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Project RSP Training on PrEP - November 13, 2015

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Project RSP Training on PrEP - November 13, 2015

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This training was conducted by AIDS Foundation of Chicago for members of Chicago's HIV workforce - in partnership with the Chicago Department of Public Health. It took place on Friday, November 13, 2015. Presenters included the CORE Center's Dr. Sybil Hosek, Jim Pickett of AFC, and two PrEP consumers - Gabe Bahena and Curtis Lewis.

This training was conducted by AIDS Foundation of Chicago for members of Chicago's HIV workforce - in partnership with the Chicago Department of Public Health. It took place on Friday, November 13, 2015. Presenters included the CORE Center's Dr. Sybil Hosek, Jim Pickett of AFC, and two PrEP consumers - Gabe Bahena and Curtis Lewis.

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Project RSP Training on PrEP - November 13, 2015

  1. 1. Chicago Department of Public Health Besly Court 11.13.15 Download these slides here: tinyurl.com/PrEPNov1315 Funding for this training provided by Gilead Sciences
  2. 2. • Who’s in the room? • Pre and post test, evaluation • Overview ARV-based prevention • Understanding PrEP – What is PrEP? – How PrEP is taken – Access to PrEP – BREAKING NEWS – And more… These slides available at: tinyurl.com/PrEPNov13155
  3. 3. 3 Please like, follow us on Facebook facebook.com/ProjectRSP
  4. 4. 4 tinyurl.com/PrEPNov18
  5. 5. 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 5
  6. 6. 6 Who’s in the room?
  7. 7. 7 Logistics
  8. 8. 8
  9. 9. What is the first word or words that come to your mind when you think about condoms? 10
  10. 10. What is the first word or words that come to your mind when you think about needle exchange? 11
  11. 11. What is the first word or words that come to your mind when you think about oral contraceptives? 12
  12. 12. What is the first word or words that come to your mind when you think about PrEP? 13
  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) 15
  14. 14. 16
  15. 15. 17
  16. 16. Condom use and effectiveness 18 JAIDS 2014 Condom Effectiveness for HIV Prevention by Consistency of Use Among MSM in the U.S. • Data from EXPLORE and VAX 004 • 16.4% reported “always” using condoms during anal sex • 70% overall effectiveness • Inconsistent use, “sometimes” use, offers minimal to no protection over time
  17. 17. 19 AJPH 1998 Variables influencing condom use in a cohort of gay and bisexual men • 23 per cent of the men reported that they always used condoms for IAI and 21 per cent for RAI • 32 per cent sometimes used condoms for IAI • 28 per cent sometimes used condoms for RAI • 45 per cent never used condoms for IAI • 50 per cent never used condoms for RAI Condom use and effectiveness
  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? 21
  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. 22
  20. 20. 23 #HIV2020 AIDS.gov/2020
  21. 21. 24
  22. 22. 25 #HIV2020 AIDS.gov/2020
  23. 23. Approved Truvada for PrEP Gay/straight men, women 18+ July 16, 2012
  24. 24. 27 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 28tinyurl.com/CDCprepguidelines
  26. 26. 30 WhatIsPrEP.org
  27. 27. 31
  28. 28. 32 • 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.
  29. 29. www.myprepexperience.org
  30. 30. 34
  31. 31. PrEP works – the science • 6 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) – PROUD (Truvada, gay men) – Ipergay (Truvada, gay men) 35
  32. 32. 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 36
  33. 33. 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 37
  34. 34. • 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. 38 PrEP works – key findings
  35. 35. 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. 39
  36. 36. 40
  37. 37. 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 41
  38. 38. 42
  39. 39. 43
  40. 40. 44
  41. 41. 45
  42. 42. 46
  43. 43. • Kaiser Permanente PrEP program in San Francisco • Provides services to over 170,000 adults in SF • Study period: July ‘12 – Feb ’15 • 1,045 referrals for PrEP – 801 at least 1 intake visit – 657 initiated PrEP • 388 person-years PrEP use • Mean duration use 7.2 mos • Increase in referrals and initiation of PrEP noted in Sept 2013 • Mean age 37 (range 20-68) • 653 gay men, 3 hetero cis women, one trans man • Of 657 initiators, 187 dx’d with at least one STI during follow-up, 78 individuals had multiple STIs – After 6 mos use, 30% dx’d with STI (18% rectal) – After 12 mos use, 50% dx’d with STI (33% rectal) 47
  44. 44. • No HIV diagnoses during 388 person-years of f/u • 143 completed survey on behavior change – Number sexual partners • # Unchanged 74% • Decreased 15% • Increased 11% – Condom use • Unchanged 56% • Decreased 41% • Increased 3% – No factors associated with increase in # partners, decrease in condom use • 657 initiators – More likely to report multiple partners – Prior PrEP use (study, other) – Not more likely to have POZ partner • 144 non-initiators – Low risk 35% – Cost concerns 15% – Not wanting to do f/u 10% – Prefer PEP 6.3% – Side effects concerns 2.8% – Concern about potentially increasing risk behavior 1.4% 48Expected incidence: as high as 8.9 per 100 person-years
  45. 45. 49
  46. 46. 50
  47. 47. 51
  48. 48. 52 www.ias2015.org www.aidsmap.com/ias2015
  49. 49. 53 www.ias2015.org www.aidsmap.com/ias2015
  50. 50. 54 www.ias2015.org www.aidsmap.com/ias2015 Dr. Sybil Hosek – CORE
  51. 51. 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 • Those who reported most sexual risk were more adherent • 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 – CORE55
  52. 52. 56 www.ias2015.org www.aidsmap.com/ias2015 Dr. Al Liu – SF DPH
  53. 53. 57 • 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
  54. 54. 58 Chicago PrEP Research
  55. 55. 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 59
