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.

1. UnityPoint Methodist Medical Center – Peoria, IL – 8.18.15
Download these slides: tinyurl.com/PeoriaPrEP_Aug18_2015

2. In the next 40 minutes
• Intros
• Pre/Post tests, evaluations
• Understanding PrEP
–What is PrEP, how it’s taken, access
–Updates from CROI 2015 and IAS 2015
• PrEP case studies, elevator speech, and more
• SO MUCH FUN
These slides available at:
tinyurl.com/PeoriaPrEP_Aug18_2015

3. Ground rules
• We are all somewhere on
the learning curve
• Participate to the fullest of
our abilities
• The only dumb questions
are the ones not asked
3

4. 4

5. 5
Who’s
in the
room?

6. 6

7. 7

8. What is the first word or
words that come to your
mind when you think
about condoms?
8

9. What is the first word or
words that come to your
mind when you think about
needle exchange?
9

10. What is the first word or
words that come to your
mind when you think about
oral contraceptives?
10

11. What is the first word or
words that come to your
mind when you think
about PrEP?
11

12. 12

13. 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)
13

14. 14

15. 15

16. 16

17. First, 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?
17

18. What is PreP?
• PrEP consists of taking the ARV drug Truvada to
prevent HIV*
• Truvada is a combination of tenofovir disoproxil
fumarate (aka tenofovir or TDF) and emtricitabine.
• Need to take 5 – 7 days* of Truvada before enough
drug is “on board” for protection in rectum.
• Three weeks for vaginal protection.
• Truvada is currently the only drug
approved by the FDA for PrEP.
18

19. 19
#HIV2020
AIDS.gov/2020

20. 20

21. 21
#HIV2020
AIDS.gov/2020

22. 22
Approved Truvada for PrEP
July 16, 2012

23. 23
tinyurl.com/CDCprepguidelines
tinyurl.com/CDCprepguidelineswebinar
May 14, 2014

24. PrEP Clinical Practice Guidelines
• 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
24tinyurl.com/CDCprepguidelines

25. 25

26. 26
WhatIsPrEP.org

27. 27

28. 28
• True or False: PrEP must be started within 72 hours
of exposure to HIV.
• The FDA approved Truvada as PrEP in what year?
• True or False: People on PrEP should be tested for
HIV every month.
• True or False: It takes longer for PrEP to achieve
protection in the vagina compared to the rectum.

29. www.myprepexperience.org

30. 30

31. PrEP works – the science
• 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)
31

32. 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 32

33. PrEP works – key findings
• Adherence!
• 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
33

34. • Some will experience 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.
34
PrEP works – key findings

35. PrEP 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.
35

36. 36

37. I don't have any regrets, but what I do
have is peace of mind. And that is exactly
what I was looking for with this
medication.
I feel great, I feel empowered, and I feel in
control of my sexual health and my health
in general.
Personal story on MyPrEPexperience.org

38. 38

39. 39

40. 40

41. PrEP’s “protease moment”
croiconference.org
PROUD – 86%
IPERGAY – 86%
www.aidsmap.com/croi2015

42. 42
There is an urgent need to mobilize clinical
efforts, service delivery, education,
implementation research, and policy to
optimize PrEP access and use.
– Dr. Raphael Landovitz/UCLA
croiconference.org

43. 43

44. 44
PrEP is more than a prescription
PrEP is a
program

45. 45

46.  Take Truvada every day
 Provider* visits every 3 mos
 HIV testing
 Tied to Rx renewal
 Hepatitis B testing
 Kidney function testing
 STI screening
 Pregnancy testing
46
*These activities don’t
all need to be done by a
doctor in their office
Taking PrEP…
What does it take?

47.  Adherence counselling
 Perfection not required, especially for
rectal exposure
 Take 5 – 7 days before
enough drug is “on board” to
provide protection in the rectum,
3 weeks for the vagina
 Then take Truvada every day
 Honest, open discussions about sex,
sexual health
 PreP is “seasonal.”
 PrEP is not forever.
47
Taking PrEP…
What does it take?

