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Project RSP Training on PrEP - July 31, 2015

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This PrEP training - a collaboration between AIDS Foundation of Chicago and the Chicago Department of Public Health - was provided to members of Chicago's HIV workforce on Friday, July 31, 2015.

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Project RSP Training on PrEP - July 31, 2015

  1. 1. Chicago Department of Public Health Besly Court 7.31.15 Download these slides: tinyurl.com/PrEPJuly2015
  2. 2. • Intros • Pre and post test, evaluation • Overview ARV-based prevention • Understanding PrEP – What is PrEP? – Updates from CROI 2015 and IAS 2015 – How PrEP is taken – Access to PrEP – PrEP case studies – And more… These slides available at: tinyurl.com/PrEPJuly2015
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  4. 4. Ground rules • We are all somewhere on the learning curve • Participate to the fullest of our abilities • The only dumb questions are the ones not asked 4
  5. 5. 5 Who’s in the room?
  6. 6. 6 Logistics
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  9. 9. What is the first word or words that come to your mind when you think about condoms? 9
  10. 10. What is the first word or words that come to your mind when you think about needle exchange? 10
  11. 11. What is the first word or words that come to your mind when you think about oral contraceptives? 11
  12. 12. What is the first word or words that come to your mind when you think about PrEP? 12
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  14. 14. What is ARV-based prevention? • Strategies that use HIV treatment drugs (antiretrovirals or “ARVs”) to prevent HIV infection – TLC+ (testing, linkage to care, plus treatment) – ARV-based microbicides – PEP (post-exposure prophylaxis) – PrEP (pre-exposure prophylaxis) 14
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  18. 18. First, what is prophylaxis? • Prophylaxis is simply the provision of medications prior to germ or virus exposure to prevent infection. • This is not a new concept. • This is not a new practice. • Example: taking malaria drugs before traveling to countries with high malaria incidence • What are examples of similar concepts? 18
  19. 19. What is PreP? • PrEP consists of taking the ARV drug Truvada to prevent HIV* • Truvada is a combination of tenofovir disoproxil fumarate (aka tenofovir or TDF) and emtricitabine. • Need to take 5 – 7 days* of Truvada before enough drug is “on board” for protection in rectum. • Three weeks for vaginal protection. • Truvada is currently the only drug approved by the FDA for PrEP. 19
  20. 20. 20 #HIV2020 AIDS.gov/2020
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  22. 22. 22 #HIV2020 AIDS.gov/2020
  23. 23. 23 Approved Truvada for PrEP July 16, 2012
  24. 24. 24 tinyurl.com/CDCprepguidelines tinyurl.com/CDCprepguidelineswebinar May 14, 2014
  25. 25. PrEP Clinical Practice Guidelines • For clinicians – But incredibly useful for providers, educators, policy folks, and advocates – YOU • Includes info on efficacy and safety evidence, guidelines for screening, providing PrEP to gay men, heterosexuals, and injection drug users, discontinuing PrEP, clinical considerations, improving adherence, reducing risk behaviors, info on financial case management, fact sheets, risk index, counseling info, and quality measures 25tinyurl.com/CDCprepguidelines
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  27. 27. 27 WhatIsPrEP.org
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  29. 29. 29 • True or False: PrEP must be started within 72 hours of exposure to HIV. • The FDA approved Truvada as PrEP in what year? • True or False: People on PrEP should be tested for HIV every month. • True or False: It takes longer for PrEP to achieve protection in the vagina compared to the rectum.
