Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

PrEP Training Slides - IDPH/MATEC/AFC training in Collinsville, June 3, '15

597 views

Published on

These are the slides presented by AFC's Jim Pickett at the IDPH/MATEC/AFC-sponsored PrEP training in Collinsville, IL June 3, 2015.

Published in: Health & Medicine
  • Be the first to comment

  • Be the first to like this

PrEP Training Slides - IDPH/MATEC/AFC training in Collinsville, June 3, '15

  1. 1. Welcome! Collinsville – June 3, 2015 These slides are available at tinyurl.com/PrEPCollinsville
  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 – Slides available at: tinyurl.com/PrEPCollinsville 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
  4. 4. 4
  5. 5. 5
  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
  10. 10. 10
  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
  12. 12. 12
  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
  14. 14. 14
  15. 15. 15
  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. 17
  18. 18. 18
  19. 19. • 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 19
  20. 20. What is PrEP? • PrEP consists of taking the ARV drug Truvada to prevent HIV. One tablet every day. • 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. 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. • 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
  26. 26. www.myprepexperience.org
  27. 27. 27
  28. 28. 28 PrEP is more than a prescription PrEP is a program
  29. 29.  Take Truvada tablet every day.  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.
  36. 36. 36
  37. 37. 37
  38. 38. 38
  39. 39. 39
  40. 40. 40 Science.
  41. 41. Science • All completed trials done on tenofovir & Truvada • 7* studies = 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) *Will discuss the other 3 soon 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
  46. 46. 46
  47. 47. 47
  48. 48. 48
  49. 49. 49 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
  50. 50. PrEP’s “protease moment” 50 PROUD – 86% IPERGAY – 86% PARTNERS DEMO – 96% croiconference.org
  51. 51. 51
  52. 52. 52 • 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.
  53. 53. 53
  54. 54. www.myprepexperience.org
  55. 55. 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 55
  56. 56. 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 56
  57. 57. PrEPception [PrEP C] 57
  58. 58. Truvada as PrEP Is the first non- barrier HIV prevention strategy fully controlled by the receptive partner. 58
  59. 59. pleasure intimacy connection emotion lust love
  60. 60. 61 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
  61. 61. 62 Reclaim pleasure
  62. 62. THOUGHTFUL RESPONSIBLE CAREFUL AWARE PRO-ACTIVE DISCIPLINED TAKING PREP IS
  63. 63. SAFER SEX TAKING PREP IS
  64. 64. 66
  65. 65. 67
  66. 66. 68
  67. 67. Accessing PrEP • Any medical provider who can write a scrip can write one for Truvada as PrEP • Most HIV docs familiar with PrEP • But….most HIV docs are not necessarily seeing HIV-negative patients • Who is delivering PrEP services in/around Collinsville? 69
  68. 68. 70
  69. 69. 71
  70. 70. Uninformed, misinformed providers
  71. 71. 73
  72. 72. Handy brochure 74 Designed to help individuals talk to their doctors about PrEP Before, during, after visit Questions to ask Web resources tinyurl.com/talkPrEPtoDr
  73. 73. 75 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
  74. 74. • 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 76 These slides are available at tinyurl.com/PrEPCollinsville
  75. 75. Groovy PrEP videos 77 WhatisPrEP.org tinyurl.com/PrEPbyKLB
  76. 76. 78
  77. 77. 79
  78. 78. Drug cost
  79. 79. Service costs
  80. 80. Lab costs
  81. 81. 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 83
  82. 82. 84 the devil is in the details
  83. 83. 85 the devil is in the details
  84. 84. 86 May 1, 2015
  85. 85. 87 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
  86. 86. 88
  87. 87. 89
  88. 88. 90
  89. 89. 91
  90. 90. Paying for PrEP – Gilead 1. Visit www.truvada.com 2. Click on the link to access information about Truvada for a PrEP indication 92
  91. 91. 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 9393
  92. 92. 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
  93. 93. 95 • 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
  94. 94. 96 USCA 2014
  95. 95. 97 • 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.
  96. 96. 98
  97. 97. 99
  98. 98. Baggage 100
  99. 99. 101
  100. 100. 102 “Party drug” “Public health disaster”
  101. 101. 103
  102. 102. 104 Condom privilege
  103. 103. 105
  104. 104. 106 ARVs are toxic
  105. 105. “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.” 107 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
  106. 106. 108
  107. 107. More focus, More energy and More resources 109
  108. 108. 110
  109. 109. 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. 111
  110. 110. 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. 112
  111. 111. 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. 113
  112. 112. 114 • 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?
  113. 113. 115
  114. 114. 1000’s NEW HIV prevention advocates
  115. 115. 119
  116. 116. 120
  117. 117. 121
  118. 118. 122
  119. 119. 123
  120. 120. 124
  121. 121. 125
  122. 122. 126
  123. 123. Thank you!! 127
  124. 124. 128
  125. 125. CONTACT Jim Pickett jpickett@aidschicago.org 129 These slides are available at tinyurl.com/PrEPCollinsville

×