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PrEP 1-2-3: A Step-by-Step Guide to Incorporating PrEP Into Practice

  • Authors: Leandro A. Mena, MD, MPH; David J. Malebranche, MD, MPH
  • CME / ABIM MOC / CE Released: 5/20/2020
  • Valid for credit through: 5/20/2021, 11:59 PM EST
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Target Audience and Goal Statement

This activity is intended for primary care providers, obstetricians & gynecologists, and ID/HIV specialists.

The goal of this activity is to increase clinician competence in identifying appropriate patients for HIV PrEP, and in following best practices for the use of PrEP, according to CDC guidance.

Upon completion of this activity, participants will:

  • Have greater competence related to
    • Initial patient evaluation for appropriateness of pre-exposure prophylaxis (PrEP)
    • Timely initiation of PrEP in appropriate individuals
    • Providing ongoing monitoring and assessment for individuals receiving PrEP


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  • Leandro A. Mena, MD, MPH

    Department of Population Health Science
    Professor of Medicine
    Division of Infectious Diseases
    University of Mississippi Medical Center
    Jackson, Mississippi


    Disclosure: Leandro A. Mena, MD, MPH, has disclosed the following relevant financial relationships:
    Served as an advisor or consultant for: Gilead Sciences; Merck; Roche; ViiV Healthcare
    Served as a speaker or a member of a speakers bureau for: Gilead Sciences; ViiV Healthcare
    Received grants for clinical research from: Binx Healthcare; Click Diagnostics; Gilead Sciences; Merck; Rheonix; Roche; ViiV Healthcare

  • David J. Malebranche, MD, MPH

    Associate Professor of Medicine
    Morehouse School of Medicine
    Atlanta, Georgia


    Disclosure: David J. Malebranche, MD, MPH, has disclosed the following relevant financial relationships:
    Served as an advisor or consultant for: Gilead Sciences
    Served as a speaker or a member of a speakers bureau for: Gilead Sciences


  • Lisa Brauer, PhD

    Medical Education Director, Medscape, LLC


    Disclosure: Lisa Brauer, PhD, has disclosed no relevant financial relationships.

  • Anita A. Galdieri, PharmD, RPh

    Senior Scientific Content Manager, Medscape, LLC


    Disclosure: Anita A. Galdieri, PharmD, RPh, has disclosed no relevant financial relationships.

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  • Amy Bernard, MS, BSN, RN-BC, CHCP

    Director, Accreditation and Compliance, Medscape, LLC


    Disclosure: Amy Bernard, MS, BSN, RN-BC, CHCP, has disclosed no relevant financial relationships.

Medscape, LLC staff have disclosed that they have no relevant financial relationships.

Peer Reviewer
This activity has been peer reviewed and the reviewer has disclosed no relevant financial relationships.

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PrEP 1-2-3: A Step-by-Step Guide to Incorporating PrEP Into Practice

Authors: Leandro A. Mena, MD, MPH; David J. Malebranche, MD, MPHFaculty and Disclosures

CME / ABIM MOC / CE Released: 5/20/2020

Valid for credit through: 5/20/2021, 11:59 PM EST


Activity Transcript

Leandro A. Mena, MD, MPH: Hello, I'm Dr Leandro Mena, chairman of the Department of Population Health Science and professor of medicine in the Division of Infectious Diseases of the University of Mississippi Medical Center. Welcome to this program entitled: PrEP 1-2-3: A Step-By-Step Guide to Incorporating PrEP Into Practice. Joining me today is Dr Dave Malebranche, who is an associate professor of medicine at Morehouse School of Medicine.

Today, we are going to talk about PrEP. "PrEP" means "pre-exposure prophylaxis" and it's the use of antiretroviral (ARV) medication to keep HIV-negative people from becoming infected with HIV. PrEP is approved by the FDA and has been shown to be safe and effective in preventing HIV infection. There are currently 2 FDA-approved regimens -- both involve taking one pill once a day. This trial is part of a comprehensive approach, and we'll learn more about it today.