  30. 30. www.myprepexperience.org
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  32. 32. PrEP works – the science • All completed trials done on tenofovir & Truvada • 4 trials = PrEP reduced risk of HIV infection – i-PrEX (Truvada in gay men and trans women) – Partners PrEP (Truvada and tenofovir in heterosexual couples) • TDF/FTC combination and Tenofovir alone comparably efficacious – TDF2 (Truvada heterosexual men & women) – Bangkok Tenofovir Study (injection drug users) 32
  33. 33. Bumps in the road for women • 2 trials = PrEP did not work – FEM-PrEP (Truvada in women – stopped 2011) – VOICE (Truvada, tenofovir – reported 2013) • Both trials had very low adherence – (though self-reports were high) • Both trials found low/undetected drug levels • Important to note – PrEP does work for women, and the FDA prevention indication includes women 33
  34. 34. PrEP works – key findings • Adherence! • High adherence achieved 90%+ reduction in risk • Truvada PrEP trials to date have not shown increases in sexual risk behavior among participants • Across all PrEP studies of Truvada, there have been no serious safety problems 34
  35. 35. • Some will experience a general “start-up syndrome” w/Truvada that includes nausea, diarrhea, abdominal pain and headaches. • Nausea most common (under 10%) and resolved in 4 to 6 weeks. • Very little drug resistance has been seen, only among those with unidentified HIV infection when they started the study. 35 PrEP works – key findings
  36. 36. PrEP side effects • 1 in 10 will have nausea that subsides quickly. • 1 in 100 will experience bone density loss, which plateaus and doesn’t progress. Not usually clinically significant. • 1 in 200 will experience kidney problems, which resolve after stopping. Can be safe to re-start. 36
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  38. 38. I don't have any regrets, but what I do have is peace of mind. And that is exactly what I was looking for with this medication. I feel great, I feel empowered, and I feel in control of my sexual health and my health in general. Personal story on MyPrEPexperience.org
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  42. 42. PrEP’s “protease moment” croiconference.org PROUD – 86% IPERGAY – 86% www.aidsmap.com/croi2015
  43. 43. 43 There is an urgent need to mobilize clinical efforts, service delivery, education, implementation research, and policy to optimize PrEP access and use. – Dr. Raphael Landovitz/UCLA croiconference.org
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  45. 45. 45 PrEP is more than a prescription PrEP is a program
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  47. 47.  Take Truvada every day  Provider* visits every 3 mos  HIV testing  Tied to Rx renewal  Hepatitis B testing  Kidney function testing  STI screening  Pregnancy testing 47 *These activities don’t all need to be done by a doctor in their office Taking PrEP… What does it take?
  48. 48.  Adherence counselling  Perfection not required, especially for rectal exposure  Take 5 – 7 days before enough drug is “on board” to provide protection in the rectum, 3 weeks for the vagina  Then take Truvada every day  Honest, open discussions about sex, sexual health  PreP is “seasonal.”  PrEP is not forever. 48 Taking PrEP… What does it take?
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  50. 50. • iPrEX Open Label • 1,603 participants, 1,225 on PrEP • Most from Peru/Ecuador, 18% USA • 100% effectiveness associated with 4+ doses a week (rectal) • 84% effectiveness in ppl who took 2 -3 doses a week • Ppl engaging in higher risk sex self-selected for PrEP • Adherence issues more pronounced among young people 50
  51. 51. What PrEP does not do • Truvada as PrEP does not – Guarantee 100% protection from HIV (what does?) – Protect a person against other STIs like chlamydia, syphilis, or gonorrhoea – Prevent pregnancy – Cure HIV – Function as a treatment regimen for someone already living with HIV. 51
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  53. 53. 53 • True or False: PrEP does not work for women. • True or False: About 25% of people who take PrEP will have nausea. • True or False: Regular STD screening is part of the PrEP program. • True or False: You don’t need to adhere perfectly to PrEP to achieve high levels of protection. • True or False: Obama says “PrEP sucks.”
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  56. 56. www.myprepexperience.org
  57. 57. Who might be a good fit for PrEP? •Person indicates an interest in taking PrEP 57
  58. 58. Who might be a good fit for PrEP? • Person is in a “magnetic” relationship –HIV-negative and has HIV+ partner who is not on meds, or not undetectable, or other mitigating circumstances 58
  59. 59. Who might be a good fit for PrEP? • Male, female, transgender person engaging in sexual activity within high prevalence area or social network, and/or: – Doesn’t use male or female condoms consistently – Diagnosed with STI(s) – Exchanges sex for money, food, shelter, drugs, etc. – Uses illicit drugs or depends on alcohol – Is or has been incarcerated – Does not know partner’s HIV status and one of the above factors is true for partner – Injects drugs one or more times daily – Shares injection equipment – Injects cocaine or meth 59
  60. 60. PrEP-C
  61. 61. pleasure intimacy connection emotion lust love
  62. 62. 62 In this sample of men who are in a relationship with a perceived HIV-negative man, we found that intimacy motivation was the strongest predictor of adopting PrEP. “Intimacy Motivations and Pre-exposure Prophylaxis (PrEP) Adoption Intentions Among HIV-Negative Men Who Have Sex with Men (MSM) in Romantic Relationships” – Annals of Behavioral Medicine August 2014
  63. 63. 63 Reclaim pleasure
