Welcome!
Chicago Department of Public Health – June 10, 2014
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
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. • We promise that what happens in RSP! stays in RSP! • Anything else? 3
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Unrestricted educational grants from Gilead in 2013, 2014
• Trainings: Help Chicago 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.blogspot.com. 6
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• We are NOT “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
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2014: Project RSP! and RSP+ Janssen grant
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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
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What is the first word or words that come to your mind when you think about condoms? 15
What is the first word or words that come to your mind when you think about needle exchange?
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What is the first word or words that come to your mind when you think about oral contraceptives?
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What is the first word or words that come to your mind when you think about PrEP? 18
Why are we talking about PrEP?
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Different Strokes for Different Folks
Prevention Paradigm 2013 and beyond Method
Contraception
HIV Prevention
Behavior
✓
✓
Barrier Methods
✓
✓
Gels
✓
Rings
✓
Oral pill
✓
Injectables
✓
Implants
✓
Surgical procedures
✓
Treatment
✓
✓ ✓
A growing prevention toolkit 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*
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We interrupt this broadcast
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Protection w/out condoms • January 23 – call between CDC, HIV Prevention Justice Alliance and other allies • Discussed 2013 MMWR Report on HIV Testing and Risk of US Gay, Bisexual and other MSM http://www.cdc.gov/mmwr/pdf/wk/mm6247.pdf – 86 community orgs sign on to letter critiquing language, testing recommendations, “unprotected sex” 24
Protection w/out condoms • 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)
• Institutional implementation of this reconceptualization of prevention has started, but will require some time to fully take effect – However, WE can implement this re-frame NOW in our prevention education efforts 25
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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) 27
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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
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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 30
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 31
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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? 36
We interrupt this broadcast - One more time 37
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Released May 14, 2014
tinyurl.com/CDCprepguidelines (PDF) tinyurl.com/CDCprepguidelineswebinar (webinar audio/slides)
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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 41
tinyurl.com/CDCprepguidelineswebinar (webinar audio/slides)
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"My job is to prevent HIV infections when I can. As the nation’s top AIDS doctor is quoted as saying, I cannot let the perfect be the enemy of the good. My personal feelings about the AIDS crisis are not a valid factor in my medical decision-making, and for patients who would benefit from a preventive prescription for Truvada I will start providing them.“ - Dr. Russell Saunders in The Daily Beast May 16, 2014
PrEP
Ken Like Barbie explains
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Ken Like Barbie recap • 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). 47
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.
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www.myprepexperience.blogspot.com
• True or False: 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.
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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. 52
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
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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) 58
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
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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 60
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.
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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.
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PrEP Clinic Walkthrough • What can a person expect when they go to a PrEP clinic? • How is it different from other medical visits?
• How can you prepare your clients for their first PrEP visit?
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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 64
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!
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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, MAs, and testing location • Process enabling improved communication and tracking of those interested in PrEP, on PrEP, discontinuing PrEP
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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 stay on PrEP 67
• True or False: 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.
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ARV-Based Prevention Pipeline (March 2014) PRE-CLINICAL
PHASE I
PHASE III
PHASE II
PHASE IV
R IPM
Pop Council
IPM
IPM
GSK
CONRAD
IPM
IPM
IPM
IPM
Janssen
CONRAD
HPTN/ACTG CONRAD
CONRAD
ACTIVE DRUG
R IPM
IPCP NIAID
IPM
Albert Einstein
TaiMed
CONRAD
R IPM
Pop Council
ImQuest
Pop Council
IPM
RTI
PBS CDC
Pop Council
Tenofovir
DAR Darunavir
TFV
Tenofovir prodrug
DAP Dapivirine
TDF
Tenofovir disoproxil fumarate
GRF Griffithsin
Oral pills
Vaginal tablet
TFV/ FTC
Tenofovir/ emtricitabine
Vaginal gel
Rectal gel
TDF/ FTC
Tenofovir disoproxil fumarate/emtricitabine IQP IQP-0528
MIV 150
MIV 150
5P12 5P12-RANTES
TMC 278
Ripilvirine
744
MVA
Maraviroc
MAb Monoclonal antibody
RAL
Raltegravir
No drug tested currently
Mintaka Vaginal ring
Pop Council
TFV
IPM
DELIVERY SYSTEM ImQuest
Gilead
IPM
Vaginal film
IPM
PB S
Phosphate buffered saline
R
Long acting injectable Thin film polymer Nano-fiber
Adapted from AVAC Report 2013: Research & Reality. www.avac.org/report2013
DS003 DS003 (BMS793)
GSK 744
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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
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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 75
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Truvada as PrEP Is the first nonbarrier HIV prevention strategy fully controlled by the receptive partner.