48. 48

49. • iPrEX Open Label
• 1,603 participants, 1,225 on PrEP
• Most from Peru/Ecuador, 18% USA
• 100% effectiveness associated
with 4+ doses a week (rectal)
• 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
49

50. 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, or gonorrhoea
– Prevent pregnancy
– Cure HIV
– Function as a treatment regimen for someone
already living with HIV.
50

51. 51

52. 52

53. 53
• True or False: PrEP does not work for women.
• True or False: About 25% of people who take
PrEP will have nausea.
• True or False: Regular STD screening is part of
the PrEP program.
• True or False: You don’t need to adhere perfectly
to PrEP to achieve high levels of protection.
• True or False: Obama says “PrEP sucks.”

54. 54

55. www.myprepexperience.org

56. Who might be a good fit for PrEP?
•Person indicates an
interest in taking PrEP
56

57. Who might be a good fit for PrEP?
• Person is in a “magnetic” relationship
–HIV-negative and has HIV+ partner who is
not on meds, or not undetectable, or other
mitigating circumstances
57

58. Who might be a good fit for PrEP?
• Male, female, transgender person engaging in 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 58

59. PrEP-C

60. pleasure
intimacy
connection
emotion
lust
love

61. 61
In this sample of men
who are in a
relationship with a
perceived HIV-negative
man, we found that
intimacy motivation was
the strongest predictor
of adopting PrEP.
“Intimacy Motivations and Pre-exposure Prophylaxis
(PrEP) Adoption Intentions Among HIV-Negative Men
Who Have Sex with Men (MSM) in Romantic
Relationships”
– Annals of Behavioral Medicine
August 2014

62. 62
Reclaim
pleasure

63. 63

64. 64

65. Accessing PrEP in Illinois
• Any medical provider who can write a scrip can
write one for Truvada as PrEP
• aidschicago.org/i-need/prep/prep-clinics-and-
providers
– Most listings are in Chicago
– ONE in Champaign-Urbana
65

66. 66

67. 67

68. Uninformed, misinformed providers

69. 69

70. Handy brochure
70
Designed to help individuals talk to
their doctors about PrEP
Before, during, after visit
Questions to ask
Web resources
tinyurl.com/talkPrEPtoDr

71. 71
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/
PrEP Warm Line

72. • MyPrEPexperience.org
• Chicago PrEP Line - (872) 215-1905
hivelimination.uchicago.edu/projects/programs/prep_hotline_linkage_to_care
• Chicago PrEP provider listing
tinyurl.com/ChicagoPrEPproviders
• Facebook group – PrEP Facts
• Facebook.com/ProjectRSP
• PrEPWatch.org
• ProjectInform.org/prep
• Truvada.com (Gilead)
• WhatisPrEP.org (video)
Web resources on PrEP
72

73. www.facebook.com/groups/PrEPFacts

74. 74

75. 75
PositivelyAware.com
Printed copies available
email distribution@tpan.com

76. 76

77. 77

78. FDA approval of
Truvada enables
private ins to cover
Medicaid
formulary
Ins companies
covering, so far
ADAP does
not cover
PrEP
78

79.  Drug costs
 Visit, service costs
 Lab costs

80. 80
the devil is in the details
 Premiums
 Deductibles
 Cost-sharing
 Drug formularies
 Drug tiers
 Shifting benefits
 Not easy to figure
all this out!

81. 81
http://ow.ly/PTYCK

82. Paying for PrEP – Gilead
1. Visit
www.truvada.com
2. Click on the link to
access information
about Truvada for a
PrEP indication
82

83. Medication Assistance Program
• 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
8383

84. 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

85. 85
• www.panfoundation.org/hiv-treatment-and-prevention
• Accepting applications for new and renewal patients. If
application for assistance is approved can begin
receiving funding immediately
• Maximum Award Level – $4,000 per year.
• Patients may apply for second grant during eligibility
period subject to funding availability
Paying for PrEP – PAN Foundation

86. 86

87. 87
USCA 2014

88. 88
• How can people pay for their PrEP
prescriptions?
• People taking PrEP need to be tested for HIV
_____ times every year.
• Why is this important?
• Who might be a good fit for PrEP?