David, can you start things off by talking about the available PrEP regimens?

David J. Malebranche, MD, MPH: Currently, we have 2 PrEP regimens available. The first one was approved in 2012, and that's tenofovir disoproxil fumarate, or TDF, combined with emtricitabine, or FTC. That's a combination pill that's recommended for all people at risk from sex or IV drug use. What we know from the studies back in 2012 when this was FDA-approved -- the iPrEx study, as well as the Partners PrEP Study -- and we know that it's effective from those studies 90% to 92% of the time in reducing new HIV acquisition when compared to the gold standard at that time, which was placebo.[Baeten 2012] We also know that the TDF and FTC was very effective and not only effective, but also had a good safety profile where only 6% of people in either arm discontinued the regimen due to adverse events (AEs).

Then the second regimen that we have available is a newer regimen -- tenofovir alafenamide combined with FTC. This is different because this version of tenofovir, which I'll refer to as "TAF" moving forward. TAF is different, because most of TDF is actually going to the bloodstream, and gets to all the tissues, including the bone, kidneys, everywhere else. TAF is a version of the prodrug that actually doesn't get activated until it's in the cells, so 90% of it actually doesn't hit the bloodstream so it doesn't get into the bones, the kidneys, other vital organs and actually doesn't become fully activated till it gets in the lymphocytes itself.

With TAF, it's recommended for people at risk through sex, excluding people at risk through receptive vaginal sex. So in this case, the DISCOVER trial basically found that TAF was effective in reducing HIV risk by about 99.7%, and that was compared to TDF, which was about 99.4%. The one drawback from the study is that they didn't really have enough cisgendered women. So the FDA approval, which happened in 2019, is for TAF to be used as PrEP among men who have sex with men, or MSM, as well as transgendered women, but it hasn't been FDA-approved for cisgender women, up to this point, because of a lack of representation in the clinical trials.

Dr Mena: Thank you, David. As I mentioned, PrEP is very simple to implement. The CDC guidance talks about 3 stages: screening; initiation; and follow-up. Screening and initiation can be combined, and sometimes it's advisable to combine because we know that we have the best opportunity to start people on PrEP shortly after they receive an HIV-negative test. When we send people home, different priorities take over, and there is a chance that people may not come back for the initiation visit, so we have a once in a lifetime opportunity probably to start PrEP shortly after screening.

So, as we screen individuals, who do we consider as a good candidate for PrEP? Certainly, anyone who's sexually active who is not living with HIV/who is not HIV-infected could potentially be a good candidate for PrEP. That includes gay and bisexual men, heterosexual men and women, transgender individuals, persons who inject drugs (PWID), and persons who overall have been prescribed post-exposure prophylaxis (PEP). It's important when they are going to have the PEP to assess their indications for PrEP so PrEP can be continued seamlessly.

David, the first step is risk assessment. Can you talk to us about that?

Dr Malebranche: Absolutely. So, when we're screening on how to assess risk, or who's an appropriate candidate for PrEP, there are 3 main kinds of risk or issues that you should be considering. One is obviously the behavioral risk that's related to contracting HIV. As providers, we want to assess and do a detailed sexual and drug use history and kind of find out what behavioral issues are happening when someone is having sex. Are they having oral sex, anal sex, vaginal sex? With or without condoms? How many partners? And in what situations?

The second point of how we should be screening is looking at other conditions that may be happening through the medical history, or that we know from the histories of our patients, that may increase the risk of any kind of AEs that they may have to the medication that they're starting, so contraindications. The one major contraindication that we talk about all the time is someone living with HIV. One of the things we always stress is ensure that someone is known to be HIV negative with the screening test. We'll get into this a little bit later on, but obviously, if someone is living with HIV, or they test positive, giving them just TDF and FTC or TAF and FTC is not going to be a full HIV treatment regimen, and you can promote resistance by that. So, you have to confirm that they're HIV negative first.

