This document summarizes research on PrEP (pre-exposure prophylaxis) conducted by various providers in Philadelphia. It finds that while awareness and willingness to use PrEP is high among at-risk groups, many barriers still exist including lack of provider knowledge, concerns about side effects and adherence, and lack of insurance coverage. Expansion of PrEP programs in health centers and community education efforts that address stigma are recommended to increase uptake among groups with highest HIV rates like black MSM and transgender women. Ongoing data collection is needed to evaluate PrEP's effectiveness in real-world settings.

1. PrEP
THE ROAD THUS FAR…

2. Road Map
 Provider Research
 Dr. Kathleen Brady, AACO
 Dr. Helena Kwakwa, Director HIV Clinical Services, PDPH
 Jennifer Chapman, Research Project Manager, CHOP
 Roadblocks: Barriers to PrEP
 Planning for the Road Ahead

3. Provider Research
Dr. Kathleen Brady, AACO- March 2015
How does it work?
 PrEP is a medication used before an exposure in order to prevent a
disease or condition.
Risk groups (CDC recommended for PrEP)
 MSM (HIV-positive sex partners, recent bacterial STIs, high number of sex
partners, history of inconsistent or no condom use, commercial sex work)
 Heterosexual men and women (HIV-positive sexual partners, recent bacterial
STIs, high number of sex partners, history of inconsistent or no condom use,
commercial sex work, living in high-prevalence area or network)
 IDUs (HIV-positive injecting partner, sharing injection equipment, undergoing
recent drug treatment but currently injecting)

4. Provider Research
Dr. Kathleen Brady, AACO- March 2015
The Need for New Prevention Options
 Only 50% of MSM in Philadelphia used a condom the last
time they had sex.
50% for receptive anal sex
53% for insertive anal sex
 Over 25% of MSM in Philadelphia are infected with
HIV(26.2%)
35.3 in African American MSM
26.9 in Latino MSM
8.8 in White MSM
PDPH/AACO National HIV Behavioral Surveillance among MSM4, 2014

5. Provider Research
Dr. Kathleen Brady, AACO- March 2015
Local Awareness of PrEP
 32% of NHBS-MSM4 participants knew someone in
Philadelphia who had taken PrEP
 6% of HIV negative men had taken PrEP
 59% of HIV negative MSM were willing to take to PrEP.
 62% of African Americans
 71% of Latino
 54% of whites
PDPH/AACO National HIV Behavioral Surveillance among MSM4, 2014

6. Provider Research
Dr. Helena Kwakwa, PDPH- November 2015
PrEP interest Survey
The PDPH administered an anonymous survey to each patient. The new
survey included 2 new questions and was distributed in May of 2012.
 If you could take a pill everyday to effectively prevent HIV, would you?
 Why? Or why not?
Lack of risk recognition is a major factor
 Men: 101
 Women:116

7. Provider Research
Dr. Helena Kwakwa, PDPH- November 2015
Survey data was collected over the course of 2 years (May 2012-
December 2014) from men and women age 18 and older.
 5 transgendered persons were excluded
 1,582 foreign born excluded
 18 excluded for missing key data elements
 5606 people were included in the final analysis
Male= 2885 Female=2721

8. Provider Research
Dr. Kathleen Brady, AACO- March 2015
Major Reasons for Disinterest in PrEP
 37% perceived low risk
 35% questioned side effects
 19% did not want to adhere to the daily regime.

9. Provider Research
Dr. Helena Kwakwa, PDPH-November 2015
Variable Male n=2885
n(%)
Female n=2721
n(%)
p-value*
Number of partners
in 12 months
Zero
1-5
>5
117 (4.1%)
2226 (77.2%)
540 (18.7%)
233 (8.6%)
2426 (89.1%)
59 (2.2%)
<0.001
Same sex partner
Yes
No
143 (5.0%)
2738 (94.9%)
189 (6.9%)
2526 (92.8%)
<0.01
Condom use
Always
Sometimes
Never
Missing
768 (26.6%)
219 (7.6%)
1848 (64.1%)
50 (1.7%)
1074 (39.5%)
204 (7.5%)
1324 (48.6%)
119 (4.4%)
<0.0001
History of sex work
Yes
No
67 (2.3%)
2810 (97.4%)
31 (1.1%)
2684 (98.6%)
<0.001
Open to PrEP
Yes
No
1771 (61.4%)
1114 (38.6%)
1490 (54.8%)
1231 (45.2%)
<0.0001
 Respondents were almost exclusively
African American.
 Testers estimated risk was much
higher for women than the women
who perceived their own risk.
 AA individuals, who sometimes never
used condoms and individuals with
high self-perceived risk were more
likely to be open to PrEP.
 Same-sex relationships were not
more likely to be open to PrEP.

