This is a training for the HIV workforce on PrEP, and is a part of Chicago's Project Ready, Set, PrEP! (RSP!) Project RSP! is an education and awareness initiative of the AIDS Foundation of Chicago. Visit us at www.myprepexperience.blogspot.com.
Project RSP! Training on PrEP - Oct 2013Jim Pickett
This training was conducted for members of the HIV workforce in Chicago on October 21, 2013 at the Chicago Department of Public Health's Mile Square location.
Project Ready, Set, PrEP! training on PrEP for HIV Prevention - UPDATED NOV 17Jim Pickett
This training on PrEP for HIV prevention was conducted by AIDS Foundation of Chicago (AFC) in collaboration with the Chicago Department of Public Health on November 17. Other partners on this training included University of Chicago. These slides comprise a 3.5 hour training designed for people in the HIV workforce that AFC and partners conduct at various times in the year. They are continually updated.
Project RSP! training on PrEP for the HIV workforce (March 19, 2015)Jim Pickett
This training on PrEP for HIV prevention was conducted by AIDS Foundation of Chicago (AFC) in collaboration with the Chicago Department of Public Health on March 19, 2015. These slides comprise a 3.5 hour training designed for people in the HIV workforce in Chicago and throughout Illinois that AFC and partners conduct at various times in the year. They are continually updated - this presentation includes recent PrEP data presented at CROI 2015 in late February.
PrEP Community Opportunities and ChallengesJim Pickett
Plenary talk by AIDS Foundation of Chicago's Jim Pickett, given at the PrEP Forum in San Francisco on March 10, 2014. Info on the forum can be found here: http://stdhivtraining.org/presentation_description.html?id=82
Project RSP! Training on PrEP for HIV PreventionJim Pickett
June 11 - UPDATED training on PrEP for HIV prevention from Chicago's Project Ready, Set, PrEP! (RSP!). Visit the Project RSP!'s My PrEP Experience blog at www.myprepexperience.blogspot.com for more informational resources, including the personal stories of individuals who have chosen to use PrEP.
HPTN 067/ADAPT study: a comparison of daily and intermittent pre-exposure pro...Илья Антипин
Mannheimer S. и др. «HPTN 067/ADAPT study: a comparison of daily and intermittent pre-exposure prophylaxis (PrEP) dosing for HIV prevention in men who have sex with men and transgender women in New York city» 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention, Vancouver, 2015. MOAC0305LB.
This workshop will cover best practices for HIV prevention in adolescents with a focus on the implementation of Pre-Exposure Prophylaxis (PrEP) and Post Exposure Prophylaxis (PEP) in SBHCs. Join this workshop to hear an overview of the HIV epidemic among adolescents in California, best practices for determining eligibility for PrEP and PEP, instructions for labs and prescriptions, and suggestions for case management and training of all SBHC staff.
Project RSP Training on PrEP - November 13, 2015Jim Pickett
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.
Project RSP! Training on PrEP - Oct 2013Jim Pickett
This training was conducted for members of the HIV workforce in Chicago on October 21, 2013 at the Chicago Department of Public Health's Mile Square location.
Project Ready, Set, PrEP! training on PrEP for HIV Prevention - UPDATED NOV 17Jim Pickett
This training on PrEP for HIV prevention was conducted by AIDS Foundation of Chicago (AFC) in collaboration with the Chicago Department of Public Health on November 17. Other partners on this training included University of Chicago. These slides comprise a 3.5 hour training designed for people in the HIV workforce that AFC and partners conduct at various times in the year. They are continually updated.
Project RSP! training on PrEP for the HIV workforce (March 19, 2015)Jim Pickett
This training on PrEP for HIV prevention was conducted by AIDS Foundation of Chicago (AFC) in collaboration with the Chicago Department of Public Health on March 19, 2015. These slides comprise a 3.5 hour training designed for people in the HIV workforce in Chicago and throughout Illinois that AFC and partners conduct at various times in the year. They are continually updated - this presentation includes recent PrEP data presented at CROI 2015 in late February.
PrEP Community Opportunities and ChallengesJim Pickett
Plenary talk by AIDS Foundation of Chicago's Jim Pickett, given at the PrEP Forum in San Francisco on March 10, 2014. Info on the forum can be found here: http://stdhivtraining.org/presentation_description.html?id=82
Project RSP! Training on PrEP for HIV PreventionJim Pickett
June 11 - UPDATED training on PrEP for HIV prevention from Chicago's Project Ready, Set, PrEP! (RSP!). Visit the Project RSP!'s My PrEP Experience blog at www.myprepexperience.blogspot.com for more informational resources, including the personal stories of individuals who have chosen to use PrEP.
