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Project RSP! training on PrEP for the HIV workforce (March 19, 2015)

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This training on PrEP for HIV prevention was conducted by AIDS Foundation of Chicago (AFC) in collaboration with the Chicago Department of Public Health on March 19, 2015. These slides comprise a 3.5 hour training designed for people in the HIV workforce in Chicago and throughout Illinois that AFC and partners conduct at various times in the year. They are continually updated - this presentation includes recent PrEP data presented at CROI 2015 in late February.

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Project RSP! training on PrEP for the HIV workforce (March 19, 2015)

  1. 1. Welcome! CDPH Training – March 19, 2015
  2. 2. What we will cover today • Intros • Overview ARV-based prevention • Understanding PrEP – What is PrEP? – PrEP research – How PrEP is taken – Access to PrEP – Talking to clients about PrEP 2
  3. 3. Ground rules • We are all here to learn • The only dumb questions are the ones not asked • Listen actively, respect others when they are talking • Participate to the fullest of our abilities 3
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  6. 6. What is the first word or words that come to your mind when you think about condoms? 6
  7. 7. What is the first word or words that come to your mind when you think about needle exchange? 7
  8. 8. What is the first word or words that come to your mind when you think about oral contraceptives? 8
  9. 9. What is the first word or words that come to your mind when you think about PrEP? 9
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  11. 11. • Sex without condoms does not automatically = “unprotected sex.” • Will no longer frame sex without condoms as “unprotected.” – Protection can mean VL suppression, it can mean sero-adaptation, and it can mean PrEP (in addition to male and female condoms) 11 Protection w/out condoms
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  13. 13. 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) 13
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  16. 16. Hold up, 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? 16
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  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. *A moving target, as we will see….. 19
  20. 20. • Truvada is approved for use as part of a comprehensive HIV prevention strategy that includes other prevention methods, such as safe sex practices, risk reduction counseling, and regular HIV testing. - FDA – Must be confirmed HIV-negative before prescription – FDA required development of Risk Evaluation and Mitigation Strategy (REMS) for use of Truvada as PrEP to ensure safe use • www.truvadapreprems.com • Medication guide • Community education • Provider training • Implementation Dateline: July 16, 2012 20
  21. 21. Released May 14, 2014 21 tinyurl.com/CDCprepguidelines (PDF) tinyurl.com/CDCprepguidelineswebinar (webinar audio/slides)
  22. 22. PrEP Clinical Practice Guideline • 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 22
  23. 23. 23 Ken Like Barbie explains PrEP
  24. 24. 24
  25. 25. Ken Like Barbie recap • PrEP involves HIV-neg person taking ARVs to reduce risk of infection before HIV exposure. • PrEP prevents HIV from reproducing in a person’s body. • In current approved form, PrEP is taken in a single pill – Truvada –once a day, every day 25
  26. 26. www.myprepexperience.org
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  28. 28. 28 PrEP is more than a prescription PrEP is a program
  29. 29.  Provider* visits every 3 mos  HIV testing  Tied to Rx renewal  Hepatitis B testing  Kidney function testing  STI screening  Pregnancy testing  Adherence counselling  Honest, open discussions about sex, sexual health 29 Taking PrEP…. what does it take? *These activities don’t all need to be done by a doctor in their office
  30. 30.  It’s not just a pill, it’s a program  Adherence (perfection not required, esp for rectal)  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 30 *This is a moving target, as we will see….. Taking PrEP…. what does it take?
  31. 31. • 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 31
  32. 32. 32 You can miss a dose here and there and still have excellent protection.
  33. 33. 33 Adherence is a much bigger deal for vaginal protection.
  34. 34. 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. 34
  35. 35. 35 • True or False: PrEP must be started within 72 hours of exposure to HIV. • What is an example of “prophylaxis?” • The FDA approved Truvada as PrEP in what year? • True or False: It takes longer for PrEP to achieve protection in the vagina compared to the rectum.
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  40. 40. 40 Science.
  41. 41. 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) 41
  42. 42. 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 42
  43. 43. Key research 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 43
  44. 44. Key research findings • 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. 44
  45. 45. 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. 45
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  49. 49. PrEP’s “protease moment” 49 PROUD – 86% IPERGAY – 86% PARTNERS DEMO – 96% croiconference.org
  50. 50. 50 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
  51. 51. PROUD – London 51
  52. 52. 52 PROUD – London
  53. 53. 53 PROUD – London Daily PrEP works in the real world. Quite well! It was easily incorporated into sexual health clinics. Results only applicable to gay men.
  54. 54. 54 Ipergay – France, Canada
  55. 55. 55 Ipergay – France, Canada
  56. 56. 56 Ipergay – France, Canada
  57. 57. 57 Ipergay – France, Canada Challenges our daily adherence messaging. Only applicable to gay men and rectums. And what do we really know about men having infrequent sex?
  58. 58. 58 Partners Demo – Kenya, Uganda
  59. 59. 59 Partners Demo – Kenya, Uganda
  60. 60. 60 Partners Demo – Kenya, Uganda
  61. 61. 61 Partners Demo – Kenya, Uganda
  62. 62. 62 Partners Demo – Kenya, Uganda