  56. 56. 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. 60
  57. 57. 61
  58. 58. 62 PrEP is more than a prescription PrEP is a program
  59. 59.  Take Truvada every day  Provider* visits every 3 mos  HIV testing every 3 mos  Tied to Rx renewal  Hepatitis B testing  Kidney function testing  Regular STI screening  Pregnancy testing 64 *These activities don’t all need to be done by a doctor in their office Taking PrEP… What does it take?
  60. 60.  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. 65 Taking PrEP… What does it take?
  61. 61. 66
  62. 62. • 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 67
  63. 63. 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. 68
  64. 64. 69
  65. 65. 70 • 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 not necessary while being on the PrEP program. • True or False: You don’t need to adhere perfectly to PrEP to achieve high levels of protection. • True or False: PrEP is forever, once you start there is no stopping.
  66. 66. 71
  67. 67. 72 tinyurl.com/PrEPNov18
  68. 68. PrEP4Love
  69. 69. Launching February 2016
  70. 70. Young gay black men Black hetero women Trans women of color
  71. 71. Love is contractible. Lust is transmittable. Touch is contagious. With PrEP, people can catch feelings, not HIV. This campaign will offer up the experiences of the heart and flesh that HIV has kept people from fully embracing… until now. With honest and visceral photography we will show how Chicagoans can love, explore, and touch freely because of PrEP.
  72. 72. Gay black men 18 to 29, individuals and partners Cisgender heterosexual black women 18 to 40, individuals and partners Transgender women of color 18 to 40, individuals and partners 8 individuals (4 couples) will be selected OPEN CASTING – DEADLINE SUNDAY 11/15 tinyurl.com/PrEP4Love
  73. 73. www.myprepexperience.org
  74. 74. Who might be a good fit for PrEP? •Person indicates an interest in taking PrEP 80
  75. 75. 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 81
  76. 76. 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 82
  77. 77. PrEP-C
  78. 78. pleasure intimacy connection emotion lust love
  79. 79. 85 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
  80. 80. 86 Reclaim pleasure
  81. 81. 87
  82. 82. 89
  83. 83. Accessing PrEP in Chicago • Any medical provider who can write a scrip can write one for Truvada as PrEP • tinyurl.com/ChicagoPrEPproviders • Chicago PrEP Line - (872) 215-1905 90
  84. 84. 91 PrEP at CORE
  85. 85. PrEP Access –The CORE program 92 • 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
  86. 86. PrEP Access –The CORE program 93 • Primary clinic location: CORE Center – Monday afternoons for youth under 25 – Tuesday evenings and Friday afternoons for all • Secondary locations: Fantus Adolescent Clinic, Wednesday/Thursday afternoons • Project Coordinator: Raymond McPherson (312/846-3578)
  87. 87. PrEP Access –The CORE program 94 • 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
  88. 88. 96
  89. 89. Uninformed, misinformed providers 97
  90. 90. 98
  91. 91. Handy brochure 99 Designed to help individuals talk to their doctors about PrEP Before, during, after visit Questions to ask Web resources tinyurl.com/talkPrEPtoDr
  92. 92. 100 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
  93. 93. • 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 101
  94. 94. www.facebook.com/groups/PrEPFacts 102
  95. 95. 103 PositivelyAware.com Printed copies available email distribution@tpan.com
  96. 96. 104
  97. 97. 105 Please like, follow us on Facebook facebook.com/ProjectRSP
  98. 98. FDA approval of Truvada enables private ins to cover Medicaid formulary Ins companies covering, so far ADAP does not cover PrEP 107
  99. 99.  Drug costs  Visit, service costs  Lab costs 108
  100. 100. 109 the devil is in the details  Premiums  Deductibles  Cost-sharing  Drug formularies  Drug tiers  Shifting benefits  Not easy to figure all this out!
  101. 101. 110 http://ow.ly/PTYCK
  102. 102. Paying for PrEP – Gilead 1. Visit www.truvada.com 2. Click on the link to access information about Truvada for a PrEP indication 111
  103. 103. 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 112112
  104. 104. 113
  105. 105. 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) – Full year benefit ($3600) available up front • No maximum lifetime benefit but pts need to recertify after 12 months 114
  106. 106. 115 • 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
  107. 107. 116
  108. 108. 117 USCA 2014
  109. 109. 118 www.ias2015.org [Quote from female sex worker participating in treatment and PrEP demo project in Johannesburg, South Africa.]
  110. 110. 119
  111. 111. 120
  112. 112. 121
  113. 113. 122 • How can people pay for their PrEP prescriptions? • What new development has just improved access to PrEP for people with insurance? • People taking PrEP need to be tested for HIV _____ times every year. • Why is this important?
  114. 114. 124
  115. 115. 125 “Party drug” “Public health disaster”
  116. 116. 126PrEP DENIALISM
  117. 117. 127
  118. 118. 128 Condom privilege
  119. 119. 129 “But ARVs are toxic…”
  120. 120. 130
  121. 121. 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. 132
  122. 122. 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. 133
  123. 123. 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. 134
  124. 124. THOUGHTFUL RESPONSIBLE CAREFUL 135 AWARE PRO-ACTIVE DISCIPLINED TAKING PREP IS
  125. 125. SAFER SEX TAKING PREP IS 136
  126. 126. 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? 137
  127. 127. 138
  128. 128. 139 "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
  129. 129. 140
  130. 130. 141
  131. 131. Thank you!! 142
  132. 132. 143
  133. 133. 144
  134. 134. CONTACT Jim Pickett jpickett@aidschicago.org Sybil Hosek sybilhosek@gmail.com 145 #yayPrEP Download these slides: tinyurl.com/PrEPNov1315

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