protect cervicovaginal tissue and the bloodstream
    • ED-PrEP using F/TDF (Truvada)
      • 2 pills 2-24 before sex and 1 pill every 24 hours for 48 hours after last sexual activity
    • No data is available for F/TAF (Descovy) or CAB (Apretude); similar counseling to F/TDF
  • PrEP does NOT protect against STIs
    • Barrier methods and routine testing encouraged
  • PrEP does not prevent pregnancy
    • Discussed options for contraception and family planning
  • PrEP care requires laboratory testing and follow-up
    • For daily F/TDF (Truvada), daily F/TAF (Descovy), or ED-PrEP with F/TDF (Truvada)
      Follow-up in 1 month then follow-up with labs every 3 months.
    • For CAB (Apretude)
      Follow-up in 1 month with labs then follow-up with labs every 2 months
  • PrEP can typically be provided completely free of charge
Table 6. PrEP Initiation Patient Counseling Checklist

Intake Laboratory Testing

The 2021 PrEP Guidelines published by the CDC include updated tables that organize the recommended laboratory tests for oral and intramuscular PrEP. As shown in Table 5. Careful considerations regarding PrEP Use and Table 7. Recommended Labs for Pre-exposure Prophylaxis Using F_TDF or F_TAF

While these tables present comprehensive information that highlight the subtleties of PrEP management, they can be challenging to interpret, especially for clinicians newly introduced to PrEP.

Below are modified tables for PrEP labs that work to simplify the guidelines. These suggestions are all drawn from related evidence-based studies. They aim to enhance patient care without sacrificing patient safety.

Note that HIV-RNA at initiation is recommended in select scenarios out of concern for delayed seroconversion or HIV acquisition during the ITRI as previously discussed. Also, labs recommended at discontinuation are represented in bold.

Detailed explanation of these lab recommendations are found in the Explanation of Suggesting Labs section.

Recommended Labs for PrEP Using F/TDF or F/TAF
Test Initiation Q3 Q6 As Indicated
HIV-Ab/Ag    
HIV-RNA

If ANY of the following:

  • Used PO PrEP in past 3mo
  • Used IM PrEP in past 12mo
  • Concern for HIV infection during ITRI1
   
  • Concern for HIV infection during ITRI
  • At discontinuation
Complete Metabolic Panel  
  • eCrCl concerns
  • ALT concerns
  • At discontinuation
STI Panel2  
  • For test-of-cure or monitoring
  • Each pregnancy
  • By patient request
  • At discontinuation
Pregnancy Test  
  • Concern for pregnancy & patient request
  • At discontinuation
Hepatitis A Ab Total      
Hepatitis B Panel3    
  • HBsAg w/ each pregnancy (26)
Hepatitis C Ab4    
  • More frequent for PWIDs (27)
  • Each pregnancy
  • Persistent ALT > 23IU/L (28)

Footnotes

  1. ITRI = Inter-test reactivity interval. The time between HIV-RNA positivity and HIV-Ag/Ab positivity
  2. Syphilis (reverse screening algorithm).
    Chlamydia and Gonorrhea at all applicable sites (genitourinary / oropharyngeal / rectal).
  3. Surface antigen (HBsAg) + surface antibody (HBsAb) + core antibody (HBcAb)
  4. If HCV-Ab is positive, obtain HCV-RNA.
Table 7. Recommended labs for PrEP Using F/TDF or F/TAF
Recommended Labs for PrEP Using Injectable Cabotegravir
Test Initiation At 1mo f/u Q2 Months As Indicated
HIV-RNA
  • Concern for HIV infection
  • At discontinuation
Complete Metabolic Panel    
  • ALT concerns
STI Panel1    
  • For test-of-cure or monitoring
  • Each pregnancy
  • By patient request
  • At discontinuation
Pregnancy Test    
  • Concern for pregnancy & patient request
  • At discontinuation
Hepatitis A Ab      
Hepatitis B Panel2    
  • HBsAg w/ each pregnancy
Hepatitis C Ab3    
  • More frequent screening for PWIDs
  • Each pregnancy
  • Persistent ALT > 23IU/L

Footnotes

  1. Syphilis (reverse screening algorithm).
    Chlamydia and Gonorrhea at all applicable sites (genitourinary / oropharyngeal / rectal).
  2. If HCV-Ab is positive, obtain HCV-RNA.
Table 8. Recommended Labs for PrEP Using Injectable Cabotegravir