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Taking PrEP – what does it take? • Adherence! Taking the pill every day. • Take 7 days before enough drug is “on board” to provide protection. – Then take Truvada every day
• Honest, open, and ongoing discussions with medical provider about sex and HIV risk. • HIV test – before 1st Rx, before each Rx renewal.
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Taking PrEP – what does it take? • • • • • •
HIV testing Hepatitis B testing Kidney function testing STI screening Pregnancy testing Doctor visits every 3 mos to conduct all the above
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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, herpes, or gonorrhoea – Prevent pregnancy – Cure HIV – Function as a treatment regimen for someone already living with HIV. 81
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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 • Research (Project PrEPare) • UC and ACCESS Grand Blvd • Howard Brown Health Center • CORE Center clinic coming soon • Chicago PrEP Working Group 84
Accessing PrEP in Chicago • U of C Infectious Disease Clinic • 1-888-824-0200 • PrEP docs: – Jean-Luc Benoit – Shirley Stephenson – David Pitrak – Renslow Sherer • NOTE: University of Chicago does not take some insurance programs (like County Care) 85
Accessing PrEP in Chicago • 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 NOTE: Access doesn’t take some HMOs. Photo ID is required
• Any problems scheduling please contact John Schneider at jschnei1@medicine.bsd.uchicago.edu 86
Accessing PrEP in Chicago • 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
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Accessing PrEP— insurance FDA approval of Truvada enables private ins to cover
ADAP does not cover PrEP
Truvada on Medicaid formulary
Ins companies covering, so far 88
Accessing PrEP – Gilead 1. Visit www.truvada.com 2. Click on the link to access information about Truvada for a PrEP indication
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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, HIVnegative, low income (200% 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
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Co-pay card program Covers all Gilead HIV Products: Stribild, Complera, Atripla, Truvada, Viread, Emtriva
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• •
•
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) – $200/month for (Truvada, Viread, Emtriva) No maximum lifetime benefit but pts need to recertify after 12 months
www.myprepexperience.blogspot.com
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The cost issue is real, and if we were to routinely prescribe PrEP to people at low risk (e.g. the “worried well�, or the monogamous HIV-negative partners of HIV-positive people on treatment), PrEP would be ridiculously cost-ineffective. But if we can reach the people at greatest risk, it will be cheaper to prevent HIV with PrEP during periods of high risk than to treat it for a lifetime.
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• True or False: 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. 96
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Be PrEPared for the unPrEPared
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PrEP ed for your doc
• Bring along a fact sheet if you think your doctor may need some PrEP ed
www.myprepexperience.blogspot.com 100
Handy brochure! Designed to help individuals talk to their doctors about PrEP Before, during, after visit Questions to ask Web resources tinyurl.com/talkPrEPtoDr
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Groovy PrEP videos
WhatisPrEP.org tinyurl.com/PrEPbyKLB 102
Web resources on PrEP
• • • • • •
MyPrEPexperience.blogspot.com Truvada.com ProjectInform.org/prep PrEPWatch.org PrEPfacts.org WhatisPrEP.org 103
Baggage
fear slut shaming morality
judgment
ignorance
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‌There is a constant message that condoms are the only way, and if you slip up or choose not to use them, you're dirty, toxic, unsafe, evil, and reckless. via facebook.com/groups/PrEPFacts
“Taking the Truvada does 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
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Messages to emphasize to 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. • Individuals in diverse situations will need different kinds of support. • Taking PrEP does not guarantee 100% protection from HIV. 110
Messages to emphasize to 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? 111
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.
www.myprepexperience.blogspot.com
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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.
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www.myprepexperience.blogspot.com
• If someone doesn’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. 115
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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 118
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? 119
Post-test
Let’s see where you are at!
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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… 122
Thank you!! 123
Please stay in touch • Betty Kritikos Betty.Kritikos@gilead.com • John Schneider jschnei1@medicine.bsd.uchicago.edu • Jessica Terlikowski jterlikowski@aidschicago.org • Project RSP! myprepexperience@gmail.com
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