Integrating Pre-Exposure Prophylaxis into the Primary Care ...

Integrating Pre-Exposure Prophylaxis into the Primary Care ...

Integrating Pre-Exposure Prophylaxis (PrEP) into the Primary Care Setting Christine Kerr, MD Medical Director of HIV, Hepatitis, and Specialty Care Hudson River HealthCare February 12, 2016 Why PrEP in the Primary Care Setting? What are the challenges around PrEP in the

primary care setting and how can they be addressed? What can we do to facilitate PrEP in these settings? What has been our experience with PrEP? What barriers and challenges are we facing as we move forward? Why PrEP in the Primary Care Setting?

Willie Sutton Model Birth Control Model/Travel Medicine Model Easy to do Part of routine preventive care and adherence work Its already being done!

Ending the Epidemic Identifying persons with HIV who remain undiagnosed and linking them to health care Linking and retaining persons with HIV to health care, getting them on anti-HIV therapy to improve their health and prevent transmission Providing Pre-Exposure Prophylaxis (PrEP) to high-risk persons to keep them HIV-negative.

Willie Sutton Go where the money is! Best way to reach HIV-negative people is not to go through HIV programs! But take the principles of talking about sex, risk, and harm reduction. 42% of PrEP users are women 11.5% of users are less than 25 years

17% of women were less than 25 (vs. 7.4% of men) J Int AIDS Soc. 2014 Nov 2;17(4 Suppl 3):19730. doi: 10.7448/IAS.17.4.19730. eCollection 2014. Two years of Truvada for pre-exposure prophylaxis utilization in the US. Flash C1, Landovitz R2, Giler RM3, Ng L3, Magnuson D3, Wooley SB4, Rawlings K4. Preventing Infections: Model 1 When you travel to parts of the world where you

can get malariawhat do you do? You should always use bed nets and avoid mosquito exposure, so dont leave your hotel When you are in a behavioral or epidemiologic environment where HIV risk is highwhat can you do? You should always use condoms for all sex all the time and only have one partner and dont have an HIV positive partner

Preventing Infections: Model 2 When you travel to parts of the world where you can get malariawhat do you do? Use bed nets and avoid mosquitos as much as possible Take anti malarial medications as pre-exposure prophylaxis When you are in a behavioral or epidemiologic environment where HIV risk is highwhat can you do? Always use condoms, but the reality is sometimes some

people wont do this Take HIV medications to prevent acquisition of HIV Preventing Unplanned Consequences of Sex Model 1: If a woman is not ready to get pregnant, we tell her to use condoms they are mostly effective, they have few side effects, and can prevent some STDs Model 2:

Talk to her about risk reduction (choosing partner, timing), talk about condom use, talk about pharmacologic birth control Why does taking a pill to lower risk of acquiring HIV need to be different? PrEP is Safe Easy

Effective Adherence is important; but we already talk about that Efficacy (MITT) 44% (15-63%) Infection Numbers: 110 in total, 10 at baseline 64 36 = 28 averted HIV Incidence and Drug Concentrations

Follow-up % Risk Reduction 95% CI 26% 44% -31 to 77% 12%

84% 21 to 99% Grant WAC Melbourne 2014; Grant et al, Lancet Infectious Diseases, published online July 22, 2014 21% 100% 12%

100% 86 to 100% (combined) No Evidence of Risk Compensation in iPrEx Study Marcus et al. PLoS One 2013 Already being done!

Who Prescribes PrEP? 20 16 12 8 4 0 m Fa

il ce ti ac r yP lM

a rn e t In ed n i ci

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se a ise NP J Int AIDS Soc. 2014 Nov 2;17(4 Suppl 3):19730. doi: 10.7448/IAS.17.4.19730. eCollection 2014. Two years of Truvada for pre-exposure prophylaxis utilization in the US. Flash C1, Landovitz R2, Giler RM3, Ng L3, Magnuson D3, Wooley SB4, Rawlings K4.

PA Barriers to implementing PREP Patient perspective Stigma Fear of being judged Lack of knowledge Barriers to implementing PREP

Provider perspective Embarrassment Lack of knowledge Availability How to use Where to refer Fear of side effects/complications Fear of resistance Medico-legal

Judgment From focus groups with patients You want to have a doctor who knows you [to get PrEP]. Then you can be more honestHes there for your wellbeing. Im sure if Im like, Doc, theres something available that could prevent me from getting HIV, he wouldnt think twice. Hed already have his script pad out Even getting PrEP isnt always easy because not even

a lot of doctors seem to be aware of it. Ive talked to various doctors about it and ER doctors and theyre theyre like Never heard of it. 2014 Nov 11;9(11):e112425. doi: 10.1371/journal.pone.0112425. eCollection 2014. Access to Healthcare, HIV/STI Testing, and Preferred Pre-Exposure Prophylaxis Providers among Men Who Have Sex with Men and Men Who Engage in Street-Based Sex Work in the US. Underhill K1, Morrow KM2, Colleran CM2, Holcomb R3, Operario D4, Calabrese SK5, Galrraga O4, Mayer KH6. From focus groups with providers THEMES

KEY QUOTES There is little consensus on the target population for PrEP This is going to be such a limited resource, that we want to make sure that its not necessarily going to all the worried well.