Talking about comorbidities. Could be hepatitis B, which we'll talk about a little bit later on. Kidney problems, bone issues, diabetes, high blood pressure. Any of these comorbid conditions that may actually influence the patient's health status that may interact with the medication as they take it. Finally, medication side effects. We talk a lot of times with risk about the potential risks, particular with TDF as PrEP, whether it may damage the kidneys or cause some kidney irritation or some bone issues. Looking at medications that patients may be on, such as steroids, things like Bactrim, nonsteroidal anti-inflammatories, all those kind of medications. You want to actually screen patients, so doing a full medication history is going to be absolutely imperative to find out if someone could be at higher risk.

And then, the final point of assessing risk and who's a good candidate for PrEP is going to looking at adherence factors. So you want to take a good social history. You want to find out what may facilitate it. Do they have social support? How do they get transportation? What is their issue with the local pharmacy? Also, how literate they are from a health professional standpoint -- what we term as "health literacy." Do your patients actually know what to do? How is their reading? How is their assessment and understanding of their own medical history and how PrEP will fit into that.

Dr Mena: That was a great explanation of how to assess risk. What kind of a procedure do you take with a patient that presents to you and just says, "I would like to start taking PrEP," yet they may not exactly disclose any specific risk?

Dr Malebranche: Yes, I think that's a great point. Patients feeling very vulnerable to discuss intimate levels of their sexual history with us can be problematic when you're determining who is going to actually be a good candidate for PrEP. If someone gives me a little bit of their sexual history, there's probably a little more that they don't quite feel comfortable telling me right now. If they say, "You know what, Doc? I think I need PrEP," or "I'm putting myself at risk," and then you ask them the specific behavioral questions and you're not really seeing a history of condom-less sex or condom-less anal sex, condom-less vaginal sex, whatever it may be, realize that if they're telling you they're interested in PrEP, that they may not be telling you the full story. In these kind of patients, I screen for the other comorbid conditions, whether there's other medications they'd be on, and trust them that they know their sexual risk or their sexual behavior a little bit better than I do. If they're thinking that they need PrEP, they probably may be right.

Dr Mena: I would say go ahead and screen them for STDs, and then you may find things that people may not exactly disclose.

Dr Malebranche: When we're talking about detailed sexual history, we want to say within a window of about 6 months. When we talk about initial questions for sexual history, a lot of providers ask what we should be talking about and typically we go by what the CDC says are the 5 Ps of sexual history, which would include partners, sexual practices, protection from STIs, past history of STIs, and pregnancy or reproductive health.

Then also, looking at social and situational factors. People come with a lot of complicated histories, and a lot of intersecting factors that define who they identify with, where they're from, what their belief system is, where they work, how they have sex, what venues they go to have sex, what kind of behaviors they do with their partners. Some of those behaviors can actually increase the risk of HIV. What I like to do in clinical practice is set a tone where patients can come in and not feel judged. I want to make sure they understand that it's a safe place and that they can talk about any details of their sexual health without any fear of judgment or stigma.

Leandro, what do you do when you're seeing patients in your practice?

Dr Mena: Sexual history is something I do routinely, and I do as part of when I ask people about other behaviors, right? Like alcohol use, or smoking, or substance use. I tell patients, "I'm about to ask you some questions that are personal and are private, and I understand you can be uncomfortable." Having these conversations are important, and it's important to let people know why you're asking those questions. I tell them, "This is important, because it's going to help me to figure out how I can better take care of you." I think, as providers, we have to stop making assumptions about who may be a risk, who may not be a risk. We have to do this in a routine way. And do it in a non-judgmental way.

Dr Malebranche: Not only is the sexual history difficult to take and often challenging for providers, but also doing a drug use history. So, we usually recommend within the timeframe of 6 months. Asking if they've injected heroin or injected cocaine or methamphetamine. Sharing needles or equipment is an important thing to ask, and if they have drug works including a tourniquet, the needles, so on and so forth, that they're sharing instead of getting from a clean space.

