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Project RSP! Training on PrEP - Oct 2013
The document outlines a training session on Project RSP, focusing on understanding pre-exposure prophylaxis (PrEP) as an HIV prevention strategy. It emphasizes education about PrEP, community experiences, and the importance of adherence to medication for effectiveness. Additionally, it provides insights into accessing PrEP, discussing research findings, and addressing misconceptions around its use and effectiveness.
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Project RSP! Training on PrEP - Oct 2013
- 1. Welcome! Project RSP! training– October 21 , 2013
- 2. Our time together •Intros • What is Project RSP? • What do YOU think about PrEP? • Overview of ARV-based prevention • Understanding PrEP – What is PrEP? – What is research telling us about PrEP? – How do you use PrEP? How do you get PrEP? – Talking to clients about PrEP • Breaks, and fun, fun, fun! 2
- 3. Ground rules • Weare all here to learn, and to gain a deeper understanding. • We know that the only dumb questions are the ones not asked. • We will listen actively, and respect others when they are talking. • We will participate to the fullest of our abilities. • We promise that what happens in RSP! stays in RSP! • Anything else? 3
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- 5. • Trainings: HelpChicago providers, educators, and others working directly with our community to understand PrEP and what it means for us and HIV prevention. • Community forums: Interactive and fun discussions done “talk show” style. October 17 at SSA – most recent. • Give voice/provide facts: Platform for PrEP users to share experiences, interested individuals to get info – click myprepexperience.blogspot.com. 5
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- 9. • We areNOT “pushing” PrEP • We are NOT telling anyone to stop using condoms or other forms of protection • We are pushing education • Knowledge is power • Ignorance is not strength 9
- 10. Honesty please What isthe first word or words that come to your mind when you think about condoms? 10
- 11. Honesty please What isthe first word or words that come to your mind when you think about PrEP? 11
- 12. Quick survey, pre-test •Help assess what you think and know now, pre-training • Post-test after training When can I stop making wild guesses and start making educated guesses? • Note changes in knowledge, perceptions 12
- 13. Your primer onARV prevention 13
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- 15. A growing preventiontoolkit Prior to exposure •Rights-focused behavior change •Voluntary counseling & testing •STI screening & treatment •Male medical circumcision •Pre-exposure prophylaxis (PrEP) •Preventive Vaccines* Point of transmission •Male and female condoms and lube •ARV treatment to prevent vertical transmission (PMTCT) •Clean injecting equipment •Post-exposure prophylaxis (PEP) •Vaginal and rectal microbicides* Treatment • Treating POZ individuals has prevention benefits • Basic care/nutrition • Prevention for positives • Education & rights-focused behavior change • Therapeutic vaccines* 15
- 16. What is ARV-basedprevention? • 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) 16
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- 18. Post-exposure prophylaxis (PEP) Provide2 or 3 ARV drug regimen after HIV exposure to stop infection • Occupational – offered to health care providers exposed to HIV, e.g. via needle stick • nPEP – offered for non-occupational exposure, meaning sexual exposure, injection drug use exposure • Must be taken within 72 hours of initial exposure • NY State guidelines – 36 hours • ARVs must be taken for 28 days 18
- 19. Post-exposure prophylaxis (PEP) •CDC guidelines last updated January 2005 http://www.cdc.gov/mmwr/preview/mmwrh tml/rr5402a1.htm#tab1 (new ones soon?) • Ethical and logistical reasons mean no randomized clinical trial • We don’t know exactly how well it works, but we have data that shows it does – From animal transmission models – Perinatal clinical trials – Studies of health-care workers receiving prophylaxis after occupational exposures – Observational studies 19
- 20. Accessing PEP • BaselineHIV testing • Any doctor is able to prescribe – 2 drug regimen – Truvada (tenofovir + emtricitabine) – 3 drug regimen – Truvada and Isentress (raltegravir) – In most cases with non-occupational exposure, likely to prescribe 3 drugs • ERs can/do start PEP, but typically only provide 3 days of meds, a “starter pack” • HIV docs the best to manage PEP, most likely to prescribe 20
- 21. Accessing PEP • Personmust be engaged with provider for duration of 28-day regimen for monitoring and HIV testing • HIV test at 4-6 wks, 3 mos, 6 mos • Can cost $1,000 + for the 28-day regimen – Insurance can cover – Medicaid coverage inconsistent – Pharma access programs can help • NASTAD fact sheet 21
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- 27. What is PrEP?* *pre-exposureprophylaxis 27
