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Project Ready, Set, PrEP! training on PrEP for HIV Prevention - UPDATED NOV 17
The document provides an overview of Project RSP focused on educating Chicago providers and the community about pre-exposure prophylaxis (PrEP) as an HIV prevention strategy. It emphasizes the importance of adherence to medication, discusses the role of antiretroviral treatment in prevention, and highlights the challenges faced in implementing prevention strategies such as PEP and PrEP. Additionally, it includes guidelines for access, community education, and research initiatives related to PrEP.
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Project Ready, Set, PrEP! training on PrEP for HIV Prevention - UPDATED NOV 17
- 1. Welcome! CDPH –November 17, 2014
- 2. Our time together • Intros • What is Project RSP? • 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. Ground rules •We are 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. 3
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- 6. • Trainings: HelpChicago providers, educators, and others working directly with our community to understand PrEP and what it means for us and HIV prevention. • Give voice/provide facts: Platform for PrEP users to share experiences, interested individuals to get info – click myprepexperience.org 6 Unrestricted educational grants from Gilead in 2013, 2014 And look for us on FB too
- 7. 7 Unrestricted educational grant from Janssen Therapeutics 2014 Exploring the Pipeline Lubes, Rings, Films, Fibers, and Shots 4 HIV Prevention • Webinar • Thursday, December 11, 2014 • 2:00-3:30pm
- 8. • We areNOT “pushing” PrEP • We are NOT telling anyone to stop using condoms or other forms of protection • We are not pitting one intervention over another • We are pushing education • Knowledge is power • Ignorance is not strength 8
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- 12. Quick survey, pre-test • Help assess what you think and know now, pre-training • Post-test after training • Note changes in knowledge, perceptions When can I stop making wild guesses and start making educated guesses? 12
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- 14. What is thefirst word or words that come to your mind when you think about condoms? 14
- 15. What is thefirst word or words that come to your mind when you think about needle exchange? 15
- 16. What is thefirst word or words that come to your mind when you think about oral contraceptives? 16
- 17. What is thefirst word or words that come to your mind when you think about PrEP? 17
- 18. Prevention Paradigm 2013and beyond Different Strokes for Different Folks Method Contraception HIV Prevention Behavior ✓ ✓ Barrier Methods ✓ ✓ Gels ✓ Rings ✓ Oral pill ✓ ✓ Injectables ✓ Implants ✓ Surgical procedures ✓ ✓ Treatment ✓
- 19. A growing preventiontoolkit Prior to exposure Point of transmission Treatment • Treating POZ individuals has prevention benefits • Basic care/nutrition • Prevention for positives • Education & rights-focused behavior change • Therapeutic vaccines* •Male and female condoms and lube •ARV treatment to prevent vertical transmission (PMTCT) •Clean injecting equipment •Post-exposure prophylaxis (PEP) •Vaginal and rectal microbicides* •Rights-focused behavior change •Voluntary counseling & testing •STI screening & treatment •Male medical circumcision •Pre-exposure prophylaxis (PrEP) •Preventive Vaccines* 19
- 20. We interrupt thisbroadcast 20
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- 22. • Sex withoutcondoms 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) • Institutional implementation has started, but will require some time to fully take effect – However, we can implement/re-frame NOW in our prevention education efforts 22 Protection w/out condoms
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- 24. 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) 24
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- 26. Post-exposure prophylaxis (PEP) Provide 2 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 26
- 27. Accessing PEP •Baseline HIV 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 27
- 28. Accessing PEP •Person must 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 28
- 29. 29 PEP challenges “Meta-analysis: only half the people who start PEP complete the course.”
- 30. 30 PEP challenges “Of those who completed the course, 31.1% failed to attend a follow-up visit that would include HIV testing.”
