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Sexual History Taking 101: How Do I Start the Conversation with My Patients?

Review the latest recommendations with

Jonathan Shuter, MD, a Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

Uriel Felsen, MD, an Associate Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

Raffaele M. Bernardo, DO, an Assistant Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

Learning Objectives:

  • Define sexual health and how it is applied in clinical settings
  • Detail the burden of sexually transmitted infections (STI) in the United States
  • Describe standardized guidelines to sexual history-taking
  • Identify affirming approaches to successful sexual history-taking

CONTENTS:

THE CASE:

A 34-year-old cis-woman comes to your office for a routine check-up and STI screening. She is asymptomatic and denies any genitourinary symptoms or concerns.

  • She married at a younger age and is now divorced. She has two young children and is taking her first steps towards returning to the dating world and sexual activity. She wants to discuss options where she can enjoy sex again but can also empower herself with tailored approaches to STI and HIV prevention
  • She has always been attracted to both men and women, but only had sex with her husband for the 10 years they were married. She is open to either gender for a sexual relationship moving forward
  • She has no medical conditions and is currently not taking any medications. She would consider condoms and birth control for contraception, but is interested in what may work best for her

Overview of Taking a Sexual History

The sexual history is a vital, yet often overlooked aspect of the clinical history and physical in medical settings

  • Topics regarding sexuality, sexual orientation and behavior, and gender identity are vital aspects of the social history that can direct providers to identify
    • sexual health and wellness recommendations
    • screening tests
    • tailored HIV and STI prevention approaches
  • When it comes to HIV pre-exposure prophylaxis, or “PrEP,” it is impossible to hold a fluent conversation about HIV prevention before first becoming proficient in talking about sex

Defining and Centering Sexual Health

The definition of sexual health has been debated and modified over the years, but most sexual health experts refer to the World Health Organization (WHO) definition:

“Sexual health is fundamental to the overall health and well-being of individuals, couples and families, and to the social and economic development of communities and countries. Sexual health, when viewed affirmatively, requires a positive and respectful approach to sexuality and sexual relationships, as well as the possibility of having pleasurable and safe sexual experiences, free of coercion, discrimination and violence.”

  •  In many health professional schools, students have historically been taught to address sex from a pathological framework centered on disease states (i.e., HIV and STIs), screening for these conditions, and treating them appropriately
  • Today’s approach to STI and HIV prevention and treatment now is proactive, focusing instead on sexual health, wellness, and prevention by creating spaces where patients feel more comfortable discussing their full and authentic selves
  • Most people receiving new HIV diagnoses report contracting it through sexual transmission | To reduce the continued burden of STI and HIV rates, eliciting a good sexual history is crucial

The Context of Taking A Sexual History in Clinical Settings

When beginning as sexual history, it is important to recognize the complex dynamics that take place within the patient-clinician encounter:

  • Patients prefer active inquiry about sexual health issues from clinicians (Ryan et al., 2018)
  • Generational differences matter in communication about sexual health (Rabathaly and Chattu, 2019)
  • Providers’ perception of how sexual history questions will be received by patients influences if a sexual history will be elicited and perceived competence led to more frequent screening (Tong et al., 2013)
  • Sexual history-taking education in medical school curricula shows promise in improving students’ confidence in and comfort with conducting sexual histories with their patients (Bourne et al., 2020)

Competing interests and within-clinic demands also contribute to difficulty with competency in sexual history taking on a visit-by-visit basis:

  • Not having enough time to discuss sensitive sexual information in a 15-minute clinical visit
  • Building trust quickly without offending with personal questions
  • Competing clinical priorities – chief complaint, other medical issues, health care maintenance
  • Requirements for screening
  • Interruptions from other clinical staff and other patients needing assistance

These contexts can put barriers in the way of clinicians having meaningful conversations with our patients around sexual health

  • Learning to address these hurdles and incorporate language and behaviors in your practice will become easier with practice
  • Implementation will, over the long term, will become seamless and improve the efficiency with which you take a sexual history

Routine review of sexual history can lead to improved patient outcomes

Words Matter: Avoiding Judgmental and Stigmatizing Language

Introductions

A provider’s approach to taking a comprehensive sexual history begins as soon as you introduce yourself to your patient

  • Consider how we greet patients and the ways in which our perceptions of their physical appearance and gender expression leads to the insertion of the titles “Mr.” or “Mrs./Ms.” before their last name.
  • Most of the time we guess correctly, but at times we may guess incorrectly and create a stigmatizing atmosphere for our patients before the full encounter even starts
  • As a result, patients may shut down and not give a fully open and honest history; some may even question if they want to follow up with us altogether

We suggest an introduction like this: “Hi, my name is Dr./NP/PA _________________. My pronouns are she/her. What would you prefer to be called and what are your pronouns?”

  • Using more open-ended language lets your patients know you are not assuming anything when it comes to their sexual and gender identities
  • Additionally, it lets them know you respect them and will address them how they would like to be addressed, not based on your assumptions

When in doubt, ask patients how they prefer to be addressed | Never make assumptions.

Language

Language is key in sexual history-taking, and questions should be framed in open-ended and affirming language that allows patients to tell their own narrative:

  • “I’m going to ask some personal questions about your sexual history now”
  • “I ask these questions to all my patients to help get a sense of their sexual health needs”
  • “What are the genders of your sexual partners”
  • “What behaviors do you enjoy when having sex”
  • “What forms of STI and HIV prevention do you use with your partners”
  • “Do you have any specific sexual health concerns you want to talk about?”

Leading with open-ended questions avoids assuming certain sexual and gender identities (or the genders of their sexual partners):

  • It allows patients to understand you are receptive to any response
  • It creates a space where they will not be judged if they acknowledge having multiple sexual partners and regardless of the consistency of their HIV/STI prevention choices
  • It allows communication to remain honest
  • It facilitates identification of necessary testing, vaccination needs, and how to move forward with a sexual health and wellness plan that works for them

Standardized Approaches to Sexual History-Taking 

There are many good resources to standardize the approach to sexual history-taking

The 5 P’s (CDC)

The most popular standardized approach to sexual history-taking comes from the CDC and is entitled “The 5 Ps” – which stand for:

  1. Partners
  2. Practices, including previous or current sex work
  3. Protection from STIs
  4. Past history of STIs
  5. Prevention of Pregnancy

These are commonly accepted categorization of the broad topics clinicians should cover during the encounter

  • They are guidelines more than hard and fast rules, ensuring thorough content in a way that feels natural to the provider
  • Flexibility is key to improve comfort and competence, including order of questions and wording

Essential Questions – Physicians for Reproductive Health

Physicians for Reproductive Health (PRH) suggests a template for sexual history-taking, particularly adolescents and emerging adults. They emphasize how to best set the atmosphere to ask sensitive sexual health questions, highlighting effective communication techniques that will help patients feel comfortable. These include:

  • Minimize note-taking, particularly during sensitive questioning
  • Talk in terms the adolescent will understand
  • Ask developmentally appropriate questions
  • Ask open-ended questions
  • Practice listening skills
  • Avoid the surrogate parent and adolescent roles
  • It’s a conversation…not an interrogation!
  • What purpose does the information serve?
  • Healthy respect and regard for privileged information

Their recommended sexual history questions cover: 

  • Gender identity : “What names and pronouns do you use for yourself?”
  • Sexual orientation “What genders are you interested in romantically?” and “Are you comfortable with your feelings?”
  • Sexual coercion, abuse, and prior or current sex work “Who makes the decisions about when to have sex and what contraception to use?” and “have you exchanged sex for goods or services?” or “have you engaged in sex work in the past or currently?”
  • Sexual activity
  • Number of partners
  • Frequency of intercourse
  • Type of sex practices
  • STI history and risk assessment “Have you ever been diagnosed with an infection?”
  • Pregnancy history and risk assessment “Have you ever been pregnant or gotten anyone pregnant?” and “What are you doing to prevent pregnancy right now?”
  • Contraceptive behaviors “What are your experiences with contraception to prevent pregnancy?”
  • Substance use

Approaching the sexual history with respect, no assumptions, and a collaborative spirit will go a long way in fostering the trust needed for honest communication about sexual health and wellness

Note: It may be helpful to explain or collaborate with the patient on how the information they provide on their sexual health will be documented in the medical record to build trust

The Wrap-Up

 The above patient will benefit from an open-ended sexual history

She is at a transitional time of her life where she is entering a new phase and would benefit from an affirming and empowering approach to her sexual health

  • Start with a discussion of her current sexual and gender identities
  • Explore what her sexual and romantic needs and desires are at this point
  • Inquire regarding her concerns and worries about returning to dating and sexual activity  after recently ending years of marriage
  • Discuss her preferred approaches to contraception
  • Evaluate her thoughts and preferred options for HIV and STI prevention (including PrEP) moving forward