Also, if they're using other noninjectable drugs during sex. Are they using poppers? Are they using other forms of methamphetamine? I would also add that other medications or other drugs, such as smoking weed and doing other things can cloud someone's judgment, so it's important to realize that when we're doing a drug history, it's not just to focus on the injectable drugs, but also focus on the drugs that can cloud someone's judgment so that they don't make the right decisions with condoms.

I think about a lot of different things that we can talk about with risk, things that may trauma either the vagina or the anal mucosa and cause a lot of problems where HIV could be easily transmitted. Is there anything else that you're thinking about, Leandro, that you use as far as assessment, that could be part of the risk profile?

Dr Mena: I think your description was very comprehensive. I think at the end, it's important for us as clinicians to really recognize that PrEP is a unique opportunity for us to develop a relationship with a patient and to earn their trust, right? The patient may not feel exactly comfortable disclosing right away. We have to really act now, in terms of making sure that they're protected. Build the relationship, earn their trust, and so many things will come out later.

One thing that it's important to discuss is actually how important adherence is for PrEP to be effective. There are a number of studies that have shown that PrEP is effective, more than 99% effective, as long as the adherence is to the drug -- either TDF/FTC, or TAF -- is actually above certain level. Sometimes when you miss 1 or 2 weeks, that may herald other adherent problems so it's important that any clinician who is providing PrEP has a process by which patients are supported. Check in with patients, make sure they're getting their medications, make sure they know how to get their medications, how to get the refills. And if they're having difficulties in adhering to medication -- having in mind that these are healthy individuals who have never taken medication every single day -- they may need some help in terms of developing strategies, how to become adherent to medication. It's critical to the effectiveness of PrEP.

Dr Malebranche: Absolutely. Remember, probably a lot of the people you're going to see are going to be younger, and so they may not be used to taking medications. So anything you can do to assess, "What would help you to remember to take this every day?"

Dr Mena: So, we're going to talk about risk of adverse outcomes. Both FTC/TDF and FTC/TAF have some risks. The most important harm that can be caused by giving someone PrEP -- either it's FTC/TAF or FTC/TDF -- is actually by giving PrEP to someone with undiagnosed HIV infection. Since this combination of drugs – FTC/TDF or FTC/TAF -- are not sufficient treatment for HIV. The virus can become resistant to either one or both of the components of PrEP. So it's really important, before giving PrEP to anyone, to confirm the HIV-negative status of that person.

For FTC/TDF, it can decrease the BMD over time, especially for people who are very adherent to the medication. It produces an average loss of about 1% per year of use. We don't know the correlation in terms of what happens over long term of use, but we know that, overall, you want to be cautious in individuals that may have a history of pathologic fractures, of people who may have chronic conditions, or may be taking medications that may contribute to osteoporosis-related bone loss. In a similar way, TDF has an impact on the renal tubules, so we should avoid its use in combination with drugs that may be nephrotoxic and especially in combination with high doses of NSAIDs. But also, I think it's important to consider nonpharmacologic drugs, especially supplements that people may be taking, that may have an effect on the kidneys.

For both TDF and TAF, the formulations that we have can suppress the virus that causes chronic hepatitis B. So it's important when we initiate people on PrEP that we know whether that person has chronic hepatitis B or not, because, although it's not a contraindication, people have chronic hepatitis B upon discontinuation of PrEP. There is a small/very small risk that, when you remove the drug, people may develop acute hepatitis. So people who have chronic hepatitis B should be monitored for several months, both clinically and with laboratories checking deliverance times because they may need treatment for hepatitis B upon discontinuation of PrEP.