Primary Care Considerations

General health screening

Sometimes, patients engaged in PrEP care do not routinely see other providers to address other aspects of preventive medicine. PrEP follow-up visits are generally straightforward and can be quick visits. Utilize this opportunity to incorporate these Grade A and B United States Preventive Services Task Force (USPSTF) recommendations. (29)

Recommendation Indication Test
(most commonly used)
Cervical Cancer Screening Women 21-65yo Pap-smear (w/ or w/ out HPV)
Colorectal Cancer Screening Adults 45-75yo FIT, colonoscopy
Intimate Partner Violence Women of reproductive age PVS, AAS
Latent Tuberculosis Adults with a risk factor: born or lived in countries with high TB prevalence, lived or is living in homeless shelters or correctional facilities, currently homeless, etc. QuantiFERON-TB Gold, TST (PPD)
Hypertension All adults Blood pressure
Diabetes Adults 35-70yo with BMI>25 HbA1c
Depression Everyone PHQ-2/ PHQ-9
EPDS in postpartum and pregnant women
Folic Acid to Prevent Neural Tube Defects All women planning or capable of pregnancy Part of Sexual History (6 P’s)
Primary Prevention of Cardiovascular Disease With Statin Medication Adults 40-75yo ASCVD Risk Calculator
Tobacco Smoking Screening and Cessation Counseling All adults Directly Asking and Counseling
Alcohol Abuse Screening All adults AUDIT-C
Drug Abuse Screening All adults NIDA Quick Screen-C
Table 9. Relevant Screening Recommendations

Vaccinations

   For the purposes of PrEP, the following vaccinations are most relevant.
Source: https://www.cdc.gov/vaccines/schedules/hcp/imz/adult.html#note-mmr

Vaccine Indication
COVID-19 Primary series and boosters recommended for everyone.
Hepatitis A No immunity based on labs.
Hepatitis B No immunity based on labs (HBsAb<10mIU/mL)
Human Papillomavirus Recommended up to 26yo. If not previously vaccinated, shared decision with patients between 27-45yo
Hypertension All adults
Influenza Recommended for everyone, annually.
Meningococcal B Shared decision for patients 16-23yo
Monkeypox (30) Rapidly changing guidelines based on local health departments though for currently: adults with risk factors such as MSM/TGWSM, engages in transactional sex, or had a known exposure.
Pneumococcal Adults 19-64yo with a risk factor: alcoholism, cigarette smoker, DM, etc.
Tetanus, diphtheria, and pertussis (Tdap) Booster (Td or Tdap) generally recommended every 10 years
Zoster All adults over 50yo
Table 10. Relevant Vaccination Recommendations

Family Planning

Given that PrEP is most often discussed along with sexual practices, it is good practice to incorporate components of family planning into your approach. There continue to be high rates of unintended pregnancies, particularly among the same groups disproportionately affected by HIV. (31)  At a time when women’s reproductive rights are constantly being challenged, it is increasingly important to provide guidance, support, and comfort to women of childbearing potential. Utilize "the 6 P’s” framework to expand on topics related to family planning and reproductive health.

Coding for PrEP Visits

   Below are the recommended visit codes for PrEP management.
This may vary based on your institution.

  • Z20.6Z20.6 (Contact with and (suspected) exposure to HIV)
  • Z79.899 (Other long term drug therapy) If PrEP is started or continued

and at least one of the following:

  • Z72.5 (high risk sexual behavior) if there are sexual risk factors
  • W46.1XXD (contact with contaminated hypodermic needle) if there are IVDU risk factors

Billing:

  • If PrEP is the only topic addressed
    • 99401 approximately 15 minutes
    • 99402 approximately 30 minutes
    • 99403 approximately 45 minutes
    • 99404 approximately 60 minutes
  • If multiple health topics are addressed, use normal billing codes based on complexity (e.g. 99213, 99214)

PrEP Continuation Visit

Section 6Follow up visits are important opportunities to ensure that the benefits of PrEP are maximized and the risks are mitigated. This section covers important counseling topics for both continuing and discontinuing PrEP. During these continuation visits, previously mentioned aspects of care should slowly be offered and provided as well.