89. 89

90. 90

91. 91
“Party drug”
“Public health disaster”

92. 92PrEP DENIALISM

93. 93

94. 94
Condom privilege

95. 95
“But ARVs are toxic…”

96. 96

97. Tips for talking about PrEP
• You need not be an expert.
• Though, it’s important you feel comfortable talking
about PrEP.
• It’s okay to not have all of the answers. Refer your
client to additional resources and/or promise to follow
up.
97

98. 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.
98

99. Messages to emphasize to clients
• PrEP is an accessible option
– Not forever, but maybe for a “season”
– If you use condoms successfully, do you need PrEP?
• It’s not just a daily pill, it’s a program.
– Holistic health care (w/regular HIV and STD
testing)
• Person must test HIV-negative to initiate
and continue PrEP.
• Adherence. Different for men and women.
99

100. THOUGHTFUL
RESPONSIBLE
CAREFUL
100
AWARE
PRO-ACTIVE
DISCIPLINED
TAKING PREP IS

101. SAFER SEX
TAKING PREP IS
101

102. CASE
STUDIES
MAKING IT “REAL”
102

103. 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?
103

104. 104

105. 105
www.ias2015.org
www.aidsmap.com/ias2015

106. 106
www.ias2015.org
www.aidsmap.com/ias2015

107. 107
www.ias2015.org
www.aidsmap.com/ias2015 Dr. Sybil Hosek – CORE

108. www.aidsmap.com/ias2015
• ATN 110
• 12 U.S. cities, including Chicago
• 200 gay (77.8%) and bi (13.7%) men, 18 – 22 (mean 20.18)
• 53% Black; 17% Latino; 21% White; 2% Asian/PI;
7% other/mixed
• Four HIV infections, not taking PrEP
• Adherence good overall, better among those not using condoms
• Black gay men’s adherence was not as high as others
• CALL TO ACTION – need better understanding of historical,
societal, behavioral, and attitudinal barriers to PrEP access
and adherence among those w/highest impact – young black
gay men
• Adherence among all groups decreased as
study visits moved from monthly to quarterly
Dr. Sybil Hosek – CORE

109. 109
www.ias2015.org
www.aidsmap.com/ias2015 Dr. Al Liu – SF DPH

110. 110
• PrEP Demo Project
• SF, DC and Miami
• 557 particps; median age 35
• 48% White; 35% Latino;
7% Black; 10% other
• 98% male; 1.3% transgender
• Overall high adherence –
higher adherence among ppl not using condoms
• Two infections, not taking PrEP
• Two main findings: “1) we must do active, engaging outreach to
African American MSM and trans women about PrEP; we will
not reach sufficient numbers through passive attempts to scale-
up PrEP, and 2) adherence was lower among African Americans,
so additional programs to understand reasons for poorer
adherence and to develop support mechanisms are needed for
populations most heavily impacted by HIV. Current tools are not
enough.” www.aidsmap.com/ias2015
Dr. Al Liu – SF DPH

111. 111
www.ias2015.org
[Quote from female sex worker participating in treatment
and PrEP demo project in Johannesburg, South Africa.]

112. 112

113. 113

114. 114

115. 115
“Interventions do not just work automatically, they
have to be made to work – and people have
responsibility for making them work. And herein
lies the rub – for the question we should ask is not
“what works?” but “what are we committed to
making work?”
– Dr. Flora Cornish
London School of Economics

116. 116
Open access
http://www.jiasociety.org/index.php/jias/issue/view/1474

117. 117
tinyurl.com/BlackPrEPsummit

118. 118

119. 119

120. Thank you!!
120

121. 121

122. CONTACT
Jim Pickett
jpickett@aidschicago.org
Sara Semelka
ssemelka@aidschicago.org
122
#yayPrEP
Download these slides:
tinyurl.com/PeoriaPrEP_Aug18_2015