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- 33. 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? 33
- 34. We interrupt thisbroadcast - One more time 34
- 35. Released May 14,2014 35 tinyurl.com/CDCprepguidelines (PDF) tinyurl.com/CDCprepguidelineswebinar (webinar audio/slides)
- 36. PrEP Clinical PracticeGuideline • 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 36
- 37. 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 in the rectum. Three weeks for vaginal protection. • Truvada is currently the only drug approved by the FDA for PrEP. 37
- 38. 38 PrEP KenLike Barbie explains
- 39. 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). 39
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- 41. • True orFalse: PEP must be started within 72 hours of exposure to HIV. • Where can you get started on PEP if your doctor’s office is closed? • What is an example of “prophylaxis?” • True or False: PrEP is a pill you take three days before you want to have sex in order to be protected from HIV. 41
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- 43. 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 • www.truvadapreprems.com • Medication guide • Community education • Provider training • Implementation 43
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- 47. A: Research •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) 47
- 48. Bumps in theroad 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 48
- 49. Key research findings • Adherence! Adherence! Adherence! (take the pill every day… every day means every day…) • 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 49
- 50. Key research findings • For some, there appears to be 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. 50
- 51. 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. 51
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- 54. We interrupt thisbroadcast - One last time 54
- 55. NEW research •iPrEX Open Label • 1,603 participants, 1,225 on PrEP • Most from Peru/Ecuador, 18% USA • 100% effectiveness associated with 4+ doses a week • 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 55
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- 58. Chicago PrEP research • 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 58
- 59. Chicago Research •SHIPP (Sustainable Health Center Implementation PrEP Pilot) – June 1 – Implementation project examining PrEP use in primary care settings in Chicago, Newark, Houston, and Philadelphia • Serves women and men • Access Grand Boulevard Specialty Clinic • 5401 South Wentworth Avenue, 773-288-6900 • PS-PrEP – Jan 1 – Randomized clinical trial of PrEP linkage program by DIS staff, UC and CDPH 59
- 60. Chicago Research •Facebook PrEP - Sept 1 – PrEP bridgers educate community about PrEP and disseminate information • Contact John Schneider at jschnei1@medicine.bsd.uchicago.edu to learn more! 60
- 61. Chicago Research •Howard Brown Health Center • Evaluating PrEP in community health center setting • Collects info on why patient AND provider are considering PrEP • Data quality can be monitored by visit types, provider, and testing location • Process enabling improved communication and tracking of those interested in PrEP, on PrEP, discontinuing PrEP 61
- 62. • True orFalse: PrEP does not work for women. • True or False: Most people who take PrEP will have nausea. • True or False: The FDA approved the HIV drug Truvada for use as prevention in July 2012. 62
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- 64. ARV-Based Prevention Pipeline(March 2014) PRE-CLINICAL PHASE I PHASE II PHASE III PHASE IV Pop Council IPM IPCP NIAID Pop Council R IPM HPTN/ACTG CONRAD IPM Gilead CONRAD Albert Einstein GSK CONRAD IPM CONRAD Janssen TaiMed Pop Council IPM IPM IPM IPM PBS IPM R IPM R Pop Council RTI Pop Council Mintaka ImQuest ImQuest DELIVERY SYSTEM Oral pills Vaginal gel Vaginal film Vaginal tablet Vaginal ring Long acting injectable Thin film polymer Phosphate Nano-fiber buffered saline PB S R Rectal gel IPM IPM IPM IPM TFV/ FTC TDF/ FTC MIV 150 TMC 278 MVA DAR Darunavir GRF TFV TDF DAP IQP IQP-0528 5P12 5P12-RANTES 744 Tenofovir Tenofovir disoproxil fumarate MIV 150 Maraviroc MAb GSK 744 Tenofovir disoproxil fumarate/emtricitabine Dapivirine Ripilvirine Monoclonal antibody Tenofovir/ emtricitabine Griffithsin DS003 DS003 (BMS793) No drug tested currently TFV Tenofovir prodrug ACTIVE DRUG RAL Raltegravir CDC CONRAD Adapted from AVAC Report 2013: Research & Reality. www.avac.org/report2013
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- 67. 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 67
