This training on PrEP for HIV prevention was conducted by AIDS Foundation of Chicago (AFC) in collaboration with the Chicago Department of Public Health on November 17. Other partners on this training included University of Chicago. These slides comprise a 3.5 hour training designed for people in the HIV workforce that AFC and partners conduct at various times in the year. They are continually updated.

1. Welcome!
CDPH – November 17, 2014

2. Our time together
• Intros
• What is Project RSP?
• Overview ARV-based prevention
• Understanding PrEP
– What is PrEP?
– PrEP research
– How PrEP is taken
– Access to PrEP
– Talking to clients about PrEP
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.
3

4. 4

5. 5

6. • Trainings: Help Chicago providers, educators,
and others working directly with our
community to understand PrEP and what it
means for us and HIV prevention.
• Give voice/provide facts: Platform for PrEP
users to share experiences, interested
individuals to get info – click
myprepexperience.org
6
Unrestricted
educational
grants from
Gilead in
2013, 2014
And look for us on FB too

7. 7
Unrestricted
educational
grant from
Janssen
Therapeutics
2014
Exploring the Pipeline
Lubes, Rings, Films, Fibers, and Shots 4 HIV Prevention
• Webinar
• Thursday, December 11, 2014
• 2:00-3:30pm

8. • We are NOT “pushing” PrEP
• We are NOT telling anyone to stop using
condoms or other forms of protection
• We are not pitting one intervention over
another
• We are pushing education
• Knowledge is power
• Ignorance is not strength 8

9. 9

11. 11

12. Quick survey, pre-test
• Help assess what you
think and know now,
pre-training
• Post-test after training
• Note changes in
knowledge, perceptions When can I stop making wild
guesses and start making
educated guesses?
12

13. 13

14. What is the first word or
words that come to your
mind when you think
about condoms?
14

15. What is the first word or
words that come to your
mind when you think about
needle exchange?
15

16. What is the first word or
words that come to your
mind when you think about
oral contraceptives?
16

17. What is the first word or
words that come to your
mind when you think
about PrEP?
17

18. Prevention Paradigm 2013 and beyond Different Strokes for Different Folks
Method Contraception HIV Prevention
Behavior ✓ ✓
Barrier Methods ✓ ✓
Gels ✓
Rings ✓
Oral pill ✓ ✓
Injectables ✓
Implants ✓
Surgical procedures ✓ ✓
Treatment ✓

19. A growing prevention toolkit
Prior to exposure Point of transmission Treatment
• Treating POZ individuals
has prevention benefits
• Basic care/nutrition
• Prevention for positives
• Education & rights-focused
behavior change
• Therapeutic vaccines*
•Male and female
condoms and lube
•ARV treatment to
prevent vertical
transmission (PMTCT)
•Clean injecting
equipment
•Post-exposure
prophylaxis (PEP)
•Vaginal and rectal
microbicides*
•Rights-focused
behavior change
•Voluntary counseling
& testing
•STI screening &
treatment
•Male medical
circumcision
•Pre-exposure
prophylaxis (PrEP)
•Preventive Vaccines*
19

20. We interrupt
this broadcast
20

21. 21

22. • 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)
• Institutional implementation has started, but will
require some time to fully take effect
– However, we can implement/re-frame NOW in our
prevention education efforts
22
Protection w/out condoms

23. 23

24. 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)
24

25. 25

26. 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 26

27. 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
27

28. 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
28

29. 29
PEP challenges
“Meta-analysis: only
half the people who
start PEP complete
the course.”

30. 30
PEP challenges
“Of those who
completed the course,
31.1% failed to attend a
follow-up visit that
would include HIV
testing.”