10. Provider Research
Dr. Helena Kwakwa, PDPH-November 2015
Variable Male n=2885
n(%)
Female n=2721
n(%)
p-value*
Age group
18-24
25-34
35-44
45-54
≥55
905 (31.4%)
909 (31.5%)
430 (14.9%)
400 (13.9%)
241 (8.3%)
1013 (37.2%)
730 (26.8%)
349 (12.8%)
396 (14.6%)
233 (8.6%)
<0.0001
Race/ethnicity
African American
Hispanic
Caucasian
Other/Missing
2654 (92%)
80 (2.8%)
144 (5.0%)
7 (0.2%)
2456 (90.3%)
107 (3.9%)
153 (5.6%)
5 (0.2%)
0.03
Self-perceived risk
Moderate/high
Low/zero
3346 (56.8%)
2549 (43.2%)
226 (8.3%)
2495 (91.7%)
<0.0001
Tester’s risk
assessment
Moderate/high
Low/zero
2065 (71.6%)
820 (28.4%)
1632 (60.0%)
1089 (40.0%)
<0.0001
HIV Testing Results
35 positive
9 women (0.3%)
26 men (0.9%)
Of the 9 women
0% considered themselves at moderate or
high risk
Tester-assessed risk was moderate or high for
44.4%
44.4% expressed disinterest in PrEP
Of the 26 men
19.2% considered themselves at moderate or
high risk
Tester-assessed risk was moderate or high for
88.5%
46.2% expressed disinterest in PrEP

11. Provider Research
Dr. Helena Kwakwa,PDPH- November 2015
 Philadelphia currently has 87
individuals enrolled.
 Goal: 300 over a three year
period.
 1/3 are women
 80% of participants are POC,
primarily African American.
 Year 2 CDC target is 21 initiations
monthly
 PrEP programs are currently being
implemented in 8 health centers.
 4 out of 5 people accessing primary
care services are learning about PrEP
for the first time (S. Bessias, HPG May 2015).
 70% of those participating in the
study showed highly protective
Truvada levels in blood.
 Support expansion at Health Centers
2, 6, 10
SHIPP(Sustainable Health Center Implementation PrEP Pilot)

12. Provider Research
Dr. Helena Kwakwa,PDPH-November 2015
 700 Referrals were made for the 87 people
currently enrolled in the study.
 People were lost at each step of the PrEP
referral process.
 Clinician referrals: 53
 Started PrEP: 26(49%)
 Peer to partner referrals: 14
 Started PrEP: 7
 Rapid testing at primary care(284) and STI
clinics(234) referred the most people.
SHIPP(Sustainable Health Center Implementation PrEP Pilot)

13.  PrEP stats are increasing and are expected to continue increasing.
 332% increase between Q1 2014 (530) and Q1 2015(1761).
 Total
 The increases have been seen in the male (1573) population, little
increase has been seen in females (188).
 Male enrollment has increased every quarter since Q3 2013
 Female enrollment has not passed 200 individuals.
 New PrEP enrollment is lowest among <24 age group.
Provider Research
Jennifer Chapman, HPG Co-Chair- July 2015
IMS National Prescription Database

14. Things PrEP Can Do (based on SPARK data)
Engage patients in primary care
 Callen-Lorde Community Health Center (New York, NY)
 29% of patients were not previously enrolled in medical care.
Connect patients to health insurance
 More than 45% of SPARK patients were uninsured at enrollment.
 68% were connected to Medicaid or ACA plans
 23% were linked to Gilead’s MAP(medical assistance program)
Improve psychological wellbeing
 At 6month visit SPARK participants reported decrease in: perceived HIV risk, sexual
anxiety, depression and sexual compulsivity
Provider Research
Jennifer Chapman, HPG Co-Chair- July 2015

15. Roadblocks
Challenges to Implementing PrEP
 Lack of Knowledge about PrEP
 Providers aren’t sure how to prescribe it.
 Highest risk populations do not know about it.
 Prescribing PrEP can be resource intensive.
 Monitoring adherence
 Coverage of Truvada
 Potential for stigma to undermine success
 Lack of PrEP related trainings
 Concerns about Insurance coverage

16. Roadblocks
Healthcare Provider Roles in PrEP, presented by J. Chapman
Study survey conducted among primary care physicians and HIV providers from
10 US cities.
The survey showed that positive attitudes toward PrEP did not translate to
prescribing it. Provider reasons for not wanting to prescribe included:
 Concerns about adherence
 Cost/reimbursement issues
 Potential toxicities
 Perception of insufficient evidence to support efficacy of PrEP.
 Primary care physicians have limited experience prescribing ARV

