Patrick Sullivan, DVM, PhD Rollins School of Public Health, Emory University

1. Involve[men]t
A Study of Race and Age Disparities in HIV/STI
Incidence and Prevalence Among MSM in Atlanta,
GA: 2009-2014
Getting to scale: How we can achieve
the reach required of prevention
services, including PrEP, to reduce
HIV incidence in MSM
Patrick Sullivan, DVM, PhD
Rollins School of Public Health, Emory University

2. Presentation Plan
• HIV in MSM Atlanta: A public health crisis and need for PrEP
• Tools and scale: what do we know?
• The PrEP Continuum
• PrEP Uptake
• HealthMindr: A comprehensive prevention app for MSM
• PrEP@Home

3. Rates of Persons Living with an HIV Diagnosis, by
County, 2012
Note. Data include persons with a diagnosis of HIV infection, regardless of the stage of disease at diagnosis, and have been statistically adjusted to account for reporting delays and missing risk-factor
information, but not for incomplete reporting.
Data Source: Centers for Disease Control and Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Division of HIV/AIDS Prevention.
* Data are not shown to protect privacy. ** State health department requested not to release data.

4. Proportion of infections attributed to male-
male sex by county, US, 2012

5. Proportion of new infections among men
attributed to male-female sex by county, 2012

6. Source: www.aidsvu.org

7. Bronfenbrenner’s Ecological Model

8. Study Design
• Recruitment
• MSM community venues and Facebook
• Eligibility
• Black and white, non-Hispanic
• Currently living in Atlanta MSA
• Ages 18 – 39 (earlier recruits had no upper limit)
• Sexually active with men, not in a main partnership
• NOT HIV-status-dependent
• Procedures
• Testing: HIV, Chlamydia, Gonorrhea, Syphilis
• Extensive self-admin computer questionnaire
• Enrollment Numbers
• 803 men took part in baseline
• 30% were prevalent HIV-positive at baseline
• 562 HIV-negative MSM enrolled in prospective
• 79% retained in study at 24 months
Baseline
Month 3
Month 6
Month 12
Month 18
Month 24
HIV/STI testing,
Questionnaire
HIV/STI testing,
Questionnaire
HIV/STI testing,
Questionnaire
HIV/STI testing,
Questionnaire
HIV/STI testing,
Questionnaire
HIV/STI testing,
Questionnaire

10. HIV Prevalence, by Race
and Age
Sullivan et al – PLoS One 2014
Black MSM: 44% White MSM: 13%

11. Population Transmission
Risk
Kelley et al – PLoS One 2012
• ‘Community viral load’ does not capture disparities in HIV exposure
between groups because it does not incorporate HIV prevalence.
• No difference in CVL or PVL between black and white MSM
• Synthesized data on disparities in HIV prevalence, viral load with
racial-patterns in sexual partnering
• Calculated prevalence of HIV viremia: 25% of BMSM vs. 8% of
WMSM had HIV VL>400 copies/ml
• Racially concordant partnerships: BMSM 71%; WMSM 70%
• Despite similar levels of sexual risk behavior (partner # and
unprotected anal sex), BMSM have higher chance of encountering an
HIV-infected and unsuppressed partner
• WMSM reach 50% chance with 7 partners
• BMSM reach 50% chance with just 3 partners

12. • Driven largely by differences in HIV prevalence.
• However, differences in HIV care continuum will also contribute.
Population Transmission Risk
Kelley et al – PLoS One 2012

13. Spatial Relationship of Stigma, Poverty and HIV
Vaughan et al – AIDS Res and Human Retrovir 2014
• Among MSM living in high
poverty areas, black MSM
reported greater gay stigma than
white MSM.
• Black MSM living with HIV were
highly concentrated in areas of
both high stigma and high
poverty.
• White MSM living with HIV were
concentrated primarily in areas
of low stigma and low poverty.

14. Condom failures, incomplete
use, errors
Hernandez-Romieu et al – STI 2014
• BMSM more likely to use condom as insertive partner in previous 6
months.
• Yet 31% of BMSM vs. 43% of WMSM users had fully effective condom
use
• No failures (breakage, slippage), no incomplete use
• 53% of BMSM and 21% of WMSM used oiled-based lubricant with
condoms in previous 6 months
• 62% vs. 32% among 18 – 24 year olds
• Conclude:
• Misclassification of protected AI
• Need for condom education remains
• PrEP is an important adjunct to condoms

16. STI Incidence
Kelley et al – AIDS Res. & Hum. Retroviruses 2015
BMSM WMSM
Rate Ratio
Infections
Rate
(% / year)
Infections
Rate
(% / year)
Urethral Chlamydia 17 4.7 14 3.0 1.6
Urethral Gonorrhea 8 2.2 1 0.2 10.3
Rectal Chlamydia 34 10.8 22 5.5 2.0
Rectal Gonorrhea 30 9.4 15 3.7 2.6
Syphilis 22 6.1 0 0.0