31. 31

32. 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. We interrupt
this broadcast
- One more time
34

35. Released May 14, 2014
35
tinyurl.com/CDCprepguidelines (PDF)
tinyurl.com/CDCprepguidelineswebinar
(webinar audio/slides)

36. 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
36

37. 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 in the rectum.
Three weeks for vaginal protection.
• Truvada is currently the only
drug approved by the FDA for PrEP.
37

38. 38
PrEP
Ken Like Barbie explains

39. 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).
39

40. www.myprepexperience.org

41. • True or False: PEP must be started within 72 hours
of exposure to HIV.
• Where can you get started on PEP if your doctor’s
office is closed?
• What is an example of “prophylaxis?”
• True or False: PrEP is a pill you take three days
before you want to have sex in order to be
protected from HIV.
41

42. 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
43

44. 44

45. 45

46. 46

47. A: 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)
– 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)
47

48. 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
48

49. Key research findings
• Adherence! Adherence! Adherence!
(take the pill every day… every day
means every day…)
• 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
49

50. Key research findings
• For some, there appears to be 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.
50

51. 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.
51

52. 52

53. 53

54. We interrupt
this broadcast
- One last time
54

55. NEW research
• iPrEX Open Label
• 1,603 participants, 1,225 on PrEP
• Most from Peru/Ecuador, 18% USA
• 100% effectiveness associated
with 4+ doses a week
• 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 55

56. 56

57. 57

58. Chicago PrEP research
• 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
58

59. Chicago Research
• SHIPP (Sustainable Health Center
Implementation PrEP Pilot) – June 1
– Implementation project examining PrEP
use in primary care settings in Chicago,
Newark, Houston, and Philadelphia
• Serves women and men
• Access Grand Boulevard Specialty Clinic
• 5401 South Wentworth Avenue, 773-288-6900
• PS-PrEP – Jan 1
– Randomized clinical trial of PrEP linkage
program by DIS staff, UC and CDPH
59

60. Chicago Research
• Facebook PrEP - Sept 1
– PrEP bridgers educate community about
PrEP and disseminate information
• Contact John Schneider at
jschnei1@medicine.bsd.uchicago.edu
to learn more!
60

61. Chicago Research
• Howard Brown Health Center
• Evaluating PrEP in community health
center setting
• Collects info on why patient AND
provider are considering PrEP
• Data quality can be monitored by visit
types, provider, and testing location
• Process enabling improved
communication and tracking of those
interested in PrEP, on PrEP,
discontinuing PrEP
61

62. • True or False: PrEP does not work for women.
• True or False: Most people who take PrEP will
have nausea.
• True or False: The FDA approved the HIV drug
Truvada for use as prevention in July 2012.
62

63. 63

64. ARV-Based Prevention Pipeline (March 2014)
PRE-CLINICAL PHASE I PHASE II PHASE III PHASE IV
Pop Council
IPM
IPCP NIAID
Pop Council
R
IPM HPTN/ACTG CONRAD IPM Gilead
CONRAD
Albert Einstein
GSK CONRAD
IPM
CONRAD
Janssen
TaiMed
Pop Council
IPM
IPM
IPM
IPM
PBS
IPM
R
IPM
R
Pop Council
RTI
Pop Council
Mintaka
ImQuest
ImQuest
DELIVERY SYSTEM
Oral pills
Vaginal gel
Vaginal film
Vaginal tablet
Vaginal ring
Long acting
injectable
Thin film
polymer
Phosphate Nano-fiber
buffered saline
PB
S
R
Rectal gel
IPM
IPM
IPM
IPM
TFV/
FTC
TDF/
FTC
MIV
150
TMC
278
MVA
DAR Darunavir
GRF
TFV
TDF
DAP
IQP IQP-0528
5P12 5P12-RANTES
744
Tenofovir
Tenofovir disoproxil
fumarate
MIV 150
Maraviroc MAb
GSK 744
Tenofovir disoproxil
fumarate/emtricitabine
Dapivirine
Ripilvirine
Monoclonal antibody
Tenofovir/
emtricitabine
Griffithsin
DS003 DS003 (BMS793)
No drug tested
currently
TFV Tenofovir
prodrug
ACTIVE DRUG
RAL Raltegravir
CDC
CONRAD
Adapted from AVAC Report 2013: Research & Reality. www.avac.org/report2013