  63. 63. 63 Partners Demo – Kenya, Uganda
  64. 64. 64 Partners Demo – Kenya, Uganda PrEP and TasP are synergistic and can be combined programmatically. Shared responsibility is important aspect. Works in resource challenged settings. Applicable to hetero women and men.
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  66. 66. 66 • 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.
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  68. 68. www.myprepexperience.org
  69. 69. Who might be a good fit for PrEP? • Person indicates an interest in taking PrEP • Person is in a “magnetic” relationship –HIV-negative and has HIV+ partner 69
  70. 70. Who might be a good fit for PrEP? • 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 70
  71. 71. Truvada as PrEP Is the first non- barrier HIV prevention strategy fully controlled by the receptive partner. 71
  72. 72. pleasure intimacy connection emotion lust love
  73. 73. 74 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
  74. 74. 75 Reclaim pleasure
  75. 75. THOUGHTFUL RESPONSIBLE CAREFUL AWARE PRO-ACTIVE DISCIPLINED TAKING PREP IS
  76. 76. SAFER SEX TAKING PREP IS
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  79. 79. Accessing PrEP in Chicago • Any medical provider who can write a scrip can write one for Truvada as PrEP • Most HIV docs familiar with PrEP • CORE Center • UC and ACCESS Grand Blvd • Howard Brown Health Center • Chicago PrEP Working Group 80
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  82. 82. Uninformed, misinformed providers
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  84. 84. Handy brochure 85 Designed to help individuals talk to their doctors about PrEP Before, during, after visit Questions to ask Web resources tinyurl.com/talkPrEPtoDr
  85. 85. 86 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
  86. 86. • MyPrEPexperience.org • Facebook group – PrEP Facts • Facebook.com/ProjectRSP (Ready, Set, PrEP) • PrEPWatch.org (advocacy) • ProjectInform.org/prep • Truvada.com (Gilead) • WhatisPrEP.org (video) Web resources on PrEP 87
  87. 87. Groovy PrEP videos 88 WhatisPrEP.org tinyurl.com/PrEPbyKLB
  88. 88. 89
  89. 89. Drug cost
  90. 90. Service costs
  91. 91. Lab costs
  92. 92. Paying for PrEP— insurance FDA approval of Truvada enables private ins to cover Truvada on Medicaid formulary Ins companies covering, so far ADAP does not cover PrEP 93
  93. 93. 94 the devil is in the details
  94. 94. 95 the devil is in the details
  95. 95. Paying for PrEP – Gilead 1. Visit www.truvada.com 2. Click on the link to access information about Truvada for a PrEP indication 96
  96. 96. Medication assistance • 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 9797
  97. 97. 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
  98. 98. Paying for PrEP – Illinois 99 PrEP4Illinois.com
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  100. 100. 101 • 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
  101. 101. 102 • Insured, insurance must cover medication for which patient seeks assistance • Patient must reside and receive treatment in U.S • Patient’s income below 500% of the Federal Poverty Level www.panfoundation.org/hiv-treatment-and-prevention PAN Foundation Eligibility
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  103. 103. 104 USCA 2014
  104. 104. 105 • How can people pay for their PrEP prescriptions? • People taking PrEP need to be tested for HIV _____ times every year. • Why is this important? • Name one barrier to PrEP access.
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  106. 106. 107
  107. 107. Baggage 108
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  109. 109. 110 “Party drug” “Public health disaster”
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  111. 111. 112 Condom privilege
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  113. 113. 114 ARVs are toxic
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  115. 115. “Although pre-exposure prophylaxis has a great potential in reducing incidence, scale-up might be inhibited by the same social or structural barriers to care outcomes for black MSM with HIV.” 116 Understanding the HIV disparities between black and white men who have sex with men in the USA using the HIV care continuum: a modelling study The Lancet HIV, December 2014 doi:10.1016/S2352-3018(14)00011-3 Rosenberg, Millett, Sullivan, del Rio, Curran MD
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  117. 117. More focus, More energy and More resources 118
  118. 118. 119
  119. 119. Messages to emphasize to clients • PrEP is an option – Not forever, but maybe for a “season” – If you use condoms successfully, do you need PrEP? • It’s not just a pill, it’s a program. – Holistic health care • Person must test HIV-negative to initiate and continue PrEP. • Adherence. Different for men and women. • Ipergay – complexities, complications. 120
  120. 120. Tips for talking about PrEP • Important you feel comfortable and confident talking about PrEP. • It’s okay to not have all of the answers and to refer your client to additional resources and/or promise to have that information next time you see him/her. 121
  121. 121. 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. 122
  122. 122. 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? 123
  123. 123. 124 • If someone doesn’t use ________ regularly, they may be a good fit for PrEP. • PrEP is not just a pill, it’s a _________. • Beyond a prescription, what is involved with taking PrEP?
  124. 124. 125
  125. 125. Chicago PrEP Working Group Researchers Medical providers Advocates Orgs/HDs HIV planning members 126
  126. 126. Chicago PrEP Working Group Researchers Medical providers Advocates CBOs HIV planning members 127
  127. 127. Chicago PrEP Working Group Researchers Medical providers Advocates CBOs HIV planning members 128
  128. 128. 129
  129. 129. 1000’s NEW HIV prevention advocates
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  136. 136. 141
  137. 137. Thank you!! 142
  138. 138. 143
  139. 139. CONTACT Jim Pickett jpickett@aidschicago.org Sara Semelka ssemelka@aidschicago.org 144

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