KEY POINTS:

  • STI and HIV prevention discussions begin with a sexual health conversation
  • Patient-centered and tailored approaches should meet patients where they are
  • Utilize affirming language over a judgmental and discriminatory tone
  • Incorporate models of sexual history-taking that work best for your patients

Learn More – Primary Sources:

Centers for Diseases Control and Prevention

American College of Obstetricians and Gynecologists

Physicians for Reproductive Health

Human Rights Campaign Glossary of Terms

American Academy of Family Physicians

National LGBT Health Education Center

New York City Department of Health

Glossary of Sexual History Terms and Language

When taking a sexual history, it is important to lead without assuming that everyone is cis-gendered and heterosexual. Approaching the questions and how to phrase them is the art of medicine, beginning with familiarizing oneself with key sexual orientation and gender identity (SOGI) terms that will help facilitate an open atmosphere in which patients feel comfortable discussing their sexual lives

Below is an abbreviated list of terms. A more expansive glossary is found on the HRC website. While it is possible that the majority of patients you encounter in clinical practice may identify as cis-gendered and heterosexual, it is paramount to create clinical spaces that are affirming and inclusive of all patients along the sexual and gender identity continuum. You may not need to use these terms with every patient and during your clinical sessions, but it is important to at least familiarize yourself with the terminology. This way we can service anyone’s sexual health needs and priorities, regardless of how they identify

According to the Human Rights Campaign (HRC), these are some basic terms and definitions around sexual identity and gender identity (SOGI) with which clinicians can familiarize themselves:

Sexual orientation | An inherent or immutable enduring emotional, romantic, or sexual attraction to other people

Lesbian | A woman who is emotionally, romantically, or sexually attracted to other women

Gay | A person who is emotionally, romantically, or sexually attracted to members of the same gender

Bisexual | A person emotionally, romantically, or sexually attracted to more than one sex, gender, or gender identity though not necessarily simultaneously, in the same way or to the same degree

LGBTQ | An acronym for “lesbian, gay, bisexual, transgender and queer”

Queer | A term people often use to express fluid identities and orientations. Often used interchangeably with “LGBTQ”

Gender identity | One’s innermost concept of self as male, female, a blend of both or neither—how individuals perceive themselves and what they call themselves. One’s gender identity can be the same or different from their sex assigned at birth

Cisgender | A term used to describe a person whose gender identity aligns with those typically associated with the sex assigned to them at birth

Transgender | An umbrella term for people whose gender identity and/or expression is different from cultural expectations based on the sex they were assigned at birth. Being transgender does not imply any specific sexual orientation. Therefore, transgender people may identify as straight, gay, lesbian, bisexual, etc.

Gender dysphoria | Clinically significant distress caused when a person’s assigned birth gender is not the same as the one with which they identify. According to the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders (DSM), the term—which replaces Gender Identity Disorder—”is intended to better characterize the experiences of affected children, adolescents, and adults”

Gender expression | External appearance of one’s gender identity, usually expressed through behavior, clothing, haircut or voice, and which may or may not conform to socially defined behaviors and characteristics typically associated with being either masculine or feminine

Genderqueer | Genderqueer people typically reject notions of static categories of gender and embrace a fluidity of gender identity and often, though not always, sexual orientation. People who identify as “genderqueer” may see themselves as being both male and female, neither male nor female, or as falling completely outside these categories

Gender transition | The process by which some people strive to more closely align their internal knowledge of gender with its outward appearance. Some people socially transition, whereby they might begin dressing, using names and pronouns, and/or be socially recognized as another gender. Others undergo physical transitions in which they modify their bodies through medical interventions

Non-binary | An adjective describing a person who does not identify exclusively as a man or a woman. Non-binary people may identify as being both a man and a woman, somewhere in between, or as falling completely outside these categories. While many also identify as transgender, not all non-binary people do

Sex assigned at birth | The sex (male or female) given to a child at birth, most often based on the child’s external anatomy. This is also referred to as “assigned sex at birth”

Commercial Support

This educational activity is supported by an independent educational grant from Gilead Sciences

Faculty Disclosures

Dr. Shuter has no relevant financial relationships to disclose

Dr. Felsen has no relevant financial relationships to disclose

Dr. Bernardo has no relevant financial relationships to disclose

Special Thanks

Special thanks to David Malebranche, MD, MPH and Ariel Watriss, MSN, NP for their insights and contribution.

HIV Pre-Exposure Prophylaxis (PrEP) – Who’s it for?

Review the latest recommendations with

Jonathan Shuter, MD, a Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

Uriel Felsen, MD, an Associate Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

Raffaele M. Bernardo, DO, an Assistant Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

SUMMARY:

There are now three types of PrEP approved by the Food and Drug Administration (FDA) currently available – oral formulations (Truvada and Descovy) and an intramuscular injection, cabotegravir. All treatments work by stopping the HIV replication process. While HIV PrEP is recommended for all individuals that it is applicable for, at this time, Descovy is not approved for the prevention of HIV for those at risk through receptive vaginal sex – including cisgender women, transgender men, and others.

  • Truvada brand name (Emtricitabine (F) 200mg with tenofovir disoproxil fumarate (TDF) 300mg) daily
  • Descovy brand name (Emtricitabine (F) 200mg with tenofovir alafenamide (TAF) 25mg) daily
  • Vocabria brand name (Cabotegravir 600mg) gluteal IM injection at month zero, month one, then every two months

Of note, we refer to Truvada as F/TDF, Descovy as F/TAF, and Vocabria as Cabotegravir throughout

BACKGROUND:

Providing Pre-exposure Prophylaxis

  • Goal of PrEP is to reduce the acquisition of HIV and its subsequent costs to individuals and society
  • PrEP has been a part of the HIV prevention landscape since 2012
  • Both HIV PrEP oral tablets contain two antiretroviral medications called nucleoside reverse transcriptase inhibitors (NRTIs)
    • These medications work by inhibiting the enzyme reverse transcriptase that HIV needs to replicate
    • Both tablets are used in many common HIV treatment regimens
  • The intramuscular injection contains an integrase strand-transfer inhibitor (INSTI) which works by inhibiting the enzyme that HIV uses to integrate its own DNA into the CD4 cell’s nucleic DNA

Oral PrEP medications

FDA Approved Regimens:

  • Truvada | Emtricitabine (F) 200mg and tenofovir disoproxil (TDF) 300mg) | one tablet orally daily, with or without food
  • Descovy | Emtricitabine (F) 200mg and tenofovir alafenamid (TAF) 25mg) | one tablet orally daily, with or without food

Alternative formulations of PrEP medications

Cabotegravir 600mg gluteal IM injection was granted FDA approval in December 2021

  • Requires IM injection at month zero, month one, then every two months afterwards
  • One three mL injection in the gluteal muscle
  • Only available for HIV negative patients without contra-indications to the medication

What many clinicians wonder next is “What patients would be good candidates for PrEP?” PrEP is a sexual health option for people interested in HIV prevention and could be appropriate for many patients you see on a daily basis.

Who It’s For – CDC Guidance and Other Considerations

The CDC recently updated guidance to recommend routine counseling of risks of transmission of HIV and PrEP options as well as routine prescribing of PrEP to appropriate candidates.  Now, discussion of PrEP is recommended for all individuals who are sexually active.

Although “risk groups” have been defined by the CDC, we caution the idea of patients as levels of “risk,” particularly when it comes to sexual health. What it involves is taking a good sexual history and documenting what behavioral choices they make, then offering PrEP as an option for HIV prevention.

PrEP is for people without HIV who could be exposed to HIV from sex or injection drug use.

The CDC provides the following recommendations:

CDC recommends the following patients should be assessed for PrEP including

  • Sexually active gay and bisexual men without HIV
  • Sexually active heterosexual men and women without HIV
  • Sexually active transgender persons without HIV
  • Persons without HIV who inject drugs
  • Persons who have been prescribed non-occupational post-exposure prophylaxis (PEP) and report behaviors that could expose them to HIV, or who have used multiple courses of PEP

For sexually active adults and adolescents:

  • Anal or vaginal sex in the past six months; and
  • HIV-positive sexual partner (especially if partner has unknown or detectable viral load); or
  • Recent bacterial STI; or
  • History of inconsistent or no condom use with sexual partner(s)

For Persons who inject drugs:

  • HIV-positive injecting partner; or
  • Shares drug preparation or injection equipment

All persons eligible for PrEP:

  • Documented negative HIV test result before prescribing PrEP; and
  • No signs/symptoms of acute HIV infection; and
  • Normal renal function; and
  • No contraindicated medications

NOTE: While the CDC compartmentalizes “risk groups” as listed above, as clinicians we must remember that sexual health does not fit neatly into static compartments. Sexuality and sexual behavior are fluid, and individuals may change their partners, behavior, and condom use over time and situation – and invite us to explain in detail

Thus, the CDC guidance is exactly what it is – guidance. Nothing replaces taking a good sexual history to discover which patients may be good candidates for PrEP.

