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.

1. Austin CBC PrEP Training – 6.23.15
Download these slides: tinyurl.com/PrEP_Austin_June2015

2. What we will cover today
• Intros
• Overview ARV-based prevention
• The CORE PrEP clinic
• Understanding PrEP
– What is PrEP?
– PrEP research
– How PrEP is taken
– Access to PrEP
– Talking to clients about PrEP
– tinyurl.com/PrEP_Austin_June2015 2

3. Ground rules
• We are all here to learn
• The only dumb questions are the
ones not asked
• Listen actively, respect others
when they are talking
• Participate to the fullest of our
abilities
3

4. 4

5. 5

6. What is the first word or
words that come to your
mind when you think
about condoms?
6

7. What is the first word or
words that come to your
mind when you think about
needle exchange?
7

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

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

10. 10

11. • 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)
11
Protection w/out condoms

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. 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?
16

17. 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.
17

18. 18

19. 19

20. • 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
Dateline: July 16, 2012
20

21. Released May 14, 2014
21
tinyurl.com/CDCprepguidelines (PDF)
tinyurl.com/CDCprepguidelineswebinar
(webinar audio/slides)

22. 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
22

23. 23
Ken Like Barbie explains
PrEP
tinyurl.com/PrEPbyKLB

24. 24

25. Ken Like Barbie recap
• PrEP involves HIV-neg person
taking ARVs to reduce risk of
infection before HIV exposure.
• In current approved form,
PrEP is taken in a single pill –
Truvada –once a day, every
day
• Seasons of risk.
• With us, by us, for us.
25

26. 26

27. www.myprepexperience.org

28. 28

29. 29
PrEP is more than a prescription
PrEP is a
program

30.  Provider* visits every 3 mos
 HIV testing
 Tied to Rx renewal
 Hepatitis B testing
 Kidney function testing
 STI screening
 Pregnancy testing
 Adherence counselling
 Honest, open discussions
about sex, sexual health
30
Taking PrEP…. what does it take?
*These activities don’t
all need to be done by a
doctor in their office

31.  It’s not just a pill, it’s a program
 Adherence (perfection not
required, esp for rectal)
 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
31
Taking PrEP…. what does it take?

32. • 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
32

33. 33
You can miss a dose here and there and still have excellent protection.

34. 34
Adherence is a much bigger deal for vaginal protection.

35. 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.
35

36. 36
• True or False: PrEP must be started within 72 hours
of exposure to HIV.
• What is an example of “prophylaxis?”
• The FDA approved Truvada as PrEP in what year?
• True or False: It takes longer for PrEP to achieve
protection in the vagina compared to the rectum.

37. 37

38. 38

39. 39
• WhatIsPrEP.org
• Educational tool – health educators at CORE
• Spanish version now available
• Disclaimer has been added re: vaginal protection

40. 40

41. 41

42. 42
Science.

43. 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)
43

44. 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 44

45. Key research 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
45

46. Key research findings
• 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.
46

47. 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.
47

48. 48

49. 49

50. PrEP’s “protease moment”
50
PROUD – 86%
IPERGAY – 86%
PARTNERS DEMO – 96%
croiconference.org

51. 51
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

52. 52

53. 53
Chicago PrEP Research

54. Chicago PrEP research/CORE
• Project PrEPare II
• Open label demonstration project AND safety study
of PrEP in young gay/MSM ages 15-22
– Actively enrolling 300 youth in 13 US sites, Chicago
– Evaluating:
• Safety of PrEP use among young HIV-neg gay/MSM
• Acceptability, patterns of use, and adherence
• Risk patterns
• Texting to encourage adherence
• Demographic and/or behavioral differences among
youth
–Interested in a PrEP study
–Who stays on PrEP
54

55. Chicago PrEP research/CORE
• Enhancing PrEP in Communities (EPIC)
• To test the effectiveness of Prepmate, a novel multi-
modal, technology-based intervention for pre-exposure
prophylaxis (PrEP) adherence support among young gay
men/MSM.
– Uses SMS support and interactive online content to enhance
PrEP adherence
• The control condition includes standard of care support
for gay/MSM who are starting PrEP.
– Brief health educator-provided adherence and risk reduction
counseling at scheduled study visits,
and access to a clinician whenever needed.
55

56. 56
• 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.

57. 57

58. www.myprepexperience.org

59. 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
59

60. 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
60

61. Truvada as PrEP
Is the first non-
barrier HIV
prevention strategy
fully controlled by
the receptive
partner.
61

63. pleasure
intimacy
connection
emotion
lust
love

64. 64
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

65. 65
Reclaim
pleasure

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

68. SAFER SEX
TAKING PREP IS

69. 69

70. 70

71. 71Meme by Pedro Alonso Serrano

72. 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
• CORE Center
• UC and ACCESS Grand Blvd
• Howard Brown Health Center
• Chicago PrEP Working Group
72

73. 73
PrEP at CORE

74. PrEP Access –The CORE program
74
• HEAT – Helping Eliminate AIDS through
Teamwork
• Health Educators are first line for PrEP Clinic
– PrEP education, screenings, initial lab tests,
benefits
– Health educator appointments available
Monday – Thursday