- 68. 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 – Injects drugs one or more times daily – Shares injection equipment – Injects cocaine or meth 68
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- 71. Truvada as PrEP Is the first non-barrier HIV prevention strategy fully controlled by the receptive partner. 71
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- 75. Taking PrEP –what does it take? • It’s not just a pill, it’s a program • Adherence • Take 7 days before enough drug is “on board” to provide protection in the rectum, 3 weeks for the vagina – Then take Truvada every day 75
- 76. Taking PrEP –what does it take? • HIV testing • Hepatitis B testing • Kidney function testing • STI screening • Pregnancy testing • Provider visits every 3 mos to conduct all the above – Honest, open discussions about sex, sexual health 76
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- 78. What PrEP doesnot 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. 78
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- 82. Accessing PrEP inChicago • Any medical provider who can write a scrip can write one for Truvada as PrEP • Most HIV docs familiar with PrEP • Research (Project PrEPare) • UC and ACCESS Grand Blvd • Howard Brown Health Center • CORE Center – clinic coming soon • Chicago PrEP Working Group 82
- 83. Accessing PrEP inChicago • Howard Brown Health Center • PEP and PrEP offered on sliding scale • Host a PrEP/PEP line • Dedicated PrEP Advocate to assist clients • Contact Bryan Bautista-Gutierrez – BryanB@howardbrown.org – 773.388.1600 83
- 84. Accessing PrEP inChicago • U of C Infectious Disease Clinic • 1-888-824-0200 • PrEP docs: – Jean-Luc Benoit – Shirley Stephenson – David Pitrak – Renslow Sherer 84
- 85. Accessing PrEP inChicago • Access Grand Blvd Specialty Clinic. • Call 773-288-6900 • PrEP docs: – Jean-Luc Benoit – John Schneider (takes clients 16-18) – David Pitrak – Teresa Kodiak (takes under 16-18) – Nancy Glick • Any problems scheduling please contact John Schneider at jschnei1@medicine.bsd.uchicago.edu 85
- 86. Accessing 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 86
- 87. Insurance Medicaid Devilin the details • Prior auth • Deductibles • Co-pays • Tiers • Confusion 87 Accessing PrEP— insurance
- 88. Accessing PrEP –Gilead 1. Visit www.truvada.com 2. Click on the link to access information about Truvada for a PrEP indication 88
- 89. 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 89 89
- 90. 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
- 91. Gilead support programs Medication Assistance Program 500% FPL Co-pay program $300/mo. 91 Newly improved – october 15, 2014
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- 94. • True orFalse: Only HIV specialists are able to prescribe Truvada as PrEP • People taking PrEP need to be tested for HIV _____ times every year. • How are people getting their PrEP prescriptions paid for? • True or False: Only people with HIV-positive partners are eligible for PrEP. 94
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- 97. Handy brochure 97 Designed to help individuals talk to their doctors about PrEP Before, during, after visit Questions to ask Web resources tinyurl.com/talkPrEPtoDr
- 98. 98 PrEP WarmLine 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/
- 99. Web resources onPrEP • MyPrEPexperience.org • Truvada.com (Gilead) • ProjectInform.org/prep • PrEPWatch.org (advocacy focused) • PrEPfacts.org • WhatisPrEP.org (video) 99
- 100. Groovy PrEP videos 100 WhatisPrEP.org tinyurl.com/PrEPbyKLB
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- 103. Messages to emphasizeto 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. 103
- 104. 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. 104
- 105. 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. 105
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- 107. 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? 107
- 108. • If someonedoesn’t use ________ regularly, they may be a good fit for PrEP. • True or False: You can take Truvada on its own for treatment. • Name one organization in Chicago that is prescribing PrEP for people who need it. 108
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- 111. 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 111
- 112. Post-test Let’s seewhere you are at! 112
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- 116. • John Schneider jschnei1@medicine.bsd.uchicago.edu • Sara Semelka ssemelka@aidschicago.org • Jim Pickett jpickett@aidschicago.org • Project RSP! myprepexperience@gmail.com 116 Connect