FTC/TAF overall appears to have a safer profile, both in the bone and in the kidneys, when compared to TDF. But again, we don't know how clinically that safety profile really correlates in terms of truly reducing the emergence of bone complications, kidney complications. In my clinic, we do a medical history. We do medication history. We ask history of pathologic fractures. We ask history of kidney disease. If everything is okay, we check the creatinine. We typically don't hold initiation of PrEP waiting for the results of the creatinine, assuming that most people that we see have no medical history of any chronic disease like diabetes or hypertension, who do not take any medication that is nephrotoxic, who have a normal creatinine, this should be no problem taking PrEP pending getting the results of those tests.

David, what kind of things do you consider when doing risk assessments for PrEP?

Dr Malebranche: I have a lot of young male patients who are on protein supplements or amino acids, creatine, those kind of things that can actually be shown to do some irritation or some damage with the kidney tubules. So, I would add that in the mix, as far as NSAIDs and some other antibiotics that we talk about. Typically, when I see a patient coming in, the baseline assessment is pretty straightforward. We get a fourth-generation HIV antigen antibody test within 1 week prior to treatment. A lot of times we will have a point-of-care (POC) test, so we'll have the rapid antigen and/or antibody tests available through a finger stick or through an oral swab that we can get to prove that someone's HIV negative before they start treatment. Then, we do a history assessment to make sure that they haven't had any flu-like symptoms, rashes, diarrhea -- any symptoms that would point to acute retroviral syndrome (ARS). If you, as a clinician, get any whiff of someone having a recent possible exposure to HIV or recent symptoms that could be a recent acute seroconversion, you want to hold off on starting PrEP for about 30 days, until you can confirm that they're HIV negative after that, before you start PrEP.

Then, we talk a lot about renal function/kidney function, as you mentioned earlier. This is where one of the differences comes between FTC/TDF and FTC/TAF. So, with FTC/TDF, the creatinine clearance (CrCl) needs to be > 60 mL/min, and for FTC/TAF, it needs to be > 30 mL/min. So with the newer formulation with TAF there's a little bit more flexibility that if someone has some mild irritation in their kidneys or slightly lower CrCl, you still can safely start them on FTC/TAF and still feel safe starting PrEP for their sexual health, regardless of this, and then just monitor them along.

And then, as you talk about the HBV serology, it's not just checking antibodies for HBV, but it's checking for the surface antigen. So, as providers, you want to check for chronic active hepatitis B, not just immunity to hepatitis B. Then, finally, we do the pregnancy test, as we talked about earlier.

Part of what we do with this initial assessment is also a lot of counseling and education. Obviously, a lot of it's going to be based on screening results. If someone's HIV negative, you can move forward with PrEP. If they test positive, then obviously you have to get them linked to care immediately. Also, you want to focus on a patient's individual needs -- find out what their background is, find out how this can fit in their life and what kind of risk they may be putting themselves at -- in that context. Also, one of the most important points that I always give with pre-exposure prophylaxis -- or PrEP -- is that it's not just a pill. It's part of a comprehensive program or comprehensive prevention plan. So the important thing is that you want to make sure people are following up for their sexual health. You want to make sure they realize that PrEP only prevents acquisition of HIV infection. It doesn't prevent against other STIs or other viral illnesses. So, it's important for them to come in and follow up with us to get swab testing for gonorrhea, chlamydia, check for syphilis. The most important part of this is checking for HIV.

Finally, the importance of follow-up. I think this is where a lot of work is being done, a lot of research is happening. When PrEP first started 8 years ago, we were actually having people always having to physically come in, and now we realize that with telemedicine, having peer navigators, nurses, other POC, healthcare personnel that can be involved in the patient's care, you can have people following up. So ask the patient again, "What may be best with you? Is it hard for you to get in to see us physically in the clinic? Would you like to do a 1-month or 3-month follow-up with a nurse or with the practitioner afterwards to check in? How would you want it to be?" Because we can give them options right now.

That's basically what I tell people when I'm coming into PrEP. Leandro, how do you do it in your practice, as far as talking to them?

