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.

1. Chicago Department of Public Health Besly Court 9.11.15
Download these slides here: tinyurl.com/PrEPSept1115
Funding for this training provided by Gilead Sciences

2. • Who’s in the room?
• Pre and post test, evaluation
• Overview ARV-based prevention
• Understanding PrEP
– What is PrEP?
– How PrEP is taken
– Access to PrEP
– BREAKING NEWS
– And more…
These slides available at:
tinyurl.com/PrEPSept1115

3. 3
Please like, follow us on Facebook
facebook.com/ProjectRSP

4. tinyurl.com/ChicagoPrEPforum
4

5. 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
5

6. 6
Who’s
in the
room?

7. 7
Logistics

8. 8

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

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

12. What is the first word or
words that come to your
mind when you think about
oral contraceptives?
12

13. What is the first word or
words that come to your
mind when you think
about PrEP?
13

15. 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)
15

16. 16

17. 17

18. Condom use and effectiveness
18
JAIDS 2014
Condom Effectiveness for HIV Prevention by Consistency of Use Among MSM in
the U.S.
• Data from EXPLORE and VAX 004
• 16.4% reported “always” using condoms during anal sex
• 70% overall effectiveness
• Inconsistent use, “sometimes” use, offers minimal to no
protection over time

19. 19
AJPH 1998
Variables influencing condom use in a cohort of gay and bisexual men
• 23 per cent of the men reported that they always used
condoms for IAI and 21 per cent for RAI
• 32 per cent sometimes used condoms for IAI
• 28 per cent sometimes used condoms for RAI
• 45 per cent never used condoms for IAI
• 50 per cent never used condoms for RAI
Condom use and effectiveness

21. 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?
21

22. 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.
22

23. 23
#HIV2020
AIDS.gov/2020

24. 24

25. 25
#HIV2020
AIDS.gov/2020

26. Approved Truvada for PrEP
Gay/straight men, women 18+
July 16, 2012

27. 27
tinyurl.com/CDCprepguidelines
tinyurl.com/CDCprepguidelineswebinar
May 14, 2014

28. 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
28tinyurl.com/CDCprepguidelines

30. 30
WhatIsPrEP.org

31. 31

32. 32
• 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.

33. www.myprepexperience.org

34. 34

35. PrEP works – the science
• 6 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)
– PROUD (Truvada, gay men)
– Ipergay (Truvada, gay men)
35

36. 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 36

37. 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
37

38. • 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.
38
PrEP works – key findings

39. 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.
39

40. 40

41. 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
41

42. 42

43. 43

44. 44

45. 45

46. 46

47. • Kaiser Permanente PrEP
program in San Francisco
• Provides services to over
170,000 adults in SF
• Study period:
July ‘12 – Feb ’15
• 1,045 referrals for PrEP
– 801 at least 1 intake visit
– 657 initiated PrEP
• 388 person-years PrEP use
• Mean duration use 7.2 mos
• Increase in referrals and
initiation of PrEP noted in
Sept 2013
• Mean age 37 (range 20-68)
• 653 gay men, 3 hetero cis
women, one trans man
• Of 657 initiators, 187 dx’d
with at least one STI during
follow-up, 78 individuals
had multiple STIs
– After 6 mos use, 30% dx’d
with STI (18% rectal)
– After 12 mos use, 50% dx’d
with STI (33% rectal)
47

48. • No HIV diagnoses during
388 person-years of f/u
• 143 completed survey on
behavior change
– Number sexual partners
• # Unchanged 74%
• Decreased 15%
• Increased 11%
– Condom use
• Unchanged 56%
• Decreased 41%
• Increased 3%
– No factors associated with
increase in # partners,
decrease in condom use
• 657 initiators
– More likely to report multiple
partners
– Prior PrEP use (study, other)
– Not more likely to have POZ
partner
• 144 non-initiators
– Low risk 35%
– Cost concerns 15%
– Not wanting to do f/u 10%
– Prefer PEP 6.3%
– Side effects concerns 2.8%
– Concern about potentially
increasing risk behavior 1.4%
48Expected incidence: as high as 8.9 per 100 person-years

49. 49

50. 50

51. 51

52. 52
www.ias2015.org
www.aidsmap.com/ias2015

53. 53
www.ias2015.org
www.aidsmap.com/ias2015

54. 54
www.ias2015.org
www.aidsmap.com/ias2015 Dr. Sybil Hosek – CORE

55. 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
• Those who reported most sexual risk were more adherent
• 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 – CORE55