  • Individuals who do not fit in the categories mentioned above could still benefit from PrEP – so be sure not to limit offering PrEP to just certain groups of people
  • Anyone who is sexually active could be a candidate for PrEP.
  • Patients who ask for PrEP may not feel comfortable sharing all their sexual behavior with medical providers due to fear of judgment and stigma
  • If a patient comes into your office inquiring about PrEP, even if they don’t verbally describe specific behaviors that the CDC defines as “risky,” they are asking for a reason

Dosage Regimen

These medications are approved to prevent HIV infection in adults and adolescents weighing at least 35 kg (77 lb) as follows:

  • Daily oral PrEP with F/TDF (Truvada) is recommended to prevent HIV infection among all persons at risk through sex or injection drug use.
  • Daily oral PrEP with F/TAF (Descovy) is recommended to prevent HIV infection among persons at risk through sex, excluding people at risk through receptive vaginal sex. F/TAF has not yet been studied for HIV prevention for receptive vaginal sex.

Selecting a Regimen

  • Determination of which oral regimen is appropriate depends on a patient’s clinical status, comorbidities, as well as potential side effects and medication interactions
    • Both F/TDF and F/TAF are equally effective in reducing HIV transmission 
    • F/TDF (Truvada) is the only FDA-approved PrEP option for cis women who have receptive vaginal sex | May be better for people with a history of hypercholesterolemia 
    • F/TAF (Descovy) is FDA-approved for use by transgender women, transgender men, and MSM | the best option for persons with osteoporosis and can be used for patients with chronic kidney disease with a CrCl as low as 30 ml/min 
  • Comorbidities
    • Hepatitis B 
    • HIV 
    • Renal disease 
  • Common side effects
    • The majority of people experience no side effects at all
    • Mild to moderate gastritis at start of med course- usually tapers within three to four weeks | Can sometimes include diarrhea
    • Headaches 
  • Medication interactions
    • Other drugs that could affect renal function may require closer renal function while PrEP is being used
    • Other antiviral medications can impact PrEP response and need to be reviewed with clinical use on a case by case basis

On-demand” PrEP

“On-demand” PrEP is not currently FDA-approved for use in the United States but many clinicians many use it in an “off-label” manner as appropriate with the needs of their patients and reflective of the studies in Europe that demonstrate its effectiveness in reducing HIV transmission.

  • Would be an option for people who may not engage in sex regularly or plan sexual encounters 
  • Involves the following regimen schedule for TDF/FTC only
    • Take two tablets at least two hours and not more than 24 hours before sex
    • Take one tablet 24 hours after first two pills taken
    • Take one tablet 48 hours after first two pills taken

PrEP Safety and Efficacy

PrEP, when used as indicated, has been determined to be safe and effective in the prevention of HIV transmission among diverse populations, including

  • Men who have sex with men and transgender women: 85 – 100% risk reduction 
  • Heterosexual women and men: 63 – 90% risk reduction 
  • Persons who Inject Drugs (PWID) regardless of sexual activity: 73.5% risk reduction 
  • Adolescents who weigh over 35kg: >95% risk reduction

Clinical considerations with initiation

  • Consider sexual health needs beyond HIV prevention- PrEP only offers prevention for HIV, not other STIs
  • These medications must be monitored closely for patients with chronic active Hepatitis B (persistent positive Hepatitis B Surface Antigen)
  • These medications require healthy kidney function (eCrCl >60 ml/min for TDF/FTC and eCrCl >30 ml/min for TAF/FTC)
  • Can be prescribed by primary care providers without requiring infectious disease specialist or consult prior to initiation [for more information see Initial Visit, Dosing, and Follow Up or Implement and Maintain a Prep Clinic in the Resource Center]
  • Cabotegravir, the intramuscular injection pending FDA approval, can be used in individuals without requiring creatinine or renal clearance, Hepatitis B status, lipid panels, or liver function tests
  • Cabotegravir may be a better option for individuals who prefer injections every two months, have poor adherence with daily medication, or have other co-morbidities such as renal or liver disease

Learn More – Primary Sources:

CDC Pre-Exposure Prophylaxis for HIV Prevention

PrEP and Adolescents: The Role of Providers in Ending the AIDS Epidemic (Hosek et al. Pediatrics, 2020) 

Emtricitabine-tenofovir concentrations and pre-exposure prophylaxis efficacy in men who have sex with men (Anderson et al. Sci Transl Med, 2012) 

Antiretroviral prophylaxis for HIV prevention in heterosexual men and women (Baeten et al, N Engl J Med, 2012) 

Bangkok Tenofovir Study Group. Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial (Choopanya et al. Lancet, 2013) 

Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial (Mayer et al, The Lancet 2020) 

Commercial Support

This educational activity is supported by an independent educational grant from Gilead Sciences

Faculty Disclosures

Dr. Shuter has no relevant financial relationships to disclose

Dr. Felsen has no relevant financial relationships to disclose

Dr. Bernardo has no relevant financial relationships to disclose

Special Thanks

Special thanks to David Malebranche, MD, MPH and Ariel Watriss, MSN, NP for their insights and contribution.

Initial Visit, Dosing, and Follow Up

Review the latest recommendations with

Jonathan Shuter, MD, a Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

Uriel Felsen, MD, an Associate Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

Raffaele M. Bernardo, DO, an Assistant Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

SUMMARY:

The initial visit for HIV PrEP will establish the start of the patient’s PrEP experience. It is a blend of education, clinical care, and establishing a new health practice for the patient

Initial Visit: What to Include

The initial visit needs to include both a comprehensive history of the patient, their sexual history, eligibility for PrEP as well as laboratory workup prior to initiation

Sexual Health History and Comprehensive Screening

  • A comprehensive sexual health history review and review of eligibility for PrEP includes
    • Gender and number of sexual partners
    • Specific sexual behaviors (oral, vaginal, anal)
    • HIV-status of sexual partners
    • Condom use practices
    • Substance use/abuse screening
    • History of sexually transmitted infections (STI)
  • Confirmation of HIV negative status (see lab tests below)
  • Assessment for acute HIV
    • A patient’s HIV negative status must be confirmed in the context of recent sexual or other possible exposure contexts in the preceding thirty days
    • If there is concern for acute HIV and someone has an initial negative HIV Ag/Ab, that may require HIV RNA testing before initiating PrEP
  • Symptoms of acute HIV may include:
    • Fever
    • Pharyngitis
    • Lymphadenopathy
    • Many other symptoms (diarrhea, headache, flu-like symptoms) or NONE AT ALL
  • Assessment for medical cautions or contraindications include
    • Hepatitis B, renal or hepatic insufficiency
  • Discussion with patients of potential, yet rare side effects, including:
    • Truvada (F/TDF 200mg/300mg): worsening renal function including kidney failure, bone thinning
    • Descovy (F/TAF 200mg/25mg): elevated cholesterol levels, weight gain
  • Other sexual health needs including STI testing or contraception, as needed

Laboratory Tests and Other Diagnostic Procedures

Initiation of Oral PrEP

  • HIV testing | must be performed and results must be negative within one week before starting PrEP to document that patients do not have HIV
    • Fourth generation HIV Ag/Ab serologic testing is preferred over either oral/fingerstick rapid Ab or serologic Ab testing
  • Renal function
    • Truvada (F/FTC) | eCrCl should be documented at >60 ml/min prior to starting PrEP
    • Descovy (F/TAF) | eCrCl should be >30 ml/min
  • Hepatitis B surface antigen should be documented negative before initiating PrEP
    • Both medications are active against Hepatitis B
    • If an individual taking HIV PrEP also has chronic active Hepatitis B and suddenly stops PrEP, they could experience a symptomatic acute Hepatitis B flare
    • Exhibit caution and educate patients about this dynamic if they have chronic active Hepatitis B
  • Urine Pregnancy Test (UPT) for individuals who may become pregnant
  • Sexually Transmitted Infection (STI) testing
    • At initial screening and semi-annual visits (or more frequently as per clinical assessment)
    • Gonorrhea and Chlamydia testing
      • Oral, pharyngeal, and anal NAAT for men who have sex with men and transgender women
      • Vaginal NAAT for cis gendered women
    • Syphilis screening
      • Treponemal IgG cascade
      • RPR
  • Hepatitis C antibody screening for PWID and MSM