Dr Mena: I talk to patients a lot about the effectiveness of PrEP/how effective it is -- because it's important they understand that -- and how the effectiveness again is linked to adherence. The more adherent they are, the more effective it's going to be. Also, people have a lot of concerns about the safety and side effects, so monitoring is essential for us to catch any kind of potential side effect early on. We know that both the impact in the bone density of FTC/TDF is actually reversible by discontinuing PrEP. The same thing happens in some of the nephrotoxic impact of TDF, that upon discontinuation of the drug, the kidney function comes back to normal almost all the time.

So, there are a number of populations for which we may need special considerations. One of those populations is women who are pregnant. There are no studies, basically, that show either the efficacy or the safety of the use of PrEP in pregnant women. Nevertheless, we know that both FTC/TDF and FTC/TAF have been used in, if not hundreds of thousands, millions of women who are pregnant for the treatment of HIV. There are not associated teratogenic effects or adverse pregnancy outcomes associated with the use of these drugs for treatment of HIV. A number of women who may be in relationships that are risk discordant -- which means that their sexual partner is HIV negative -- are planning to become pregnant. And although there are specific ways to conceive in a safer way, PrEP has become actually a much safer way to add that extra safety to many women who want to become pregnant from their partner who is living with HIV. We know that pregnancy itself increases the risk of women to become HIV infected, in part because of the changes that happen in the female genital tract, because of the hormones and the changes associated with the pregnancy. We have to assess the risk versus the benefit of getting a woman infected during pregnancy and the chance that vertical transmission may happen during that pregnancy in utero if the HIV infection happens during the pregnancy.

We also know that there are very few studies on transgender-identifying people, especially transgender women. Very few have been included in many of the PrEP trials, so we have limited knowledge about the effectiveness and the safety of PrEP in transgender-identifying individuals. We know that in the iPrEx study and the DISCOVER study there were several/a number of transgender women and among those women who had detectable levels of PrEP in their bloodstream, there were no infections. Suggesting that, for transgender women who are adherent to medication/who are adherent to PrEP, the risk of the PrEP will confer the same kind of protection that it does to other populations. There are some reports also that transgender women who are taking hormones at high doses, the hormones may reduce the levels of tenofovir in the blood. But there is no really clear evidence that that reduction in blood levels of tenofovir is associated with any decrease in the protective effect of tenofovir as long as the woman is adherent to the medication.

The last population that I think is important to mention are adolescents. Adolescents can be a particular risk for HIV infection because it's a time in life where people are exploring, right? There is very often a lack of cognitive maturity in the brain to control impulses and developing of knowledge and building relationships. Both TDF/FTC and TAF/FTC have been approved for adolescents who are at least 35 kg in weight so there really is not an age limit. In this particular group, which drug to use may be particularly important. Because adolescence is a time of fast growth where many/everyone are developing their bone density, so perhaps drugs that are safer and have a lesser impact in the BMD may be, in the long term, beneficial. I think this is a subject of research right now, and it certain times being considered, as novel PrEP regimens are being developed. The other thing that's really important is that adolescents, no surprise to anyone who is a parent of one, are very often not very adherent to medication. So it's really important for providers who are caring for adolescents to make sure that they have the resources to support adolescents that may include things like frequent monthly check-ins, making sure that they refill their medication, making sure that they are taking their medication every day.

Dr Malebranche: I think a lot of it is around kind of initiating PrEP and having options now. The potential side effects are minimal. Even when you have some of the studies that are talking about bone density loss or kidney irritation or kidney problems, even that happens at a low rate. In the DISCOVER trial, people discontinued for < 2% of these AEs. I think when we have PrEP, it's about talking to each of these categories of patients and finding out what the patient's medical history is. To me, there's a difference between someone who's in their 60s and has high blood pressure and diabetes, and maybe high cholesterol, and you're trying to figure out if they want to do PrEP. Do you want to put them on FTC/TDF or do you want to put them on FTC/TAF? I think that's where you get into these conversations about which may be better, as far as weight gain, cholesterol -- which tends to be some of the potential side effect concerns with the FTC/TAF regimens -- versus bone density loss or kidney irritation or kidney problems, which is more common with FTC/TDF.