Current models of care are not always well suited for prescribing PrEP We are not used to having people that come back for check-ins on a regular basis. We wouldnt be able to operate it if RNs were excluded from providing [it]. Providers need more capacity before they can prescribe PrEP

If we wanted our medical assistants or anyone to provide PREP, they would require some counseling training. So it would require some supports, both around education, around adherence, and also financially, because we have as many uninsured as we do wed have to have access to meds and Im sure its expensive.

Themes, continued Quotes Monitoring patients on PrEP will be challenging I think a lot of young people tend to have less stable schedules.

PrEP has public health benefit They might take it just 3 days before an event, if they know that theyre going to have a party or something special. And so only treating the positive partner isnt going to eliminate all the infections, and so finding the right balance between treatment

and PrEP I think is important to have as a target. 2012;7(7):e40603. doi: 10.1371/journal.pone.0040603. Epub 2012 Jul 11. A qualitative study of provider thoughts on implementing pre-exposure prophylaxis (PrEP) in clinical settings to prevent HIV infection. Arnold EA1, Hazelton P, Lane T, Christopoulos KA, Galindo GR, Steward WT, Morin SF. 2014 - Have you heard about Pre-Exposure Prophylaxis for HIV?

2014 - Have you heard of the New York State guidelines to prescribe PREP (www.hivguidelines.org)? 2014- Do you think you have patients who would be interested in taking medication to prevent HIV? Never thought about itoops! 2014- What are the barriers to referring patients

to PREP or to prescribing PREP? 2014- Would you rather prescribe these medications yourself or refer to a specialist? What can we do to facilitate use of PrEP? Patient level outreach Provider level outreach Advocacy/Public Health

Our Outreach Plan Our Team Patient Level Outreach Clinic setting Brochures/posters Through serodiscordant partners Patients with STIs, patients requesting HIV testing

All primary care patients (posters, flyers, ask about Hep C buttons/ask about PrEP) Peer work Outreach - doh, local colleges/high schools, drug treatment centers, social media Provider Outreach

Our PrEP Educator Model Speaking at Best Practices/Grand Rounds Speaking at monthly staff meetings Facilitating guidelines, order sets, and templates in eCW Our solution

PrEP Educator Tannya Mannain, LCSW Now Candice Melvin, LPN 845-260-0043 Adherence specialist Responsibilities Patient and Provider education Guidelines Cultural competency Linkage to care for general sexual health Outreach to communities at risk

Outreach to primary care providers Tracking and monitoring Including adherence assessments/techniques Prior authorizations, linkage to Patient-assistance programs Making appointments and follow-up Issues with payment Cost almost $12k/year 91% of that is drug cost

Covered by many insurances, including Medicaid Prior auth frequently necessary Pharma support copay cards www.GileadCoPay.com or 1-877-505-6986 Lack of awareness of support from both patients and providers For completely uninsured/undocumented Gilead Advancing Access Program

www.pparx.com Lab costs Cost of visits Consult, 1 month, then every 3 months Uninsured Lab Costs Initial: 79.90 Monthly: 26.52 Lab test

Cost HIV Ab/Ag 4th gen 12.27 BMP 7.25

RPR 3.27 Urinalysis 4.00 NAAT Gc/CT

42.86 Pregnancy 3.00 Hep Panel (A, B, C) 7.25

HIV RNA PCR ** 117.59 Current numbers at 1 yr 56 patients total for program. 34 screened for PrEP, 2 PEP 13 Screened and never started 7 screened started and stopped medication

25 patients currently on within last 30 days Barriers Slow Uptake Relatively few patients prescribed PrEP More consults, but patients reluctant to pursue after initial consultation Are the barriers at the provider or the patient level?

2014 - Have you heard about Pre-Exposure Prophylaxis for HIV? 2015 - Have you heard about Pre-Exposure Prophylaxis for HIV? 2014 - Have you heard of the New York State guidelines to prescribe PREP (www.hivguidelines.org)?

2015- Have you heard of the New York State guidelines to prescribe PREP (www.hivguidelines.org)? 2014- What are the barriers to referring patients to PREP or to prescribing PREP? 2015-What are the barriers to referring patients to PREP or to prescribing PREP? 2014- Would you rather prescribe these

medications yourself or refer to a specialist? 2015 - Would you rather prescribe these medications yourself or refer to a specialist? I am not given enough time in my schedule to do this comfortably. After a year of PrEP work

Still need to build patient base Improved knowledge among providers Improved knowledge of HIV guidelines, where to refer, and improved comfort among prescribing. Barriers to PrEP Solutions

Lack of awareness -Work on serodiscordant couples -Public Health Messaging -Primary Care providers to talk with patients -Peer work -Community outreach Dont know where to get

-Increase knowledge so primary care providers feel more comfortable -Link to easy consultation when needed Not sure can afford -PrEP educator knowledgeable about PA, pharma support

Providers dont know how to provide -www.hivguidelines.org -Support through experienced team Patients not interested -If you build it, they will come.

Resources www.hivguidelines.org CEI PEP/PrEP Line: 1-866-637-2342 http://www.nyc.gov/html/doh/html/living/pre p-pep.shtml www.truvada.com Thank you To Demetre Daskalakis, MD for the use of his slides.

To our HRHC team HIV-team and non-HIV team to motivating our response to PrEP To you, for being part of the team to bring us closer to the end of AIDS

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