Initiation of intramuscular PrEP

  • Administration of cabotegravir 600mg via one 3mL intramuscular injection in the gluteal muscle
    • Can consider trial of cabotegravir 30mg daily for four weeks prior to initiation of IM injections if patients are anxious about side effects
  • Initiation of cabotegravir requires a second dose four weeks after the first dose (one month follow up visit) and every eight weeks after with HIV testing at visits
  • Schedule is initial administration (month 0), one month after initiation (month one), then every eight weeks afterwards (month three, five, seven, etc.)
    • Follow-up visit one month after initial injection should include second dose and HIV Ag/Ab test and HIV-1 RNA assay with subsequent two-month intervals
  • The following laboratory tests are NOT indicated before starting CAB injection or for monitoring patients during its use:
    • Creatinine or eCrCl
    • hepatitis B serology
    • lipid panels
    • liver function tests

Medication choices and dosing

  • The two current choices for oral PrEP are F/TDF 200/300 (Truvada) and F/TAF 200/25 (Descovy)
    • Only F/TDF (Truvada) is FDA-approved for cis women engaging in vaginal sex
    • Both are FDA-approved for men who have sex with men and transgender women
    • Both are fixed-dose, daily tablets that can be taken with or without food
  • Prescriptions can be written either as thirty days with two refills or as a ninety-day course depending on insurance coverage allowance
  • Cabotegravir is now FDA-approved, administered at month zero, month one, then every two months (eight weeks) afterwards starting from month three, five, seven, etc.

Ongoing monitoring

The current recommendations for ongoing care for oral PrEP include:

  • In-person or telehealth follow up visit every three months
  • Prescription refills every three months
  • HIV test every three months (typically done as part of refill of prescription on the same timeline and can be administered as at-home testing)
  • Renal and hepatic labs every six months
  • UPT as indicated
  • STI testing as directed by sexual health review done at each follow up visit.
  • Assessment of sexual and general health needs
  • Review of any new medications and medical updates

Similar recommendations apply to intramuscular PrEP, with timing intervals every two months but would not require renal or hepatic lab results at initiation or during follow-up

Learn More – Primary Sources

PrEP Provider Toolkit

ACHA Guidelines: HIV Pre-Exposure Prophylaxis

Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2017 Update

Commercial Support

This educational activity is supported by an independent educational grant from Gilead Sciences

Faculty Disclosures

Dr. Shuter has no relevant financial relationships to disclose

Dr. Felsen has no relevant financial relationships to disclose

Dr. Bernardo has no relevant financial relationships to disclose

Special Thanks

Special thanks to David Malebranche, MD, MPH and Ariel Watriss, MSN, NP for their insights and contribution.

The PrEP Guidelines Center

Review the latest recommendations with

Jonathan Shuter, MD, a Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

Uriel Felsen, MD, an Associate Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

Raffaele M. Bernardo, DO, an Assistant Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

SUMMARY:

The Centers for Disease Control and Prevention (CDC) makes recommendations for the use of PrEP as biomedical HIV prevention. Based on a systematic review of the literature, these evidence-based guidelines offer a practical approach to identifying patients who would be appropriate candidates for PrEP, ordering relevant tests and laboratory procedures, and how to conduct initial and follow-up visits for patients. Given the evolving nature of PrEP research, these recommendations will be revised and updated for clinical practice on a regular basis. This section will also review other supportive guidelines and statements from ACOG and USPSTF

General Guidelines for PrEP 

Safety and Efficacy

PrEP, when used as indicated, has been determined to be safe and effective in the prevention of HIV transmission among diverse populations and should be a consideration to anyone who is sexually active, including:

  • Men who have sex with men and transgender women: 92% to 100% reduction in HIV transmission in clinical trials and real-world analysis
  • Heterosexual women and men – 63% to 93% reduction in HIV transmission
  • Persons who Inject Drugs (PWID) – 73.5% reduction in HIV transmission
  • Adolescents who weigh over 35kg – over 95% reduction in HIV transmission

Eligibility

The United States Prevention Services Task Force (USPSTF) recommends offering PrEP with effective antiretroviral therapy to persons at high risk of HIV acquisition

  • FDA approved oral formulation is one pill taken once a day or intramuscular injection is once very eight weeks
  • Either F/TDF 200/300mg (Truvada) or F/TAF 200/25 (Descovy) are currently approved for oral use and cabotegravir is approved for intramuscular use
  • Insurance must provide medication coverage for preventive services with Grade A recommendation

CDC Guidelines for Screening Eligibility

  • The CDC recommends that providers should

Inform all sexually active adults and adolescents that PrEP can protect them from getting HIV

Note: We caution against seeing patients as levels of “risk,” particularly when it comes to sexual health | What it involves is taking a good sexual history and documenting what behavioral choices they make, then offering PrEP as an option for HIV prevention

  • PrEP is for people without HIV who could be exposed to HIV from sex or injection drug use
  • CDC recommends the following should be assessed for PrEP including
    • Sexually active gay and bisexual men without HIV
    • Sexually active heterosexual men and women without HIV
    • Sexually active transgender persons without HIV
    • Persons without HIV who inject drugs
    • Persons who have been prescribed non-occupational post-exposure prophylaxis (PEP) and report behaviors that could expose them to HIV, or who have used multiple courses of PEP
  • For sexually active adults and adolescents
    • Anal or vaginal sex in the past six months and
    • HIV-positive sexual partner (especially if partner has unknown or detectable viral load) or
    • Recent bacterial STI or
    • History of inconsistent or no condom use with sexual partner(s)
  • For persons who inject drugs
    • HIV-positive injecting partner or
    • Shares drug preparation or injection equipment
  • All persons eligible for PrEP
    • Documented negative HIV test result before prescribing PrEP and
    • No signs/symptoms of acute HIV infection and
    • Normal renal function and
    • No contraindicated medications

Note: While the CDC compartmentalizes “risk groups” as listed above, clinicians should remember that sexual health does not fit neatly into static compartments | Sexuality and sexual behavior are fluid, and individuals may change their partners, behavior, and condom use over time and situations

Other Considerations

Follow-up

  • Patients taking PrEP can be followed closely by medical staff who are both clinical and non-clinical to assure proper usage and safety
    • Current recommended follow-up every three months for oral PrEP or every two months for intramuscular PrEP
    • Use of in-person and telemedicine visits
    • Specific laboratory testing is indicated upon initial visit and subsequent follow-up

Women’s Health

The American College of Obstetricians and Gynecologists (ACOG) recommends providers working with women at risk of HIV transmission be aware and up to date on this preventative health tool and encourage strong adherence as key to its effectiveness

Future Directions

  • Future delivery systems of PrEP are in various stages of clinical development and research and will likely become available as options in the future:
    • Long acting injectables – now FDA approved!
    • Implants
    • Long-acting oral agents
    • Patches

Learn More – Primary Sources:

CDC Guidelines Pre-Exposure Prophylaxis

National Clinician Consulting Center: PrEP: Pre-Exposure Prophylaxis

National Institute of Health (NIH): Pre-Exposure Prophylaxis (PrEP)

NIH guidelines for clinicians on PrEP among individuals who are trying to conceive or are pregnant, postpartum, or breastfeeding

World Health Organization (WHO) compendium of PrEP publications

ACOG: Preexposure Prophylaxis for the Prevention of Human Immunodeficiency Virus

Commercial Support

This educational activity is supported by an independent educational grant from Gilead Sciences

Faculty Disclosures

Dr. Shuter has no relevant financial relationships to disclose

Dr. Felsen has no relevant financial relationships to disclose

Dr. Bernardo has no relevant financial relationships to disclose

Special Thanks

Special thanks to David Malebranche, MD, MPH and Ariel Watriss, MSN, NP for their insights and contribution.