HPTN 067/ADAPT study: a comparison of daily and intermittent pre-exposure pro...Илья Антипин
Mannheimer S. и др. «HPTN 067/ADAPT study: a comparison of daily and intermittent pre-exposure prophylaxis (PrEP) dosing for HIV prevention in men who have sex with men and transgender women in New York city» 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention, Vancouver, 2015. MOAC0305LB.
This workshop will cover best practices for HIV prevention in adolescents with a focus on the implementation of Pre-Exposure Prophylaxis (PrEP) and Post Exposure Prophylaxis (PEP) in SBHCs. Join this workshop to hear an overview of the HIV epidemic among adolescents in California, best practices for determining eligibility for PrEP and PEP, instructions for labs and prescriptions, and suggestions for case management and training of all SBHC staff.
Project RSP Training on PrEP - November 13, 2015Jim Pickett
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.
Project Ready, Set, PrEP! training on PrEP - Updated 9/5/14Jim Pickett
This training on PrEP for HIV prevention was conducted by AIDS Foundation of Chicago (AFC) in collaboration with the Chicago Department of Public Health and MATEC on September 5, 2014. Other partners on this training included John Stroger Hospital and Gilead. These slides comprise a 3.5 hour training designed for people in the HIV workforce AFC and partners conduct at various times in the year.
Project RSP! Training on PrEP for HIV PreventionJim Pickett
This is a training on PrEP (pre-exposure prohylaxis) for HIV prevention, designed for people who work in the HIV prevention field. The training is designed by AIDS Foundation of Chicago's Project Ready, Set, PrEP! (RSP!). For more information on PrEP, visit the project's blog at www.myprepexperience.blogspot.com.
PrEP Training Slides - Austin CBC, CORE Center, AFCJim Pickett
These slides were used for the HIV workforce PrEP training conducted by AIDS Foundation of Chicago on June 23, 2015 at Austin CBC in collaboration with the CORE Center.
PrEP training slides - Lisle, April 16, 2015Jim Pickett
These slides are part of a one-day training by Illinois Department of Public Health, Midwest AIDS Training and Education Center, and AIDS Foundation of Chicago (AFC) called "PrEP: What is it and How Am I to Integrate it in My Conversations with Clients?" They were presented by Jim Pickett, Director of Prevention Advocacy and Gay Men's Health at AFC.
PrEP Training Slides - IDPH/MATEC/AFC training in Collinsville, June 3, '15Jim Pickett
This document provides an overview of a presentation on pre-exposure prophylaxis (PrEP) given in Collinsville. The presentation covers what PrEP is, how it works, research on its efficacy, potential side effects, guidelines for use, barriers to access, and ways to pay for PrEP medications and services. The goal is to educate providers, advocates, and clients about PrEP as an HIV prevention strategy.
This document provides information about pre-exposure prophylaxis (PrEP) - the use of antiretroviral drugs like Truvada to prevent HIV infection. It discusses PrEP's approval by the FDA in 2012, key research findings on its effectiveness in reducing HIV risk, who may be good candidates for PrEP, how to access it through insurance or clinics like Howard Brown, and resources for learning more about PrEP. Statistics on early PrEP prescriptions in the US show it is being prescribed to both men and women across many states, with over 1,700 unique users since 2011 and increasing uptake since FDA approval. The document aims to educate about PrEP as one strategy among many to prevent HIV, not
PrEP Training - Springfield, IL - May 14, 2015Jim Pickett
This PrEP training was delivered by Jim Pickett to people working in HIV in Springfield, IL on May 14, 2015. This training was conducted in collaboration with AIDS Foundation of Chicago, Illinois Department of Public Health, and the Midwest AIDS Training and Education Center.
Project RSP Training on PrEP - September 11, 2015Jim Pickett
This document summarizes a presentation on pre-exposure prophylaxis (PrEP) given by the Chicago Department of Public Health. The presentation includes an overview of PrEP, how it works, guidelines for use, results from clinical trials demonstrating its effectiveness, potential side effects, and strategies for adherence. It discusses factors to consider in identifying individuals who may benefit from PrEP and addresses access to PrEP programs in Chicago.
Project RSP Training on PrEP - July 31, 2015Jim Pickett
This document provides an overview and slides from a presentation on pre-exposure prophylaxis (PrEP) given by the Chicago Department of Public Health. The presentation covers introductory topics, an overview of antiretroviral-based prevention including PrEP, details on how PrEP works and is administered, updates on clinical trials and guidelines, access and insurance coverage for PrEP, and case studies. Resources for providers and patients are also listed to provide education and support around PrEP.