Discussion points for follow up

   During your follow-up PrEP visit, discuss the following topics:

PrEP Continuation Patient Counseling Checklist
  • Review any issues filling or paying for the prescription
  • Assess for side effects and other concerns
  • Discuss adherence: reasons for missed doses and strategies to improve adherence
  • Review any continuing risk factors and risk reduction strategies
    • Reinforce the point that PrEP does not protect against STIs or prevent pregnancy
  • Review previous labs and discuss related management
  • Discuss and provide other aspects of primary care
Table 11. PrEP Continuation Patient Counseling Checklist

Addressing discontinuation

   The use of PrEP should always be a shared decision with your patients. Carefully discuss the following points without placing pressure on the patient to continue.

PrEP Continuation Patient Counseling Checklist
  • Address and document the reasons why the patient wishes to stop
  • Ensure that the patient does not have +HBsAg as discontinuation may potentially lead to hepatic flares. Consider a referral to hepatology for monitoring and further management.
  • Retest for HIV and STIs (+pregnancy status, if applicable)
    • Encourage barrier methods, routine testing, and risk-reduction strategies if the patient continues to engage in high risk sex and/or IVDU
  • Share with the patient that PrEP can be restarted whenever they want
  • Protection from oral PrEP will wane after a week
  • If the patient discontinues cabotegravir (Apretude), there is risk of developing HIV resistance during the “tail period” which is when the drug remains in the body but not at adequate concentrations to prevent HIV infections.
    • If PrEP indications still exist, start on oral PrEP with either F/TDF or F/TAF within 8 weeks of last injection. At the minimum, q3 month HIV-RNA testing and monitoring is recommended for a year after the last cabotegravir (Apretude) injection
Table 12. PrEP Discontinuation Patient Counseling Checklist

Advanced Topics

Section 7This section will be covering a couple of topics that go beyond the basics of providing PrEP such as counseling for patients who opt for event-driven PrEP and for patients who acquire HIV while on PrEP. Lastly, there will be a detailed explanation of the labs that have been suggested in prior sections. We hope that this section works to build an even deeper understanding of PrEP.

Event-Driven PrEP (ED-PrEP)

   Although the data is limited, event-driven PrEP (ED-PrEP) with F/TDF (Truvada) appears to be an efficacious alternative strategy, offering similar protection against HIV infections as daily dosing. ED-PrEP may be appropriate for patients who are MSM and do not prefer daily ingestion. There are a couple of important points to note and discuss with your patients:

Event-Driven PrEP Patient Counseling Checklist
  • ED-PrEP does not have FDA approval in the United States though existing studies show that it may be just as effective in preventing HIV infections as daily dosing
  • Only F/TDF (Truvada) should be used for ED-PrEP
  • Only indicated for individuals who are MSM to prevent HIV infections that occur sexually
  • ED-PrEP may cause more significant GI side effects
  • It should not be used if the patient has HBV infection or does not know their HBV status

The 2-1-1 Rule for PrEP on-Demand

  • Initial Dose: Take 2 pills 2-24 hours before sex
  • Second Dose: Take 1 pill 24 hours after the initial dose
  • Follow-up Doses: Take 1 pill 24 hours after the second dose (48 hours after the initial dose)
  • If sexual activity continues, take 1 pill everyday and continue for 2 days after the last sexual event.
  • Additional notes for follow-up doses:
    • If a gap of <7 days occurs between sexual event, take 1 pill everyday and continue for 2 days after the last sexual event.
    • If a patient has been off of PrEP for >7 days, restart the 2-1-1 cycle
Table 13. ED-PrEP Patient Counseling Checklist
Source: https://checkhimout.ca/what-is-prep/resources/

HIV Acquisition while on PrEP & Risk of resistance

In rare circumstances, patients may acquire an HIV infection while taking PrEP. Usually, this occurs when there are subtherapeutic drug concentrations to prevent an HIV infection, such as when there is poor adherence or acquisition during the initial week of PrEP initiation. Since these new HIV infections occur in the presence of partial drug pressure, resistance mutations may develop, which is an often-cited concern.