Implement and Maintain a PrEP Program in Your Clinic

Review the latest recommendations with  

Jonathan Shuter, MD, a Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

Uriel Felsen, MD, an Associate Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

Raffaele M. Bernardo, DO, an Assistant Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

SUMMARY:

Pre-exposure prophylaxis (PrEP) should be viewed as a sexual health program that our patients can utilize. It involves integration of targeting sexual history-taking, comprehensive behavioral evaluations, and a discussion of a patient’s approach to achieving sexual pleasure while also incorporating HIV prevention options tailored to their needs

KEY POINTS:

  • PrEP is a highly effective prevention tool that can reduce HIV transmission among our patients
  • PrEP is a service that can be folded into a clinical practice similar to other specialized services
  • Successful PrEP delivery requires passion, planning, and utilization of innovative delivery systems
  • PrEP is an HIV prevention option that can be used by anyone who is sexually active

PrEP is a program, not a pill

PrEP Regimens

  • Currently there are two daily oral PrEP regimens that patients can access and an intramuscular regimen every eight weeks
    • F/TDF 200mg/300mg orally daily (Truvada)
    • F/TAF 200mg/25mg orally daily (Descovy)
    • Cabotegravir 600mg IM every eight weeks after initiation phase of administration at week zero and week four
  • Promotes overall sexual health
  • Monitors and screens actively for sexual transmitted infections (STIs)
  • Serves as a gateway to normalizing routine health care
  • Will soon involve other delivery systems beyond pills and injections

PrEP as a collaborative effort

  • Involvement with local community-based organizations to create programs
  • Continued involvement with community to evaluate and improve services
  • Provision of other social programs can help assist in healthcare access

Innovative models

PrEP has been FDA-approved as an HIV prevention option since 2012

Traditional Models

  • Traditional models for PrEP evaluation and distribution were primarily clinic-based
  • over time these models have evolved to include approaches that provide more ways in which patients can access this sexual health option

Telemedicine

  • Telemedicine: While telehealth models for PrEP were being explored earlier, the onset of the COVID-19 pandemic accelerated the use of telemedicine for PrEP services
    • As an option for in person visits
    • As a bridge between in person visits
    • Coupled with at home HIV and STI testing
    • Used to access “PrEP mentors” who provide expert guidance

Pharmacy-Based

  • Pharmacy-based: Given the demand to see more patients placed on primary care providers in outpatient clinics, there may not be enough time for them to conduct a thorough sexual history and PrEP evaluation. PrEP programs that are pharmacist-led have been shown to be effective, as pharmacists are uniquely poised to bring a level of expertise that many clinicians may not have:
    • Experienced guidance on medications, side effects, and drug interactions
    • Familiarity with navigating the red tape PrEP with varied insurance plans
    • Familiarity with patient assistance programs for patients who are uninsured or underinsured

Multi-disciplinary and other models

  • Multidisciplinary models
    • Community-led and maintained
    • Peer-navigators facilitate linkage to care and continued engagement
  • Nurse-led programs

Ongoing monitoring

See our post on Initial Visit, Dosing, and Follow-up for initiation of PrEP

The current recommendations for ongoing care once oral PrEP has been initiated include:

  • In-person or telehealth follow up visit every three months
  • Prescription refills every three months
  • HIV test every three months (typically done as part of refill of prescription on the same timeline and can be administered as at-home testing)
  • Renal and hepatic labs every six months
  • UPT as indicated
  • STI testing as directed by sexual health review done at each follow up visit.
  • Assessment of sexual and general health needs
  • Review of any new medications and medical updates

The current recommendations for ongoing care once IM PrEP has been initiated include all the above at two-month intervals except renal and hepatic lab monitoring

Practical Tip

While there is no “how-to” manual about starting and maintaining a PrEP program, there are some things you should consider when establishing one at your workplace:

  • Personnel
    • Recruit staff who are passionate and interested in doing sexual health & PrEP work
    • Some of the routine follow ups and other visits do not have to be conducted by a medical provider
    • You can have medical assistants and peer navigators involved as much as they would like
  • Timing
    • consider either integrating PrEP visits as part of everyday sessions OR make special clinic days or sessions devoted to seeing patients interested in PrEP
    • You can always start small and ramp up available hours of service if needed
  • Pharmacy
    • Get pharmacy staff involved from the beginning throughout the process if you have a pharmacy on site
    • Skilled pharmacists can help to navigate patients through patient assistance programs and copay cards as well as insurance coverage for generic versus brand name PrEP
    • If you don’t have a pharmacy on-site, identify a local pharmacy who handles HIV and PrEP often to make the process easier for patients

Note: Mail-order delivery is a must-have option for many patients

  • Optimize Electronic Medical Records
    • Create “smart sets” for PrEP visits, both initial and follow-up
    • This can help providers walk patients through appropriate history, physical exam details, and appropriate lab orders
  • Telehealth is an essential aspect of many PrEP programs that allows for quick “check-ins” and other follow-up
    • Ensures that patients have enough refills for PrEP
    • Can identify what testing is necessary if they cannot make a visit in person
  • Marketing
    • Make sure your clinic’s website, waiting area, and exam rooms include information about PrEP services you offer will help ease some of the stigma patients may feel about asking about PrEP themselves

Learn More – Primary Sources:

Funding Resources

Primary Sources

Commercial Support

This educational activity is supported by an independent educational grant from Gilead Sciences

Faculty Disclosures

Dr. Shuter has no relevant financial relationships to disclose

Dr. Felsen has no relevant financial relationships to disclose

Dr. Bernardo has no relevant financial relationships to disclose

Special Thanks

Special thanks to David Malebranche, MD, MPH and Ariel Watriss, MSN, NP for their insights and contribution.

Downloadable Infographics

For Healthcare Professionals | For Your Patients

Feel free to download and use these infographics

For Healthcare Professionals

Infographics for Your Patients

Take Control of Your Sexual Health

This information was prepared for you by

Jonathan Shuter, MD, a Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

Uriel Felsen, MD, an Associate Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

Raffaele M. Bernardo, DO, an Assistant Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

SUMMARY:

Who you have sex with and what kind of sex you have are your choices. Some things, like who else your partner or partners have sex with, are out of your control but can affect you. The group of infections that can be passed through sex have been called many different names: venereal diseases or VDs, sexually transmitted diseases or STDs, and sexually transmitted infections or STIs. On this site, we will call them STDs.

How You Can Take Control of your Sexual Health

  • It’s possible to have sex with someone and not know they have an STD or HIV, but there are tools available that can help you take control of your sexual health
    • Good tests are available for most STDs
    • Good treatments are available for most STDs
    • There are vaccines against STD viruses like HPV and hepatitis B that also prevent cancers
    • Talk to your healthcare team and learn about PrEP
  • When you take PrEP, you take control of your risk for HIV
    • You choose your health care team
    • You choose your PrEP medicine
    • By checking in with your healthcare professional, you can make sure that
      • PrEP is a good option and safe for you
      • You check, treat, and control your risk for other STDs
  • Making the decision to take control of your sexual health is powerful | Your sexual health is just as important as other parts of your health
  • Some additional things you can discuss with your healthcare professional include
    • Eating healthier
    • Exercising more
    • If you smoke, talk to your health care team about quitting
    • If you use alcohol or other drugs, talk to your health care team about getting help to cut down or quit
    • If you have depression, anxiety, or other mental health issues, work with your healthcare team so you can get the help that you need
    • Vaccines can prevent serious infections, and new vaccine information comes out every year | Make sure with your health care team that you get all the vaccines that are right for you
  • Remember that heart disease is the #1 killer in the US | Keeping your heart healthy can add years to your life
    • If you have high blood pressure, work with your health care team to get it under control
    • If you have diabetes, work with your health care team to manage your sugar
    • If you have high cholesterol, work with your health care team to bring it down

Remember, you are driving this train.  Do everything that you can to make sure that the ride is smooth, the journey is enjoyable, and that you reach your destination safely and in good health

Learn More – Primary Sources 

There are many good websites with information people interested in learning more about PrEP. Here are a few:

CDC: PrEP (Pre-exposure Prophylaxis)

NIH: Pre-Exposure Prophylaxis

New York State Department of Health

PleasePrEPMe (California State)

CDC: PrEP Is for Women (cdc.gov)

Commercial Support

This educational activity is supported by an independent educational grant from Gilead Sciences

Faculty Disclosures

Dr. Shuter has no relevant financial relationships to disclose

Dr. Felsen has no relevant financial relationships to disclose

Dr. Bernardo has no relevant financial relationships to disclose

Women’s Health (PrEP to Protect You and Your Baby)

This information was prepared for you by

Jonathan Shuter, MD, a Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

Uriel Felsen, MD, an Associate Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

Raffaele M. Bernardo, DO, an Assistant Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine.

SUMMARY:

If you are thinking about getting pregnant, are pregnant, or have a baby, you are probably thinking a lot about both your health and the health of the baby. If you are trying to get pregnant and your partner is living with HIV, it is VERY important that you speak to your health care team about ways to lower the chance of HIV transmission. The group of infections that can be passed through sex have been called many different names: venereal diseases or VDs, sexually transmitted diseases or STDs, and sexually transmitted infections or STIs. On this site, we will call them STDs. In addition to HIV, other STDs, like herpes and syphilis, can also be dangerous for the baby. It is important that you speak with your health care team about controlling your risk for STDs and treating any you may have before, during, and after your pregnancy

What is PrEP?

  • PrEP stands for Pre-Exposure Prophylaxis
    • “Pre-exposure” means having medicine in your system even before you have sex
    • “Prophylaxis” means the medicine prevents you from getting HIV even if your partner has it

What’s Changed?