17. HIV Incidence
Black MSM White MSM
Overall
Incidence rate 6.5% / year 1.7% / year
New HIV infections 24 8
% HIV-positive at end of study 11.3% 3.6%
Age 18 – 24
Incidence rate 10.9% / year 0.9% / year
New HIV infections 16 1
% HIV-positive at end of study 16.6% 1.6%
Age 25+
Incidence rate 3.6% / year 1.9% / year
New HIV infections 8 7
% HIV-positive at end of study 6.0% 4.5%

18. Effects of Rectal STI on HIV incidence?
• Unadjusted HR: 3.7 (1.4, 9.4)
• Adjusted, weighted HR: 2.8 (1.2, 6.4)
• Estimates ‘causal’ effect of rectal STI on HIV incidence
• Adjustment for behavioral confounders attenuates the
association by 24%
• Population attributable fraction: 14.6% (6.8, 31.4)
• Despite significant ‘causal’ HR, rectal STI only mildly
contribute to HIV incidence in the population.
• PAF driven by both HR and STI incidence
Vaughan et al 2015, BMC Medical Research Methodology
Kelley et al 2015, AIDS Res Human Retrov

19. Tools and Scale: What Do
We Know?

20. Estimated percent of new HIV infections among MSM
prevented by three prevention approaches, four countries
Source: Sullivan et al, Lancet 2012

21. Source: Brookmeyer et al, PLoS ONE 2014

22. Source: Brookmeyer et al, PLoS ONE 2014

23. To make modest impacts on HIV
transmissions among MSM, we will
need to achieve 30-50% coverage of
multiple interventions
So how are we doing?

24. Estimated Efficacy of Interventions and
Estimated Uptake among MSM, US
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
TasP nPEP PreP Condom Use IDI GLI
Efficacy Uptake

25. The PrEP Continuum

26. All MSM in InvolveMENt cohort

27. PrEP Continuum: Black MSM

28. PrEP Continuum: White MSM

29. HIV acquisitions under observation

30. Population without Health Insurance
Rates of Persons Living with an HIV Diagnosis & Percent
of Population without Health Insurance, by County, 2012
Note. Data include persons with a diagnosis of HIV infection, regardless of the stage of disease at diagnosis, and have been statistically adjusted to account for reporting delays and missing risk-factor
information, but not for incomplete reporting.
Data Source: Centers for Disease Control and Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Division of HIV/AIDS Prevention.
* Data are not shown to protect privacy. ** State health department requested not to release data.
Persons Living with an HIV Diagnosis

32. PrEP Continuum: Lessons
• We need more of:
• Awareness
• Education
• Health insurance
• Adherence support
• We need better algorithms to identify MSM who are likely to become
infected with HIV. These algorithms need to accurately reflect the risk
for black MSM.

33. American Men’s Internet Survey (AMIS)
• Need to have behavioral surveillance data on HIV risks, protective
behaviors, and use of prevention services
• Monitor trends in risks, behaviors and service use over time, and in
smaller subpopulations
• Complement to in-person HIV behavioral surveillance conducted in 21
US cities
• Uses survey instruments consistent with national behavioral
surveillance program in large cities.

34. • Annual, cross-sectional internet-based survey
• Core questionnaire and modules
• Recruited through social networking sites, gay-
oriented sites, mobile social-sexual networking
sites
• 2013: Dec 2013-April 2014; 2014: Sept 2014- Apr
2015

35. Demographics: AMIS 2013 and 2014 cycles
Characteristic AMIS 2013 (%)
N = 10,377
AMIS 2014 (%)
N =9,470
Age Group
15-24 19 15
25-29 15 14
30-39 19 21
40+ 48 50
Urbanicity
Rural 37 30
Urban 63 68

36. Demographics: AMIS 2013 and 2014 cycles
(cont)
Characteristic AMIS 2013 (%)
N = 10,377
AMIS 2014 (%)
N = 9,470
Education
< High School 1 2
High School 9 8
Some college 32 32
College or graduate 57 57
Race
White NH 78 74
Black NH 3 5
Hispanic 10 14
Other 8 8

37. Awareness of PrEP by race, 7003 US MSM, 2013-2015
59 59 59 57 57
0
10
20
30
40
50
60
70
80
90
100
Overall Black White Hispanic Others
%Aware
Group
P = > 0.05

