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.

1. Welcome!
South Side Help Center – November 12, 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
• 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?
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4. 4

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

7. facebook.com/ProjectRSP
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10. 10

11. 11

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

13. 13

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

17. Your primer on ARV prevention
17

18. 18

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

21. HIV testing is the gateway to all ARV-prevention
21

22. *
*PEP
22

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
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27. 27

28. 28

29. 29

30. 30

31. 31

32. What is
PrEP?*
*pre-exposure prophylaxis
32

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

34. PrEP
Ken Like Barbie explains
34

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

37. www.myprepexperience.blogspot.com

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

41. PrEP
Truvada
41

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
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44. 44

45. 45

46. 46

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

55. The research continues
55

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

57. Seat belts don’t do everything, either
57

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

59. www.myprepexperience.blogspot.com

60. 60

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

64. 64

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
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67. Why would someone want to take PrEP?
67

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

70. What about…
70

71. SEX

72. DANGER
RISK
SHAME

74. pleasure
intimacy
connection
emotion
lust
love

75. Honesty please
What is the first word or
words that come to your
mind when you think
about PrEP?
75

76. pleasure
intimacy
connection
emotion
love

77. pleasure
intimacy
connection
emotion
love

78. pleasure
intimacy
connection
emotion
lust
love

79. 79

80. 80

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
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83. 83

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
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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

88. Be prepared for the unPrEPared,
and the unPEPared too
88

89. myprepexperience.blogspot.com
89

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

92. Medication assistance form
See NASTAD fact sheet
92

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

94. 94

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

96. PrEP prescriptions – how many, who?
96

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

98. PrEP prescriptions – how many, who?
98

99. PrEP prescriptions – how many, who?
99

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

101. 101

102. 102

103. 103

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

105. Helping your clients
understand PrEP
105

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

111. www.myprepexperience.blogspot.com

112. 112

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

115. Post-test
Let’s see where
you are at!
115

116. 116

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

119. Thank you!!
119

120. Please stay in touch
• Jaime Martinez
jmartinez@cookcountyhhs.org
• Jessica Terlikowski
jterlikowski@aidschicago.org
• Keven Cates
kevenc@howardbrown.org
• Jim Pickett
jpickett@aidschicago.org
• Project RSP!
myprepexperience@gmail.com
120