  • Until 2012
    • The only ways to avoid getting HIV from sex were
      • To not have sex
      • Never have sex with someone with HIV
      • Use condoms properly every single time
    • And still … way too many people still got HIV from sex
  • Today, there are more ways to reduce your risk of HIV
    • Newer medications for people with HIV that really work
      • If your partner has HIV, make sure your partner takes HIV meds and has an undetectable HIV viral load | “Undetectable” means that the HIV virus cannot be found in the person’s blood
      • Someone who STAYS undetectable by taking meds the right way can’t give anyone else the virus through sex
    • Take PrEP to protect yourself if you don’t have HIV

More on PrEP

  • When PrEP medicine is taken correctly it provides safe and excellent protection against HIV
  • IF YOU DON’T TAKE IT, IT CAN’T WORK
  • In most states, you cannot get PrEP without a physician prescription | In certain states, pharmacists may provide PrEP to people without a doctor’s prescription

What You Need to Know About PrEP Medications During Pregnancy

TDF/FTC (pills)

  • TDF/FTC is one pill that contains 2 medicines and is also known as
    • Truvada
    • Tenofovir disoproxil fumarate/emtricitabine
  • Takes about a week to build up to protective levels in your system, except in the vagina where it can take three weeks
  • TDF has been used as a medicine for HIV since 2001 and FTC since 2004
    • These meds have been around for a long time
  • Use of TDF/FTC in pregnancy
    • Many pregnant women have used TDF/FTC, both women living with HIV and women on PrEP
    • It is considered safe for both mom and baby
    • Less is known about TDF/FTC if you’re breastfeeding (more below)

Cabotegravir (injection)

  • Cabotegravir injection is also known as
    • Apretude
    • CAB-LA
  • Has been used in the US as a medicine for HIV since January 2021
  • Cabotegravir use in pregnancy
    • Has been used by very few pregnant and breastfeeding women
    • There is no sign yet of any significant risk, but it is too early to say anything about its safety with confidence

Note: TAF/FTC is another combination pill that is effective at preventing HIV but has not been approved as a PrEP medication for vaginal sex, so TDF/FTC and cabotegravir are the only medicines for use in people who are or are trying to get pregnant

If You are Already on PrEP Medication During the Time You are Trying to Get Pregnant

TDF/FTC

  • Continue it unless you, together with your health care team, decide that the chance of HIV transmission from your partner(s) is extremely low, such as
    • If you stop having sex during pregnancy
    • If your partner is HIV negative (and both you and your partner have no other partners)
    • If your partner is living with HIV, takes meds consistently and correctly, and has kept an undetectable viral load

Note: Remember that it will take up to three weeks to be safely back on PrEP again if you decide to restart it

Cabotegravir

  • Discuss with your health care team whether to
    • Continue
    • Stop
    • Switch to TDF/FTC

Breastfeeding

  • TDF/FTC
    • Appears to be safe for mom and baby if you are breastfeeding
    • However, there is not enough experience to know for sure
  • Cabotegravir
    • Almost nothing is known about cabotegravir and breastfeeding since this is a newer medication

Note: If you are thinking about taking PrEP and breastfeeding, you should discuss this with your health care team, including your baby’s pediatrician

Learn More – Primary Sources

There are many good websites with information people interested in learning more about PrEP. Here are a few:

CDC: PrEP Is for Women (cdc.gov)

CDC: PrEP (Pre-exposure Prophylaxis)

NIH: Pre-Exposure Prophylaxis

International Association of Providers of AIDS Care (iapac.org): Pre-Exposure Prophylaxis (PrEP)

New York State Department of Health

PleasePrEPMe (California State)

Commercial Support

This educational activity is supported by an independent educational grant from Gilead Sciences

Faculty Disclosures

Dr. Shuter has no relevant financial relationships to disclose

Dr. Felsen has no relevant financial relationships to disclose

Dr. Bernardo has no relevant financial relationships to disclose

Why PrEP?

This information was prepared for you by

Jonathan Shuter, MD, a Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

Uriel Felsen, MD, an Associate Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

Raffaele M. Bernardo, DO, an Assistant Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

SUMMARY:

PrEP is one of the most effective ways for you to lower your chance of getting HIV infection. It can be used in combination with other methods including condoms, making sure any sexual partners living with HIV are taking their meds the right way and staying undetectable, and not sharing needles or injection equipment if you inject drugs. PrEP can work for everyone regardless of biological sex, gender identity, or sexual orientation and can also reduce the chance of HIV transmitted through injection drug use. PrEP puts YOU in control of your sexual health.

What is PrEP?

  • PrEP stands for Pre-Exposure Prophylaxis
    • “Pre-exposure” means having medicine in your system even before you have sex
    • “Prophylaxis” means the medicine prevents you from getting HIV even if your partner has it
  • There are different PrEP options to choose from (read more about these medications by tapping the ‘More About PrEP Meds’ entry’ at the top of this entry)

TDF/FTC (pills)

  • TDF/FTC is one pill that contains two medicines and is also known as
    • Truvada
    • Tenofovir disoproxil fumarate/emtricitabine

TAF/FTC (pills)

  • TAF/FTC, similar to TDC/FTC, is one pill that contains two medicines and is also known as
    • Descovy
    • Tenofovir alafenamide/emtricitabine

Cabotegravir (injection)

  • Cabotegravir injection is also known as
    • Apretude
    • CAB-LA

PrEP Works

  • Many studies done across the globe have proven that when PrEP is taken correctly and consistently it is HIGHLY effective in preventing HIV infection
  • When PrEP doesn’t work, it is usually because people miss too many doses of the medicine or don’t take it at all

PrEP is Safe

  • Most people who take PrEP don’t have side effects
  • When side effects do happen, they are usually mild and often go away after a few weeks of taking PrEP

Other Considerations:

  • By law, almost all health insurances in the US must cover the costs of PrEP including
    • Medicine
    • Doctor visits
    • Blood tests
    • HIV testing
    • STD testing
  • PrEP can adapt to what’s happening in your life since your risk for HIV can change
    • It’s a good idea to talk to your health care team about stopping PrEP before making that decision
    • If things change again, you can restart
  • PrEP does not protect against other STDs like gonorrhea, chlamydia, or syphilis
    • Condoms are very good at preventing these infections when used correctly

NOTE: You have to be on most PrEP medicines for at least one week before you can be sure that they’re working, and for at least three weeks if you are a cisgender woman or transgender man who has vaginal sex | You will also need an HIV test before restarting

Learn More – Primary Sources 

There are many good websites with information people interested in learning more about PrEP. Here are a few:

JAMA: Preventing HIV With PrEP 

CDC: PrEP (Pre-exposure Prophylaxis)

NIH: Pre-Exposure Prophylaxis

International Association of Providers of AIDS Care (iapac.org): Pre-Exposure Prophylaxis (PrEP)

New York State Department of Health

PleasePrEPMe (California State)

CDC: PrEP Is for Women (cdc.gov)

Commercial Support

This educational activity is supported by an independent educational grant from Gilead Sciences

Faculty Disclosures

Dr. Shuter has no relevant financial relationships to disclose

Dr. Felsen has no relevant financial relationships to disclose

Dr. Bernardo has no relevant financial relationships to disclose

More About PrEP Meds

This information was prepared for you by

Jonathan Shuter, MD, a Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

Uriel Felsen, MD, an Associate Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

Raffaele M. Bernardo, DO, an Assistant Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine.

SUMMARY:

There are three PrEP Meds Available in the US. Two types you can take in a pill form by mouth and one type is a needle injection. All three can reduce your risk of HIV if taken according to instructions. Below, we review these medications that can help keep you safe and healthy.