I think with me and my patients that I see, I kind of talk to them about all those things, and what's good now is that we have a couple of options, so people can choose. In my practice, I actually see that with the FTC/TAF regimen is that the pill's a little bit smaller, so while we talk about all these other things that patients feel are important when they're doing PrEP, and why they may choose either FTC/TDF or FTC/TAF, for a lot of my patients I've seen they just want the smaller pill. So be prepared, as clinicians, that that may actually come up. Both of them are taken once a day, with or without food, and it's important to take them every day, but one of the parts that is important to patients that we overlook sometimes is just the size of the pill. I've heard that an awful lot with my patients.

Dr Mena: I agree. I think whatever regimen you take, what's really simple about this is it's only one pill once a day.

Dr Malebranche: Right.

Dr Mena: You give people 90-days’ supply or 30 days with 2 refills. Again, adherence is key. The other thing that is really important is timing initiation is critical. We know that people have priorities in life, they receive an HIV test, and at that moment when you tell someone, "You're HIV negative," there's a small window of opportunity that people are open to behavioral change, to do things that would keep them HIV negative. The moment that people walk out of your office, other priorities take over. "I have to do my homework, I have to take care of my friend, I have to go to work." So the extent that we can connect "You're HIV negative, this is something that we can give you, so you can stay HIV negative," the more effective we're going to be in reducing the numbers of HIV infections in our communities.

Dr Malebranche: Absolutely. I couldn't agree more about the timing of it. If you work with a good pharmacy, like in my history of prescribing PrEP, there's been good pharmacies that I can call on the phone at that moment. So, I think the most important take-home message for a lot of providers is confirm that they're HIV negative first, but these other labs that we're talking about -- these hepatitis B labs, the CrCl, the urinalysis, those kind of things -- you can order at that time, and you can follow up later. But that shouldn't stop you from starting PrEP with someone, especially if you feel that in their sexual networking or their sexual behavior they may be putting themselves at risk and you need to start it that day. A lot of us, what we do in clinical practice is we start somebody on PrEP, we call the prescription that day -- they can start that day -- and we wait for the labs to come out. If it comes back in a couple days, if there's anything abnormal, we can tell them. But most often/more often than not, you don't see any problems with the CrCl or with the urinalysis or anything else, so you can just continue patients on PrEP. I think that's a really important point.

Dr Mena: I do that all the time, David, in my practice.

Dr Malebranche: So after they come in for the initial assessment you want to have a follow-up. The CDC recommends following people about 3 months after initiation. You test them for HIV, you measure their CrCl, you provide continued counseling and adherence and risk reduction support. You also want to, importantly, screen them for STIs. Particularly with MSM, triple-site testing for gonorrhea and chlamydia is going to be profoundly important. But at baseline, the STIs you should be following up for every 3 months would be HIV, syphilis, as well as gonorrhea and chlamydia. You want to obviously check for STIs, women with reproductive potential you want to get ß-hCG to rule out pregnancy. Then, you want to also assess with your patients who are using IV drugs whether they have access to sterile needles, whether they're trying to get rehab or drug treatment services. You want to assess all these things as they come in.

Typically, 3 months is when the CDC recommends for the first follow-up, but I will tell you that, clinically, there are often times where I have a patient follow-up a month later. It may not have to be a physical visit, but it can be a phone call with a nurse, a follow-up by a peer navigator, or a video chat via telemedicine. But something to make sure you're checking the patient, to make sure they're okay. Potential side effects, adherence, as well as any other medications they may have started or stopped in that time.

Then in addition to that, when you're following up after the first 3 months/you're following up 3 months to 6 months after that. So every 3 months after the first follow-up, you do want again to test for HIV, you want to do the counseling and risk support. And then you want to again check for STIs, do a ß-hCG for pregnancy, and then check in with the people who are using IV drugs for the support services and the clean works that they may need. Then, every 6 months after the first follow-up, you want to follow up with a serum creatinine, also a urinalysis when clinically appropriate, and then screen for bacterial STIs.