Project RSP! Training on PrEP - Peoria, IL - August 18, 2015Jim Pickett
This AIDS Foundation of Chicago training on PrEP for the HIV workforce took place in Peoria, IL on August 18, 2015. The training was conducted in collaboration with the Illinois Public Health Association and Central Illinois FRIENDS of PWA, Inc.
Dr. Kathleen Brady's presentation on PrEP (pre-exposure prophylaxis) for HIV, as given to the Philadelphia HIV Prevention Planning Group (HPG) on March 25, 2015.
Dr. Sarah Wood and Kimberley Desir's presentation to the RWPC's Positive Committee on Children's Hospital of Philadelphia's PrEP program, Project PrEPare, from April 2013.
Dr. Sarah Wood and Kimberley Desir's presentation to the RWPC's Positive Committee on Children's Hospital of Philadelphia's PrEP program, Project PrEPare, from April 2013.
This document discusses HIV pre-exposure prophylaxis (PrEP). It summarizes evidence from clinical trials that taking the antiretroviral medication Truvada daily reduces the risk of HIV infection by 86%. It acknowledges concerns that PrEP could reduce condom use or encourage risky behavior, but clinical trials found high adherence to daily dosing was very protective. Immediate cost is a major barrier to widespread use, but PrEP may become more affordable over time, similar to oral contraceptives. Guidelines are needed on targeting high-risk groups and determining how long individuals need to remain on PrEP.
HIV treatment and PrEP options have advanced significantly since 2015. Key points:
1) Treatment as prevention is now recommended, with antiretroviral therapy shown to reduce HIV transmission by 96% and dramatically lower prevalence over time if treatment is scaled up.
2) PrEP using daily oral Truvada was found to reduce HIV risk by up to 92% in multiple studies when taken consistently, though adherence is important. Intermittent or on-demand PrEP was also found highly effective in some populations.
3) Several real-world demonstration projects confirmed PrEP's effectiveness in different settings and populations, with up to 86% reduced risk of HIV acquisition when PrEP was provided.
Clinician's perspective on PrEP - Dr Dan ClutterbuckHIVScotland
This presentation was given by Dr Dan Clutterbuck of NHS Lothian and NHS Borders, at the HIV Scotland 'PrEP Roundtable Discussion' event on 25 August 2015.
This document provides information on PrEP (pre-exposure prophylaxis) for HIV. It discusses current US recommendations for PrEP, including identifying high-risk candidates such as men who have sex with men, transgender individuals, injection drug users, and heterosexual men and women. The document reviews PrEP clinical trials that found risk of HIV transmission was lowest with consistent PrEP use. It outlines guidelines for providing PrEP, including testing, prescribing Truvada, monitoring side effects, and supporting adherence. Discontinuing PrEP guidelines are also reviewed.
Expert panelists:
Dr. Tafadzwa Chakare, Technical Director, Jhpiego, Lesotho
Dr. More Mungati, STAR-L Director, EGPAF Lesotho
Facilitator:
Dr. Seema Ntjabane, Care & Treatment Specialist, USAID-Lesotho
The Rectal Revolution is Here - January 29, 2015 - New Orleans, LAJim Pickett
IRMA's Jim Pickett provided an update on rectal microbicide research and advocacy at the "Building Healthy Communities by Breaking Down Barriers - 2015 CBO Orientation", presented by Louisiana Department of Health and Hospitals. Presentation was made on Jan 29, 2015.
January 29, 2015 – New Orleans
Dec 11, '14 WEBINAR - Lubes, Rings, Films, Fibers, and Shots 4 HIV PreventionJim Pickett
Project RSP+ Webinar - December 11, 2014. Presentation explores the pipeline of new HIV prevention technologies in the research and development phase. This project is an initiative of the AIDS Foundation of Chicago.
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Project RSP Training on PrEP - July 31, 2015Jim Pickett
This document provides an overview and slides from a presentation on pre-exposure prophylaxis (PrEP) given by the Chicago Department of Public Health. The presentation covers introductory topics, an overview of antiretroviral-based prevention including PrEP, details on how PrEP works and is administered, updates on clinical trials and guidelines, access and insurance coverage for PrEP, and case studies. Resources for providers and patients are also listed to provide education and support around PrEP.