TDF/FTC

  • TDF/FTC is one pill that contains two medicines and is also known as
    • Truvada
    • Tenofovir disoproxil fumarate/emtricitabine
  • Takes about a week to build up to protective levels in your system, except in the vagina where it can take three weeks
  • TDF has been used as a medicine for HIV since 2001 and FTC since 2004
    • These meds have been around for a long time
  • The combination of these two medications, TDF/FTC, has been used in the US for PrEP since 2012
    • Generic TDF/FTC has been used in the US since 2020
    • This means that the pill can look different based on which company makes it
    • Generic TDF/FTC is just as effective as “brand-name” Truvada
  • When and how to take TDF/FTC
    • It is a tablet that you take once a day, every day, if there’s a chance you could get HIV from your partner(s)
    • You can take it with or without food

Side Effects

  • TDC/FTC has very few side effects | In fact, most people will have no significant side effects
  • Stomach
    • Sometimes TDC/FTC can upset your stomach
    • Unless it is making you very sick, this side effect usually passes after two to four weeks if you stay on the medicine
  • Kidney (also known as renal)
    • Side effects are very rare
    • Your healthcare professional will want to do a blood test every six to twelve months to check your kidneys
    • If there is a kidney problem on TDF/FTC, it usually gets better after stopping the medicine
  • Thinning of bones
    • Side effects are very rare but can also occur
    • TDC/FTC does not usually cause pain
    • Taking calcium and vitamin D pills may help to avoid bone side effects

TAF/FTC

  • TAF/FTC, similar to TDC/FTC, is one pill that contains two medicines and is also known as
    • Descovy
    • Tenofovir alafenamide/emtricitabine
  • Takes about a week to build up to protective levels in your system
  • TAF has been used as a medicine for HIV since 2015 and FTC since 2004
    • These meds have been around for a long time
  • TAF/FTC has been used in the US for PrEP since 2019
  • TAF/FTC is ONLY approved for use by
    • Cisgender men
    • Transgender women
    • It is not known whether it works in cisgender women since its ability to prevent HIV in the vagina is uncertain
  • When and how to take TAF/FTC
    • Taken the same way as TDF/FTC
    • One pill once per day, if there’s a chance you could get HIV from your partner(s)
    • You can take it with or without food

Side Effects

  • TAF/FTC has very few side effects | In fact, most people will have no significant side effects
  • Stomach
    • Sometimes it can upset your stomach
    • Unless it is making you very sick, this side effect usually passes after two to four weeks if you stay on the medicine
  • Kidney and bone effects
    • TAF/FTC probably has fewer kidney and bone side effects than TDF/FTC
    • Your healthcare professional will want to do a blood test every six to twelve months to check your kidneys
    • Taking calcium and vitamin D pills may help to avoid bone side effects

Note: You don’t have to take PrEP pills at exactly the same time every day | It’s more important that if you’re taking oral PrEP you make sure to get it in your system every day

Cabotegravir

  • Cabotegravir injection is also known as
    • Apretude
    • CAB-LA
  • Cabotegravir has been used in the US as a medicine for HIV since January 2021
  • In December 2021, cabotegravir was approved for PrEP as a long-acting injection every two months
    • The protection that you get from cabotegravir every two months is at least as good as taking TDF/FTC or TAF/FTC every day
    • One of the best things about cabotegravir is that you get the injection every two months, and you don’t have to worry about taking pills
  • If you decide to take cabotegravir PrEP
    • You will have to see your healthcare professional every two months for the injection
    • If you’re worried you might miss an injection, you should speak to your healthcare professional
  • To start cabotegravir PrEP
    • You either have to get an injection every month for the first two months or
    • You can take cabotegravir pills every day for a month before switching to an injection every two months
  • It is not known how long you have to wait after your first injection until you are protected
    • It would make sense to wait seven days as is done for the other types of PrEP
    • If you are switching from TDF/FTC or TAF/FTC to cabotegravir, you do not have to wait
  • The cabotegravir injections must be given in the buttocks

Side Effects

  • In general, cabotegravir is considered safe
  • The only common side effect is pain or swelling where you get the injection
  • This usually happens less and less as you stay on the drug
  • You can take over the counter pain relievers (like Tylenol) and/or use heating pads to relieve the pain
  • It is rare for people to stop cabotegravir because of the pain

Other Things You Should Know

  • What if you don’t want to take a pill every day?
    • Depending on how frequently someone is at risk for HIV, taking a pill every day may not be the best option
    • People with less frequent risk who have decided to take TDF/FTC may talk to their provider about the possibility of “on-demand” or “2-1-1” PrEP instead of taking a pill every day
    • This is an option that has only been recommended for men who have sex with men, and you should discuss it with your provider if you don’t want to take a pill every day
  • Switching from one PrEP drug to another
    • If you want to switch from one PrEP medicine to another, it can probably be done safely, but it is something that you should discuss with your healthcare professional to make sure it is done safely and correctly
  • Stopping and restarting PrEP
    • You might consider stopping PrEP if you are no longer at risk for HIV
    • Remember that once PrEP is stopped, you will no longer have protective levels of the medication in your system
    • If you stop PrEP, you will need an HIV test first to make sure it is negative before you can restart

Learn More – Primary Sources

There are many good websites with information people interested in learning more about PrEP. Here are a few:

CDC: PrEP (Pre-exposure Prophylaxis)

NIH: Pre-Exposure Prophylaxis

International Association of Providers of AIDS Care (iapac.org): Pre-Exposure Prophylaxis (PrEP)

New York State Department of Health

PleasePrEPMe (California State)

CDC: PrEP Is for Women

Commercial Support

This educational activity is supported by an independent educational grant from Gilead Sciences

Faculty Disclosures

Dr. Shuter has no relevant financial relationships to disclose

Dr. Felsen has no relevant financial relationships to disclose

Dr. Bernardo has no relevant financial relationships to disclose

Staying Healthy with PrEP: What to Expect at Your Visit

This information was prepared for you by

Jonathan Shuter, MD, a Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

Uriel Felsen, MD, an Associate Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

Raffaele M. Bernardo, DO, an Assistant Professor of Medicine in the Division of Infectious Diseases at Montefiore Medical Center and the Albert Einstein College of Medicine

SUMMARY:

What is PrEP?

  • PrEP stands for Pre-Exposure Prophylaxis
    • “Pre-exposure” means having medicine in your system even before you have sex
    • “Prophylaxis” means the medicine prevents you from getting HIV even if your partner has it

What’s Changed?

  • Until 2012
    • The only ways to avoid getting HIV from sex were
      • To not have sex
      • Never have sex with someone with HIV
      • Use condoms properly every single time
    • And still … way too many people still got HIV from sex
  • Today, there are more ways to reduce your risk of HIV
    • Newer medications for people with HIV that really work
      • If your partner has HIV, make sure your partner takes HIV meds and has an undetectable HIV viral load | “Undetectable” means that the HIV virus cannot be found in the person’s blood
      • Someone who STAYS undetectable by taking meds the right way can’t give anyone else the virus through sex
    • Take PrEP to protect yourself if you don’t have HIV

More on PrEP

  • When PrEP medicine is taken correctly it provides safe and excellent protection against HIV
  • IF YOU DON’T TAKE IT, IT CAN’T WORK
  • In most states, you cannot get PrEP without a physician prescription | In certain states, pharmacists may provide PrEP to people without a doctor’s prescription

WHAT TO EXPECT WHEN YOU GO FOR A VISIT:

The Health Care Team Will Probably Ask You About

  • Your sexual history, your sexual preferences, and your sexual risks
    • Don’t be embarrassed
    • These questions are important to help you and your health care team create an HIV prevention plan that works for you to keep you healthy
  • Ask you about your other medical history
  • Do a physical examination
  • Test your blood for
    • HIV test:  You can’t take PrEP if you already have HIV
    • Kidney test to see how your kidneys are working: Needed before starting some PrEP meds
    • Pregnancy test (if you are able to get pregnant). Most PrEP treatments are considered to be safe during pregnancy, but pregnant women should review any medicines that they take with their health care teams.
  • Test you for other infections that can be spread through sex
    • These infections are also known as Sexually Transmitted Diseases or STDs | They are also sometimes called STIs (Sexually Transmitted Infections)
    • The STDs that you will most likely be tested for are syphilis, gonorrhea, and chlamydia
    • The tests usually involve swabs from the genital, anal, and oral areas | The syphilis test is a blood test
    • Often, patients can collect their own swabs (like Q-tips) from these areas
    • Hepatitis B: Tests for liver infection | Some of the PrEP medicines can cause problems in people who have hepatitis B infection (a type of liver infection caused by a virus)

The Healthcare Team Will Probably Discuss the Following with You

  • What is PrEP?
  • What are your different PrEP choices?
  • How to take PrEP correctly
  • What are the side effects to look for?
    • Serious side effects are very rare!
  • Safer sex: What are ways to avoid other STDs

Next Steps Before You Leave

  • You will likely get a prescription
    • To start PrEP right away or
    • Start taking it after your blood tests come back okay
  • Until December 2021, PrEP was only available as pills
    • There is now another choice – an injection that you take every two months
    • Your health care team may discuss with you the choice of pills or injections
  • You will get an appointment for a follow-up visit in 1 to 3 months
  • As long as you are on PrEP, your health care team will probably need to see you 2 to 4 times a year for a check-up, an HIV test, and STD testing

Learn More – Primary Sources

There are many good websites with information people interested in learning more about PrEP. Here are a few

CDC: PrEP (Pre-exposure Prophylaxis)

NIH: Pre-Exposure Prophylaxis

New York State Department of Health

PleasePrEPMe (California State)

CDC: PrEP Is for Women

Commercial Support

This educational activity is supported by an independent educational grant from Gilead Sciences

Faculty Disclosures

Dr. Shuter has no relevant financial relationships to disclose

Dr. Felsen has no relevant financial relationships to disclose

Dr. Bernardo has no relevant financial relationships to disclose

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American Gastroenterology Association (AGA) Clinical Practice Obesity Guideline Including Pharmacological Interventions

Summary: 

Obesity, defined by the CDC as a weight that is higher than what is considered healthy for a given height, has been increasing in prevalence over several decades. Roughly two thirds of adults are considered obese or overweight, with a recent estimate putting the prevalence of adults with obesity at nearly 42% of the population. It is customary to use BMI calculations as both a screening tool and to further characterize the degree of obesity, but it is important to note that BMI does not diagnose a patient’s health or even degree of body fat. Healthcare providers should combine appropriate clinical assessments, considering body weight, central fat distribution, functional status, and presence of obesity related complications, to create a more accurate picture of a patient’s health. In recent years we have gained a better understanding of what contributes to obesity and what helps a patient maintain a healthy weight. The AGA has accordingly updated their guidelines on pharmacological interventions for adults with obesity to better help clinicians care for their obese patients.  