Again, I think as the science kind of moves along with PrEP, we're going to see that some of these monitoring follow-ups may change, but for right now we're recommending following up every 3 months, and then every 6 months. But typically, you want to see patients on a quarterly level. One of the most important parts of this is getting people in the habit of primary care. So, look at PrEP as kind of a gateway to getting particularly younger people who may not feel they need primary care/get them in the doctor's office and get them seeing people, and get them used to taking care of themselves in a very pro-active method.

Dr Mena: So, David, we really have gone over pretty much the CDC guidance on providing PrEP, and overall/and we talk all the time about how simple PrEP is. It's one pill once a day, simple to providers to do, simple to patients to do. Nevertheless, we know there are many patients and many providers who are not yet on board. What sort of things do you think should be considered to do these? And what makes this a little bit more complex than the simplicity of just giving one pill once a day?

Dr Malebranche: The science is there. We know that PrEP works. Whether it's FTC/TDF or FTC/TAF, both of them are highly effective, actually over 99% effective in reducing the risk of HIV. There is sexual stigma that is in society and that exists within medical practices and in providers' minds. It starts off with us. Check your own biases at the door. Check your judgment and your preconceived notions or how you feel about certain sexual behaviors, and make sure that doesn't get conveyed to the patient so that they feel uncomfortable. Try to use nonjudgmental language that's free of stigma. Then, increasing the facilitators and minimizing barriers to PrEP. This is about taking a good sexual and social history. You want to make sure that you know your patients' lives. What they do day-to-day, and what socially affirming things they have in their lives -- whether it's work, school, their family, their friends, other loved ones -- that can help them and make sure that they take their medication every day and they're adherent with their PrEP.

Then, what are some of the barriers? Is it more logistical? Is it more belief system? Is it more stigma that someone's criticizing them because they're taking PrEP and they think they're promiscuous because they're taking PrEP? These are all things you can take in the sexual history. Then, figure out what works for them and what kind of support you can provide, and provide that support as a provider. Then, the final things we talk about are considering the whole patient. Patients have very diverse and intersecting lives and identities. So, making sure you're taking the whole patient into account, because again, the goal is to get people used to taking care of their health, being empowered, and being proactive about their health. You want to make sure that they feel comfortable coming to you and they don't disengage because they've been turned off by something you do.

Dr Mena: The only thing I have to add is recognition that many of these individuals are in populations that are affected by many health disparities. We have a unique opportunity to engage them in primary care, and intervene early, before they develop many current diseases.

In conclusion, I think it's important to remark that PrEP is here to stay. In 2012 we had 1 product; now we have 2. There will be down the pipeline many different formulations with many different ways that we're going to be able to do PrEP. PrEP, right now, is simple -- as simple as one pill once a day. There are 2 regimens currently available -- TDF/FTC and TAF/FTC. Again, as we said before, timing of initiation is very important. As clinicians, as providers, we have a duty to provide the best care we can to our patients, which includes addressing our patients' sexual health. We should identify patients who can benefit from PrEP, offer PrEP and support our patients' adherence.

Dr Malebranche: I think those are good concluding remarks. I'd also add PrEP is actually more than a pill -- it's a program and it's about getting people to engage in their sexual health. There's a lot of judgment, there's a lot of stigma out there, so when a patient comes in wanting PrEP, it's an important component of your role, as a provider, to make sure that you're making them feel comfortable and encouraging them to do what's best for HIV prevention. The science is conclusive and studies show that it works, but it's that person-to-person interaction that is going to dictate both follow-up and adherence of our patients with this scientific breakthrough.

Dr Mena: So, I want to thank everyone for participating in this program -- David, thank you for this great discussion. And thank you for participating in this activity. Please continue on to answer the questions that follow, and complete the evaluation.

This is a verbatim transcript and has not been copyedited.

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