38. Awareness of PrEP by age, 7003 US MSM, 2013-2015
59
40
46
65 66
58
0
10
20
30
40
50
60
70
80
90
100
Overall 15-17 18-24 25-29 30-39 40 +
%Aware
Age Group
P = <0.001

39. Awareness of PrEP by geography, 7003 US MSM, 2013-
2015
59 58 55
59 62
49
64
0
10
20
30
40
50
60
70
80
90
100
Overall South Midwest Northeast West Rural Urban
%Aware
Geographic Group
P = <0.001P = 0.001

40. Awareness of PrEP by year, 7003 US MSM, 2013-2015
59
49
66
0
10
20
30
40
50
60
70
80
90
100
Overall 2013/14 2014/15
%Aware
Year
P = <0.001

41. Willingness to use PrEP by race, 6760 US MSM, 2013-
2015
50
58
47
60
49
0
10
20
30
40
50
60
70
80
90
100
Overall Black White Hispanic Others
%Willing
Group
Yes DK No P = <0.001

42. Willingness to use PrEP by age, 6760 US MSM, 2013-
2015
50
67
59 53 50 44
0
10
20
30
40
50
60
70
80
90
100
Overall 15-17 18-24 25-29 30-39 40 +
%Willing
Age Group
Yes DK No P = <0.001

43. Willingness to use PrEP by geography, 6760 US MSM,
2013-2015
50 51 47 45 51 48 50
0
10
20
30
40
50
60
70
80
90
100
Overall South Midwest Northeast West Rural Urban
%Willing
Geographic Group
Yes DK NoP = <0.001 P = > 0.05

44. Willingness to use PrEP by year, 6760 US MSM, 2013-
2015
50 46 52
22 24
21
28 30 27
0
10
20
30
40
50
60
70
80
90
100
Overall 2013/14 2014/15
%Willing
Year
Yes DK No P = <0.001

45. Use of PrEP by race, 6864 US MSM, 2013-2015
2.9 2.5 2.8 3.5 2.9
0
10
20
30
40
50
60
70
80
90
100
Overall Black White Hispanic Others
%Used
Group
P = 0.003

46. Use of PrEP by age, 6864 US MSM, 2013-2015
2.9 0 1.5 3.9 3.8 2.8
0
10
20
30
40
50
60
70
80
90
100
Overall 15-17 18-24 25-29 30-39 40 +
%Used
Age Group
P < 0.001

47. Use of PrEP by geography, 6864 US MSM, 2013-2015
2.9 2.6 2.2 2.6 4.5 1.3 3.8
0
10
20
30
40
50
60
70
80
90
100
Overall South Midwest Northeast West Rural Urban
%Used
Geographic Group
P < 0.001P = 0.002

48. Use of PrEP by year, 6864 US MSM, 2013-2015
2.9 1.4 3.9
0
10
20
30
40
50
60
70
80
90
100
Overall 2013/14 2014/15
%Aware
Year
P = 0.001

49. Factors associated with awareness, willingness,
and use or PreP, US MSM, 2013-2015
Characteristic Awareness Willingness Used
aOR (95% CI)
Black -- 1.0 (0.7, 1.3) --
Hispanic -- 0.8 (0.7, 0.97) --
Other -- 0.9 (0.7, 1.03) --
15-17 0.9 (0.4, 2.0) 0.9 (0.4, 2.0)
0.5 (0.3, 0.8)
18-24 0.6 (0.5, 0.8) 0.6 (0.5, 0.8)
25-29 1.1 (0.9, 1.3) 1.1 (0.9, 1.3) 1.1 (0.7, 1.6)
40+ 0.7 (0.6, 0.8) 0.7 (0.6, 0.8) 0.8 (0.5, 1.1)
West 1.2 (1.1, 1.4) 1.3 (1.1, 1.5) 1.6 (1.2, 2.3)
Midwest 0.9 (0.8, 1.1) 0.9 (0.7, 1.03) 0.8 (0.5, 1.3)
Northeast 1.1 (0.9, 1.3) 1.1 (0.9, 1.3) 1.0 (0.6, 1.5)
v.whitev.30-39v.South

50. Factors associated with awareness, willingness,
and use or PreP, US MSM, 2013-2015
Characteristic Awareness Willingness Used
aOR (95% CI)
< High school 0.8 (0.5, 1.4) 0.8 (0.5, 1.4) --
College degree 2.0 (1.7, 2.5) 2.0 (1.7, 2.5) --
Graduate education 3.9 (3.1, 4.6) 3.8 (3.1, 4.6) --
2014 2.2 (2.0, 2.5) 1.2 (1.1, 1.4) 2.8 (2.0, 4.0)
Rural 0.7 (0.6, 0.7) 0.6 (0.6, 0.7) 0.4 (0.3, 0.6)
v.
Highschool
v.
2013
v.
Urban