Although this is not a matter to be taken lightly, the resistance patterns most often caused by F/TDF (Truvada) and F/TAF (Descovy) are commonly seen and can be easily managed. (32)  This is best summarized by one study that stated that we “should respect but not fear” resistance caused by oral PrEP. (33)

This same investigation utilized a mathematical model to predict that the number of HIV infections that can be prevented with PrEP far exceeds the number of drug-resistant infections caused by PrEP. Many analyses corroborate this. (34)

Click the image to open table in new window

Table 14. HIV-Acquisition While on PrEP Patient Counseling Checklist

Cabotegravir is from an entirely different class of antiretroviral medication called integrase strand transfer inhibitors (INSTI). We rely heavily on INSTIs for HIV treatment and, thus, should be much more cautious. Especially since cabotegravir has a long “tail phase” where subtherapeutic drug levels allow HIV infections to take hold and develop resistance patterns. This is why current recommendations call for continued use of F/TDF (Truvada) or F/TAF (Descovy) for a year after the last cabotegravir injection. The data on this is limited and still under investigation. (35)

   Regardless of which PrEP medication is used, frequent testing is the most effective way to detect HIV infections as soon as possible and prevent further communal spread.

The detailed management of HIV goes beyond the purposes of this toolkit. Check with your local institution about the process of connecting patients to HIV care.

Whether or not you feel comfortable managing HIV, this is a critical time for patients to be consoled and engaged in proper care. You may be the first point of contact after a positive result.

Explanation of suggested labs

Complete Metabolic Panel

  • A CMP is helpful in determining the estimated creatinine clearance (eCrCl).
    • F/TDF (Truvada) eCrCl ≥ 60ml/min
    • F/TAF (Descovy): eCrCl ≥ 30ml/min
  • Although current guidelines recommend different testing intervals based on age and eCrCl at initiation, these details may be cumbersome to remember. We recommend a CMP every 6 months for the sake of simplicity.
  • A CMP also helps determine if there is any existing or developing transaminitis which can be reflective of a multitude of related clinical scenarios e.g. hepatitis A/B/C infection, alcoholic liver disease, NAFLD, or hepatotoxicity from cabotegravir (Apretude)
  • For this reason, even though a full CMP is not officially recommended for any forms of PrEP, we recommend it as it is commonly ordered, relatively inexpensive, and a highly useful lab for the patient populations in consideration

STI Panel

  • More frequent testing may be performed if the patient engages in unprotected sex, sex with new partners, has concerning symptoms, or is directly requesting testing.
  • Remember that most STI infections are asymptomatic so testing should not be overlooked based on the absence of symptoms.
  • We suggest routine STI testing regardless of the patient’s sex or gender. This is to reduce confusion and respond to the overall worsening rates of STIs across the country.
  • Syphilis: testing algorithms may vary based on your institution. There are more advantages with the reverse sequence screening algorithm where treponemal immunoassays (EIA/CIA) are utilized first before the commonly used non-treponemal test (RPR/VDRL). Click here for a review on testing and managing the results of syphilis.
  • Chlamydia & Gonorrhea: test all applicable sites based on sexual practices (i.e. urogenital, pharynx, rectum). Swabs are either Aptima Combo 2 Assay or the Xpert CT/NG. Review chlamydia. Review gonorrhea.
    • Urogenital - first-catch urine samples are typically used. Contrary to the collecting procedures for a urinary tract infection (UTI), patients should be instructed not to clean their urethral opening with an alcohol swab and should urinate directly and immediately into the sample cup, not midstream.
    • Self-collected vaginal swabs is another option that can be offered to individuals AFAB. They perform better than clinician-collected samples and have the advantages of preserving patient comfort and circumventing the inability to provide a urine sample. (36)
  • Pharynx - recommended if a patient performs oral sex.
  • Rectum - recommended if the patient engages in receptive anal intercourse (RAI). It is also possible for patients AFAB to get rectal infections from vaginal secretions without actually engaging in anal sex. Shared decisions should be made and samples may be self-collected. (37)

Pregnancy Test

  • Recommended for all sexually active patients of child-bearing potential. More frequent testing may be indicated if the patient is not on a reliable form of birth control and/or has related concerns. Conversely, frequency of testing may be reduced if a patient is on a reliable form of birth control or is not reporting any sexual activity during the interim period.

Hepatitis A Virus Total Ab

Hepatitis A Virus Total Ab
  • There are overlapping patient populations at higher risk for contracting both HIV and HAV. This includes MSM/TGWSM, PWIDs, individuals who are incarcerated, and individuals experiencing homelessness. For this reason we recommend obtaining a total HAV Antibody (HAV IgG+IgM) and providing vaccination if appropriate. Post-vaccination serology is not routinely recommended.