Diagnosis 

All adults should be screened for obesity by obtaining a height and weight and calculating BMI during a routine physical exam 

BMI can be calculated via calculator or by dividing weight (kg) over height (m)2 

  • Underweight: <18.5 kg/m 2 
  • Normal weight: ≥18.5 to 24.9 kg/m 2 
  • Overweight: ≥25.0 to 29.9 kg/m 2 
  • Obesity: ≥30 kg/m 2 

Obesity can be further characterized by class 

  • Class I: 30.0 to 34.9 kg/m 2 
  • Class II: 35.0 to 39.9 kg/m 2  
  • Class III: ≥40 kg/m 2 

A BMI over 25 kg/m 2 should prompt further evaluation including 

  • Measurement of waist circumference: > 40 inches in men and > 35 inches in women is associated with increased risk for obesity related complications 
  • Screening for obesity related complications (see below) 
  • Consideration of causes of weight gain not related to diet and activity level (e.g., hypothyroidism, drug side effect, depression, Cushing’s syndrome)  
  • Blood pressure measurement  
  • Fasting glucose and lipid levels 

Note: A BMI > 23 kg/m2 may indicate the need for further evaluation in patients of South Asian, Southeast Asian, and East Asian descent as obesity related complications develop at lower BMIs in these populations 

 Obesity related complications 

  • Type 2 Diabetes Mellitus (T2DM), Prediabetes  
  • Cardiovascular disease 
  • Hypertension 
  • Hyperlipidemia 
  • Obstructive sleep apnea 
  • Obesity hypoventilation syndrome 
  • Nonalcoholic fatty liver disease 
  • Osteoarthritis 
  • Stroke 
  • Certain malignancies (e.g., colorectal cancer, endometrial cancer) 
  • Depression  
  • PCOS, Infertility  
  • GERD  
  • Urinary incontinence 
  • VTE 
  • Gallstones  

Lifestyle Interventions 

The cornerstones of weight loss management are individualized dietary changes and increased physical activity. Recent guidelines, including the USPSTF recommendations, recommend the use of behavioral therapy and a multidisciplinary approach involving weight loss counselors, psychologists, physical therapists and dieticians to assist the patient in establishing and reaching their weight loss goals.  

Weight loss goals should be modest 

  • A weight reduction of 5% to 10% of initial body weight is sufficient to yield significant health benefits including decreased risk of diabetes and cardiovascular disease  
  • A 5% weight loss within 3 months is used by the US Food and Drug Administration (FDA) to assess the efficacy of medications to treat obesity 

Increased calorie expenditure 

  • Adults should perform at least 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity aerobic activity per week (or an equivalent combination of these)  

Decreased calorie intake 

  • Reducing daily calorie intake to 1200 to 1500 for women and 1500 to 1800 for men  
  • Estimating an individual’s daily energy requirements and aiming for an energy deficit of 500 kcal/d or 750 kcal/d  

Pharmacological Therapies 

In adults with obesity or overweight with weight-related complications, who have had an inadequate response to lifestyle interventions, the AGA recommends adding pharmacological agents to lifestyle interventions over continuing lifestyle interventions alone.

Clinical Considerations 

Anti-obesity medications (AOMs) are not recommended for: 

  • Pregnant women  
  • Patients with bulimia nervosa  

Use caution when starting AOMs for patients with: 

  • Diabetes treated with insulin or insulin secretagogues (e.g., sulfonylureas) as AOMs may decrease blood sugar levels 
  • Hypertension or those on blood pressure lowering agents, as AOMs may lower blood pressure as weight is lost  
  • Binge eating disorder  

Cost of AOMs may limit their access and data on cost-effectiveness is limited 

Recommended Anti-Obesity Medications 

Semaglutide (Wegovy)     

  • Largest magnitude of net benefit, so can be considered first line prior to other drugs 
  • Dosing is started at 0.25 mg/week escalated gradually to goal of 2.4 mg/week 
  • Delays gastric emptying, may cause nausea and emesis which is mitigated by slow taper to goal dose 
  • Can maintain on highest dose tolerated  
  • Contraindications: History of pancreatitis|Hx or FHx of Medullary Thyroid Cancer| Hx of FHx of MEN-2A or MEN-2B 
  • Associated with increased risk of pancreatitis and biliary disease  
  • Used in Diabetes under brand name Ozempic 

Liraglutide (Saxenda)   

  • Escalate dose gradually to a target dose of 3mg daily  
  • Can maintain at highest dose tolerated 
  • Associated with nausea, emesis due to delayed gastric emptying 
  • Associated with increased risk of pancreatitis and biliary disease 
  • Contraindications: History of pancreatitis or FHx of Medullary Thyroid Cancer| Hx of FHx of MEN-2A or MEN-2B 
  • Used in DM under brand name Victoza 

Tirzepatide (Mounjaro) 

  • Not included in AGA guidelines, but promising results from recent trial published in NEJM (see “Primary Sources – Learn More” below)

Phentermine-Topiramate ER (Qsymia) 

  • Useful in patients who also have migraines given the Topamax component  
  • Avoid in patients with cardiovascular disease and hypertension 
  • Monitor HR and BP regularly while on this medicine 
  • Topamax is teratogenic and women of child-bearing age should be appropriately counseled  
  • Pregnancy test should be obtained prior to initiation 
  • Multiple drug interactions exist 

Naltrexone-Bupropion ER (Contrave) 

  • Useful in patients with concomitant depression or desire to quit smoking  
  • Avoid in patients with seizure disorders and those on opiates 
  • Monitor HR and BP regularly while on this medicine 

Orlistat (Xenical) 

  • No longer recommended due to minimal effects and significant GI adverse effects  

Phentermine (Adipex) 

  • Approved by the FDA for short term use (12 weeks) but used off label for chronic weight loss management 
  • Typically not recommended as first line therapy due to side effects and potential for abuse 
  • Avoid in patients with cardiovascular disease 
  • Avoid in patients with history of drug abuse 
  • Monitor HR and BP regularly while on this medicine 

Diethylpropion (Amfepramone) 

  • Approved by the FDA for short term use (12 weeks) but used off label for chronic weight loss management  
  • Typically not recommended as first line therapy due to side effects and potential for abuse 
  • Avoid in patients with cardiovascular disease 
  • Monitor HR and BP regularly while on this medicine 

Future therapies 

Gelesis100 Oral Superabsorbent hydrogel 

  • Space occupying gel to decrease appetite and PO intake 
  • Delivered in the form of a pill with 3 pills take with water prior to lunch and dinner 
  • For patients with BMI of 25 to 40 kg/m 2 
  • Currently in use via clinical trials  

Surgical Management 

While not addressed in the recent AGA guidelines, the AGA did publish guidelines in 2017 that included surgical management options

Bariatric Endoscopy 

  • Intragastric balloon 
  • Aspiration therapy  
  • Endoscopic sleeve gastroplasty 
  • Transoral outlet reduction 

Bariatric Surgery 

  • Laparoscopic sleeve gastrectomy  
  • Laparoscopic Roux-en-Y gastric bypass  
  • Adjustable gastric banding 

Primary Sources – Learn More: 

AGA Clinical Practice Guideline on Pharmacological Interventions for Adults With Obesity

Behavioral Weight Loss Interventions to Prevent Obesity-Related Morbidity and Mortality in Adults US Preventive Services Task Force Recommendation Statement

White Paper AGA: POWER — Practice Guide on Obesity and Weight Management, Education, and Resources

Pharmacological Management of Obesity: An Endocrine Society Clinical Practice Guideline

AJMC: A Review of Current Guidelines for the Treatment of Obesity

CDC: Overweight and Obesity

NEJM: Tirzepatide Once Weekly for the Treatment of Obesity

CDC: Adult BMI Calculator | Healthy Weight, Nutrition, and Physical Activity