Project RSP! training on PrEP for the HIV workforce (March 19, 2015)

Welcome!
CDPH Training – March 19, 2015
What we will cover today
• Intros
• Overview ARV-based prevention
• Understanding PrEP
– What is PrEP?
– PrEP research
– How PrEP is taken
– Access to PrEP
– Talking to clients about PrEP
2
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
5
What is the first word or
words that come to your
mind when you think
about condoms?
6
What is the first word or
words that come to your
mind when you think about
needle exchange?
7
What is the first word or
words that come to your
mind when you think about
oral contraceptives?
8
What is the first word or
words that come to your
mind when you think
about PrEP?
9
10
• 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
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
15
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
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.
*A moving target, as we will see…..
19
• 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
Released May 14, 2014
21
tinyurl.com/CDCprepguidelines (PDF)
tinyurl.com/CDCprepguidelineswebinar
(webinar audio/slides)
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
Ken Like Barbie explains
PrEP
24
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 –
Truvada –once a day, every
day
25
www.myprepexperience.org
27
28
PrEP is more than a prescription
PrEP is a
program
 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
29
Taking PrEP…. what does it take?
*These activities don’t
all need to be done by a
doctor in their office
 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
30
*This is a moving target, as we will see…..
Taking PrEP…. what does it take?
• 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
31
32
You can miss a dose here and there and still have excellent protection.
33
Adherence is a much bigger deal for vaginal protection.
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.
34
35
• 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.
36
37
38
39
40
Science.
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)
41
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 42
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
43
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.
44
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.
45
46
47
48
PrEP’s “protease moment”
49
PROUD – 86%
IPERGAY – 86%
PARTNERS DEMO – 96%
croiconference.org
50
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
PROUD – London
51
52
PROUD – London
53
PROUD – London
Daily PrEP works in the real world.
Quite well! It was easily incorporated
into sexual health clinics. Results
only applicable to gay men.
54
Ipergay – France, Canada
55
Ipergay – France, Canada
56
Ipergay – France, Canada
57
Ipergay – France, Canada
Challenges our daily adherence
messaging. Only applicable to
gay men and rectums. And what
do we really know about men
having infrequent sex?
58
Partners Demo – Kenya, Uganda
59
Partners Demo – Kenya, Uganda
60
Partners Demo – Kenya, Uganda
61
Partners Demo – Kenya, Uganda
62
Partners Demo – Kenya, Uganda
63
Partners Demo – Kenya, Uganda
64
Partners Demo – Kenya, Uganda
PrEP and TasP are synergistic and can be
combined programmatically. Shared
responsibility is important aspect. Works
in resource challenged settings.
Applicable to hetero women and men.
65
66
• 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.
67
www.myprepexperience.org
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
69
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
70
Truvada as PrEP
Is the first non-
barrier HIV
prevention strategy
fully controlled by
the receptive
partner.
71
Project RSP! training on PrEP for the HIV workforce (March 19, 2015)
pleasure
intimacy
connection
emotion
lust
love
74
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
75
Reclaim
pleasure
THOUGHTFUL
RESPONSIBLE
CAREFUL
AWARE
PRO-ACTIVE
DISCIPLINED
TAKING PREP IS
SAFER SEX
TAKING PREP IS
78
79
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
80
81
82
Uninformed, misinformed providers
84
Handy brochure
85
Designed to help individuals talk to
their doctors about PrEP
Before, during, after visit
Questions to ask
Web resources
tinyurl.com/talkPrEPtoDr
86
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
• MyPrEPexperience.org
• Facebook group – PrEP Facts
• Facebook.com/ProjectRSP (Ready, Set, PrEP)
• PrEPWatch.org (advocacy)
• ProjectInform.org/prep
• Truvada.com (Gilead)
• WhatisPrEP.org (video)
Web resources on PrEP
87
Groovy PrEP videos
88
WhatisPrEP.org
tinyurl.com/PrEPbyKLB
89
Drug cost
Service costs
Lab costs
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
93
94
the devil is in the details
95
the devil is in the details
Paying for PrEP – Gilead
1. Visit
www.truvada.com
2. Click on the link to
access information
about Truvada for a
PrEP indication
96
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
9797
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
Paying for PrEP – Illinois
99
PrEP4Illinois.com
100
101
• 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
102
• Insured, insurance must cover
medication for which patient seeks
assistance
• Patient must reside and receive
treatment in U.S
• Patient’s income below 500% of the
Federal Poverty Level
www.panfoundation.org/hiv-treatment-and-prevention
PAN Foundation Eligibility
103
104
USCA 2014
105
• How can people pay for their PrEP
prescriptions?
• People taking PrEP need to be tested for HIV
_____ times every year.
• Why is this important?
• Name one barrier to PrEP access.
106
107
Baggage
108
109
110
“Party drug”
“Public health disaster”
111
112
Condom privilege
113
114
ARVs are toxic
115
“Although
pre-exposure
prophylaxis has a
great potential in reducing incidence, scale-up
might be inhibited by the same social or
structural barriers to care outcomes for black
MSM with HIV.”
116
Understanding the HIV disparities between black and white men who
have sex with men in the USA using the HIV care continuum: a modelling
study
The Lancet HIV, December 2014
doi:10.1016/S2352-3018(14)00011-3
Rosenberg, Millett, Sullivan, del Rio, Curran MD
117
More focus, More energy and
More resources 118
119
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.
• Ipergay – complexities, complications.
120
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.
121
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.
122
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?
123
124
• 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?