Hepatitis B Virus Panel (surface Ag, surface Ab, core Ab)

  • There are overlapping patient populations at higher risk for contracting both HIV and HBV such as MSM/TGWSM and PWIDs. Screening for HBV is also recommended for those born in countries with prevalence >2%, pregnant patients, and patients with abnormal ALT levels. Full details of general HBV screening. This is the rationale we used to recommend HBV screening as PrEP intake labs.
  • In accordance with guidelines published by the United States Preventive Services Task Force (USPSTF) and the American College of Physicians (ACP), we recommend Hepatitis B surface antigen (HBsAg), total Hepatitis B surface antibody (HBsAb), and total Hepatitis B core antibody (HBcAb). Vaccination is recommended if appropriate. Post-vaccination serology is generally not recommended (only select populations). (38)

Hepatitis C Virus Ab

  • Both the CDC and the USPSTF recently updated their recommendations for HCV screening to include all adults 18 years of age or older.For review of screening guidelines, click here. Similar to the previously mentioned viral hepatitis infections, there are many overlapping risk factors between contracting HCV and HIV: MSM, transgender women, and PWIDs. (39)
  • HCV antibody testing (HCV Ab) is recommended at intake. Preferably, a HCV Ab test that reflexively tests for HCV RNA would be most helpful in determining next-step strategies. Review of HCV test interpretation.
  • More frequent testing may be recommended particularly among PWIDs who share injection equipment.

Lipid Panel

  • We decided to forego the inclusion of the lipid panel when a patient is receiving F/TAF (Descovy). Although it is well-established that F/TAF (Descovy) may cause worsening cholesterol-related parameters, existing 96-week and 144-week data from the DISCOVER trial found very minimal changes in such lab values. No significant adverse events or discontinuations resulted from these lipid changes. To further help patients decide, it may be worth mentioning that F/TDF (Truvada) is actually related to slightly improved lipid profiles. It is also weight neutral whereas F/TAF (Descovy) can lead to roughly 1.5 pounds of weight gain a year.

    These disease-oriented data points do not equate to patient-oriented outcomes.

    To expand on this, even though F/TDF (Truvada) may cause declines in bone mineral density (BMD), no actual increases in fractures have actually been connected to its use. (40)  Likewise, the slightly worsening lipid profiles of those on F/TAF (Descovy) have not been associated with higher rates of conditions such as pancreatitis or heart attacks. (41)  If use of F/TDF (Truvada) does not necessitate the routine use of DEXA scans or more frequent renal function monitoring, neither should the use of F/TAF (Descovy) necessitate the need of lipid panels.

    It is not our intention to carelessly overlook these potentially harmful differences. Certainly, if a patient has medical conditions or concerns related to their weight and/or cholesterol, counseling and monitoring should be performed.

    In our opinion, this is more appropriate in the setting of a general health assessment rather than a focused visit for PrEP care. Again, the intention of these modifications is to structure a simplified and consistent approach that provides more patient-centered, evidence-based, and comprehensive care.

Resources

ResourcesA summary of tables, handouts, and additional information for providers and patients.

References


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  7. Masciotra, Luo, W., Westheimer, E., Cohen, S. E., Gay, C. L., Hall, L., Pan, Y., Peters, P. J., & Owen, S. M. (2017). Performance evaluation of the FDA-approved DetermineTM HIV-1/2 Ag/Ab Combo assay using plasma and whole blood specimens. Journal of Clinical Virology, 91, 95–100. https://doi.org/10.1016/j.jcv.2017.03.019 

  8. Daar, Pilcher, C. D., & Hecht, F. M. (2008). Clinical presentation and diagnosis of primary HIV-1 infection. Current Opinion in HIV & AIDS, 3(1), 10–15. https://doi.org/10.1097/COH.0b013e3282f2e295 

  9. Centers for Disease Control and Prevention. (2021). Estimated HIV incidence and prevalence in the United States, 2015–2019. U.S. Department of Health and Human Services. https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-supplemental-report-vol-26-1.pdf 

  10. Centers for Disease Control and Prevention. (2021). Diagnoses of HIV infection in the United States and dependent areas, 2019. U.S. Department of Health and Human Services.   https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2018-updated-vol-32.pdf 

  11. Centers for Disease Control and Prevention. (2022). Diagnoses of HIV infection in the United States and dependent areas, 2020. U.S. Department of Health and Human Services.
    https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2020-updated-vol-33.pdf 

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