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PrEP Training Slides - Austin CBC, CORE Center, AFC

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These slides were used for the HIV workforce PrEP training conducted by AIDS Foundation of Chicago on June 23, 2015 at Austin CBC in collaboration with the CORE Center.

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PrEP Training Slides - Austin CBC, CORE Center, AFC

  1. 1. Austin CBC PrEP Training – 6.23.15 Download these slides: tinyurl.com/PrEP_Austin_June2015
  2. 2. What we will cover today • Intros • Overview ARV-based prevention • The CORE PrEP clinic • Understanding PrEP – What is PrEP? – PrEP research – How PrEP is taken – Access to PrEP – Talking to clients about PrEP – tinyurl.com/PrEP_Austin_June2015 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
  17. 17. 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. 17
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  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 tinyurl.com/PrEPbyKLB
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  25. 25. Ken Like Barbie recap • PrEP involves HIV-neg person taking ARVs to reduce risk of infection before HIV exposure. • In current approved form, PrEP is taken in a single pill – Truvada –once a day, every day • Seasons of risk. • With us, by us, for us. 25
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  27. 27. www.myprepexperience.org
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  29. 29. 29 PrEP is more than a prescription PrEP is a program
  30. 30.  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 30 Taking PrEP…. what does it take? *These activities don’t all need to be done by a doctor in their office
  31. 31.  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 31 Taking PrEP…. what does it take?
  32. 32. • 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 32
  33. 33. 33 You can miss a dose here and there and still have excellent protection.
  34. 34. 34 Adherence is a much bigger deal for vaginal protection.
  35. 35. 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. 35
  36. 36. 36 • 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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  39. 39. 39 • WhatIsPrEP.org • Educational tool – health educators at CORE • Spanish version now available • Disclaimer has been added re: vaginal protection
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  42. 42. 42 Science.
  43. 43. 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) 43
  44. 44. 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 44
  45. 45. 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 45
  46. 46. 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. 46
  47. 47. 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. 47
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  50. 50. PrEP’s “protease moment” 50 PROUD – 86% IPERGAY – 86% PARTNERS DEMO – 96% croiconference.org
  51. 51. 51 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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  53. 53. 53 Chicago PrEP Research
  54. 54. Chicago PrEP research/CORE • Project PrEPare II • Open label demonstration project AND safety study of PrEP in young gay/MSM ages 15-22 – Actively enrolling 300 youth in 13 US sites, Chicago – Evaluating: • Safety of PrEP use among young HIV-neg gay/MSM • Acceptability, patterns of use, and adherence • Risk patterns • Texting to encourage adherence • Demographic and/or behavioral differences among youth –Interested in a PrEP study –Who stays on PrEP 54
  55. 55. Chicago PrEP research/CORE • Enhancing PrEP in Communities (EPIC) • To test the effectiveness of Prepmate, a novel multi- modal, technology-based intervention for pre-exposure prophylaxis (PrEP) adherence support among young gay men/MSM. – Uses SMS support and interactive online content to enhance PrEP adherence • The control condition includes standard of care support for gay/MSM who are starting PrEP. – Brief health educator-provided adherence and risk reduction counseling at scheduled study visits, and access to a clinician whenever needed. 55
  56. 56. 56 • 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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  58. 58. www.myprepexperience.org
  59. 59. 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 59
  60. 60. 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 60
  61. 61. Truvada as PrEP Is the first non- barrier HIV prevention strategy fully controlled by the receptive partner. 61
  62. 62. pleasure intimacy connection emotion lust love
  63. 63. 64 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
  64. 64. 65 Reclaim pleasure
  65. 65. THOUGHTFUL RESPONSIBLE CAREFUL AWARE PRO-ACTIVE DISCIPLINED TAKING PREP IS
  66. 66. SAFER SEX TAKING PREP IS
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  69. 69. 71Meme by Pedro Alonso Serrano