75. PrEP Access –The CORE program
75
• Primary clinic location: CORE Center, Friday
afternoons (will expand if necessary)
• Secondary locations: Fantus Adolescent Clinic,
Wednesday/Thursday afternoons; Austin CBC
– TBD
• Project Coordinator: Raymond McPherson
(312/846-3578)
• Linkage-to-PrEP Liaison: TBN

76. PrEP Access –The CORE program
76
• Initial screening appointment in PrEP
clinic will include Rx if necessary lab
tests are in medical record (HIV, CrCl)
• 1 month f/u appointment for
adherence, side effects
• 3 month f/u, then quarterly
• Adherence, risk reduction support
provided in clinic by HE, HEAT staff
• Access to research opportunities

77. PrEP Access –The CORE program
77
What have we
learned so far?

78. 78

79. 79

80. Handy brochure
80
Designed to help individuals talk to
their doctors about PrEP
Before, during, after visit
Questions to ask
Web resources
tinyurl.com/talkPrEPtoDr

81. 81
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

82. • MyPrEPexperience.org
• Facebook group – PrEP Facts
• Facebook.com/ProjectRSP (Ready, Set, PrEP)
• PrEPWatch.org (advocacy)
• ProjectInform.org/prep
• Truvada.com (Gilead)
• WhatisPrEP.org (video)
• PrEP providers in Chicago area
aidschicago.org/i-need/prep/prep-clinics-and-providers
Web resources on PrEP
82

83. Groovy PrEP videos
83
WhatisPrEP.org
tinyurl.com/PrEPbyKLB

85. 85

86. 86

87. Paying for PrEP— insurance
FDA approval of
Truvada enables
private ins to cover
Truvada
on
Medicaid
formulary
Ins companies
covering, so far
ADAP
does not
cover
PrEP
87

88. 88
the devil is in the details

89. 89
the devil is in the details

90. 90
Our records indicate that you have received
Truvada in the past year with no other
antiretroviral agents which would suggest use for
preexposure prophylaxis. Prophylactic treatment
is not a covered benefit as listed in the Exclusion
Section of your member contract.
.
May 1, 2015

91. 91

92. 92

93. 93

94. Paying for PrEP – Gilead
1. Visit
www.truvada.com
2. Click on the link to
access information
about Truvada for a
PrEP indication
94

95. Medication assistance
• Gilead will provide Truvada for PrEP at no cost for
individuals who qualify for the assistance program
Program
Element
Truvada PrEP Medication Assistance Program
Eligibility
Criteria
US resident, uninsured or no drug coverage, HIV-
negative, low income (500% FPL)
Drug
Fulfillment
Product dispensed by Covance Specialty
Pharmacy, labeled for individual patient use and
shipped to prescriber (30 day supply); no card or
voucher option
Recertification
Period
6 months, with 90 day status check
9595

96. 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

97. 97
• 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.
• www.panfoundation.org/hiv-treatment-and-prevention
Paying for PrEP – PAN Foundation

98. 98

99. 99
USCA 2014

100. 100
• Name three details about the PrEP clinic at
the CORE Center.
• How can people pay for their PrEP
prescriptions?
• People taking PrEP need to be tested for HIV
_____ times every year.
• Why is this important?

101. 101

102. Messages to emphasize to clients
• PrEP is an option
– Not forever, but maybe for a “season”
– If you use condoms successfully, do you need PrEP?
• It’s not just a pill, it’s a program.
– Holistic health care
• Person must test HIV-negative to initiate
and continue PrEP.
• Adherence. Different for men and women.
102

103. 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.
103

104. 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.
104

105. 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?
105

106. 106
• If someone doesn’t use ________
regularly, they may be a good fit for PrEP.
• PrEP is not just a pill, it’s a _________.
• Beyond a prescription, what is involved
with taking PrEP?

107. 107

108. 108
"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

109. PrEP Access and
Implementation
Chicago efforts
109

110. Chicago PrEP
Working
Group
Researchers
Medical
providers
Advocates
Orgs/HDs
HIV planning
members
110

111. Chicago PrEP
Working
Group
Researchers
Medical
providers
Advocates
CBOs
HIV planning
members
111

112. 112
Organization Clinic Refer Research Ed/Train Advocacy
ACCESS Grand Boul X X
AFC X X X
Center on Halsted x X
Chicago DPH (funder) X X
Chicago House X X X
CORE Center X X
Fantus Clinic X
Friend Family Health X
Howard Brown X X X
Illinois DPH X
Lurie Child Hospital X X
MATEC X
Mt. Sinai X
TPAN X X X
U Chicago X X

113. Chicago PrEP
Working
Group
Researchers
Medical
providers
Advocates
CBOs
HIV planning
members
113

114. Chicago PrEP
Working
Group
Researchers
Medical
providers
Advocates
CBOs
HIV planning
members
114

115. Chicago PrEP
Working
Group
Researchers
Medical
providers
Advocates
CBOs
HIV planning
members
115

116. 116

117. 117

118. 118

119. Thank you!!
119

120. • Sybil Hosek
sybilhosek@gmail.com
• Margo Bell
belmar@cookcountyhhs.org
Download slides
tinyurl.com/PrEP_Austin_June2015
• Raymond McPherson
raymond_mcpherson@rush.edu
• Jim Pickett
jpickett@aidschicago.org
120
Connect