- 28. Hold up, whatis 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? 28
- 29. PrEP Ken Like Barbieexplains 29
- 30. Ken Like Barbierecap • 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 once a day, every day (Truvada). 30
- 31. What is PreP? •Truvada is a combination of tenofovir disoproxil fumarate (aka tenofovir or TDF) and emtricitabine. • Need to take 7 days of Truvada before enough drug is “on board” for protection • Truvada is currently the only drug approved by the FDA for PrEP. 31
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- 33. “Taking the Truvadadoes not make me ‘reckless’ in my decision to have unprotected sex, it makes me feel supported by a community of doctors and advocates who recognize the nuances of my situation, and are doing all they can to help me stay negative.” – Woman with HIV+ partner who started PrEP because they wanted to have a child 33
- 34. • True orFalse: PEP is taken for 7 days after exposure to HIV and then you are done. • True or False: PEP is for people who have been exposed to HIV in an occupational setting, or through sex, drug taking behaviors. • Name an example of “prophylaxis.” • “True or False: Truvada is a combination of two drugs in one tablet. 34
- 35. PrEP Truvada • PrEP willnot always be only Truvada • Researchers are currently exploring other ARV drugs that could also be used for PrEP • For instance, the ARV drug Maravoric (brand name Selzentry) is currently in clinical trials as a potential PrEP drug • Scientists are also researching the possibility of intermittent use of PrEP – May not have to be taken daily – PrEP could be delivered via injection, and could provide long term protection • Implications for treatment as well! 35
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- 37. Dateline: July 16,2012 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312210.htm Today, the US Food and Drug Administration approved Truvada (emtricitabine/tenofovir disoproxil fumarate), the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIVinfected partners. - FDA 37
- 38. Dateline: July 16,2012 • 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 • Medication guide • Community education • Provider training • Implementation 38
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- 42. Testing drugs forprevention Slide adapted from International Partnership for Microbicides
- 43. How did weget here? (Research!) • All completed trials done on tenofovir & Truvada • 3 trials = PrEP reduced risk of HIV infection – i-PrEX (Truvada in gay men and trans women) 44% reduction overall (reported 2010) Efficacy at 90% + with good adherence – Partners PrEP (Truvada and tenofovir in het couples) 75% reduction Truvada (reported 2011) – TDF2 (Truvada heterosexual men & women) 63% reduction overall (reported 2011) 43
- 44. How did weget here? (Research!) • 2 trials = PrEP did not work – FEM-PrEP (Truvada in women – stopped 2011) – VOICE (Truvada, tenofovir – reported 2013) • Both had very low adherence – though self-reports were high) • Low/undetected drug levels • June ‘13 - Bangkok Tenofovir Study (BTS) – CDC study of injection drug users (2,400 +) • Median age 31, 80% male – Daily tenofovir (75% chose directly-observed therapy) – It works! 49% overall, 74% high adherers 44
- 45. Home-grown Chicago PrEPresearch • Project PrEPare – Feasibility and acceptability trial of PrEP – Enrolled 68 young gay/MSM • ages 18-22 • 53% African-American, 40% Latino – Randomized to Truvada, placebo, or no-pill arm – On study for 6 months • very high retention (98.5%) • self-reported adherence averaged 62% (range 43% - 83%); detectable drug levels ranged from 63% - 20% • unprotected sexual activity decreased across all study arms 45
- 46. Home-grown Chicago PrEPresearch • iPrEx OLE (Open Label Extension) – First – what does “Open Label” mean? – iPrEx randomized trial was diverse worldwide, but not in the US – Missing representation from communities most affected domestically – Asked Chicago’s Project PrEPare participants if they would like to join iPrEx; 46 of 68 agreed – Data soon! 46
- 47. Home-grown Chicago PrEPresearch • 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, including Chicago – How safe is PrEP use is among HIVuninfected young gay/MSM? • And many more questions 47
- 48. Key research findings/Truvada •Adherence! Adherence! Adherence! • High adherence achieved 90%+ reduction in risk • Side effects – there appears to be a general “start-up syndrome” w/Truvada that includes nausea, diarrhea, abdominal pain and headaches for some individuals. • Nausea most common ( occurring in under 10% of people) and resolved in 4 to 6 weeks 48
- 49. Key research findings/Truvada •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 • Very little drug resistance has been seen, only among those with unidentified HIV infection when they started the study 49
