Alyson Decker, NP, MPH Clinical Prevention Consultant San Francisco Department of Public Health As part of the city’s Getting to Zero campaign and the national response to eliminating HIV, the SFDPH is trying to increase HIV pre-exposure prophylaxis, or PrEP, prescribing in the city to individuals at risk for HIV infection. Have you heard of PrEP? ………

What is PrEP? PrEP is a once-daily pill for HIV negative individuals that can help prevent HIV infection. PrEP is FDA approved as a combination, fixed-dose antiretroviral medication called Truvada®.

PrEP can “do more” than prevent HIV Empower receptive partners to take control of prevention Reduce the burden of HIV anxiety Reboot conversations about HIV prevention Connect patients to primary care and insurance Improve our approach to sexual health Empower: PrEP can empower receptive partners to take control of prevention. PrEP is the first HIV prevention strategy that is truly in the receptive partner’s control without negotiation or discussion with the insertive partner (as was the case for the female condom). This is a truly powerful innovation, that has the potential to have a positive and empowering psychological impact. Anxiety: A lot of people have been talking about this anecdotally – PrEP as an anti anxiety medication. Reboot: PrEP can be used to move outside the “scripts” of “You use condoms every time you have sex, right?” to actually talking to clients about what they are doing and what they want and need to do to protect their sexual health. PrEP can allow us to move beyond the “see not evil” represented in the monkey picture to ask about clients’ ideal sex lives and/or definition of sexual health. Giving clients permission to tell us that they don’t always use condoms can open up real and better conversations about HIV prevention strategies 4. Connect: PrEP also has the potential to bring clients “in” to medical care who might not ever see a reason to go to the doctor. PrEP a “gateway drug” to medical care Coming regularly for HIV and STI testing allows increased access to other types of care that patients might need Needing to pay for PrEP might help engage someone in health insurance (e.g., Medicaid), when they never had a reason to apply before 5. Improve: And last but not least, PrEP can help improve our approach to sexual health. Going beyond even the 1:1 conversations with clients, PrEP has the potential to help us as providers think about the sexual health of our clients more broadly and holistically. PrEP requires us to TALK to patients about their sex lives, and to manage their care as part of their overall health. What could be better than that? Could PrEP have a domino effect that could improve sexual health care more broadly? Golub SA, NYC DOHMH, 2016

Who may benefit from PrEP? Men who have sex with men (MSM) Trans women People who inject drugs Heterosexual men and women Risk Recent history of syphilis or rectal STD (high priority) Anal sex without condoms Multiple sexual partners HIV+ sex partner HIV+ injection partner Shares needles or equipment Transactional relationships “High priority populations for HIV preventative care.” *** “Anyone who wants to take control of his/her sexual health regardless of partners or circumstances of having sex.” “In modeling, the number needed to treat was lowest among those who have condomless receptive anal intercourse.” “For females, their risk is often an extension of their partner’s risk (bisexual male partners, IDU) Anyone who asks for PrEP

Case Marcus is a 27 year-old male who has never been seen by a primary care provider and presents to initiate care with you. How do you ask him about his sexual health? Let’s review a case so I can understand more about PrEP and how you discuss it with patients in your practice.

How do you take a quick sexual history? Ask about “PrEP”

Case Marcus, can you tell me more about your sex life? We made up a pneumonic that I find helpful for remembering what to elicit during a sexual history. Studies have shown that patients are not great at estimating their own HIV risk. “Can I tell you more why people similar to you choose to use PrEP?”; Would you like to hear more about PrEP? “Why are you not on PrEP?” “Is it possible that PrEP could move you closer to your ideal sex life?” Some patient quotes: “more health conscious in general”, “extra layer of protection”, “more comfortable and free” What are your thoughts on Marcus’ risk for HIV?