125
Chicago PrEP
Working
Group
Researchers
Medical
providers
Advocates
Orgs/HDs
HIV planning
members
126
Chicago PrEP
Working
Group
Researchers
Medical
providers
Advocates
CBOs
HIV planning
members
127
Chicago PrEP
Working
Group
Researchers
Medical
providers
Advocates
CBOs
HIV planning
members
128
129
1000’s
NEW
HIV prevention
advocates
Project RSP! training on PrEP for the HIV workforce (March 19, 2015)
Project RSP! training on PrEP for the HIV workforce (March 19, 2015)
Project RSP! training on PrEP for the HIV workforce (March 19, 2015)
Project RSP! training on PrEP for the HIV workforce (March 19, 2015)
135
136
137
138
139
140
141
Thank you!!
142
143
CONTACT
Jim Pickett
jpickett@aidschicago.org
Sara Semelka
ssemelka@aidschicago.org
144
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Project RSP! training on PrEP for the HIV workforce (March 19, 2015)

  • 1. Welcome! CDPH Training – March 19, 2015
  • 2. What we will cover today • Intros • 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 • 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. 17
  • 18. 18
  • 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. *A moving target, as we will see….. 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
  • 24. 24
  • 25. 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 – Truvada –once a day, every day 25
  • 27. 27
  • 28. 28 PrEP is more than a prescription PrEP is a program
  • 29.  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 29 Taking PrEP…. what does it take? *These activities don’t all need to be done by a doctor in their office
  • 30.  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 30 *This is a moving target, as we will see….. Taking PrEP…. what does it take?
  • 31. • 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 31
  • 32. 32 You can miss a dose here and there and still have excellent protection.
  • 33. 33 Adherence is a much bigger deal for vaginal protection.
  • 34. 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. 34
  • 35. 35 • 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.
  • 36. 36
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  • 38. 38
  • 39. 39
  • 41. 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) 41
  • 42. 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 42
  • 43. 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 43
  • 44. 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. 44
  • 45. 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. 45
  • 46. 46
  • 47. 47
  • 48. 48
  • 49. PrEP’s “protease moment” 49 PROUD – 86% IPERGAY – 86% PARTNERS DEMO – 96% croiconference.org
  • 50. 50 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
  • 53. 53 PROUD – London Daily PrEP works in the real world. Quite well! It was easily incorporated into sexual health clinics. Results only applicable to gay men.
  • 57. 57 Ipergay – France, Canada Challenges our daily adherence messaging. Only applicable to gay men and rectums. And what do we really know about men having infrequent sex?
  • 58. 58 Partners Demo – Kenya, Uganda
  • 59. 59 Partners Demo – Kenya, Uganda
  • 60. 60 Partners Demo – Kenya, Uganda
  • 61. 61 Partners Demo – Kenya, Uganda
  • 62. 62 Partners Demo – Kenya, Uganda
  • 63. 63 Partners Demo – Kenya, Uganda
  • 64. 64 Partners Demo – Kenya, Uganda PrEP and TasP are synergistic and can be combined programmatically. Shared responsibility is important aspect. Works in resource challenged settings. Applicable to hetero women and men.
  • 65. 65
  • 66. 66 • 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.
  • 67. 67
  • 69. 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 69
  • 70. 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 70
  • 71. Truvada as PrEP Is the first non- barrier HIV prevention strategy fully controlled by the receptive partner. 71
  • 74. 74 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
  • 78. 78
  • 79. 79
  • 80. 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 80
  • 81. 81
  • 82. 82
  • 84. 84
  • 85. Handy brochure 85 Designed to help individuals talk to their doctors about PrEP Before, during, after visit Questions to ask Web resources tinyurl.com/talkPrEPtoDr
  • 86. 86 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
  • 87. • MyPrEPexperience.org • Facebook group – PrEP Facts • Facebook.com/ProjectRSP (Ready, Set, PrEP) • PrEPWatch.org (advocacy) • ProjectInform.org/prep • Truvada.com (Gilead) • WhatisPrEP.org (video) Web resources on PrEP 87
  • 89. 89
  • 93. 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 93
  • 94. 94 the devil is in the details
  • 95. 95 the devil is in the details
  • 96. Paying for PrEP – Gilead 1. Visit www.truvada.com 2. Click on the link to access information about Truvada for a PrEP indication 96
  • 97. 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 9797
  • 98. 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
  • 99. Paying for PrEP – Illinois 99 PrEP4Illinois.com
  • 100. 100
  • 101. 101 • 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
  • 102. 102 • Insured, insurance must cover medication for which patient seeks assistance • Patient must reside and receive treatment in U.S • Patient’s income below 500% of the Federal Poverty Level www.panfoundation.org/hiv-treatment-and-prevention PAN Foundation Eligibility
  • 103. 103
  • 105. 105 • How can people pay for their PrEP prescriptions? • People taking PrEP need to be tested for HIV _____ times every year. • Why is this important? • Name one barrier to PrEP access.
  • 106. 106
  • 107. 107
  • 109. 109
  • 111. 111
  • 113. 113
  • 115. 115
  • 116. “Although pre-exposure prophylaxis has a great potential in reducing incidence, scale-up might be inhibited by the same social or structural barriers to care outcomes for black MSM with HIV.” 116 Understanding the HIV disparities between black and white men who have sex with men in the USA using the HIV care continuum: a modelling study The Lancet HIV, December 2014 doi:10.1016/S2352-3018(14)00011-3 Rosenberg, Millett, Sullivan, del Rio, Curran MD
  • 117. 117
  • 118. More focus, More energy and More resources 118
  • 119. 119
  • 120. 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. • Ipergay – complexities, complications. 120
  • 121. 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. 121
  • 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. 122
  • 123. 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? 123
  • 124. 124 • 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?
  • 125. 125
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