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- 51. What PrEP doesnot do • Truvada as PrEP does not – Guarantee 100% protection from HIV – Protect a person against other STIs like chlamydia, syphilis, herpes, or gonorrhoea – Prevent pregnancy – Cure HIV – Function, on its own, as a treatment regimen for someone already living with HIV. – Why is Truvada, on it’s own, not considered adequate for treatment? 51
- 52. Seat belts don’tdo everything, either 52
- 53. • PrEP hasbeen proven to work with which populations? • True or False: New forms of PrEP may include injections with long-term protection. • True or False: Truvada on its own is not considered adequate for treatment. 53
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- 56. Why PrEP doesnot work for treatment • People with HIV require taking at least three ARVs together • The two drugs in Truvada are not sufficient to control the virus • A HIV+ person taking Truvada on its own runs the risk of developing resistance to the drug, which will limit drugs s/he can take for treatment 56
- 57. CDC – ClinicalPractice Guidelines • For clinicians – not “all purpose” • Being drafted – expect to publish soon – Now – peer review, public engagement draft guidelines – Next step to HHS for approval – then publish • Includes info on evidence, guidelines for screening, providing PrEP to gay men and heterosexuals, discontinuing PrEP, clinical considerations, improving adherence, reducing risk behaviors, info on financial case management, fact sheets, risk index, counseling info, and quality measures 57
- 58. Taking PrEP –what does it take? • Adherence! Taking the pill every day. • Take 7 days before enough drug is “on board” to provide protection – Still must take Truvada every day • Honest, open, ongoing discussions with medical provider about sex, HIV risk • HIV antibody test – before 1st prescription, and then every 3 mos. Rx renewal tied to renewed HIV-negative test. 58
- 59. Taking PrEP –what does it take? • • • • Hepatitis B testing Kidney function testing Bone density testing STI screening (and treatment if necessary) • Pregnancy testing • Doctor visits approx. every 3 mos to conduct all the above 59
- 60. Why would someonewant to take PrEP? 60
- 61. Who might bea good fit for PrEP? • Person indicates an interest in taking PrEP • Person is in a “magnetic” relationship –HIV-negative and has HIV+ partner –Serodiscordant 61
- 62. Who might bea 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 62
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- 67. Honesty please What isthe first word or words that come to your mind when you think about PrEP? 67
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- 70. Is PrEP cost-effective? •The following factors impact the cost-effectiveness of PrEP:1-13 (Modelling studies) – Medication cost and availability of insurance coverage – Targeted use among men and women at high risk – Efficacy – Changes in risk behavior • Several analyses show PrEP to be cost-effective, particularly when targeted to individuals at high risk of HIV acquisition2-5 1. Smith D. National Prevention Conference 2011. Atlanta. #E04 2. Juusola JL, et al. Ann Intern Med 2012;156:541-550 3. Desai K, et al. AIDS 2008;22:1829-1839 4. Walensky R, et al. CID 2012;epub April 3 5. Anderson J, et al. EACS 2009. Cologne. 6. Buchbunder S, et al. CROI 2012. Seattle. #1066 7. Grant R, et al. IAC 2006. Toronto. #THLB0102 8. Supervie V, et al. PNAS 2010;107:12381–12386 9. Paltiel DA, et al. Clin Infect Diseases 2009;48:806-15 10. Hill A, et al. CROI 2006. Denver. #Y-127 11. Hallett T, et al. CROI 2011. Boston. #99LB 12. Pretorius C, et al. PLoS ONE 2010;5:e13646 13. Abbas U, et al. PLoS ONE 2007;2:e875 70
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- 72. Accessing PrEP • Anydoctor who can write a prescription can write one for Truvada as PrEP • Most HIV docs are familiar with PrEP • CORE, John Stroger Hospital, Howard Brown Health Center, ACCESS Grand Blvd, TPAN (for referrals) and more 72
- 73. Accessing PrEP –Howard Brown • Howard Brown Health Center – primary care services, including PrEP access • HBHC providers experienced with PrEP, existing patient population accessing PrEP • Dedicated adherence counselor, like case manager for PrEP patients www.howardbrown.org 73
- 74. Accessing PrEP –Howard Brown • Assists w/accessing medication assistance, copay programs • Walgreens onsite – reduce anxiety over filling prescription some might think “embarrassing” • Pediatrician on-staff for 18 to 25 • Trans Health Advocates, Adherence Counselors support transgender patients accessing hormones, PrEP www.howardbrown.org 74
- 75. PrEP ed foryour doc • Bring along a fact sheet if you think your doctor may need some PrEP ed www.myprepexperience.blogspot.com 75
- 76. Be prepared forthe unPrEPared, and the unPEPared too 76
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- 78. Accessing PrEP— insurance FDAapproval of Truvada enables private ins to cover Truvada on Medicaid formulary ADAP does not cover PrEP Ins companies covering, many have pre-auth reqs 78
- 79. Accessing PrEP –Gilead 1. Visit www.truvada.com 2. Click on the link to access information about Truvada for a PrEP indication 79