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This document discusses HIV pre-exposure prophylaxis (PrEP). It summarizes evidence from clinical trials that taking the antiretroviral medication Truvada daily reduces the risk of HIV infection by 86%. It acknowledges concerns that PrEP could reduce condom use or encourage risky behavior, but clinical trials found high adherence to daily dosing was very protective. Immediate cost is a major barrier to widespread use, but PrEP may become more affordable over time, similar to oral contraceptives. Guidelines are needed on targeting high-risk groups and determining how long individuals need to remain on PrEP.
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1) Treatment as prevention is now recommended, with antiretroviral therapy shown to reduce HIV transmission by 96% and dramatically lower prevalence over time if treatment is scaled up.
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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
• 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
5. Unrestricted
educational
grant from
Gilead for
2013
• Trainings: Help Chicago 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
12. • We are NOT “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
12
14. Honesty please
What is the first word or
words that come to your
mind when you think
about condoms?
14
15. Honesty please
What is the first word or
words that come to your
mind when you think
about PrEP?
15
16. 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
16
19. 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*
19
20. 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)
20
23. 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
23
24. 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
24
25. 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
25
26. 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
26
33. 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?
33
35. 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).
35
36. 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.
36
38. “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
38
39. • True or False: 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, or drug taking behaviors.
• Name an example of “prophylaxis.”
• True or False: Truvada is a combination of two
drugs in one tablet.
39
40. PrEP
Truvada
• PrEP will not 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!
40
42. 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
42
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
47. Testing drugs for prevention
Slide adapted from International Partnership for Microbicides
48. How did we get here? (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)
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)
– Bangkok Tenofovir Study (injection drug users)
49% overall, 74% high adherers (2013)
48
49. How did we get 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
49
50. Home-grown Chicago PrEP research
• 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
50
51. Home-grown Chicago PrEP research
• 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!
51
52. Home-grown Chicago PrEP research
• Project PrEPare II
– Open label demonstration project AND
safety study of PrEP in young gay/MSM
ages 15-22
Need 15 to 17 yr. olds now
– 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
52
53. 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
53
54. 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
54
56. What PrEP does not 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?
56
58. • PrEP has been 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.
58
61. Why PrEP does not 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
61
62. CDC – Clinical Practice Guidelines
•
•
•
•
Interim guidelines for different pops already available
Final guidelines being drafted – expect to publish soon
For clinicians – not “all purpose”
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
• Remember the REMS
www.truvadapreprems.com
62
63. New, handy brochure!
Designed to help individuals talk to their
doctors about PrEP
Before, during, after visit
Questions to ask
Web resources
http://www.cdc.gov/hiv/pdf/risk_PrEP_TalkingtoDr_FINALcleared.pdf
63
65. 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, on-going discussions with medical
provider about sex, HIV risk
• HIV antibody test – before 1st Rx, then every 3 mos.
Rx renewal tied to renewed HIV-negative test.
65
66. 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
66
68. 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
–Serodiscordant
68
69. 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
69
81. 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
81
84. Accessing PrEP
• Any doctor 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
84
85. 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
85
86. 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
86
87. PrEP ed for your doc
• Bring along a fact sheet, or
that CDC brochure, if you
think your doctor may need
some PrEP ed
www.myprepexperience.blogspot.com
87
90. Accessing PrEP— insurance
FDA approval of
Truvada enables
private ins to cover
Truvada
on
Medicaid
formulary
ADAP
does not
cover PrEP
Ins companies
covering, many have
pre-auth reqs
90
91. Accessing PrEP – Gilead
1. Visit
www.truvada.com
2. Click on the link to
access information
about Truvada for a
PrEP indication
91
93. 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, 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
95. 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
• 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
95
97. PrEP prescriptions – how many, who?
• 1,774 unique PrEP users between
January 2011 and March 2013 (starting
before FDA approval)
• 1,674 prescribers (620 also prescribed
Truvada as Tx)
97
100. PrEP prescriptions – how many, who?
• Approx. half of all Rx were started before
FDA approval in summer 2012
• Approx. half of all Rx written for female
PrEP users
• Largest percentage Rx written in the
Southeast
• Average age of PrEP users + 35 yrs
• Approx. 13% of users since
FDA approval are under the age of 25
100
104. • What doesn’t PrEP 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.
104
106. 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.
• Taking PrEP does not guarantee 100%
protection from HIV.
106
107. 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 someone uses condoms consistently and
correctly, with no
problems,
do they need PrEP
too?
107
108. 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
108
109. 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.
109
110. Strategies for adherence
– Take pill each day at same time
– What are some other
strategies?
– What should you do if you
forget a dose?
110
113. 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
113
114. 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?
114
117. Web resources on PrEP
• 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
117
118. 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…
118
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