17. PrEP Roadblock
PrEP Knowledge, Attitudes, Awareness, and Experience Among a National Sample
of US Primary Care and HIV Providers
 HIV specialist doctors more comfortable with all aspects of PrEP prescription
than PCP(based on survey)
Implications: provider interventions need customization
for PCPs:
 Increasing knowledge of PrEP procedures
 Navigating logistical barriers
 Uncomfortable with aspects of sexual history discussion
HIV providers:
 High levels of PrEP knowledge and experience
 Capacity not identified as a barrier

18. Roadblocks
YMSM PrEP Panel- October 2015
D. Cameron of Philly Black Pride stated that many heterosexual people did not believe
PrEP applied to them.
 He explained that many heterosexual’s he knew believed that they had no risk
of contracting HIV. He informed them that PrEP wasn’t the right prevention
tool for everyone, but it can be useful for all kinds of people.
S.Udell, a medical student at UPenn said that he received more negative feedback
when he first began PrEP than he does now. He explained that some heterosexual
people thought he engaged in promiscuous behavior. Some people used the term
“Truvada Whore” to describe people taking PrEP.
Have you received any negative feedback about your PrEP use?
 D. Cameron stated that he had. Some people called him promiscuous or
assumed that he did not use condoms because he took PrEP. He added that
some people believed that PrEP increased risky behavior, there is fear in the
community that PrEP would cause people to stop using condoms.

19. Planning for the Road Ahead
“There needs to be close collaboration between clinical and community
settings…PrEP should be administered in a primary care site”
 Medical providers, social workers and testing counselors need
to work as a team to complete the PrEP referral process.
 Individuals who seroconvert while taking PrEP need to be
quickly linked to care.
 Adherence requires monitoring and ongoing counseling.

20. Planning for the Road Ahead
“Doctors need to be as comfortable talking about PrEP as they are
about weight management, exercise and smoking cessation”- Dr.
Kwakwa
 What it takes to prescribe PrEP well
 Conversations about risk
 Baseline laboratory testing
 Writing prescriptions for insured patients and learning how to properly
process (medical assistance program) paperwork for uninsured patients.
 Retention in care for the highest risk groups.
 HIV prevention needs to be discussed in a way that encourages and
empowers sexual expression.

21. Planning for the Road Ahead
FOA 15-1509
 The purpose of this FOA is to support health departments to collaborate with
CBO’s, healthcare clinics to develop comprehensive models of prevention care
behavioral health and social services models for MSM of color who are at risk for
HIV acquisition.
 B.Shanon reported that this funding would be used to support the promotion of
PrEP in the near future.
 Social marketing around PrEP would be two-prong, targeting both community and
providers.
 AACO wants testers to be educated about PrEP and able to inform clients, esp.
high-risk negatives.
 Training was held in the spring of 2015

22. Philadelphia Board of Health Recommendations
 1. PDPH should continue to implement PrEP coordination plan key activities:
 Clinician and provider education and support
 Prevention workforce development
 Community outreach and evaluation
 2. Primary care providers and HIV specialists should seek appropriate education/training to
effectively prescribe PrEP
 3. The Medicaid program should maintain its commitment to provide PrEP on its formulary
 4. The PA Department of Health should seek additional funding to expand its SPBP(Special
Pharmaceutical Benefits Program).
 5. PDPH and clinical providers should collect surveillance data to evaluate the incidence of HIV
infection and viral resistance in newly diagnosed persons who were taking PrEP.
Planning for the Road Ahead

23. Planning for the Road Ahead
“Transgender women are 49times more likely to be infected than the general population”,
Transgender Women and PrEP for HIV Prevention: What We Know and What We Still Need to Know, The
National Center for Innovation in HIV Care
 Black transgender women are three times more likely to be living with HIV than their
white and Latina counterparts.
 Only iPrex and OLE(Open Label Extension) study were confirmed to have enrolled
transgender women.
 Transwomen made up 14.6% of all participants in iPrex and 12.9% in iPrex OLE studies.

24. Planning for the Road Ahead
“Transgender women are 49times more likely to be infected than the general population”,
Transgender Women and PrEP for HIV Prevention: What We Know and What We Still Need to Know, The
National Center for Innovation in HIV Care
 Further research should be done to determine if PrEP interacts with cross-sex hormone
therapy.
 Targeted recruitment of transgender women should be used when testing all new forms
of HIV prevention/treatment.
 Transgender women should be studied separately from gay and bisexual mend and other
MSM.
 “Studies of PrEP use in transgender women populations should be designed and tailored
specifically for this population, rather than adapted from or subsumed into studies for MSM”-
Leading researchers at the Center of Excellence for Transgender Health