- 80. Medication assistance form SeeNASTAD fact sheet 80
- 81. Co-pay card program • • • • • • • • • • Coversall 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, every 3 mos for Truvada as PrEP Maximum benefits: Stribild, Complera Atripla – Monthly $400 – Annual $4,800 Maximum benefits Truvada, Viread, Emtriva – Monthly $200 – Annual $2,400 Benefit automatically renews after 12 mos without need to re-enroll, every 3 mos for Truvada as PrEP, with HIVtest Service Provider: Covance for PrEP 877.505.6986
- 82. PrEP prescriptions –how many, who? • “Status of Truvada (TVD) for HIV Pre-Exposure Prophylaxis (PrEP) in the United States: An Early Drug Utilization Analysis” – presented at Interscience Conference on Antimicrobial Agents and Chemotherapy, Sept ’13 • RM Mera, MK Rawlings, A Pechonkina, JF Rooney, T Peschel, A Cheng Gilead Sciences, Inc., Foster City, CA • http://www.natap.org/2013/ICAAC/ICAAC_18.htm • Drug info from 55% of all US pharmacies, “nationally representative” • 49 states, 700 cities, • Algorithm to exclude treatment, PEP, off-label Hep-B treatment 82
- 83. PrEP prescriptions –how many, who? • 1,774 unique PrEP users between January 2011 and March 2013 • 1,674 prescribers (620 also prescribed Truvada as Tx) • Roughly half of all Rx were started before FDA approval in summer 2012 • Half of all Rx written for female PrEP users • Largest percentage Rx written in the Southeast • Average age of PrEP users + 35 yrs • Roughly 13% of users since FDA approval under age of 25 83
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- 87. • What doesn’tPrEP do? • True or False: PrEP is highly recommended for people who use condoms consistently and correctly. • True or False: PrEP is only for people in serodiscordant relationships. • True or False: ADAP will not cover Truvada as PrEP. • While taking PrEP, you need to get tested for HIV every ______ months. 87
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- 89. Messages to emphasizeto clients • PrEP is an OPTION (remember who might be a good fit for PrEP) – Not forever, but maybe for a “season” • Person must test HIV-negative to initiate and continue PrEP. • Daily adherence to PrEP is essential to reduce person’s risk of HIV – and can be very effective. • Taking PrEP does not guarantee 100% protection from HIV. 89
- 90. Messages to emphasizeto clients • Daily use of Truvada as PrEP cannot and does not function as HIV treatment. • PrEP user must be engaged with regular health care for prescription, to ensure remaining negative, staying adherent, kidney health, etc. • PrEP doesn’t make male or female condoms obsolete! – If you someone uses condoms consistently and correctly, with no problems, do they need PrEP too? 90
- 91. Tips for talkingabout 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. www.myprepexperience.blogspot.com 91
- 92. Tips for talkingabout 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. 92
- 93. Strategies for adherence –Take pill each day at same time – What are some other strategies? – What should you do if you forget a dose? 93
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- 96. Client scenario activities •Break off into small groups • We will provide sample client scenarios • Read assigned scenarios over with your group, consider potential responses, take notes, assign person to report • Re-convene and report back • 10 hot minutes from now 96
- 97. 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? 97
- 98. Post-test Let’s see where youare at! 98
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- 100. Web resources onPrEP • My PrEP Experience www.myprepexperience.blogspot.com (training slides) • RSP on FB https://www.facebook.com/ProjectRSP • Project PrEPare www.projectprepare.net • Howard Brown www.howardbrown.org • Truvada as PrEP www.Truvada.com • Project Inform www.projectinform.org/prep • AVAC www.avac.org 100
- 101. Evals! Fact sheets! •Please take a moment to fill out the evaluation so we can continue to adapt and improve this training. • Pick up your complimentary PrEP fact sheets in English and/or Spanish on the way out… 101
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- 103. Please stay intouch • Sybil Hosek sybilhosek@gmail.com • Jessica Terlikowski jterlikowski@aidschicago.org • Betty Kritikos Betty.Kritikos@gilead.com • Keven Cates kevenc@howardbrown.org • Jim Pickett jpickett@aidschicago.org • Project RSP! myprepexperience@gmail.com 103
Editor's Notes
- #5 Jim and or/JessicaFor smaller groups, people will say who they are, what organization they work with, and will rate their PrEP knowledge/comfortability on a 1 to 5 scale. 1 = not knowing much and 5 = knowing a LOT about PrEP and very comfortable. For larger group, we will have ppl introduce themselves to each other, those sitting nearby, and we will do a show of hands for the 1 to 5 scale on PrEP knowledge
- #12 .
- #37 Sybil
- #51 Sybil
- #53 Staci
- #65 Jim and/or Jessica
- #66 Jim and/or Jessica
- #67 Jim and/or Jessica
- #78 Jim and/or Jessica