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  65. 65. PrEP Linkage and Retention – Year 1* • First Visit – HIV Ab/ag, acute infection screen, hepatitis B, Creatinine, U/A with micro, STIs, other as clinically relevant • Second Visit (1-2 weeks later)** – PrEP prescription • Third Visit (1 month later) – Evaluate adherence, ongoing risk and side effects • Fourth Visit (3 months later) – HIV Ab/Ag • Fifth Visit (3 months later) – HIV Ab/Ag • Sixth Visit (3 months later) – HIV Ab/Ag, Creatinine 65 *Focused exam, clinical work-up, STIs, adherence, partner elicitation, risk- reduction, condom use (if appropriate), hormone therapy, anal cancer screening **Optional; prescription can be given during first visit
  66. 66. Case 1 • 20 y/o YBMSM “Billy” with HIV for one year presents with his HIV negative wife • Can we have kids doc? • Wife is interested, but states that they don’t have money for sperm washing • Billy’s viral load is undetectable • They use condoms intermittently
  67. 67. Case 2 • 20 y/o YBMSM Maurice comes in for HIV testing, has a new partner. • Discussed PrEP, client not interested because of concerns about side effects and just taking a medication in general, “that we don’t know much about” • Had sex with a new partner and heard from a friend that the individual was HIV positive and did not use condom. Now asking for PEP • Follows up for HIV testing, completed 4 weeks of PEP • PrEP shared decision making discussion ensues • Client is now on PrEP and first in implementation project 67
  68. 68. Case 3 18 y/o young Black client KJ comes in for hormones. Transitioning to transwoman. Has receptive sex only with male partners - unknown HIV status PrEP discussion ensues. Client is not interested. Discuss getting on hormones first and re-engaging about PrEP later Comes in 3 months later, visibly more female. Mentions has started getting more attention on way home from work. PrEP discussion re-ensues, this time “started” PrEP Missed first PrEP follow-up appointment 68
  69. 69. Case 4 • 26 y/o BMSM, Fabrice comes in with his partner Chris who I see for HIV • Chris and Fabrice together for 6 years • Monogamous relationship • Chris has had VL <50 for 4 years • PrEP for Fabrice? 69
  70. 70. Case 4 continued • Start Fabrice on PrEP, doing well has been on it a year. Creatinine just above normal limit. • Chris still undetectable • Continue PrEP? 70
  71. 71. Case 4 continued • Fabrice comes in for 12 month follow-up • I am considering stopping PrEP • Doc, can I get viagra? 71
  72. 72. Case 4 Continued • Threesome • No STIs • What now? 72
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  76. 76. Accessing PrEP in Chicago • Any medical provider who can write a scrip can write one for Truvada as PrEP • tinyurl.com/ChicagoPrEPproviders 76
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  79. 79. Uninformed, misinformed providers
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  81. 81. Handy brochure 81 Designed to help individuals talk to their doctors about PrEP Before, during, after visit Questions to ask Web resources tinyurl.com/talkPrEPtoDr
  82. 82. 82 PrEPline, 855-448-7737 The CCC Pre-Exposure Prophylaxis Service 11 a.m. – 6 p.m. EST http://nccc.ucsf.edu/2014/09/29/introducing-the-ccc-prepline/ PrEP Warm Line
  83. 83. • MyPrEPexperience.org • Chicago PrEP Line - (872) 215-1905 hivelimination.uchicago.edu/projects/programs/prep_hotline_linkage_to_care • Chicago PrEP provider listing tinyurl.com/ChicagoPrEPproviders • Facebook group – PrEP Facts • Facebook.com/ProjectRSP • PrEPWatch.org • ProjectInform.org/prep • Truvada.com (Gilead) • WhatisPrEP.org (video) Web resources on PrEP 83
  84. 84. www.facebook.com/groups/PrEPFacts
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  86. 86. 86 PositivelyAware.com Printed copies available email distribution@tpan.com
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  89. 89. FDA approval of Truvada enables private ins to cover Medicaid formulary Ins companies covering, so far ADAP does not cover PrEP 89
  90. 90.  Drug costs  Visit, service costs  Lab costs
  91. 91. 91 the devil is in the details  Premiums  Deductibles  Cost-sharing  Drug formularies  Drug tiers  Shifting benefits  Not easy to figure all this out!
  92. 92. 92 http://ow.ly/PTYCK
  93. 93. Paying for PrEP – Gilead 1. Visit www.truvada.com 2. Click on the link to access information about Truvada for a PrEP indication 93
  94. 94. Medication Assistance Program • Gilead will provide Truvada for PrEP at no cost for individuals who qualify for the assistance program Program Element Truvada PrEP Medication Assistance Program Eligibility Criteria US resident, uninsured or no drug coverage, HIV- negative, low income (500% FPL) Drug Fulfillment Product dispensed by Covance Specialty Pharmacy, labeled for individual patient use and shipped to prescriber (30 day supply); no card or voucher option Recertification Period 6 months, with 90 day status check 9494
  95. 95. Co-pay card program Covers all Gilead HIV Products: Stribild, Complera, Atripla, Truvada, Viread, Emtriva • Assists patients with commercial insurance who reside in the US, or US Territories • Not valid for Rx that are eligible to be reimbursed by any federal or state funded healthcare benefit program • Co-pay benefit provides assistance for co-pays above $0 • Monthly benefit provided for 12 mos after activation of card – $400/month for all STRs (Stribild, Complera, Atripla) – $300/month for (Truvada, Viread, Emtriva) • No maximum lifetime benefit but pts need to recertify after 12 months
  96. 96. 96 • www.panfoundation.org/hiv-treatment-and-prevention • Accepting applications for new and renewal patients. If application for assistance is approved can begin receiving funding immediately • Maximum Award Level – $4,000 per year. • Patients may apply for second grant during eligibility period subject to funding availability Paying for PrEP – PAN Foundation
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  98. 98. 98 USCA 2014
  99. 99. 99 • How can people pay for their PrEP prescriptions? • People taking PrEP need to be tested for HIV _____ times every year. • Why is this important? • Who might be a good fit for PrEP?