66. 66

67. 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
67

68. 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
68

69. 69

70. 70

71. Truvada as PrEP
Is the first non-barrier
HIV
prevention strategy
fully controlled by
the receptive
partner.
71

72. 72

73. www.myprepexperience.org

74. 74

75. Taking PrEP – what does it take?
• It’s not just a pill, it’s a
program
• Adherence
• Take 7 days before enough
drug is “on board” to provide
protection in the rectum, 3
weeks for the vagina
– Then take Truvada every day
75

76. Taking PrEP – what does it take?
• HIV testing
• Hepatitis B testing
• Kidney function testing
• STI screening
• Pregnancy testing
• Provider visits every 3 mos
to conduct all the above
– Honest, open discussions
about sex, sexual health
76

77. 77

78. 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.
78

79. 79

80. 80

81. www.myprepexperience. org

82. 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
• Research (Project PrEPare)
• UC and ACCESS Grand Blvd
• Howard Brown Health Center
• CORE Center – clinic coming soon
• Chicago PrEP Working Group
82

83. Accessing PrEP in Chicago
• Howard Brown Health Center
• PEP and PrEP offered on sliding
scale
• Host a PrEP/PEP line
• Dedicated PrEP Advocate to assist
clients
• Contact Bryan Bautista-Gutierrez
– BryanB@howardbrown.org
– 773.388.1600
83

84. Accessing PrEP in Chicago
• U of C Infectious Disease Clinic
• 1-888-824-0200
• PrEP docs:
– Jean-Luc Benoit
– Shirley Stephenson
– David Pitrak
– Renslow Sherer
84

85. Accessing PrEP in Chicago
• Access Grand Blvd Specialty Clinic.
• Call 773-288-6900
• PrEP docs:
– Jean-Luc Benoit
– John Schneider (takes clients 16-18)
– David Pitrak
– Teresa Kodiak (takes under 16-18)
– Nancy Glick
• Any problems scheduling please contact
John Schneider at
jschnei1@medicine.bsd.uchicago.edu
85

86. Accessing 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
86

87. Insurance
Medicaid
Devil in the details
• Prior auth
• Deductibles
• Co-pays
• Tiers
• Confusion
87
Accessing PrEP— insurance

88. Accessing PrEP – Gilead
1. Visit
www.truvada.com
2. Click on the link to
access information
about Truvada for a
PrEP indication
88

89. 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
89 89

90. 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

91. Gilead
support
programs
Medication
Assistance
Program
500% FPL
Co-pay
program
$300/mo.
91
Newly improved – october 15, 2014

92. 92

93. 93

94. • True or False: Only HIV specialists are able to
prescribe Truvada as PrEP
• People taking PrEP need to be tested for HIV
_____ times every year.
• How are people getting their PrEP prescriptions
paid for?
• True or False: Only people with HIV-positive
partners are eligible for PrEP.
94

95. 95

97. Handy brochure
97
Designed to help individuals talk to
their doctors about PrEP
Before, during, after visit
Questions to ask
Web resources
tinyurl.com/talkPrEPtoDr

98. 98
PrEP Warm Line
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/

99. Web resources on PrEP
• MyPrEPexperience.org
• Truvada.com (Gilead)
• ProjectInform.org/prep
• PrEPWatch.org (advocacy focused)
• PrEPfacts.org
• WhatisPrEP.org (video)
99

100. Groovy PrEP videos
100
WhatisPrEP.org
tinyurl.com/PrEPbyKLB

101. 101

102. 102

103. 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.
103

104. 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.
104

105. 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.
105

106. 106

107. 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?
107

108. • If someone doesn’t use ________
regularly, they may be a good fit for PrEP.
• True or False: You can take Truvada on its
own for treatment.
• Name one organization in Chicago that is
prescribing PrEP for people who need it.
108

109. 109

110. 110

111. 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
111

112. Post-test
Let’s see where
you are at!
112

113. 113

114. Thank you!!
114

115. 115

116. • John Schneider
jschnei1@medicine.bsd.uchicago.edu
• Sara Semelka
ssemelka@aidschicago.org • Jim Pickett
jpickett@aidschicago.org
• Project RSP!
myprepexperience@gmail.com
116
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