Focusing on reported benefits of PrEP… “Here are some things people say about taking PrEP” “I feel good. It's like an extra layer of protection.” “Feeling more comfortable and free during sex and in life.” “Less shame about my sexual habits." Another strategy for presenting information about PrEP is talking about the reported benefits. Not only focusing or risk reduction – “you should take PrEP because your risk assessment tells me you are at high risk of HIV infection” – but focusing on [CLICK] Let me tell you about why people like you choose to engage in HIV prevention… Here are a couple of quotations from people in the NYC PrEP demonstration project about why they chose to stay on PrEP. “It’s made me more health conscious in general.” “Opens up doors to date HIV+ w/out same kind of worry ” Source: SPARK PrEP Demonstration Project; R01AA022067 (Golub, PI)

We are providing a patient educational tool to help patients remember some of the important points while taking PrEP. Truvada is safer than aspirin. “Messaging has not been clear so we are just telling patients that PrEP is >90% effective, not 100%”. “consistent with messaging”

The 3 Keys to Starting and Tracking Patients PrEP Prescription Clinical Evaluation $ Labs Financing PrEP Prescription Starting with first visit, and every 3 months after

Baseline testing Screen for symptoms of acute HIV infection HIV test within 7 days (4th Generation Ag/Ab test preferred) STD testing (GC/CT urine, pharyngeal, rectal; serum RPR/VDRL) Creatinine (contraindicated if CrCl <60 ml/min) HBV surface antigen HCV antibody Pregnancy test Pocket Card “Do you screen patients who have receptive anal intercourse with rectal GC/CT swabs?” Risk of HIV resistance if patient HIV infected when beginning PrEP Renal elimination of Truvada thus risk if underlying renal impairment/dysfunction STI: GC/CT (site specific testing if available) and RPR/VDRL Opportunity to screen patient for hepatitis and immunize if non-immune; Also risk for HBV flare when Truvada discontinued if patient has chronic HBV infection

PrEP Pocket Card

Assess risk for acute infection at PrEP initiation

* TAF/FTC (Descovy) is NOT approved for PrEP ICD-10: Z20.6 - Contact with and (suspected) exposure to human immunodeficiency virus [HIV]

Follow-up every 3 months… Screen for symptoms of acute HIV infection HIV test 3-site STD testing Creatinine (q 6 months) HCV Ab (q 12 months) Pregnancy test Consider standing orders, order templates/order sets for f/u visits. * Patients should report to clinic immediately if they develop symptoms compatible with acute HIV infection (fever with sore throat, rash or headache).

The majority of CT/GC infections will be missed if only urine is screened Kent et al., Clin Inf Dis 2005

Make labs easy Standing orders Self collection of STD swabs Posters for your bathrooms SHOW IMAGES OF SELF-SWABBING University of Washington STD Prevention Training Center

Case Marcus returns to clinic 4 months later. He was taking PrEP daily but his prescription ran out last month. He would like to continue PrEP and requests a new prescription. Marcus reports having condomless anal sex 2 nights ago. Rule out acute HIV Rule out PEP eligibility Assess adherence Screen for STIs What is your next step?

Post-exposure Prophylaxis (PEP) Exposure within 72 hours and patient has not been adherent to PrEP for past 7 days 28 day course of ARVs, and then option to transition seamlessly to PrEP There is no evidence that PEP “masks” seroconversion

What if my patient has a positive HIV test on PrEP? Discontinue PrEP to avoid development of HIV resistance Ensure patient is linked to an HIV-primary care provider for care and early initiation of ART Contact local health department at 415-487-5506

PrEP considerations for adolescents “Currently the data on the efficacy and safety of PrEP for adolescents are insufficient. Therefore, the risks and benefits of PrEP for adolescents should be weighed carefully in the context of local laws and regulations about autonomy in health care decision-making by minors.”(CDC GLs, 2014) Anticipatory Guidance: engage before risks occur Adherence concerns Confidentiality concerns  payment? www.seicus.org “possibility of bone or other toxicities among youth who are still growing” Consider “the safety evidence available when TDF/FTC is used in treatment regimens for HIV-infected youth” ATN 110 and 113 Adherence decreased as time between study visits increased (from monthly to quarterly) among 200 YMSM Special considerations: perceived low HIV risk, inconsistent condom use, high STD rates in youth, declining sexual education/hiv prevention education, low HIV testing, homelessness, substance use CA allows minors aged ≥12 years to “consent to medical care related to the prevention of a sexually transmitted disease” Prevent parents from receiving information in explanation of benefits 7-14 days in advance: Myhealthmyinfo.org May qualify for Medi-Cal Sensitive Services Same day registration before visit is complete DPH Emergency Youth PrEP Fund

Take home messages: Take a thorough sexual history to identify patients who might benefit from PrEP. Offer PrEP to patients identified as having risks for HIV. Conduct an HIV test to confirm a patient is HIV negative before starting them on PrEP. Follow-up with patients every 3 months for HIV/STD testing and 90-day PrEP refill.