1.
Chicago Department of Public Health Besly Court 11.13.15
Download these slides here: tinyurl.com/PrEPNov1315
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/PrEPNov13155

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

4.
4
tinyurl.com/PrEPNov18

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

9.
What is the first word or
words that come to your
mind when you think
about condoms?
10

10.
What is the first word or
words that come to your
mind when you think about
needle exchange?
11

11.
What is the first word or
words that come to your
mind when you think about
oral contraceptives?
12

12.
What is the first word or
words that come to your
mind when you think
about PrEP?
13

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)
15

14.
16

15.
17

16.
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

17.
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

18.
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

19.
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

20.
23
#HIV2020
AIDS.gov/2020

21.
24

22.
25
#HIV2020
AIDS.gov/2020

23.
Approved Truvada for PrEP
Gay/straight men, women 18+
July 16, 2012

24.
27
tinyurl.com/CDCprepguidelines
tinyurl.com/CDCprepguidelineswebinar
May 14, 2014

25.
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

26.
30
WhatIsPrEP.org

27.
31

28.
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.

29.
www.myprepexperience.org

30.
34

31.
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

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 36

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
37

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.
38
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.
39

36.
40

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
41

38.
42

39.
43

40.
44

41.
45

42.
46

43.
• 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

44.
• 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

45.
49

46.
50

47.
51

48.
52
www.ias2015.org
www.aidsmap.com/ias2015

49.
53
www.ias2015.org
www.aidsmap.com/ias2015

50.
54
www.ias2015.org
www.aidsmap.com/ias2015 Dr. Sybil Hosek – CORE

51.
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

52.
56
www.ias2015.org
www.aidsmap.com/ias2015 Dr. Al Liu – SF DPH

53.
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

54.
58
Chicago PrEP Research

55.
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

56.
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

57.
61

58.
62
PrEP is more than a prescription
PrEP is a
program

59.
 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?

60.
 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?

61.
66

62.
• 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

63.
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

64.
69

65.
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: PrEP is forever, once you start there is
no stopping.

66.
71

67.
72
tinyurl.com/PrEPNov18

68.
PrEP4Love

69.
Launching
February 2016

70.
Young gay black men
Black hetero women
Trans women of color

71.
Love is contractible. Lust is transmittable.
Touch is contagious. With PrEP, people
can catch feelings, not HIV. This campaign
will offer up the experiences of the heart
and flesh that HIV has kept people from
fully embracing… until now. With honest
and visceral photography we will show how
Chicagoans can love, explore, and touch
freely because of PrEP.

72.
Gay black men 18 to 29, individuals and partners
Cisgender heterosexual black women 18 to 40, individuals and partners
Transgender women of color 18 to 40, individuals and partners
8 individuals (4 couples) will be selected
OPEN CASTING – DEADLINE SUNDAY 11/15
tinyurl.com/PrEP4Love

73.
www.myprepexperience.org

74.
Who might be a good fit for PrEP?
•Person indicates an
interest in taking PrEP
80

75.
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
81

76.
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 82

77.
PrEP-C

78.
pleasure
intimacy
connection
emotion
lust
love

79.
85
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

80.
86
Reclaim
pleasure

81.
87

82.
89

83.
Accessing PrEP in Chicago
• Any medical provider who can
write a scrip can write one for
Truvada as PrEP
• tinyurl.com/ChicagoPrEPproviders
• Chicago PrEP Line - (872) 215-1905
90

84.
91
PrEP at CORE

85.
PrEP Access –The CORE program
92
• 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

86.
PrEP Access –The CORE program
93
• 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)

87.
PrEP Access –The CORE program
94
• 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

88.
96

89.
Uninformed, misinformed providers
97

90.
98

91.
Handy brochure
99
Designed to help individuals talk to
their doctors about PrEP
Before, during, after visit
Questions to ask
Web resources
tinyurl.com/talkPrEPtoDr

92.
100
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

93.
• 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
101

94.
www.facebook.com/groups/PrEPFacts
102

95.
103
PositivelyAware.com
Printed copies available
email distribution@tpan.com

96.
104

97.
105
Please like, follow us on Facebook
facebook.com/ProjectRSP

98.
FDA approval of
Truvada enables
private ins to cover
Medicaid
formulary
Ins companies
covering, so far
ADAP does
not cover
PrEP
107

99.
 Drug costs
 Visit, service costs
 Lab costs
108

100.
109
the devil is in the details
 Premiums
 Deductibles
 Cost-sharing
 Drug formularies
 Drug tiers
 Shifting benefits
 Not easy to figure
all this out!

101.
110
http://ow.ly/PTYCK

102.
Paying for PrEP – Gilead
1. Visit
www.truvada.com
2. Click on the link to
access information
about Truvada for a
PrEP indication
111

103.
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
112112

104.
113

105.
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)
– Full year benefit ($3600) available
up front
• No maximum lifetime benefit but pts need to
recertify after 12 months 114

106.
115
• 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

107.
116

108.
117
USCA 2014

109.
118
www.ias2015.org
[Quote from female sex worker participating in treatment
and PrEP demo project in Johannesburg, South Africa.]

110.
119

111.
120

112.
121

113.
122
• How can people pay for their PrEP prescriptions?
• What new development has just improved access
to PrEP for people with insurance?
• People taking PrEP need to be tested for HIV
_____ times every year.
• Why is this important?

114.
124

115.
125
“Party drug”
“Public health disaster”

116.
126PrEP DENIALISM

117.
127

118.
128
Condom privilege

119.
129
“But ARVs are toxic…”

120.
130

121.
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.
132

122.
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.
133

123.
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.
134

124.
THOUGHTFUL
RESPONSIBLE
CAREFUL
135
AWARE
PRO-ACTIVE
DISCIPLINED
TAKING PREP IS

125.
SAFER SEX
TAKING PREP IS
136

126.
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?
137

127.
138

128.
139
"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

129.
140

130.
141

131.
Thank you!!
142

132.
143

133.
144

134.
CONTACT
Jim Pickett
jpickett@aidschicago.org
Sybil Hosek
sybilhosek@gmail.com
145
#yayPrEP
Download these slides:
tinyurl.com/PrEPNov1315