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  102. 102. 102 “Party drug” “Public health disaster”
  103. 103. 103PrEP DENIALISM
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  105. 105. 105 Condom privilege
  106. 106. 106 Condom privilege
  107. 107. 107 “But ARVs are toxic…”
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  109. 109. 109 www.ias2015.org www.aidsmap.com/ias2015
  110. 110. 110 www.ias2015.org www.aidsmap.com/ias2015
  111. 111. 111 www.ias2015.org www.aidsmap.com/ias2015 Dr. Sybil Hosek – CORE
  112. 112. www.aidsmap.com/ias2015 • ATN 110 • 12 U.S. cities, including Chicago • 200 gay (77.8%) and bi (13.7%) men, 18 – 22 (mean 20.18) • 53% Black; 17% Latino; 21% White; 2% Asian/PI; 7% other/mixed • Four HIV infections, not taking PrEP • Adherence good overall, better among those not using condoms • Black gay men’s adherence was not as high as others • CALL TO ACTION – need better understanding of historical, societal, behavioral, and attitudinal barriers to PrEP access and adherence among those w/highest impact – young black gay men • Adherence among all groups decreased as study visits moved from monthly to quarterly Dr. Sybil Hosek – CORE
  113. 113. 113 www.ias2015.org www.aidsmap.com/ias2015 Dr. Al Liu – SF DPH
  114. 114. 114 • PrEP Demo Project • SF, DC and Miami • 557 particps; median age 35 • 48% White; 35% Latino; 7% Black; 10% other • 98% male; 1.3% transgender • Overall high adherence – higher adherence among ppl not using condoms • Two infections, not taking PrEP • Two main findings: “1) we must do active, engaging outreach to African American MSM and trans women about PrEP; we will not reach sufficient numbers through passive attempts to scale- up PrEP, and 2) adherence was lower among African Americans, so additional programs to understand reasons for poorer adherence and to develop support mechanisms are needed for populations most heavily impacted by HIV. Current tools are not enough.” www.aidsmap.com/ias2015 Dr. Al Liu – SF DPH
  115. 115. 115 www.ias2015.org [Quote from female sex worker participating in treatment and PrEP demo project in Johannesburg, South Africa.]
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  119. 119. Tips for talking about PrEP • You need not be an expert. • Though, it’s important you feel comfortable talking about PrEP. • It’s okay to not have all of the answers. Refer your client to additional resources and/or promise to follow up. 119
  120. 120. Tips for talking about PrEP • As a provider, you are viewed as a trusted source of information. • Remember any perspectives/opinions you have about PrEP and/or people who use PrEP will translate to your clients. 120
  121. 121. Messages to emphasize to clients • PrEP is an accessible option – Not forever, but maybe for a “season” – If you use condoms successfully, do you need PrEP? • It’s not just a daily pill, it’s a program. – Holistic health care (w/regular HIV and STD testing) • Person must test HIV-negative to initiate and continue PrEP. • Adherence. Different for men and women. 121
  122. 122. THOUGHTFUL RESPONSIBLE CAREFUL 122 AWARE PRO-ACTIVE DISCIPLINED TAKING PREP IS
  123. 123. SAFER SEX TAKING PREP IS 123
  124. 124. PrEP elevator speech • You get in the elevator at the 95th floor with someone who has just asked you about PrEP. You have until ground level to explain it to them. »What do you say? • Take a few moments to think • Volunteers to share? 124
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  126. 126. 126 "Interventions do not just work automatically, they have to be made to work – and people have responsibility for making them work. And herein lies the rub – for the question we should ask is not “what works?” but “what are we committed to making work?” – Dr. Flora Cornish London School of Economics
  127. 127. 127 Open access http://www.jiasociety.org/index.php/jias/issue/view/1474
  128. 128. 128 tinyurl.com/BlackPrEPsummit
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  132. 132. Thank you!! 132
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  134. 134. CONTACT Jim Pickett jpickett@aidschicago.org John Schneider jschnei1@medicine.bsd.uchicago.edu 134 #yayPrEP Download these slides: tinyurl.com/PrEPJuly2015

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