  70. 70. 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 72
  71. 71. 73 PrEP at CORE
  72. 72. PrEP Access –The CORE program 74 • HEAT – Helping Eliminate AIDS through Teamwork • Health Educators are first line for PrEP Clinic – PrEP education, screenings, initial lab tests, benefits – Health educator appointments available Monday – Thursday
  73. 73. PrEP Access –The CORE program 75 • Primary clinic location: CORE Center, Friday afternoons (will expand if necessary) • Secondary locations: Fantus Adolescent Clinic, Wednesday/Thursday afternoons; Austin CBC – TBD • Project Coordinator: Raymond McPherson (312/846-3578) • Linkage-to-PrEP Liaison: TBN
  74. 74. PrEP Access –The CORE program 76 • Initial screening appointment in PrEP clinic will include Rx if necessary lab tests are in medical record (HIV, CrCl) • 1 month f/u appointment for adherence, side effects • 3 month f/u, then quarterly • Adherence, risk reduction support provided in clinic by HE, HEAT staff • Access to research opportunities
  75. 75. PrEP Access –The CORE program 77 What have we learned so far?
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  78. 78. Handy brochure 80 Designed to help individuals talk to their doctors about PrEP Before, during, after visit Questions to ask Web resources tinyurl.com/talkPrEPtoDr
  79. 79. 81 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
  80. 80. • MyPrEPexperience.org • Facebook group – PrEP Facts • Facebook.com/ProjectRSP (Ready, Set, PrEP) • PrEPWatch.org (advocacy) • ProjectInform.org/prep • Truvada.com (Gilead) • WhatisPrEP.org (video) • PrEP providers in Chicago area aidschicago.org/i-need/prep/prep-clinics-and-providers Web resources on PrEP 82
  81. 81. Groovy PrEP videos 83 WhatisPrEP.org tinyurl.com/PrEPbyKLB
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  84. 84. 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 87
  85. 85. 88 the devil is in the details
  86. 86. 89 the devil is in the details
  87. 87. 90 Our records indicate that you have received Truvada in the past year with no other antiretroviral agents which would suggest use for preexposure prophylaxis. Prophylactic treatment is not a covered benefit as listed in the Exclusion Section of your member contract. . May 1, 2015
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  91. 91. Paying for PrEP – Gilead 1. Visit www.truvada.com 2. Click on the link to access information about Truvada for a PrEP indication 94
  92. 92. 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 9595
  93. 93. 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
  94. 94. 97 • 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. • www.panfoundation.org/hiv-treatment-and-prevention Paying for PrEP – PAN Foundation
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  96. 96. 99 USCA 2014
  97. 97. 100 • Name three details about the PrEP clinic at the CORE Center. • How can people pay for their PrEP prescriptions? • People taking PrEP need to be tested for HIV _____ times every year. • Why is this important?
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  99. 99. 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. 102
  100. 100. 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. 103
  101. 101. 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. 104
  102. 102. 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? 105
  103. 103. 106 • 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?
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  105. 105. 108 "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
  106. 106. PrEP Access and Implementation Chicago efforts 109
  107. 107. Chicago PrEP Working Group Researchers Medical providers Advocates Orgs/HDs HIV planning members 110
  108. 108. Chicago PrEP Working Group Researchers Medical providers Advocates CBOs HIV planning members 111
  109. 109. 112 Organization Clinic Refer Research Ed/Train Advocacy ACCESS Grand Boul X X AFC X X X Center on Halsted x X Chicago DPH (funder) X X Chicago House X X X CORE Center X X Fantus Clinic X Friend Family Health X Howard Brown X X X Illinois DPH X Lurie Child Hospital X X MATEC X Mt. Sinai X TPAN X X X U Chicago X X
  110. 110. Chicago PrEP Working Group Researchers Medical providers Advocates CBOs HIV planning members 113
  111. 111. Chicago PrEP Working Group Researchers Medical providers Advocates CBOs HIV planning members 114
  112. 112. Chicago PrEP Working Group Researchers Medical providers Advocates CBOs HIV planning members 115
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  116. 116. Thank you!! 119
  117. 117. • Sybil Hosek sybilhosek@gmail.com • Margo Bell belmar@cookcountyhhs.org Download slides tinyurl.com/PrEP_Austin_June2015 • Raymond McPherson raymond_mcpherson@rush.edu • Jim Pickett jpickett@aidschicago.org 120 Connect

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