56. 56
www.ias2015.org
www.aidsmap.com/ias2015 Dr. Al Liu – SF DPH

57. 57
• 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

58. 58
Chicago PrEP Research

59. 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
59

60. 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.
60

61. 61

62. 62
PrEP is more than a prescription
PrEP is a
program

64.  Take Truvada every day
 Provider* visits every 3 mos
 HIV testing every 3 mos
 Tied to Rx renewal
 Hepatitis B testing
 Kidney function testing
 Regular STI screening
 Pregnancy testing
64
*These activities don’t
all need to be done by a
doctor in their office
Taking PrEP…
What does it take?

65.  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.
65
Taking PrEP…
What does it take?

66. 66

67. • 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
67

68. 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.
68

69. 69

70. 70
• 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 not
necessary while being on 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 endorses PrEP.

71. 71

72. tinyurl.com/ChicagoPrEPforum
72

74. www.myprepexperience.org

75. Who might be a good fit for PrEP?
•Person indicates an
interest in taking PrEP
75

76. 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
76

77. 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 77

78. PrEP-C

79. pleasure
intimacy
connection
emotion
lust
love

80. 80
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

81. 81
Reclaim
pleasure

82. 82

84. 84

85. Accessing PrEP in Chicago
• Any medical provider who can
write a scrip can write one for
Truvada as PrEP
• tinyurl.com/ChicagoPrEPproviders
85

86. 86
PrEP at CORE

87. PrEP Access –The CORE program
87
• 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

88. PrEP Access –The CORE program
88
• Primary clinic location: CORE Center
– Monday afternoons for youth under 25
– Tuesday evenings and Friday afternoons for all
• Secondary locations: Fantus Adolescent Clinic,
Wednesday/Thursday afternoons
• Project Coordinator: Raymond McPherson
(312/846-3578)

89. PrEP Access –The CORE program
89
• 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

91. 91

92. Uninformed, misinformed providers
92

93. 93

94. Handy brochure
94
Designed to help individuals talk to
their doctors about PrEP
Before, during, after visit
Questions to ask
Web resources
tinyurl.com/talkPrEPtoDr

95. 95
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

96. • 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
96

97. www.facebook.com/groups/PrEPFacts
97

98. 98
PositivelyAware.com
Printed copies available
email distribution@tpan.com

99. 99

100. 100
Please like, follow us on Facebook
facebook.com/ProjectRSP

102. FDA approval of
Truvada enables
private ins to cover
Medicaid
formulary
Ins companies
covering, so far
ADAP does
not cover
PrEP
102

103.  Drug costs
 Visit, service costs
 Lab costs
103

104. 104
the devil is in the details
 Premiums
 Deductibles
 Cost-sharing
 Drug formularies
 Drug tiers
 Shifting benefits
 Not easy to figure
all this out!

105. 105
http://ow.ly/PTYCK

106. Paying for PrEP – Gilead
1. Visit
www.truvada.com
2. Click on the link to
access information
about Truvada for a
PrEP indication
106

107. 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
107107

108. 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
108

109. 109
• 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

110. 110

111. 111
USCA 2014

112. 112

113. 113
www.ias2015.org
[Quote from female sex worker participating in treatment
and PrEP demo project in Johannesburg, South Africa.]

114. 114

115. 115
• 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?

117. 117

118. 118
“Party drug”
“Public health disaster”

119. 119PrEP DENIALISM

120. 120

121. 121
Condom privilege

122. 122
“But ARVs are toxic…”

123. 123

125. 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.
125

126. 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.
126

127. 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.
127

128. THOUGHTFUL
RESPONSIBLE
CAREFUL
128
AWARE
PRO-ACTIVE
DISCIPLINED
TAKING PREP IS

129. SAFER SEX
TAKING PREP IS
129

130. 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?
130

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132. 132
"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

133. tinyurl.com/ChicagoPrEPforum
133

134. 134
Open access
http://www.jiasociety.org/index.php/jias/issue/view/1474

135. 135

136. 136

137. Thank you!!
137

138. 138

139. 139

140. CONTACT
Jim Pickett
jpickett@aidschicago.org
Sybil Hosek
sybilhosek@gmail.com
140
#yayPrEP
Download these slides:
tinyurl.com/PrEPSept1115