51. Limitations
• Not representative of US MSM
• Underrepresentation of black MSM
• Men without internet access
• Misclassification bias
• Social desirability bias
• 2013 and 2014 samples not the same men

52. Percent of MSM Intersted in PrEP, Eligible
by Lab Screening, and Started PrEP at
Month 1, South Africa, 2014-2015
0
10
20
30
40
50
60
70
80
90
100
Interested Lab Eligible Started
Chart Title
Port Elizabeth Cape Town

54. 0 10 20 30 40 50 60 70 80 90 100
HIV treatment resources
nPEP screening
Help me choose which…
nPEP information
Find my testing frequency
Compare HIV tests
RNA test information
Couples testing information
PrEP screening
STI information
Testing location…
PrEP information
Find testing locations
Plan an HIV test
FAQs
My test plan
Product information
Ordering
Assessment outcome
Initial assessment
Percent of Users
PageAccessed
First Visit Ever
App Pages Accessed by Users

55. 0 10 20 30 40 50 60 70 80 90 100
HIV treatment resources
nPEP screening
Help me choose which HIV test
nPEP information
Find my testing frequency
Compare HIV tests
RNA test information
Couples testing information
PrEP screening
STI information
Testing location information
PrEP information
Find testing locations
Plan an HIV test
FAQs
My test plan
Product information
Ordering
Assessment outcome
Initial assessment
Percent of Users
PageAccessed
First Visit Ever
App Pages Accessed by Users

56. Preliminary Evaluation Results (n=37)
• 57% reported ordering condoms during the first month
• 91% report using the ordered condoms
• 38% ordered home test kits in the fist month
• 2/3 of test kit orders were not planning on being tested soon
• 1/3 of users who did not have a testing schedule now do
• 10% started PrEP

57. PrEP at Home
• There is a need to bring PrEP to scale to achieve
maximal effectiveness
• CDC Guidance for PrEP calls for at least four
follow-up visits per year, primarily due to
potential development of drug resistance in the
case of HIV infection
• We estimate that between 879,000 – 1,696,000
US MSM would be behaviorally eligible for PrEP
• If this group of eligible men received
recommended quarterly screenings as part of a
PrEP intervention, between 3,518,000 -
6,785,000 patient visits per year would be
required for clinic-based HIV, STI and creatinine
testing
• A home care kit could alleviate the economic
burden on patients, providers and the healthcare
system

58. Pilot testing
• Provider: “Anything to help me do PrEP well,
to be able to provide the services, I think it’s
fantastic.”
• Provider: “I think it’s great. I think that we
have to decentralize … particularly for
folks who don’t have good experiences or
access to providers … the idea that you have
to come into a visit in order to get some of
the medical care particularly around PrEP
where (patients are) usually generally young
healthy folks is not necessary.”
• Patient: “ I think it’s pretty useful especially
for the STI testing … I would highly
encourage this to be out in the world. I think
it will help a lot.”
• 4/15 patients rated themselves as more
likely to remain on PrEP if a home kit was
0 2 4 6 8 10 12 14 16
Home STI/HIV kit
Home counseling
Home STI/HIV kit
Home counseling
Patientn=15Providern=10
Provider and patient interest in having a home testing system and
a home counseling system
Extremely interested Somewhat interested A little interested Not at all interested
0 2 4 6 8 10 12 14 16
Urine specimen
Throat specimen
Rectal specimen
Dried blood spot
Small tube blood
Difficulty of specimen collection reported by 15 MSM respondents
following piloting of a home STI/HIV kit
Not at all difficult A little difficult Moderately difficult Difficult Very difficult

59. PrEP@Home Video

60. Team and funders
• Colleagues
• Hannah Cooper
• Carlos del Rio
• Ralph DiClemente
• Paula Frew
• Colleen F. Kelley
• Mark Mulligan
• John Peterson (GSU)
• Eli Rosenberg
• Laura F. Salazar (GSU)
• Travis Sanchez
• Gina Wingood
• Aaron Siegler
• R01-MH085600
• R01-HD067111
• R21-MH103187
• R01-AI094575
• P30-AI050409
Supported by
National Institutes of
Health #:
• Dedicated team of staff:
▫ Project coordinators
▫ Recruiters
▫ Event staff
▫ Retention specialists
▫ Data managers, analysts
• Colleagues
• Steve Goodreau
• Rob Brookmeyer
• Chris Beyrer
• Stefan Baral
• Linda-Gail Bekker
• Refilwe Phawanamafuya
• Rob Stephenson
• Joanne Stekler
• Rob Driggers
• Adam Vaughan
MAC AIDS Fund
Gilead Sciences